When to insert Nuvaring after a break. How does the contraceptive ring work?

There are quite a few methods of contraception.

One of the new ones is the NuvaRing vaginal contraceptive ring.

It is very convenient to use and has minimal side effects.

What is it and how does this contraceptive work?

The contraceptive ring is a combined hormonal contraceptive drug, which contains microdoses of hormones and. NuvaRing is an elastic, smooth, transparent ring with a diameter of 54 mm and 4 mm thickness.

It is inserted into the vagina for 3 weeks. Inside the body, the ring changes shape to match the individual contours of the body. Thanks to this, it is not felt at all and does not bring discomfort.

After the hormonal vaginal circle has been established and its membrane has warmed up to body temperature, hormones that suppress ovulation begin to be released every day.

Big advantage this tool is that hormones act only on the uterus and ovaries, without affecting the digestive organs, liver, and intestines.

This results in fewer side effects such as excess weight, nausea, cholepathies and others. Hormones also affect the mucus in the cervix, making it denser and thereby preventing sperm from moving forward.

Did you know? Condoms are considered one of the most popular methods of contraception. They were invented a long time ago. For example, in Ancient Greece a goat's bladder was used as a condom, in ancient Africa - crocodile skin, and in China - silk.

How to insert NuvaRing correctly

You should insert the vaginal circle yourself from the 1st to the 5th day of the menstrual cycle:

You should take a comfortable position: lying, squatting or standing, leaning against the wall and raising one leg.
With clean hands, squeeze the ring, reducing its size.
Then it is installed deep into the vagina - it is smooth and will slip quickly, taking the required position.
If after installation there is a feeling of discomfort, adjust the ring with your fingers.

How long should it stay in the vagina?

The NuvaRing ring is inserted into the vagina for exactly 21 days. On day 22 he is pulled out. Moreover, they do this on the same day of the week on which the contraceptive was administered. Then you need a break of 7 days. During this period, menstruation begins. And on day 8, a new contraceptive ring is introduced.

How to extract

It is necessary to remove the contraceptive in the same way as to insert it, only in reverse order. The vaginal circle is pulled out by prying it with the index finger or squeezing it between the middle and index fingers.

What to do if the ring falls out

Sometimes it happens that the NuvaRing falls out. In this case, the hormonal vaginal circle is washed with water (not hot) and reinserted.

Important!This is allowed if the ring fell out no more than three hours ago. If more time has passed, then they throw it away and buy a new one.

What is the probability of getting pregnant

Vaginal rings are very effective means contraception if used correctly. According to statistics, out of 1000 girls who strictly follow the rules of use, only 3 become pregnant. And if the timing of insertion and removal of the ring is violated, conception occurs in 8 out of 1000.

Impact on the female body and side effects

Side effects during the period of use of the contraceptive in question do not occur often:

You may feel dizzy and have a headache;
mood changes dramatically;
nausea occurs;
libido decreases;
breast enlarges;
Vaginitis is also possible;
the menstrual cycle is disrupted.

Most often, these effects appear at the beginning of using NuvaRing and soon go away on their own.

Important!If swelling of the legs, difficulty breathing, severe abdominal pain and severe blurred vision appear, then you should urgently visit a doctor.

Contraindications for use

Some females should absolutely not use vaginal contraception.

Contraindications include:

vein diseases;
chronic liver diseases;
diabetes;
obesity;
vaginal bleeding of unknown etiology;
tumors;
individual intolerance to the drug.

Advantages and disadvantages

The benefits include:

high efficiency;
convenient to use, replacing only once a month;
minimum hormones;
the menstrual cycle becomes regular;
the likelihood of developing uterine and ovarian cancer is reduced;
guarantee of natural intimate life;
hormones act locally;
rapid restoration of reproductive function;
You don’t have to tell your partner about contraception;
PMS symptoms decrease.

Did you know?The first mentions of intrauterine contraception appeared4 thousand years ago. The girls put silver balls and springs into themselves. And Cleopatra used sea sponges, soaking them in wine sauce.

The disadvantages include:

NuvaRing does not protect against sexually transmitted infections;
possible pain in the mammary glands;
the nature of menstrual flow changes;
many side effects;
a large list of contraindications.

The NuvaRing contraceptive ring has many advantages and protects well from unwanted pregnancy. But, taking into account all the disadvantages and contraindications, it is recommended to use a contraceptive only after consulting a doctor.

Among the methods of pregnancy planning, great importance is given to the prevention of unwanted conception. For this purpose they use various means contraception: condoms, pills, IUDs. But there are also quite exotic pharmacological forms, for example, a vaginal contraceptive ring called NuvaRing (or Nova Ring). Many women are hearing about this for the first time, so it is necessary to pay attention to the features, method of use, indications and limitations of this remedy.

Characteristics

The pharmacological form is a flexible ring made of latex, which contains two active components: estrogen and gestagen. Therefore, NuvaRing belongs to the combined hormonal contraceptives with a predominantly local mechanism of action. The gestagen is etonogestrel, and the group of estrogens is ethinyl estradiol - synthetic analogues of natural hormones female body. The diameter of the ring is 5.4 cm, and its thickness is only 4 mm. These sizes are suitable for most women, which is ensured by the flexibility of the shape and its adjustment to the individual characteristics of the genital organs.

Effects contraceptive ring caused by the action active substances, included in its composition.

Etonogestrel and ethinyl estradiol bind to the corresponding receptors, thereby blocking the local effects of natural hormones - estrogens and progesterone. This is mainly manifested in the suppression of ovulation and inhibition of secretory transformation of the endometrium.

As soon as the ring is inserted into the vagina, its membrane takes on the temperature human body, becoming permeable to substances inside. The medicinal components are contained in low doses; they act primarily on the uterus and ovaries, without affecting other systems and organs. Based on the mechanism of action of etonogestrel and ethinyl estradiol, conceiving a child becomes impossible. The egg does not mature and remains in the follicle, and the thin mucous membrane of the uterus prevents implantation of the embryo.

Distribution in the body

Substances contained in the ring are actively released from it and absorbed through the vaginal mucosa. They enter the bloodstream, where they reach maximum concentration approximately three days (ethinyl estradiol) and a week (etonogestrel) from the start of use. Bioavailability is high, comparable to the use of tablet contraceptives. Once in the blood plasma, the active substances bind to proteins (mainly albumin) and in this form are transported to target organs. Metabolism occurs in the liver, the half-life of drugs ranges from 29 to 36 hours, and excretion from the body is carried out by the kidneys (with urine) and intestines (with bile).

Indications

The NuvaRing ring is used as routine contraception. But he also has medicinal properties, which allows you to use this pharmacological form with some gynecological diseases. We are talking about menstrual dysfunction, when the cycle is irregular and periods are painful.

When using a ring to prevent unwanted conception, you can be confident in its reliability and high effectiveness. The probability of pregnancy occurring within a year of using a contraceptive does not exceed 0.9. This is a high figure, comparable to taking hormonal pills. But besides this, the NuvaRing ring has other advantages:

Ease of use (replacement is carried out once a month).
A predominantly local effect on the genital organs is provided.
There is no chance of weight gain.
The menstrual cycle is normalized.
Reduced risk oncological diseases uterus and ovaries.
The ring does not affect sensations during sexual intercourse.
Rapid resumption of fertility (4 weeks after extraction).

A wide list of positive qualities should increase patients' adherence to this method of contraception. But, compared to other means of contraception, it also has a number of disadvantages. Firstly, using a ring is quite unusual for a woman. Secondly, it does not protect against sexually transmitted infections (unlike a condom). And thirdly, there are many contraindications and restrictions for using NuvaRing.

As a contraceptive, the ring has many advantages. But there are certain disadvantages that limit its use.

Usage

Before using the ring, a woman should consult a gynecologist. The doctor will conduct an examination, based on the results of which he will tell whether she can use such a contraceptive. The specialist should explain how and when it is best to administer it and what can be expected in the long term.

Acting according to the instructions, a woman can easily install the NuvaRing ring herself. To do this, she must first choose suitable posture: lying on your back, squatting or standing with your leg elevated. Squeezing the contraceptive with two fingers, she inserts it. The position of the ring in the vagina should be comfortable, and contraceptive effect does not depend on its accuracy.

The time when you start using the ring is important. Optimal timing introductions are determined by several factors:

No other contraceptives were used on the first day of the menstrual cycle.
After taking combined estrogen-gestagen drugs (tablets or patches) - on the last day of the interval between their administration.
Switching from monocomponent gestagenic agents - at any time of the cycle.
With early abortion - immediately after termination of pregnancy.
IN postpartum period or for an abortion in the second trimester - after 1 month.

The ring remains in the vagina for 3–4 weeks. Use beyond this period reduces the contraceptive effect. If the NuvaRing falls out spontaneously, it must be reinserted as soon as possible. If the ring was in external environment over 3 hours, then its effect also decreases. In the intervals between the installation of a contraceptive, as well as in the first 7 days of its use, you should use additional means in the form of a condom (after childbirth or abortion this is not necessary).

Side effects

The NuvaRing contraceptive ring has a number of side effects. They are observed from different frequency and not for all women. Much depends on the individual characteristics of the body. The following side effects may occur while using the ring:

Gynecological: inflammatory processes(cervicitis), vaginal discharge, itching, burning and dryness in the vagina, scanty bleeding (including contact and acyclic), discomfort during sexual intercourse, ectropion, cervical polyps; swelling and tenderness of the mammary glands, mastopathy.
Urological: cystitis, dysuric disorders (frequent urge).
Digestive: nausea, loss of appetite, abdominal pain, flatulence, constipation.
Neuropsychiatric: migraine headaches, visual disturbances, dizziness, weakness and fatigue, irritability, decreased libido, depression.
Skin-allergic: itching, pinpoint rash, urticaria, acne.
Vascular: sensation of heat, thrombotic conditions.

In addition to effects due to content active ingredients, the ring may simply fall out of the vagina, rupture, or cause discomfort due to the shape itself. But to keep the risk of any side effects minimal, it should be used only after consulting a doctor and undergoing an appropriate examination. Compliance with all recommendations and requirements of the instructions will minimize adverse events.

The use of the NuvaRing ring may be associated with various unpleasant symptoms. But their likelihood can be reduced by strictly observing all conditions of use.

Restrictions and contraindications

Like any medicine, the ring with etonogestrel and ethinyl estradiol has certain limitations that make the use of NuvaRing impossible or extremely undesirable. All such conditions must be taken into account by the doctor at the examination stage.

The contraceptive in question has a number of contraindications. The instructions for the NuvaRing contraceptive ring indicate that it should not be used in the following cases:

Thrombotic conditions, including predisposition to them.
Associated migraine (combined with neurological disorders).
Diabetes complicated by angiopathy.
Heavy liver pathology(including oncology).
Hormone-sensitive gynecological tumors.
Metrorrhagia with unknown cause.
Pregnancy (confirmed and probable).
Individual hypersensitivity to the components of the ring.

