How to glue the Evra patch. The Evra patch has come off - what to do? What to do if pregnancy occurs while using the Evra hormonal patch

Description:

Modern combined hormonal contraceptive(patch) for transdermal use.

Manufacturer:
Janssen-Cilag (Belgium).

Composition and release form

Transdermal therapeutic system(TTS) square shape, with a beige matte backing, rounded corners, a colorless adhesive layer and a transparent protective film; the inscription "EVRA" is embossed on the backing.

Active substance: 1 TTC contains norelgestromin 6 mg, ethinyl estradiol 600 mcg (releases norelgestromin 203 mcg, ethinyl estradiol 33.9 mcg within 24 hours).

Excipients:
Composition of the TTS base: outer layer made of pigmented low density polyethylene and inner layer made of polyester. Composition of the TTC middle layer: adhesive mixture of polyisobutylene-polybutene, crospovidone, polyester non-woven material, lauryl lactate. Composition of the removable protective layer of TTS: polyethylene terephthalate film, polydimethylsiloxane coating.

pharmachologic effect

Contraceptive for transdermal use. Inhibits the gonadotropic function of the pituitary gland, suppresses the development of the follicle and interferes with the ovulation process. The contraceptive effect is enhanced by increasing the viscosity of cervical mucus and reducing the susceptibility of the endometrium to the blastocyte. Pearl index – 0.90.

The pregnancy rate does not depend on factors such as age, race and increases in women weighing more than 90 kg.

Pharmacokinetics

After application of the Evra patch, norelgestromin and ethinyl estradiol quickly appear in the serum, reaching a plateau after approximately 48 hours, and remain in equilibrium concentrations throughout the period of wearing the patch. This eliminates the daily rise and fall in serum hormone levels that occurs when using oral contraceptives. The study examined the pharmacokinetics of norelgestromin and ethinyl estradiol in 37 women when the Evra patch was applied to the skin of the abdomen, buttocks, arms or back for 7 days. In all three studies, serum concentrations of norelgestromin and ethinyl estradiol remained within the target range throughout the entire period of wearing the Evra patch, regardless of application site. Absorption of norelgestromin when applied to all sites - buttocks, arm and torso - was therapeutically equivalent.

Evra allows for continuous administration of norelgestromin and ethinyl estradiol into the systemic circulation and suppresses follicle development for another two full days after completing the recommended 7-day period of wearing the patch. Even after a 2-day delay in patch replacement, serum concentrations of the two hormones remained within the target range. Because norelgestromin and ethinyl estradiol continue to provide contraceptive effect during this 2-day period, additional contraception is not necessary if up to 2 days are missed. During each of the three 7-day periods of Evra attachment, 30 women wore the patch on their abdomen in one of the six various conditions: normal activity, sauna, hydromassage, treadmill, cool water immersion, or a combination of these. During the study under the influence elevated temperature, humidity, cold and/or physical exercise in a fitness club, only one (1.1%) of 87 patches came off completely on its own. Values maximum concentration serum levels of norelgestromin and ethinyl estradiol indicate that none of these conditions resulted in a sudden release of excess hormones.

Indications for use

Contraception (warning unwanted pregnancy) among women.

Mode of application

The patient should be informed that to achieve maximum contraceptive effect It is necessary to strictly follow the instructions for use of TTS Evra. Only one TTS can be used at a time.

Each used TTC is removed and immediately replaced with a new one on the same day of the week (“replacement day”) on days 8 and 15 menstrual cycle(2nd and 3rd week). TTS can be changed at any time on the day of replacement. During the 4th week, from the 22nd to 28th day of the cycle, TTC is not used. A new contraceptive cycle begins the day after the end of the 4th week; the next TTS should be stuck on, even if there was no menstruation or it has not ended.

Under no circumstances should a break in the application of TTC Evra be longer than 7 days, otherwise the risk of pregnancy increases. In such situations, it is necessary to simultaneously use a barrier method of contraception for 7 days, because the risk of ovulation increases with each day that the recommended duration of the period is exceeded application of TTS. In case of sexual intercourse during such an extended period, the probability of conception is very high.