Conditions such as hypertension, dyslipidemia, heart defects, systemic diseases connective tissue, inflammatory pathology intestines, sickle cell anemia. Some restrictions relate to difficulties when introducing a contraceptive into the vagina, which can be observed with uterine prolapse, constipation, rectal diverticula, hernial protrusions of the wall Bladder.

special instructions

If pregnancy develops while using NuvaRing, the ring will have to be removed immediately. Studies confirming safety combined contraceptives local action for the fetus is not enough to clearly indicate the absence of undesirable consequences. You should also not use this method while breastfeeding your baby. The effectiveness of the ring in adolescent girls is unknown.

In women using combinations of estrogens and progestins as contraceptives, there have been cases of increased blood pressure, but a direct relationship between these events has not yet been established. At correct intake Antihypertensive drugs neutralize this effect. There are indications of the influence active ingredients, included in the ring, on tolerance to carbohydrates. But this does not require any changes in glucose-lowering therapy.

NuvaRing components may have a certain effect on the results of some laboratory tests: liver function tests, thyroid and adrenal hormones, kidney function tests, lipid spectrum, coagulogram. But all changes are within the reference values. The use of tampons does not affect the effectiveness of the ring.

If, while using the drug in question, a woman experiences any symptoms described as side effects or other alarming symptoms, she should immediately consult a doctor. Mild reactions do not require removal of the ring, but in some cases you should still stop using it and switch to other contraceptives.

Every woman should remember about contraindications and other restrictions that could become an obstacle to using NuvaRing.

Interaction

Estrogen-progestin contraceptives, including NuvaRing, may interact with other medications. Acceleration of metabolism, and therefore reduction contraceptive effect may be observed with parallel administration of inducers of microsomal oxidation in the liver. Such drugs include barbiturates, rifampicin, carbamazepine, ritonavir, and preparations based on St. John's wort. The effect of the ring is inhibited by taking antibiotics from the group of ampicillin and tetracycline. Therefore, the patient should inform the doctor about all medications taken.

The NuvaRing ring is highly effective contraceptive hormonal origin. Due to its shape, it has predominantly local action on the genitals. There are other positive qualities that contribute to the widespread use of the ring. But it can only be used in strict accordance with medical recommendations and instructions. This allows you to minimize the risk of adverse events and achieve a stable result.

Ethinyl estradiol* + Etonogestrel* (Ethinylestradiol* + Etonogestrel*)

ATX

G02BB01 Intravaginal rings containing gestagen and estrogen

Pharmacological group

Combined contraceptive (estrogen + gestagen) [Estrogen, gestagen; their homologues and antagonists in combinations]

Compound

Description of the dosage form

A smooth, transparent, colorless or almost colorless ring without major visible damage with a transparent or almost transparent area at the junction.

pharmachologic effect

Pharmacological effect: contraceptive.

Pharmacodynamics

Mechanism of action. The drug NuvaRing® is a combined hormonal contraceptive, containing etonogestrel and ethinyl estradiol. Etonogestrel is considered a progestogen (19-nortestosterone derivative) that has a high affinity for progesterone receptors in target organs.

Ethinyl estradiol is considered an estrogen and is widely used in the production of contraceptives.

hemolytic-uremic syndrome;

conditions that may make it difficult to use vaginal ring: cervical prolapse, bladder hernia, rectal hernia, severe.

Use during pregnancy and breastfeeding

The drug NuvaRing® is intended for the prevention of pregnancy. If a woman wants to stop using the medicine to become pregnant, she is advised to wait until her natural cycle returns to conceive, because this will help to correctly calculate the date of conception and birth.

The use of NuvaRing® during pregnancy is contraindicated. If pregnancy occurs, the ring must be removed. Extensive epidemiological studies have not revealed an increased risk of developing birth defects in children born to women who took COCs before pregnancy, as well as teratogenic effects in cases where women took COCs for early stages pregnancy without knowing about it. Although this applies to all COCs, it is not known whether this also applies to NuvaRing®. Clinical examination in a small group of women showed that, despite the fact that the drug NuvaRing® is administered into the vagina, the concentrations of contraceptive sex hormones inside the uterus when using the drug NuvaRing® are similar to those when using COCs. Pregnancy outcomes in women who used the drug NuvaRing® during clinical trial, not described.

Use of the drug NuvaRing® during the period breastfeeding contraindicated. The composition of the drug can affect lactation, reduce the amount and change the composition breast milk. Small amounts of contraceptive sex hormones and/or their metabolites may be excreted in milk, but there is no evidence negative influence on children's health was not received.

Side effects

When using medications, you may experience side effects, occurring with varying frequencies: often (?1/100); infrequently (?1/1000,<1/100); редко (?1/10000, <1/1000) см. табл. 1.

1The list of side effects is based on data obtained from spontaneous reports. It is not possible to accurately determine the frequency.

2Data from an observational cohort study?1/10000 -<1/1000 женщино-лет.

3Local reactions in a partner include reports of local reactions on the penis (particularly pain, bruising and abrasions).

Side effects that occurred when taking CGC are described in detail in the “Special Instructions” section: pancreatitis, cerebrovascular disorders, benign and malignant liver tumors, chloasma, changes in insulin resistance.

In women with hereditary forms of angioedema, exogenous estrogens may cause or worsen symptoms of angioedema.

Interaction

Interaction with other medications

Interactions between hormonal contraceptives and other medications may lead to the development of acyclic bleeding and/or contraceptive failure. The literature describes the following interactions with combined oral contraceptives in general.

Hepatic metabolism: interactions may occur with drugs that induce liver microsomal enzymes, which can lead to increased clearance of sex hormones. Interactions have been established, in particular with phenytoin, barbiturates, primidone, carbamazepine, rifampicin, and also, possibly, with oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin and drugs containing St. John's wort (Hypericum perforatum). When treating with any of the listed drugs, you should temporarily use a barrier method of contraception (condom) in combination with the use of the drug NuvaRing® or choose another method of contraception. During concomitant use of drugs that induce microsomal enzymes, and for 28 days after their discontinuation, barrier methods of contraception should be used.

Antibiotics: A decrease in the effectiveness of oral contraceptives containing ethinyl estradiol has been observed with concomitant use of antibiotics such as tetracyclines. The mechanism of this effect has not been studied. In a study of pharmacokinetic interactions, oral administration of amoxicillin (875 mg 2 times a day) or doxycycline (200 mg/day, and then 100 mg/day) for 10 days while using the drug NuvaRing® had a slight effect on the pharmacokinetics of etonogestrel and ethinyl estradiol. When using antibiotics (excluding and), a barrier method of contraception (condom) should be used during treatment and for 7 days after discontinuation of antibiotics.

If concomitant therapy must be continued after 3 weeks of use of the ring, then the next ring should be administered urgently, without the usual interval.

Pharmacokinetic studies have not revealed the impact of the simultaneous use of antifungal agents and spermicides on the contraceptive effectiveness and safety of the drug NuvaRing®. When combined with suppositories and antifungal medications, the risk of ring rupture slightly increases. Hormonal contraceptives can cause disruption of the metabolism of other drugs. Accordingly, their concentrations in plasma and tissues may increase (in particular) or decrease (in particular lamotrigine).

To exclude possible interactions, you should read the instructions for use of other drugs.

Other types of interaction

Laboratory research. The use of contraceptive steroids may affect the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal, and kidney function; on the plasma concentration of transport proteins, in particular corticosteroid binding globulin and SHBG in plasma; for lipid/lipoprotein fractions; on indicators of carbohydrate metabolism; as well as on indicators of blood clotting and fibrinolysis. The indicators mainly change within normal values.

Sharing with tampons. Pharmacokinetic data show that the use of tampons does not affect the absorption of hormones released from the NuvaRing® vaginal ring. In rare cases, the ring may be accidentally removed when removing the tampon (see the subsection What to do if the ring has been temporarily removed from the vagina in the section "Dosage and Administration").

Directions for use and doses

Intravaginally. To achieve a contraceptive effect, NovaRing® must be used according to the instructions.

A woman can independently insert the NuvaRing® vaginal ring into the vagina.

The doctor should inform the woman how to insert and remove the NuvaRing® vaginal ring (Fig. 1, 2).

To insert the ring, the woman should choose a comfortable position, in particular standing, raising one leg, squatting or lying down. The NuvaRing® vaginal ring should be squeezed and inserted into the vagina until the ring is in a comfortable position. The exact position of the ring in the vagina is not decisive for the contraceptive effect (Fig. 3).

Method of administration (see Figure 4a, 4b, 4c).

1. Insert the ring into the vagina with one hand, and, if necessary, spread the labia with the other hand (Fig. 4a).

2. Push the ring into the vagina until the ring is in a comfortable position (Fig. 4b).

3. Leave the ring in the vagina for 3 weeks (Figure 4c).

After administration (see How to start using NuvaRing®), the ring should be in the vagina continuously for 3 weeks. It is advisable for a woman to regularly check whether it remains in the vagina. If the ring was accidentally removed, then you need to follow the instructions in the subsection What to do if the ring was temporarily removed from the vagina.

The NuvaRing® vaginal ring should be removed after 3 weeks, on the same day of the week when the ring was inserted into the vagina. After a week's break, a new ring is inserted (in particular, if the NuvaRing® vaginal ring was installed on Wednesday at about 10 p.m., then it should be removed on Wednesday 3 weeks later at about 10 p.m. A new ring is inserted on the next Wednesday). To remove the ring, you need to pick it up with your index finger or squeeze it with your index and middle fingers and pull it out of the vagina (Fig. 5).

The used ring should be placed in a bag (keep out of the reach of children and pets) and thrown away. Bleeding associated with discontinuation of the NuvaRing® drug often begins 2-3 days after removal of the NuvaRing® vaginal ring and may not completely stop until a new ring is installed.

How to start using NuvaRing®

In the previous cycle, hormonal contraceptives were not used. The drug NuvaRing® should be administered on the 1st day of the cycle (i.e., on the 1st day of menstruation). It is allowed to install a ring on days 2–5 of the cycle, but in the first cycle, in the first 7 days of using the drug NuvaRing®, additional use of barrier methods of contraception is suggested.

Switching from combined hormonal contraceptives (CHCs). A woman should insert the NuvaRing® vaginal ring on the last day of the usual interval between cycles of taking CHC (tablets or patch). If a woman has taken CHC correctly and regularly and is sure that she is not pregnant, she can switch to using the vaginal ring on any day of the cycle. In no case should you exceed the recommended hormone-free interval of the previous method.