Start of application of TTS Evra

If the woman did not use hormonal contraception during the previous menstrual cycle
Contraception with TTC Evra begins on the first day of menstruation. One TTC Evra is glued to the skin and used for the whole week (7 days). The day of gluing the first TTS Evra (1st day/start day) determines the subsequent days of replacement. The replacement day will fall on the same day of each week (8th and 15th days of the cycle). On the 22nd day of the cycle, TTC is removed, and from the 22nd to 28th day of the cycle the woman does not use TTC Evra. The next day is considered the first day of the new contraceptive cycle. If a woman does not start using TTC Evra from the first day of the cycle, then she should simultaneously use barrier methods of contraception during the first 7 days of the first contraceptive cycle.
If a woman switches from using a combined oral contraceptive to using TTC Evra
TTC Evra should be applied to the skin on the 1st day of menstruation, which began after stopping the combined oral contraceptive. If menstruation does not begin within 5 days after taking the contraceptive pill, then pregnancy must be ruled out before starting to use TTC Evra.

If the use of Evra begins after the 1st day of menstruation, then for 7 days it is necessary to simultaneously use barrier methods of contraception. If more than 7 days have passed since the last contraceptive pill, a woman may be ovulating and should therefore consult a doctor before starting to use TTC Evra. Sexual intercourse during this extended drug-free period contraceptive pills may lead to pregnancy.
If a woman switches from using progestogen-only medications to using TTC Evra
A woman can switch from using a drug containing only a progestogen at any day (on the day the implant is removed, on the day the next injection is due), but during the first 7 days of using TTC Evra, a barrier method should be used to enhance the contraceptive effect.

After an abortion or miscarriage

After an abortion or miscarriage before the 20th week of pregnancy, you can immediately begin using TTC Evra. If a woman begins to use TTC Evra immediately after an abortion or miscarriage, then additional methods no contraception required. A woman should know that ovulation can occur within 10 days after an abortion or miscarriage. After an abortion or miscarriage in the 20th week of pregnancy or late use TTC Evra can be started on the 21st day after an abortion or miscarriage, or on the 1st day of the first menstruation.
After childbirth
Women who are not breastfeeding should start using TTC Evra no earlier than 4 weeks after birth. If a woman starts using TTC Evra later, then during the first 7 days she must additionally use a barrier method of contraception. If sexual intercourse has taken place, pregnancy must be excluded before starting the use of TTC Evra, or the woman must wait until her first menstruation.

In case of complete or partial peeling off of TTS Evra

If TTS Evra has completely or partially peeled off, then an insufficient amount of its active ingredients enters the blood. Even if the TTS Evra is partially peeled off in less than a day (up to 24 hours): the TTS Evra should be re-glued in the same place or immediately replaced with a new TTS Evra. Additional contraception is not required. The next TTS Evra must be glued on the usual “replacement day”.

If partial peeling occurs for more than 24 hours (24 hours or longer), and if the woman does not know exactly when the TTC Evra partially or completely peeled off, pregnancy may occur. A woman should start right away new cycle, gluing a new TTS Evra and consider this day the first day of the contraceptive cycle. Barrier methods contraception should be used simultaneously only in the first 7 days of a new cycle.

You should not try to re-glue TTS Evra if it has lost its adhesive properties; instead, you need to immediately glue the new TTS Evra. Do not use additional adhesive tapes or bandages to hold the Evra TTS in place.

If the next days of replacing TTS Evra are missed

At the beginning of any contraceptive cycle (1st week/1st day)

If there is an increased risk of pregnancy, a woman should glue the first TTC Evra of the new cycle as soon as she remembers it. This day is considered the new "1st day" and a new "replacement day" is counted. Non-hormonal contraception should be used simultaneously during the first 7 days of a new cycle. In case of sexual intercourse during such an extended period without the use of TTC Evra, conception may occur.

In the middle of the cycle (2nd week/8th day or 3rd week/15th day):
if 1 or 2 days have passed since the date of replacement (up to 48 hours): the woman should immediately glue a new TTS. The next TTS must be glued on the usual “replacement day”. If during the 7 days preceding the first missed day of TTC attachment, the use of TTC was correct, then additional contraception is not required;

if more than 2 days have passed since the replacement date (48 hours or more): exists increased risk occurrence of pregnancy. The woman should stop the current contraceptive cycle and immediately begin a new 4-week cycle with a new Evra TTC. This day is considered the new "1st day" and a new "replacement day" is counted. Barrier contraception should be used simultaneously during the first 7 days of a new cycle;

at the end of the cycle (4th week/22nd day): if the TTC is not removed at the beginning of the 4th week (22nd day), then it should be removed as quickly as possible. The next contraceptive cycle should begin on the usual “replacement day,” which is the day after the 28th day. Additional contraception is not required.