Switching from progestogen-only medications (mini-pills, progestin-only oral contraceptives, implants, injectables, or hormone-containing intrauterine systems - IUDs). A woman taking mini-pills or progestin-only oral contraceptives can switch to using NuvaRing® on any day. The ring is inserted on the day of removal of the implant or IUD. If a woman received injections, then use of the drug NuvaRing® begins on the day when the next injection should have been given. In all these cases, the woman should use a barrier method of contraception for the first 7 days after insertion of the ring.

After an abortion in the first trimester. A woman can insert the ring immediately after an abortion. In this case, she does not need additional contraceptives. If the use of the drug NuvaRing® immediately after an abortion is undesirable, you need to follow the recommendations given in the subsection. In the previous cycle, hormonal contraceptives were not used. In the interval, the woman is recommended an alternative method of contraception.

After childbirth or after an abortion in the second trimester. A woman is recommended to insert the ring no earlier than the 4th week after childbirth (if she is not breastfeeding) or an abortion in the second trimester. If the ring is installed at a later date, then it is proposed to use an additional barrier method during the first 7 days. But if sexual intercourse has already taken place, then before using the drug NuvaRing® you need to exclude pregnancy or wait until your first menstruation.

Contraceptive results and cycle control may be impaired if a woman does not comply with the recommended regimen. To avoid a decrease in the contraceptive effect, the following recommendations should be followed.

What to do if the break in using the ring is prolonged. If you had sexual intercourse during a break from using the ring, pregnancy should be ruled out. The longer the break, the higher the likelihood of pregnancy. If pregnancy is excluded, the woman should insert a new ring into the vagina as quickly as possible. Over the next 7 days, an additional barrier method of contraception, in particular a condom, can be used.

What to do if the ring has been temporarily removed from the vagina. The ring must remain in the vagina continuously for 3 weeks. If the ring was accidentally removed, it should be washed with cold or slightly warm (not hot) water and immediately inserted into the vagina.

— If the ring remained outside the vagina for less than 3 hours, then its contraceptive effect is not reduced. The woman should insert the ring into the vagina as quickly as possible (no later than after 3 hours).

— If the ring was outside the vagina for more than 3 hours during the 1st or 2nd week of use, the contraceptive result may decrease. The woman should insert the ring into the vagina as quickly as possible. Over the next 7 days, you need to use a barrier method of contraception, in particular a condom. The longer the ring was outside the vagina and the closer this period is to the 7-day break in using the ring, the higher the likelihood of pregnancy.

— If the ring was outside the vagina for more than 3 hours on the 3rd week of use, the contraceptive result may decrease. The woman should throw away this ring and choose one of the following two methods:

1. Immediately install a new ring (the new ring can be used for the next 3 weeks. There may be no bleeding associated with the cessation of the medication. But spotting or bleeding in the middle of the cycle is possible).

2. Wait for bleeding associated with the cessation of the medication, and insert a new ring no later than 7 days after removing the previous ring (this option should be chosen only if the regimen of use of the ring was not violated during the first 2 weeks).

What to do in case of prolonged use of the ring. If the drug NuvaRing® was used for no more than a maximum period of 4 weeks, then the contraceptive result remains sufficient. A woman can take a week's break from using the ring and then insert a new ring.

If the NuvaRing® vaginal ring remains in the vagina for more than 4 weeks, the contraceptive result may worsen, so pregnancy must be excluded before inserting a new ring. If a woman does not adhere to the recommended regimen and bleeding does not occur after a week's break in using the ring, then pregnancy should be ruled out before inserting a new ring.

How to shift or delay the onset of menstrual bleeding. To delay menstrual-like withdrawal bleeding, a woman can insert a new ring without a week's break. The next ring should be used within 3 weeks. This may cause spotting or bleeding. Then, after the usual one-week break, the woman returns to regular use of the drug NuvaRing®.

To postpone the onset of bleeding to another day of the week, a woman may be advised to take a shorter break from using the ring (for as many days as needed). The shorter the break in ring use, the higher the likelihood of no bleeding occurring after ring removal, and the occurrence of bleeding or spotting during the use of the next ring.

The safety and effectiveness of NuvaRing® in adolescent girls under 18 years of age have not been studied.

Overdose

Serious consequences of an overdose of hormonal contraceptives have not been described. Possible symptoms include nausea, vomiting and light vaginal bleeding in young girls. There are no antidotes. Treatment is symptomatic.

special instructions

If any of the diseases, conditions or risk factors listed below are present, the benefits of using the drug NuvaRing® and the possible risks for each individual woman should be assessed before she starts using the drug NuvaRing®. In case of exacerbation of diseases, deterioration of the condition, or the appearance of any of the conditions listed below for the first time, a woman should consult a doctor to decide on the possibility of further use of the drug NuvaRing®.

Circulatory disorders

The use of hormonal contraceptives may be associated with the development of venous thrombosis (deep veins and pulmonary) and arterial thrombosis, as well as associated complications, sometimes with death.

The use of any COC will increase the risk of developing VTE compared to the risk of VTE in patients not using COCs. The greatest risk of developing VTE is observed in the 1st year of COC use. Data from a large prospective cohort study of the safety of various COCs suggest that the greatest increase in risk compared with the risk in women not using COCs is observed in the first 6 months after starting COC use or resuming their use after a break (4 weeks or more). In non-pregnant women not using oral contraceptives, the risk of developing VTE is 1 to 5 per 10,000 woman-years (WY). In women using oral contraceptives, the risk of developing VTE ranges from 3 to 9 cases per 10,000 women. But the risk increases to a lesser extent than during pregnancy, when it is 5-20 cases per 10,000 YL (pregnancy data are based on the actual duration of pregnancy in studies; when converted to a pregnancy duration of 9 months, the risk ranges from 7 to 27 cases per 10,000 ZhL). In postpartum women, the risk of developing VTE ranges from 40 to 65 cases per 10,000 women. VTE is fatal in 1–2% of cases.

According to research results, the increased risk of developing VTE in women using NuvaRing® is similar to that in women using COCs (adjusted risk ratio, see Table 2 below). A large prospective observational study, TASC (Transatlantic Active Study of the Safety of NuvaRing® for Cardiovascular Stress), assessed the risk of VTE in women who started using NuvaRing® or COCs, switched to NuvaRing® or COCs from other contraceptives, or resumed using NuvaRing®. ® or COC, in a population of typical users. Women were followed up for 24–48 months. The results showed a similar level of risk of developing VTE in women using the drug NuvaRing® (8.3 cases per 10,000 YL) and women using COCs (9.2 cases per 10,000 YL). For women using COCs other than those containing desogestrel, gestodene and drospirenone, the incidence of VTE was 8.5 cases per 10,000 women.

A retrospective cohort study initiated by the FDA (US Food and Drug Administration) showed that the incidence of VTE in women who started using the drug NuvaRing® was 11.4 cases per 10,000 YL, while in women who started using COCs containing levonorgestrel, the incidence of VTE is 9.2 cases per 10,000 vitreous.

table 2

Assessment of the risk (risk ratio) of developing VTE in women using the drug NuvaRing®, compared with the risk of developing VTE in women using COCs

1Incl. low-dose COCs containing the following progestins: chlormadinone acetate, cyproterone acetate, desogestrel, dienogest, drospirenone, ethynodiol diacetate, gestodene, levonorgestrel, norethindrone, norgestimate or norgestrel.

2Taking into account age, body mass index, duration of use, history of VTE.

3 Incl. low-dose COCs containing the following progestins: norgestimate, norethindrone or levonorgestrel.

4Taking into account age, place and year of inclusion in the survey.

There are extremely rare cases of thrombosis of other blood vessels (in particular the arteries and veins of the liver, mesenteric vessels, kidneys, brain and retina) when using COCs. It is unknown whether these cases are related to the use of COCs. Possible symptoms of venous or arterial thrombosis may be unilateral swelling and/or pain in the lower extremity, local increase in temperature in the lower extremity, hyperemia or discoloration of the skin on the lower extremity; sudden severe chest pain, probably radiating to the left arm; attack of shortness of breath, cough; any unusual, severe, prolonged headaches; sudden partial or complete loss of vision; double vision; slurred speech or; dizziness; collapse, accompanied or not accompanied by a focal epileptic seizure; sudden weakness or severe numbness on one side of the body or any part of the body; movement disorders; acute stomach

Risk factors for the development of venous thrombosis and embolism:

- age;

- presence of diseases in the family history (venous thrombosis and embolism in brothers/sisters at any age or in parents at a young age). If a hereditary predisposition is suspected, before starting any hormonal contraceptives, the woman should be referred to a specialist for consultation;

- prolonged immobilization, major surgical interventions, any surgical interventions on the lower extremities or serious trauma. In such situations, it is proposed to stop using the medication (in the case of a planned operation, at least 4 weeks in advance) with subsequent resumption of use no earlier than 2 weeks after complete restoration of motor activity;

- probably thrombophlebitis of the superficial veins and.

There is no consensus on the likely role of these conditions in the etiology of venous thrombosis.

Risk factors for the development of complications of arterial thromboembolism:

- age;

- smoking (with heavy smoking and with age, the risk increases even more significantly, especially in women over 35 years of age);

- dislipoproteinemia;

— obesity (body mass index more than 30 kg/m2);

- increased blood pressure;

- migraine;

- heart valve disease;

- atrial fibrillation;

- presence of diseases in the family history (arterial thrombosis in brothers/sisters at any age or parents at a relatively early age).

If a hereditary predisposition is suspected, before starting any hormonal contraceptives, the woman should be referred to a specialist for consultation. Biochemical factors that may indicate hereditary or acquired predisposition to venous or arterial thrombosis include activated protein C resistance, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).

Other conditions that can lead to unwanted circulatory problems include diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome and chronic inflammatory bowel disease (particularly Crohn's disease or ulcerative colitis), as well as sickle cell disease. It is necessary to take into account the increased risk of thromboembolism in the postpartum period.

An increase in the frequency or severity of migraine (which may be a prodromal symptom of cerebrovascular accidents) while using hormonal contraceptives may be a reason to immediately discontinue use of hormonal contraceptives.

Women using CHCs should be advised to consult a doctor if possible symptoms of thrombosis occur. If thrombosis is suspected or confirmed, CHC use should be discontinued. In this case, it is necessary to use effective contraception, since anticoagulants (coumarins) have a teratogenic effect.

Risk of developing tumors

The most important risk factor for developing cervical cancer is infection with a human virus. Epidemiological studies have shown that long-term use of COCs leads to an additional increase in this risk, but it remains unclear to what extent this is due to other factors, such as more frequent cervical smear examinations and differences in sexual behavior, including. use of barrier contraceptives. It remains unclear how this result is related to the use of the drug NuvaRing®.

A meta-analysis of 54 epidemiological studies found a small increase (1.24) in the relative risk of breast cancer in women taking COCs. The risk gradually decreases over 10 years after stopping the drugs. rarely occurs in women under 40 years of age, so the additional incidence of breast cancer in women who take or have taken COCs is small compared to the overall risk of developing breast cancer. Breast cancer diagnosed in women who use COCs is clinically less severe than cancer diagnosed in women who have never used COCs. The increased risk of breast cancer may be due to both earlier detection of breast cancer in women taking COCs, the biological effects of COCs, or a combination of both.

In rare cases, women taking COCs have developed benign, and even more rarely, malignant liver tumors. In some cases, these tumors led to the development of life-threatening bleeding into the abdominal cavity. The doctor should consider the possibility of a liver tumor in the differential diagnosis of diseases in a woman taking NuvaRing® if symptoms include acute pain in the upper abdomen, liver enlargement, or signs of intra-abdominal bleeding.

Other states

Women with hypertriglyceridemia or a corresponding family history have an increased risk of developing pancreatitis when taking hormonal contraceptives.

If a constant increase in blood pressure is observed when using the drug NuvaRing®, you should contact your doctor to decide whether it is necessary to remove the vaginal ring and prescribe antihypertensive therapy. With adequate blood pressure control using antihypertensive drugs, it is possible to resume use of the drug NuvaRing®.

During pregnancy and during the use of COCs, the development or worsening of the following conditions was noted (although their relationship with the use of contraceptives has not been definitively established): jaundice and/or itching caused by cholestasis, formation of gallstones, porphyria, systemic lupus erythematosus, hemolytic uremic syndrome, Sydenham's chorea (minor chorea), pregnancy, hearing loss due to otosclerosis, (hereditary) angioedema.

Acute or chronic liver dysfunction may serve as a reason to discontinue the drug NuvaRing® until liver function indicators normalize. Recurrence of cholestatic jaundice, which was observed earlier during pregnancy or when using sex hormones, requires discontinuation of the drug NuvaRing®.

Although estrogens and progestogens may have an effect on peripheral and tissue tolerance to, there is no evidence to support the need to change hypoglycemic therapy during the use of hormonal contraceptives. But women with diabetes should be under constant medical supervision when using NuvaRing®, especially in the first months of contraception.

There is evidence of a worsening of Crohn's disease and ulcerative colitis with the use of hormonal contraceptives.

In rare cases, pigmentation of the facial skin (chloasma) may occur, especially if it occurred earlier during pregnancy. Women predisposed to the development of chloasma should avoid exposure to sunlight and UV radiation while using the drug NuvaRing®.

The following conditions may prevent the ring from being inserted correctly or may cause it to fall out: cervical prolapse, bladder and/or rectal hernia, severe chronic constipation.

In very rare cases, women have unintentionally inserted the NuvaRing® vaginal ring into the urethra and possibly into the bladder. If symptoms of cystitis appear, you need to consider the possibility of incorrect insertion of the ring.

Cases of vaginitis have been described during the use of the drug NuvaRing®. There is no evidence that the treatment of vaginitis affects the effectiveness of the use of the drug NuvaRing®, as well as evidence that the use of the drug NovaRing® affects the effectiveness of the treatment of vaginitis.

Very rare cases of difficult ring removal have been described that required removal by a medical professional.

Medical examination/consultation

Before prescribing the drug NuvaRing® or resuming its use, you should carefully review the woman’s medical history (including family history) and conduct a gynecological examination to exclude pregnancy. It is necessary to measure blood pressure, conduct an examination of the mammary glands, pelvic organs, including a cytological examination of cervical smears and some laboratory tests, to exclude contraindications and reduce the risk of possible side effects of the drug. The frequency and nature of medical examinations depend on the individual characteristics of each patient, but medical examinations are carried out at least once every 6 months. A woman should read the instructions and follow all recommendations. The woman should be informed that NuvaRing® does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Reduced efficiency

The effectiveness of the drug NuvaRing® may decrease if the regimen is not followed or concomitant therapy is carried out.

Changes in the nature of menstruation

While using the drug NovaRing®, acyclic bleeding (spotting or sudden bleeding) is likely to occur. If such bleeding is observed after regular cycles with the correct use of the drug NuvaRing®, you should contact your gynecologist to conduct the necessary diagnostic tests, incl. to exclude organic pathology or pregnancy. A diagnostic curettage may be required. Some women do not bleed after the ring is removed. If the drug NuvaRing® was used according to the instructions, it is unlikely that the woman is pregnant. If the recommendations of the instructions are not followed and there is no bleeding after removing the ring, as well as if there is no bleeding for two cycles in a row, pregnancy must be excluded.

The effect of ethinyl estradiol and etonogestrel on the sexual partner

The possible pharmacological effects and extent of exposure of ethinyl estradiol and etonogestrel to male sexual partners (due to absorption through penile tissue) have not been studied.

Ring damage

In rare cases, when using the drug NuvaRing®, ring rupture was observed.

The core of the drug NuvaRing® is considered solid, so its contents remain intact, and the release of hormones does not change significantly. If the ring ruptures, it often falls out of the vagina (see the recommendations in the subsection What to do if the ring has been temporarily removed from the vagina in the “Method of administration and dosage” section). If the ring breaks, a new ring must be inserted.

Ring falling out

Sometimes the NuvaRing® vaginal ring may fall out of the vagina, in particular if it is inserted incorrectly, the tampon is removed, during sexual intercourse, or due to severe or chronic constipation. In this regard, it is advisable for a woman to regularly check the presence of the NuvaRing® vaginal ring in the vagina. If the NuvaRing® vaginal ring falls out of the vagina, you must follow the recommendations of the subsection What to do if the ring has been temporarily removed from the vagina in the “Method of administration and dosage” section.

vaginal ring 2.7 mg+11.7 mg: pack. 1 or 3 pcs. Reg. No.: P N015411/01

Clinical and pharmacological group:

Hormonal contraceptive for intravaginal administration

Release form, composition and packaging

Vaginal ring smooth, transparent, colorless or almost colorless, without major visible damage, with a transparent or almost transparent area at the junction.

Excipients: ethylene and vinyl acetate copolymer (28% vinyl acetate) - 1677 mg, ethylene and vinyl acetate copolymer (9% vinyl acetate) - 197 mg, magnesium stearate - 1.7 mg.

1 PC. - waterproof bags made of aluminum foil (1) - cardboard packs.
1 PC. - waterproof bags made of aluminum foil (3) - cardboard packs.

Description of the active components of the drug " Nuvaring ®»

pharmachologic effect

A combined hormonal contraceptive drug containing etonogestrel and ethinyl estradiol.

Etonogestrel is a progestogen (19-nortestosterone derivative) that binds with high affinity to progesterone receptors in target organs. Ethinyl estradiol is an estrogen and is widely used in the production of contraceptives.

The contraceptive effect of the drug NuvaRing ® is due to a combination of various factors, the most important of which is the suppression of ovulation.

Efficiency

In clinical studies, it was found that the Pearl index (an indicator reflecting the frequency of pregnancy in 100 women during 1 year of contraception) in women aged 18 to 40 years for the drug NuvaRing ® was 0.96 (95% CI: 0.64-1.39) and 0.64 (95% CI: 0.35-1.07) in the statistical analysis of all randomized participants (ITT analysis) and the analysis of study participants who completed them according to the protocol (PP analysis), respectively. These values were similar to the Pearl index values obtained in comparative studies of combined oral contraceptives (COCs) containing levonorgestrel/ethinyl estradiol (0.150/0.030 mg) or drospirenone/ethinyl estradiol (3/0.30 mg).

With the use of the drug NuvaRing ®, the cycle becomes more regular, the pain and intensity of menstrual-like bleeding decreases, which helps reduce the incidence of iron deficiency conditions. There is evidence of a reduction in the risk of endometrial and ovarian cancer with the use of the drug. In addition, high-dose COCs (0.05 mg ethinyl estradiol) reduce the risk of developing ovarian cysts, pelvic inflammatory diseases, benign changes in the mammary glands and ectopic pregnancy. It is not entirely clear whether low-dose hormonal contraceptives offer similar benefits.

Nature of bleeding

A comparison of bleeding patterns over a one-year period in 1000 women using NovaRing ® and COCs containing levonorgestrel/ethinyl estradiol (0.150/0.030 mg) showed a significant reduction in the incidence of breakthrough bleeding or spotting when using NovaRing ® compared to COCs. . In addition, the frequency of cases where bleeding occurred only during a break in the use of the drug was significantly higher among women using the drug NuvaRing ® .

Effect on bone mineral density

A comparative two-year study of the effect of the drug NuvaRing (n=76) and a non-hormonal intrauterine device (n=31) did not reveal any effect on bone mineral density in women.

Children

Indications

- contraception.

Dosage regimen

NuvaRing ® is inserted into the vagina once every 4 weeks. The ring is in the vagina for 3 weeks and then removed on the same day of the week on which it was placed in the vagina; after a week's break, a new ring is inserted. For example: if the NuvaRing ® ring was installed on Wednesday at approximately 10:00 pm, then it should be removed on Wednesday 3 weeks later at approximately 10:00 pm; on the following Wednesday a new ring is inserted.

Bleeding associated with discontinuation of the drug usually begins 2-3 days after removal of NuvaRing ® and may not completely stop until a new ring is installed.

Hormonal contraceptives were not used in the previous menstrual cycle

NuvaRing ® should be administered on the first day of the cycle (i.e., the first day of menstruation). It is possible to install a ring on days 2-5 of the cycle, however, in the first cycle in the first 7 days of using the drug NuvaRing ®, additional use of barrier methods of contraception is recommended.

Switching from taking combined oral contraceptives

NuvaRing ® should be administered on the last day of the free interval in taking combined hormonal contraceptives (tablets or patches). If a woman has been taking the combined hormonal contraceptive correctly and regularly and is confident that she is not pregnant, she can switch to using a vaginal ring on any day of her cycle.

The duration of the interval in taking hormonal contraceptives should not exceed the recommended period.

Switching from progestin-only contraception (mini-pill, implant, or injectable contraception) or progestogen-releasing intrauterine device (IUD)

A woman taking the mini-pill can switch to using NuvaRing ® on any day (the ring is inserted on the day the implant or IUD is removed or on the day of the next injection). In all these cases, the woman should use a barrier method of contraception for the first 7 days after insertion of the ring.

After an abortion performed in the first trimester of pregnancy

You can start using NuvaRing ® immediately after an abortion. In this case, there is no need for additional use of other contraceptives. If the use of NuvaRing ® immediately after an abortion is undesirable, the ring should be used in the same way as if hormonal contraceptives were not used in the previous cycle. In the interval, the woman is recommended an alternative method of contraception.

After childbirth or abortion performed in the second trimester of pregnancy

The use of NuvaRing ® should begin within the 4th week after childbirth (if the woman is not breastfeeding) or abortion in the second trimester. If the use of NuvaRing ® is started at a later date, then additional use of barrier methods of contraception is necessary in the first 7 days of using NuvaRing ® . However, if sexual intercourse has already taken place during this period, then it is necessary to first exclude pregnancy or wait until the first menstruation before starting to use the drug NuvaRing ® .