Changing the replacement day

In order to postpone menstruation by one cycle, a woman must apply a new TTC Evra at the beginning of the 4th week (22nd day), thereby skipping the period free from the use of TTS Evra. Intermenstrual bleeding or spotting may occur. After 6 consecutive weeks of TTC use, there should be a 7-day TTC-free interval. After this interval ends, regular use of the drug is resumed.

If, on the designated day during the week free from use, a woman wants to change the day of replacement, she must complete the current cycle by removing the third TTC Evra; a woman can choose a new day of replacement by gluing the first TTC Evra of the next cycle on the selected day. The period free from the use of TTS Evra should in no case be more than 7 days. The shorter this period, the higher the likelihood that a woman will not have another menstruation, and during the next contraceptive cycle, intermenstrual bleeding or spotting may occur.

How to properly stick TTS Evra

TTC Evra should be applied to clean, dry, intact and healthy skin of the buttocks, abdomen, outer upper arm or upper torso with minimal hair growth, in areas where it will not come into contact with tight-fitting clothing.

To avoid possible irritation, each subsequent TTC Evra must be glued to a different area of the skin; this can be done within the same anatomical area.

TTC Evra must be pressed tightly so that its edges are in good contact with the skin. To prevent a decrease in the adhesive properties of TTC Evra, do not apply makeup, creams, lotions, powders and others local remedies on those areas of the skin where it is glued or will be glued.

A woman should inspect the Evra TTC daily to ensure that it is firmly attached.

Used TTS must be disposed of carefully according to instructions.

Side effect

When using TTS Evra, the following may be observed: side effects:

From the central nervous system and peripheral nervous system: dizziness, migraine, paresthesia, hypoesthesia, convulsions, tremor, emotional lability, depression, anxiety, insomnia, drowsiness.

From the outside of cardio-vascular system: increased blood pressure, palpitations, edema syndrome, varicose veins veins

From the outside digestive system: gingivitis, anorexia or increased appetite, gastritis, gastroenteritis, dyspepsia, abdominal pain, vomiting, diarrhea, flatulence, constipation, hemorrhoids.

From the outside respiratory system: infections upper sections respiratory tract, shortness of breath, bronchial asthma.

From the outside reproductive system: pain during sexual intercourse (dyspareunia), vaginitis, dysmenorrhea, decreased libido, enlarged mammary glands, menstrual irregularities (including intermenstrual bleeding, hypermenorrhea), changes in vaginal secretion, changes in cervical mucus, lactation not occurring in connection with childbirth , ovarian dysfunction, mastitis, breast fibroadenomas, ovarian cysts.

From the urinary system: urinary tract infections.

From the outside musculoskeletal system: muscle cramps, myalgia, arthralgia, ostalgia (including back pain, pain in lower limbs), tendinosis (tendon changes), muscle weakness.

Dermatological reactions: itchy skin, urticaria, skin rash, contact dermatitis, bullous rash, acne, skin discoloration, eczema, increased sweating, alopecia, photosensitivity, dry skin.

From the organs of vision: conjunctivitis, visual impairment.

From the side of metabolism: weight gain, hypertriglyceridemia, hypercholesterolemia.
Other flu-like syndrome, feeling tired, allergic reactions, chest pain, asthenic syndrome, fainting, anemia, abscesses, lymphadenopathy.

Rarely (with frequency from >0.01% to<0.1%) гипертонус или гипотонус мышц, нарушение координации движений, дисфония, гемиплегия, невралгия, ступор, повышение либидо, деперсонализация, апатия, паранойя, доброкачественные опухоли молочных желез, рак шейки матки in situ, боль в промежности, изъязвление гениталий, атрофия молочных желез, cнижение АД, энантема, сухость во рту или усиленное слюноотделение, колит, боль при мочеиспускании, гиперпролактинемия, меланоз, нарушения пигментации кожи, хлоазма, ксерофтальмия, снижение массы тела или ожирение, воспаление подкожной клетчатки, непереносимость алкоголя, холецистит, холелитиаз, нарушение функции печени, пурпура, "приливы" крови к лицу, тромбоз (в т.ч. тромбоз глубоких вен, тромбоз легочной артерии), тромбофлебит поверхностных вен, боль в венах, эмболия легочной артерии.