The contraceptive effect and cycle control may be impaired if the patient does not comply with the recommended regimen. To avoid loss of contraceptive effect in case of deviation from the regimen, you must follow the following recommendations.

Extending the break from using the ring

If you had sexual intercourse during a break from using the ring, pregnancy should be ruled out. The longer the break, the higher the likelihood of pregnancy. If pregnancy is ruled out, a new ring should be inserted into the vagina as quickly as possible. Over the next 7 days, an additional barrier method of contraception, such as a condom, can be used.

If the ring has been temporarily removed from the vagina

If the ring remained outside the vagina less than 3 hours, the contraceptive effect will not decrease. The ring should be reinserted into the vagina as soon as possible.

If the ring was left outside the vagina for more than 3 hours during the first or second week of use, then the contraceptive effect may be reduced. You should place the ring in your vagina as soon as possible. Over the next 7 days, you must use a barrier method of contraception, such as a condom. The longer the ring was outside the vagina and the closer this period is to the 7-day break in using the ring, the higher the likelihood of pregnancy.

If the ring was outside the vagina for more than 3 hours during the third week of use, then the contraceptive effect may be reduced. The woman should throw away this ring and choose one of two methods:

1. Immediately install a new ring. Please note that the new ring can be used for the next 3 weeks. In this case, there may be no bleeding associated with the cessation of the drug's effect. However, spotting or bleeding in the middle of the cycle is possible.

2. Wait for bleeding associated with the cessation of the drug’s effect, and insert a new ring no later than 7 days after removing the previous ring. This option should only be chosen if the ring use regimen has not previously been violated during the first 2 weeks.

Extended use of the ring

If the drug NuvaRing ® was used no more than a maximum period of 4 weeks, then the contraceptive effect remains sufficient. You can take a week's break from using the ring and then insert a new ring. If NuvaRing ® remained in the vagina more than 4 weeks, then the contraceptive effect may worsen, so pregnancy must be ruled out before inserting a new ring.

To change the time of onset of menstrual bleeding

To postpone (prevent) menstrual-like withdrawal bleeding, you can insert a new ring without a week's break. The next ring must be used within 3 weeks. This may cause bleeding or spotting. Then, after the usual one-week break, you should return to regular use of NuvaRing ®.

To postpone the onset of bleeding on another day of the week, it can be recommended to take a shorter break from using the ring (for as many days as necessary). The shorter the interval between ring use, the higher the likelihood that there will be no bleeding after ring removal, and no bleeding or spotting will occur when the next ring is used.

Ring damage

In rare cases, when using NuvaRing ®, ring rupture has been observed. The core of the NuvaRing ® ring is solid, so its contents remain intact, and the release of hormones does not change significantly. If the ring ruptures, it usually falls out of the vagina. If the ring ruptures, a new ring must be inserted.

Ring falling out

NuvaRing ® has sometimes been reported to fall out of the vagina, for example, when it is inserted incorrectly, when a tampon is removed, during sexual intercourse, or due to severe or chronic constipation. In this regard, it is advisable for a woman to regularly check the presence of the NuvaRing ® ring in the vagina.

Incorrect insertion of the ring

In very rare cases, women have unintentionally inserted NuvaRing ® into the urethra. When symptoms of cystitis appear, it is necessary to consider the possibility of incorrect insertion of the ring.

Safety and effectiveness of the drug NuvaRing for teenagers under 18 years of age have not been studied.

Rules for using NuvaRing ®

A woman can independently insert NuvaRing ® into the vagina. To insert the ring, a woman should choose the position that is most comfortable for her, for example, standing, raising one leg, squatting, or lying down. NuvaRing ® must be squeezed and inserted into the vagina until the ring is in a comfortable position. The exact position of NuvaRing ® in the vagina is not decisive for the contraceptive effect.

After insertion, the ring must remain in the vagina continuously for 3 weeks. If the ring was accidentally removed, it should be washed with warm (not hot) water and immediately inserted into the vagina.

To remove the ring, you can pick it up with your index finger or squeeze it between your index and middle fingers and pull it out of the vagina. The used ring should be placed in a bag (keep out of the reach of children and pets) and discarded.

Side effect

When using the drug, side effects may occur, occurring with varying frequencies: often (≥1/100), infrequently (<1/100, ≥1/1 000), редко (<1/1000, ≥1/10 000).

Often	Infrequently	Rarely	Post-marketing data 1
Infections and infestations
Vaginal infection	Cervicitis, cystitis, urinary tract infections
From the immune system
			Hypersensitivity
Metabolism
Weight gain	Increased appetite
Mental disorders
Depression, decreased libido	Mood changes
From the nervous system
Headache, migraine	Dizziness, hypoesthesia
From the side of the organ of vision
	Visual impairment
From the cardiovascular system
	"Hot flashes", increased blood pressure	Venous thromboembolism 3
From the digestive system
Abdominal pain, nausea	Bloating, diarrhea, vomiting, constipation
From the skin
Acne	Alopecia, eczema, skin itching, rash		Hives
From the musculoskeletal system
	Back pain, muscle spasms, pain in limbs
From the urinary system
	Dysuria, urinary urgency, pollakiuria
From the genital organs and breast
Engorgement and tenderness of the mammary glands, genital itching in women, dysmenorrhea, pain in the pelvic area, vaginal discharge	Amenorrhea, discomfort in the mammary glands, enlarged mammary glands, lumps in the mammary glands, cervical polyps, contact (during sexual intercourse) spotting (bleeding), dyspareunia, ectropion of the uterus, fibrocystic mastopathy, menorrhagia, metrorrhagia, discomfort in the pelvic area, premenstrual syndrome, uterine spasm, burning sensation in the vagina, vaginal odor, painful sensations in the vagina, discomfort and dryness of the vulva and vaginal mucosa		Local reactions in partner 2
From the body as a whole
	Fatigue, irritability, malaise, swelling
Others
Discomfort when using the vaginal ring, loss of the vaginal ring	Difficulty using a contraceptive, rupture (damage) of the ring, sensation of a foreign body in the vagina

1 The list of side effects is based on data obtained from spontaneous reports. It is not possible to accurately determine the frequency.

2 Local reactions in a partner include reports of local reactions on the penis.

3 Observational cohort study data: ≥1/10,000 -<1/1000 женщин-лет.

Contraindications

- venous thrombosis (including a history), including thromboembolism;

- arterial thrombosis (including a history), including cerebrovascular accidents, myocardial infarction and/or precursors of thrombosis, including angina pectoris, transient ischemic attack;

— heart defects with thrombogenic complications;

- predisposition to the development of venous or arterial thrombosis, including hereditary diseases: resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant);

— migraine with focal neurological symptoms in the anamnesis;

- diabetes mellitus with vascular damage;

- pronounced or multiple risk factors for venous or arterial thrombosis;

- pancreatitis (including a history), in combination with severe hypertriglyceridemia;

- severe liver diseases, until normalization of liver function indicators;

- liver tumors, malignant or benign (including in history);

- established or suspected hormone-dependent malignant tumors (for example, genital organs or breast);

- vaginal bleeding of unknown etiology;

— pregnancy (including suspected);

- hypersensitivity to any of the active or excipients of the drug NuvaRing ®.

If any of the above conditions occur, you should immediately stop using the drug.

WITH caution the drug should be prescribed if any of the following diseases, conditions or risk factors are present; in such cases, the doctor must carefully weigh the benefit-risk ratio of using the drug NuvaRing ®:

- presence of diseases in the family history (venous thrombosis and embolism and/or arterial thrombosis in brothers/sisters at any age or in parents at a relatively early age;

- prolonged immobilization, major surgical interventions, any surgical interventions on the lower extremities or serious trauma;

— obesity (body mass index more than 30 kg/m2);

— thrombophlebitis of superficial veins;

- smoking (especially in women over 35 years old);

- dislipoproteinemia;

- heart valve disease;

- atrial fibrillation;

- arterial hypertension;

- diabetes;

- acute or chronic liver dysfunction;

- jaundice and/or itching caused by cholestasis;

- cholelithiasis;

- porphyria;

- systemic lupus erythematosus;

- hemolytic-uremic syndrome;

- Sydenham's chorea (minor chorea);

- hearing loss due to otosclerosis;

- (hereditary) angioedema;

- chronic inflammatory bowel diseases (Crohn's disease and ulcerative colitis);

- sickle cell anemia;

- chloasma;

- conditions that make it difficult to use a vaginal ring: cervical prolapse, bladder hernia, rectal hernia, severe chronic constipation.

In case of exacerbation of diseases, deterioration of the condition, or the occurrence of any of the listed conditions, you should first consult a doctor to decide on the possibility of further use of the drug NuvaRing ® .

Pregnancy and lactation

The drug NuvaRing ® is intended to prevent pregnancy. If a woman wants to stop using the drug in order to become pregnant, it is recommended to wait for the restoration of the natural cycle to conceive, as this will help to correctly calculate the date of conception and birth.

Pregnancy

The use of NuvaRing ® during pregnancy is contraindicated. If pregnancy occurs, the ring should be removed. Extensive epidemiological studies have not revealed an increased risk of congenital malformations in children born to women who took COCs before pregnancy, as well as teratogenic effects in cases where women took COCs in early pregnancy without knowing about it. Although this applies to all COCs, it is not known whether this also applies to NuvaRing ® . A clinical study in a small group of women showed that, despite the fact that the drug NuvaRing ® is inserted into the vagina, the concentrations of contraceptive hormones inside the uterus when using the drug NuvaRing ® are similar to those when using COCs. Pregnancy outcomes in women who used NuvaRing ® during a clinical trial have not been described.

Breastfeeding period

The use of NuvaRing ® during breastfeeding is not indicated. The composition of the drug can affect lactation, reduce the amount and change the composition of breast milk. Small amounts of contraceptive steroids and/or their metabolites may be excreted in milk, but there is no evidence of their negative effects on the health of children.

Use for liver dysfunction

Contraindicated in severe liver diseases (until normalization of function indicators).

Application for children

The safety and effectiveness of NuvaRing ® for adolescents under 18 years of age has not been studied.

special instructions

If any of the diseases, conditions or risk factors listed below are present, the benefits of using the drug NuvaRing ® and the possible risks for each individual woman should be assessed before she starts using the drug NuvaRing ® . In case of exacerbation of diseases, deterioration of the condition, or the occurrence of any of the conditions listed below for the first time, a woman should consult a doctor to decide on the possibility of further use of the drug NuvaRing ® .

Circulatory disorders

The use of hormonal contraceptives may be associated with the development of venous thrombosis (deep vein thrombosis and pulmonary embolism) and arterial thrombosis, as well as associated complications, sometimes fatal.

The use of any COC increases the risk of developing venous thromboembolism (VTE) compared to the risk of VTE in patients not using COCs. The greatest risk of developing VTE is observed in the first year of COC use. Data from a large prospective cohort study of the safety of various COCs suggest that the greatest increase in risk, compared with the risk in women not using COCs, is observed in the first 6 months after starting COC use or resuming their use after a break (4 weeks or more). . In nonpregnant women not using oral contraceptives, the risk of developing VTE is 1 to 5 per 10,000 woman-years (WY). In women using oral contraceptives, the risk of developing VTE ranges from 3 to 9 cases per 10,000 women. The increase in risk occurs to a lesser extent than in pregnancy, where the risk is 5-20 per 10,000 YL (pregnancy data are based on the actual duration of pregnancy in standard studies; based on the assumption that pregnancy lasts 9 months, the risk is 7 to 27 cases per 10,000 YL). In postpartum women, the risk of developing VTE ranges from 40 to 65 cases per 10,000 women. VTE is fatal in 1-2% of cases.

According to research results, women using the drug NuvaRing ® are at greater risk of developing VTE, similar to that of women using COCs (adjusted risk ratio is presented in the table below). A large prospective observational study, TASC (Transatlantic Active Study of the Safety of Cardiovascular Safety of NuvaRing ®), assessed the risk of VTE in women who started using NuvaRing ® or COCs, switched to NuvaRing ® or COCs from other contraceptives, or resumed use the drug NuvaRing ® or COCs, in the population of typical users. The women were observed for 24-48 months. The results showed a similar level of risk of developing VTE in women using the drug NuvaRing ® (incidence of 8.3 cases per 10,000 YL) and in women using COCs (incidence of 9.2 cases per 10,000 YL). For women using COCs, excluding desogestrel, gestodene and drospirenone, the incidence of VTE was 8.9 cases per 10,000 women.

A retrospective cohort study initiated by the FDA (US Food and Drug Administration) showed that the incidence of VTE in women who started using the drug NuvaRing ® was 11.4 cases per 10,000 YL, while in women of those who started using COCs containing levonorgestrel, the incidence of VTE is 9.2 cases per 10,000 YL.

Assessment of the risk (risk ratio) of developing VTE in women using the drug NuvaRing ® compared with the risk of developing VTE in women using COCs

Epidemiological study, population	Comparator(s)	Risk ratio (RR) (95% CI)
TAS (Dinger, 2012) Women who started using the drug (including again, after a break) and switched from other means of contraception.	All available COCs during Study 1	OR 2: 0.8 (0.5-1.5)
	Available COCs, except those containing desogestrel, gestodene, drospirenone	OR 2: 0.9 (0.4-2.0)
"FDA Initiated Study" (Sydney, 2011) Women who started using combined hormonal contraceptives (CHCs) for the first time during the study period.	COCs available during study period 3	OR 4: 1.09 (0.55-2.16)
	Levonorgestrel /0.03 mg ethinyl estradiol	OR 4: 0.96 (0.47-1.95)

1 Incl. low-dose COCs containing the following progestins: chlormadinone acetate, cyproterone acetate, desogestrel, dienogest, drospirenone, ethynodiol diacetate, gestodene, levonorgestrel, norethindrone, norgestimate or norgestrel.

2 Taking into account age, BMI, duration of use, history of VTE.

3 Incl. low-dose COCs containing the following progestins: norgestimate, norethindrone or levonorgestrel.

4 Taking into account age, place and year of inclusion in the study.

There are extremely rare cases of thrombosis of other blood vessels (for example, arteries and veins of the liver, mesenteric vessels, kidneys, brain and retina) with the use of COCs. It is unknown whether these cases are related to the use of COCs.

Possible symptoms of venous or arterial thrombosis may include pain in one leg and/or swelling; sudden severe chest pain, possibly radiating to the left arm; attack of shortness of breath, cough; any unusual, severe, prolonged headaches; sudden partial or complete loss of vision; double vision; slurred speech or aphasia; dizziness; collapse, accompanied or not accompanied by a focal epileptic seizure; sudden weakness or severe numbness on one side of the body or any part of the body; movement disorders; "sharp" stomach.

Risk factors for the development of venous thrombosis and embolism:

- age;

- presence of diseases in the family history (venous thrombosis and embolism in brothers/sisters at any age or in parents at a relatively early age). If a hereditary predisposition is suspected, before starting any hormonal contraceptives, the woman should be referred to a specialist for consultation;

- prolonged immobilization, major surgical interventions, any surgical interventions on the lower extremities or serious trauma. In such situations, it is recommended to stop using the drug (in the case of a planned operation, at least 4 weeks in advance) with subsequent resumption of use no earlier than 2 weeks after complete restoration of motor activity;

- for obesity (body mass index more than 30 kg/m2);

— possibly thrombophlebitis of the superficial veins and varicose veins.

There is no consensus on the possible role of these conditions in the etiology of venous thrombosis.

Risk factors for the development of complications of arterial thromboembolism:

— age;

— smoking (with heavy smoking and with age, the risk increases even more significantly, especially in women over 35 years of age);

— dyslipoproteinemia;

— obesity (body mass index more than 30 kg/m2);

— hypertension;

— migraine;

— heart valve disease;

— atrial fibrillation;

— presence of diseases in the family history (arterial thrombosis in brothers/sisters at any age or in parents at a relatively early age). If a hereditary predisposition is suspected, the woman should be referred to a specialist for consultation before starting any hormonal contraceptives.

Biochemical factors that may indicate hereditary or acquired predisposition to venous or arterial thrombosis include activated protein C resistance, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).

Other conditions that can cause unwanted circulatory problems include diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome and chronic inflammatory bowel disease (such as Crohn's disease or ulcerative colitis), as well as sickle cell anemia.

It is necessary to take into account the increased risk of thromboembolism in the postpartum period.

Risk of developing tumors

The most important risk factor for developing cervical cancer is infection with the human papillomavirus (HPV). Epidemiological studies have shown that long-term use of COCs leads to an additional increase in this risk, but it remains unclear to what extent this is due to other factors such as more frequent cervical smear examinations and differences in sexual behavior, including. use of barrier contraceptives. It remains unclear how this effect is related to the use of the drug NuvaRing ®.

A meta-analysis of 54 epidemiological studies found a small increase (1.24) in the relative risk of breast cancer in women taking combined hormonal oral contraceptives. The risk gradually decreases over 10 years after stopping the drugs. Breast cancer rarely develops in women under 40 years of age, so the additional incidence of breast cancer in women who take or have taken COCs is small compared to the overall risk of developing breast cancer. Breast cancer diagnosed in women who use COCs is clinically less severe than cancer diagnosed in women who have never used COCs. An increased risk of developing breast cancer may be
due to both the fact that women taking COCs are diagnosed with breast cancer earlier and the biological effects of COCs, or a combination of both of these factors.

In rare cases, cases of development of benign, and even more rarely, malignant liver tumors have been observed in women taking COCs. In some cases, these tumors led to the development of life-threatening bleeding into the abdominal cavity. The doctor should consider the possibility of a liver tumor in the differential diagnosis of diseases in a woman taking NuvaRing ® if symptoms include acute pain in the upper abdomen, liver enlargement, or signs of intra-abdominal bleeding.

Other states

Women with hypertriglyceridemia or a corresponding family history have an increased risk of developing pancreatitis when taking hormonal contraceptives.

Many women taking hormonal contraceptives experience a slight increase in blood pressure, but clinically significant increases in blood pressure are rare. A direct connection between the use of hormonal contraceptives and the development of arterial hypertension has not been established. If a constant increase in blood pressure is observed when using the drug NuvaRing ®, it is necessary to contact your doctor to decide whether it is necessary to remove the vaginal ring and prescribe antihypertensive therapy. With adequate blood pressure control using antihypertensive drugs, it is possible to resume use of the drug NuvaRing ®.

During pregnancy and during the use of combined oral contraceptives, the development or worsening of the following conditions was noted, although their relationship with the use of contraceptives has not been definitively established: jaundice and/or itching caused by cholestasis, formation of gallstones, porphyria, systemic lupus erythematosus, hemolytic -uremic syndrome, Sydenham's chorea (minor chorea), herpes of pregnancy, hearing loss due to otosclerosis, (hereditary) angioedema.

Acute or chronic liver dysfunction may serve as a reason to discontinue the drug NuvaRing ® until liver function indicators normalize. Recurrence of cholestatic jaundice, previously observed during pregnancy or during the use of sex steroids, requires discontinuation of the drug NuvaRing ® .

Although estrogens and progestogens may influence peripheral insulin resistance and tissue glucose tolerance, there is no evidence to support the need to change hypoglycemic therapy during the use of hormonal contraceptives. However, women with diabetes should be under constant medical supervision when using the drug NuvaRing ® , especially in the first months of contraception.

There is evidence of a worsening of Crohn's disease and ulcerative colitis with the use of hormonal contraceptives.

The following conditions may prevent the ring from being inserted correctly or may cause it to fall out: cervical prolapse, bladder and/or rectal hernia, severe chronic constipation.

In very rare cases, women have unintentionally inserted the NuvaRing ® vaginal ring into the urethra and possibly into the bladder. When symptoms of cystitis appear, it is necessary to consider the possibility of incorrect insertion of the ring.

Cases of vaginitis have been described during use of the drug NuvaRing ® . There is no evidence that treatment of vaginitis affects the effectiveness of the use of the drug NuvaRing ® , as well as evidence of the influence of the use of the drug NuvaRing ® on the effectiveness of treatment of vaginitis.

Very rare cases of difficult ring removal have been described that required removal by a medical professional.

Medical examination/consultation

Before prescribing the drug NuvaRing ® or resuming its use, you should carefully review the woman’s medical history (including family history) and conduct a gynecological examination to exclude pregnancy. It is necessary to measure blood pressure, conduct an examination of the mammary glands, pelvic organs, including a cytological examination of cervical smears and some laboratory tests, to exclude contraindications and reduce the risk of possible side effects of the drug. The frequency and nature of medical examinations depend on the individual characteristics of each patient, but medical examinations are carried out at least once every 6 months. A woman should read the instructions and follow all recommendations. The woman should be informed that NuvaRing ® does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Reduced efficiency

The effectiveness of the drug NuvaRing ® may decrease if the regimen is not followed or concomitant therapy is carried out.

Reduced cycle control

During use of the drug NovaRing ®, acyclic bleeding (spotting or sudden bleeding) may occur. If such bleeding is observed after regular cycles while using the drug NuvaRing ® correctly, you should contact your gynecologist to conduct the necessary diagnostic tests, incl. to exclude organic pathology or pregnancy. A diagnostic curettage may be required.

Some women do not bleed after the ring is removed. If the drug NuvaRing ® was used according to the instructions, it is unlikely that the woman is pregnant. If the recommendations of the instructions are not followed and there is no bleeding after removing the ring, as well as if there is no bleeding for two cycles in a row, pregnancy must be excluded.

Effects of ethinyl estradiol and etonogestrel on a sexual partner

The extent of exposure and possible pharmacological effects of ethinyl estradiol and etonogestrel on male sexual partners due to absorption through penile tissue have not been studied.

Laboratory research

The use of contraceptive steroids may affect the results of certain laboratory tests, including biochemical indicators of liver, thyroid, adrenal and kidney function, plasma levels of transport proteins (for example, corticosteroid binding globulin and sex hormone binding globulin), lipid/lipoprotein fractions, carbohydrate metabolism parameters and indicators of coagulation and fibrinolysis. Indicators, as a rule, vary within normal values.

Impact on the ability to drive vehicles and operate machinery

Based on information about the pharmacodynamic properties of the drug NovaRing ®, it can be expected that it does not affect the ability to drive vehicles and operate machinery.

Considering the pharmacodynamic properties of the drug NuvaRing ®, its effect on the ability to drive a car and use complex equipment is not expected.

Overdose

Serious consequences of an overdose of hormonal contraceptives have not been described.

Alleged symptoms: nausea, vomiting, slight vaginal bleeding in young girls.

Treatment: carry out symptomatic therapy. There are no antidotes.

Drug interactions

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Storage conditions and periods

The drug should be stored out of the reach of children at a temperature of 2° to 8°C. Shelf life - 3 years.

Drug interactions

Interactions between hormonal contraceptives and other drugs may lead to the development of acyclic bleeding and/or contraceptive failure.

The literature describes the following interactions with combined oral contraceptives in general.

There may be an interaction with drugs that induce microsomal enzymes, which can lead to increased clearance of sex hormones. Interactions have been established with the following drugs: phenytoin, barbiturates, primidone, carbamazepine, rifampicin, and possibly also oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin and preparations containing St. John's wort.

When treating any of the listed drugs, you should temporarily use a barrier method of contraception (condom) in combination with the drug NuvaRing ® or choose another method of contraception. During concomitant use of drugs that cause the induction of microsomal liver enzymes, and for 28 days after their discontinuation, barrier methods of contraception should be used.

If concomitant therapy is to be continued after 3 weeks of ring use, the next ring should be administered immediately without the usual interval.

A decrease in the effectiveness of oral contraceptives containing ethinyl estradiol has been observed with concomitant use of antibiotics such as ampicillin and tetracyclines. The mechanism of this effect has not been studied. In a pharmacokinetic interaction study, oral administration of amoxicillin (875 mg 2 times / day) or doxycycline (200 mg / day, and then 100 mg / day) for 10 days while using the drug NuvaRing ® had a slight effect on the pharmacokinetics of etonogestrel and ethinyl estradiol. When using antibiotics (except amoxicillin and doxycycline) you should use a barrier method of contraception (condom) during treatment and for 7 days after stopping antibiotics. If concomitant therapy is to be continued after 3 weeks of ring use, the next ring should be administered immediately without the usual interval.

Pharmacokinetic studies did not reveal the effect of the simultaneous use of antifungal agents and spermicides on the contraceptive effectiveness and safety of the drug NuvaRing ®. When combined with suppositories and antifungal drugs, the risk of ring rupture slightly increases.

Hormonal contraceptives can cause disruption of the metabolism of other drugs. Accordingly, their concentrations in plasma and tissues may increase (for example, cyclosporine) or decrease (for example, lamotrigine).

To exclude possible interactions, it is necessary to study the instructions for use of other drugs.

Pharmacokinetic data show that the use of tampons does not affect the absorption of hormones released from the NovaRing ® vaginal ring. In rare cases, the ring may be accidentally removed when removing the tampon.

Description:

A modern combined hormonal contraceptive (ring) for intravaginal administration.

Manufacturer:

ORGANON (Netherlands)

Composition and release form

The vaginal ring is smooth, transparent, colorless or almost colorless, without major visible damage, with a transparent or almost transparent area at the junction.

Active ingredients: ethinyl estradiol 2.7 mg, etonogestrel 11.7 mg. Excipients: ethylene vinyl acetate copolymer (28% vinyl acetate), ethylene vinyl acetate copolymer (9% vinyl acetate), magnesium stearate.

pharmachologic effect

Combined hormonal contraceptive drug for intravaginal use. Contains etonogestrel, which is a progestogen, a derivative of 19-nortestosterone, and ethinyl estradiol, which is an estrogen. The main mechanism of contraceptive action of the drug NuvaRing is inhibition of ovulation. The progestin component (etonogestrel) inhibits the synthesis of LH and FSH by the pituitary gland and, thus, prevents follicle maturation (blocks ovulation).

The Pearl index, an indicator reflecting the frequency of pregnancy in 100 women during a year of contraception, when using the drug NuvaRing is 0.96. The use of the drug reduces the pain and intensity of menstrual-like bleeding, reduces the frequency of acyclic bleeding and the likelihood of developing iron deficiency conditions. In addition, there is evidence of a reduced risk of endometrial and ovarian cancer with the use of the drug. NuvaRing does not reduce bone mineral density.

Indications for use

Intravaginal contraception (prevention of unwanted pregnancy) in women.

Mode of application

NuvaRing is inserted into the vagina once every 4 weeks. The ring is in the vagina for 3 weeks and then removed on the same day of the week on which it was placed in the vagina; after a week's break, a new ring is inserted. For example: if the NuvaRing ring was installed on Wednesday at approximately 10:00 pm, then it should be removed on Wednesday 3 weeks later at approximately 10:00 pm; on the following Wednesday a new ring is inserted.

Bleeding associated with discontinuation of the drug usually begins 2-3 days after removal of the NuvaRing and may not completely stop until a new ring is installed.

Start using Nuvaring

Hormonal contraceptives were not used in the previous menstrual cycle
NuvaRing should be administered on the first day of the cycle (i.e., the first day of menstruation). It is possible to install a ring on days 2-5 of the cycle, however, in the first cycle in the first 7 days of using the drug NuvaRing, additional use of barrier methods of contraception is recommended.

Switching from taking combined oral contraceptives

NuvaRing should be administered on the last day of the free interval in taking combined hormonal contraceptives (pills or patch). If a woman has been taking the combined hormonal contraceptive correctly and regularly and is confident that she is not pregnant, she can switch to using a vaginal ring on any day of her cycle. The duration of the interval in taking hormonal contraceptives should not exceed the recommended period.

Switching from progestin-only contraception (mini-pill, implant, or injectable contraception) or progestogen-releasing intrauterine device (IUD)

A woman taking the mini-pill can switch to using NuvaRing on any day (the ring is inserted on the day the implant or IUD is removed or on the day of the next injection). In all these cases, the woman should use a barrier method of contraception for the first 7 days after insertion of the ring.

After an abortion performed in the first trimester of pregnancy

You can start using NuvaRing immediately after an abortion. In this case, there is no need for additional use of other contraceptives. If the use of NuvaRing immediately after an abortion is undesirable, the ring should be used in the same way as if hormonal contraceptives were not used in the previous cycle. In the interval, the woman is recommended an alternative method of contraception.

After childbirth or abortion performed in the second trimester of pregnancy

The use of NuvaRing should begin within the 4th week after childbirth (if the woman is not breastfeeding) or abortion in the second trimester. If the use of NuvaRing is started at a later date, then additional use of barrier methods of contraception is necessary in the first 7 days of using NuvaRing. However, if sexual intercourse has already taken place during this period, you must first exclude pregnancy or wait until your first menstruation before starting to use the drug NuvaRing.

Extending the break from using the ring

If the ring has been temporarily removed from the vagina

If the ring remains outside the vagina for less than 3 hours, the contraceptive effect will not decrease. The ring should be reinserted into the vagina as soon as possible.

If the ring was left outside the vagina for more than 3 hours during the first or second week of use, the contraceptive effect may be reduced. You should place the ring in your vagina as soon as possible. Over the next 7 days, you must use a barrier method of contraception, such as a condom. The longer the ring was outside the vagina and the closer this period is to the 7-day break in using the ring, the higher the likelihood of pregnancy.

If the ring was left outside the vagina for more than 3 hours during the third week of use, the contraceptive effect may be reduced. The woman should throw away this ring and choose one of two methods:
Immediately install a new ring. Please note that the new ring can be used for the next 3 weeks. In this case, there may be no bleeding associated with the cessation of the drug's effect. However, spotting or bleeding in the middle of the cycle is possible.

Wait for bleeding associated with the cessation of the drug, and insert a new ring no later than 7 days after removing the previous ring. This option should only be chosen if the ring use regimen has not previously been violated during the first 2 weeks.

Extended use of the ring

If the drug NuvaRing was used for no more than a maximum period of 4 weeks, then the contraceptive effect remains sufficient. You can take a week's break from using the ring and then insert a new ring. If NuvaRing remains in the vagina for more than 4 weeks, the contraceptive effect may deteriorate, so pregnancy must be ruled out before inserting a new ring.

To change the time of onset of menstrual bleeding

To delay (prevent) menstrual-like withdrawal bleeding, you can insert a new ring without a week's break. The next ring must be used within 3 weeks. This may cause bleeding or spotting. Then, after the usual one-week break, you should return to regular use of NuvaRing.

To postpone the onset of bleeding to another day of the week, it may be recommended to take a shorter break from using the ring (for as many days as necessary). The shorter the interval between ring use, the higher the likelihood that there will be no bleeding after ring removal, and no bleeding or spotting will occur when the next ring is used.

Ring damage

In rare cases, ring rupture has occurred when using NuvaRing. The core of the NuvaRing ring is solid, so its contents remain intact, and the release of hormones does not change significantly. If the ring ruptures, it usually falls out of the vagina. If the ring ruptures, a new ring must be inserted.

Ring falling out

NuvaRing has sometimes been reported to fall out of the vagina, for example, when it was inserted incorrectly, when a tampon was removed, during sexual intercourse, or due to severe or chronic constipation. In this regard, it is advisable for a woman to regularly check the presence of the NuvaRing ring in the vagina.

Incorrect insertion of the ring

In very rare cases, women have inadvertently inserted NuvaRing into the urethra. When symptoms of cystitis appear, it is necessary to consider the possibility of incorrect insertion of the ring.

Rules for using NuvaRing

The patient can independently insert NuvaRing into the vagina. To insert the ring, a woman should choose the position that is most comfortable for her, for example, standing, raising one leg, squatting, or lying down. NuvaRing must be squeezed and inserted into the vagina until the ring is in a comfortable position. The exact position of NuvaRing in the vagina is not decisive for the contraceptive effect.

To remove the ring, you can pick it up with your index finger or squeeze it between your index and middle fingers and pull it out of the vagina.

Side effect

The following side effects may occur when using Nuvaring:

System-organ class	Often (? 1/100)	Infrequently (< 1/100, ? 1/1000)	Rarely (< 1/1000)
Infections and infestations	Vaginal infection (candidiasis, vaginitis)	Cystitis, cervicitis, urinary tract infections
The immune system			Hypersensitivity
Metabolic disorders	Weight gain	Increased appetite
Mental disorders	Depression, decreased libido	Mood changes
From the nervous system	Headache, migraine	Dizziness
From the side of the organ of vision		Visual impairment
From the cardiovascular system		"Tides"
From the digestive system	Abdominal pain, nausea	Bloating, diarrhea, vomiting, constipation
From the skin		Alopecia, eczema, itchy skin	Skin rash
From the musculoskeletal system		Pain in the lumbar region, muscle spasms, pain in the limbs
From the urinary system		Dysuria, urgency, pollakiuria
From the reproductive system	Engorgement and tenderness of the mammary glands, genital itching in women, pelvic pain, vaginal discharge	Amenorrhea, cervical polyps, contact (during sexual intercourse) spotting (bleeding), dyspareunia, ectropion of the uterus, fibrocystic mastopathy, menorrhagia, metrorrhagia, premenstrual syndrome, dysmenorrhea, uterine spasm, burning sensation in the vagina, dryness of the vulva and mucous membrane vagina.	Local reactions on the part of the penis (sensation of a foreign body by the partner during sexual intercourse, irritation of the penis with increased sensitivity to the components of the drug)
	Vaginal ring prolapse	Rupture (damage) of the ring, fatigue, malaise, abdominal pain, swelling, sensation of a foreign body in the vagina

Contraindications for use

Venous thrombosis (including a history), including deep vein thrombosis, pulmonary embolism;
- arterial thrombosis (including a history), including stroke, transient cerebrovascular accidents, myocardial infarction and/or precursors of thrombosis, including angina pectoris, transient ischemic attack;
- heart defects with thrombogenic complications;
- changes in blood parameters indicating a predisposition to the development of venous or arterial thrombosis, including resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant);
- migraine with focal neurological symptoms;
- arterial hypertension (systolic blood pressure? 160 mm Hg. or diastolic blood pressure? 100 mm Hg.);
- diabetes mellitus with vascular damage;
- pancreatitis incl. history, in combination with severe hypertriglyceridemia;
- severe liver diseases, until normalization of liver function indicators;
- liver tumors (including in history);
- hormone-dependent malignant tumors (for example, breast cancer), established, suspected or in history;
- bleeding from the vagina of unknown etiology;
- pregnancy (including suspected);
- lactation period;
- surgical interventions followed by long-term immobilization;
- smoking (15 or more cigarettes per day) in women 35 years of age and older;
- hypersensitivity to the components of the drug.

The drug should be prescribed with caution if any of the following disease conditions or risk factors are present; in such cases, the doctor must carefully weigh the benefit-risk ratio of using the drug NuvaRing:

Venous or arterial thrombosis (in siblings and/or parents);
- obesity (body mass index more than 30 kg/m2);
- dislipoproteinemia;
- varicose veins (in combination with thrombophlebitis of the superficial veins);
- atrial fibrillation;
- diabetes;
- systemic lupus erythematosus;
- hemolytic-uremic syndrome;
- epilepsy;
- chronic inflammatory bowel diseases (Crohn's disease and ulcerative colitis);
- sickle cell anemia;
- congenital hyperbilirubinemia (Gilbert, Dubin-Johnson, Rotor syndromes);
- chloasma;
- uterine fibroids;
- fibrocystic mastopathy;
- conditions that make it difficult to use a vaginal ring: cervical prolapse, bladder hernia, rectal hernia, severe chronic constipation;
- adhesions in the vagina;
- smoking (less than 15 cigarettes per day) in women 35 years of age and older.

If the disease worsens, the condition worsens, or other risk factors appear, the woman should also consult a doctor and possibly discontinue the drug.

Although a cause-and-effect relationship has not been convincingly proven, caution should be exercised when prescribing NovaRing if the following conditions/diseases have previously developed or worsened during the use of any other hormonal contraceptives or previous pregnancy: jaundice and/or itching associated with cholestasis, formation of gallstones, porphyria, Sydenham's chorea, herpes of pregnancy, otosclerosis with hearing loss, (hereditary) angioedema.

Recurrence of cholestatic jaundice and/or cholestasis with itching, which was observed during pregnancy or previous use of sex hormones, is grounds for discontinuing the use of NuvaRing.

Use of NuvaRing during pregnancy and breastfeeding

The use of NuvaRing is contraindicated during pregnancy, suspected pregnancy and lactation. NuvaRing is contraindicated during breastfeeding. NuvaRing can affect lactation, reduce the amount and change the composition of breast milk. Small amounts of contraceptive steroids and/or their metabolites may be excreted in milk.

Use for liver dysfunction

NuvaRing is contraindicated in severe liver diseases (until normalization of function indicators).

special instructions

Before prescribing or resuming the use of the drug NuvaRing, you should conduct a medical examination: analyze your medical history (including family history) and exclude pregnancy; measure blood pressure; conduct an examination of the mammary glands, pelvic organs, including cytological examination of smears from the cervix; conduct some laboratory tests to exclude contraindications and reduce the risk of possible side effects of the drug NuvaRing. The frequency and nature of medical examinations are carried out by a specialist, taking into account the individual characteristics of each woman, but at least once every 6 months.

The patient should read the instructions for use of the drug NuvaRing and follow all recommendations.

It should be kept in mind that NuvaRing does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Women aged 40 years and older, women with cervical intraepithelial neoplasia, as well as women who smoke at any age require additional consultation with a gynecologist before prescribing NuvaRing.

The effectiveness of the drug NuvaRing may decrease if the regimen is not followed.

While using NuvaRing, acyclic bleeding (spotting or sudden bleeding) may occur. If such bleeding is observed after regular cycles while using NuvaRing in accordance with the instructions, you should contact your gynecologist to conduct the necessary diagnostic tests, incl. to exclude a malignant tumor and pregnancy. A diagnostic curettage may be required.

Some women do not bleed after the ring is removed. If NuvaRing is used as directed, it is unlikely that the woman is pregnant. If the recommendations of the instructions are not followed and there is no bleeding after removing the ring, as well as if there is no bleeding in two cycles in a row, pregnancy must be excluded.

The most important risk factor for developing cervical cancer is infection with the human papillomavirus (HPV). Epidemiological studies have shown that long-term use of combined hormonal contraceptives further increases this risk, but the extent to which this is due to other factors remains unclear. The positive role of regular examinations of women by a gynecologist and the use of barrier methods of contraception are obvious. There is no information about an increased risk of developing cervical cancer in HPV-infected women using NuvaRing.

Studies have found a small increase in the relative risk (1.24) of developing breast cancer in women taking combined hormonal oral contraceptives, but this risk gradually decreases over 10 years after discontinuation of the drugs. Breast cancer is rare in women under 40 years of age, so the additional incidence of breast cancer in women who have received or continue to use combined oral contraceptives is small compared to the overall risk of developing breast cancer. There is evidence that women who have taken oral combined contraceptives have less breast cancer than women who have never used such medications. The possibility of the effect of the drug NuvaRing on the incidence of breast cancer is being studied.

In rare cases, benign liver tumors were observed in women taking combined oral contraceptives, and even more rarely, malignant ones. In some cases, these tumors led to the development of life-threatening bleeding into the abdominal cavity. If severe pain appears in the upper abdomen, liver enlargement, or signs of intra-abdominal bleeding in a woman using NuvaRing, a liver tumor should be excluded.

Although many women taking hormonal contraceptives experience a slight increase in blood pressure, clinically significant hypertension is rare. A direct connection between the use of hormonal contraceptives and the development of arterial hypertension has not been established. However, if, when using the drug NuvaRing, there is a constant increase in blood pressure, the patient should contact her gynecologist; in such cases, the ring should be removed, antihypertensive therapy should be prescribed and the issue of choosing the most acceptable method of contraception, incl. possible resumption of use of the drug NuvaRing.

Although estrogens and progestogens can influence peripheral insulin resistance and tissue tolerance to glucose, there is no evidence to support the need to change hypoglycemic therapy during the use of hormonal contraceptives. However, women with diabetes should be under constant medical supervision when using NuvaRing, especially in the first months of contraception.

Serious surgery (including on the lower extremities) is a contraindication to the use of the drug. In case of planned surgery, it is recommended to stop using the drug at least 4 weeks in advance, and resume no earlier than 2 weeks after complete restoration of motor activity.

Women predisposed to the development of chloasma should avoid exposure to sunlight and ultraviolet radiation while using NuvaRing.

The extent of exposure and possible pharmacological effects of ethinyl estradiol and etonogestrel on the glans mucosa and skin of the penis have not been studied.

Impact on the ability to drive vehicles and operate machinery

Considering the pharmacodynamic properties of the drug NuvaRing, its effect on the ability to drive a car and use complex equipment is not expected.

Overdose

Serious consequences of an overdose of hormonal contraceptives have not been described. Suspected symptoms: nausea, vomiting, slight vaginal bleeding in young girls.

Treatment: carry out symptomatic therapy. There are no antidotes.

Drug interactions

Interactions between hormonal contraceptives and other drugs may lead to the development of acyclic bleeding and/or contraceptive failure. There may be an interaction with drugs that induce microsomal enzymes, which can lead to increased clearance of sex hormones.

The effectiveness of NovaRing may be reduced with simultaneous use of antiepileptic drugs (phenytoin, phenobarbital, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate), anti-tuberculosis drugs (rifampicin), antimicrobial drugs (ampicillin, tetracycline, griseofulvin), possibly antiviral drugs (ritonavir) and medicines containing St. John's wort.

When treating any of the listed drugs, a woman should temporarily use a barrier method of contraception in combination with the drug NuvaRing or choose another method of contraception. When treating with drugs that induce liver enzymes, a barrier method (condom) should be used during treatment and for 28 days after discontinuation of such drugs.

If concomitant therapy is to be continued after 3 weeks of ring use, the next ring should be administered immediately without the usual interval.

During treatment with antibiotics (excluding amoxicillin and doxycycline), it is necessary to use a barrier method of contraception (condom) during treatment and for 7 days after their discontinuation. If concomitant therapy is to be continued after 3 weeks of ring use, the next ring should be administered immediately without the usual interval.

As a result of pharmacokinetic studies, no effect on the contraceptive effectiveness and safety of the drug NuvaRing when used simultaneously with antifungals and spermicides was identified. When combined with suppositories and antifungal agents, the risk of ring rupture increases slightly.

To exclude possible interactions, it is necessary to study the instructions for use of other drugs.

The use of tampons does not affect the effectiveness of NuvaRing. In rare cases, the ring may be accidentally removed when removing the tampon.

Storage conditions and periods

NuvaRing should be stored out of the reach of children at a temperature of 2° to 8°C (in the refrigerator).