Contraindications for use

Venous thrombosis, incl. history (including deep vein thrombosis, pulmonary embolism);
- Arterial thrombosis, incl. history (including acute cerebrovascular accident, myocardial infarction, retinal artery thrombosis) or precursors of thrombosis (including angina pectoris or transient ischemic attack);
- The presence of serious or multiple risk factors for arterial thrombosis: severe arterial hypertension (more than 160/100 mmHg), diabetes mellitus with vascular damage;
- Hereditary dyslipoproteinemia;
- Hereditary predisposition to venous or arterial thrombosis (for example, activated protein C resistance, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies - antibodies against cardiolipin, lupus anticoagulant);
- Migraine with aura;
- Confirmed or suspected breast cancer;
- Endometrial cancer and confirmed or suspected estrogen-dependent tumors;
- Aadenoma and liver carcinoma;
- Genital bleeding;
- Postmenopausal period;
- Age up to 18 years;
- Postpartum period (4 weeks);
- Lactation period;
- Hypersensitivity to the components of the drug.

Do not use on the mammary glands, as well as on hyperemic, irritated or damaged areas of the skin.

Caution should be used when there is a family history of venous or arterial thromboembolism in brothers, sisters or parents at a relatively young age; with prolonged immobilization; obesity (body mass index more than 30 kg/m2, calculated as the ratio of body weight in kilograms to the square of height in meters); thrombophlebitis of superficial veins and varicose veins; dyslipoproteinemia; arterial hypertension; lesions of the heart valve apparatus; atrial fibrillation; diabetes mellitus; systemic lupus erythematosus; hemolytic-uremic syndrome; Crohn's disease; ulcerative colitis; liver dysfunction; hypertriglyceridemia (including family history); acute impairment of liver function during a previous pregnancy or previous use of sex hormones; for menstrual irregularities; renal dysfunction.

Use of the drug Evra during pregnancy and lactation

The drug Evra is contraindicated during pregnancy and lactation.

Use for liver and kidney dysfunctions

Evra should be used with caution in case of liver dysfunction; acute impairment of liver function during a previous pregnancy or previous use of sex hormones.
Use with caution in case of impaired renal function.

Use in children under 12 years of age

The drug Evra is contraindicated in children and adolescents under 18 years of age.

special instructions

There is no clinical evidence that the transdermal contraceptive system is in any way safer than oral contraceptives.

Before starting or resuming the use of TTC Evra, it is necessary to obtain a detailed medical history (including family history) and exclude pregnancy. Blood pressure should be measured and a physical examination should be performed, taking into account contraindications and warnings.

If a hereditary predisposition to venous thromboembolism is suspected (if venous thromboembolism occurred in a brother, sister or parent at a relatively young age), the woman should be referred for consultation with a specialist before deciding on the use of hormonal contraception.

The risk of vascular complications is increased in women with thrombophlebitis of the superficial veins and varicose veins, as well as in obesity (body mass index more than 30 kg/m2).

In case of prolonged immobilization, after major surgery on the lower extremities or severe trauma, it is recommended to stop using hormonal contraceptives (for planned surgery, this should be done 4 weeks before it) and resume hormonal contraception no earlier than 2 weeks later. after complete remobilization.

Some epidemiological studies have found an increased risk of cervical cancer in women who use combined oral contraceptives for a long time.

Women taking combined oral contraceptives may develop liver tumors, which can cause life-threatening intra-abdominal bleeding. If women using TTC Evra experience severe pain in the upper abdomen, liver enlargement or symptoms of intra-abdominal bleeding, differential diagnosis should be carried out to exclude a possible liver tumor.

Women with hypertriglyceridemia or a family history of this disease may have an increased risk of pancreatitis when using combined hormonal contraceptives.

If pharmacologically uncontrolled arterial hypertension occurs in women while using combined hormonal contraceptives, the drug should be discontinued. The use of TTC Evra can be resumed after normalization of blood pressure.

The following conditions have been reported to occur or be aggravated by oral use of combined hormonal contraceptives, but there is no convincing evidence that they are associated with the use of combined oral contraceptives. These include: jaundice and/or pruritus associated with cholestasis; cholelithiasis; porphyria; systemic erythematosis; hemolytic-uremic syndrome; Sydenham's chorea; gestational herpes, otosclerosis-related hearing loss. Hormonal contraceptives may affect some endocrine parameters, liver function markers, and blood components:
concentrations of prothrombin and coagulation factors VII, VIII, IX and X increase; the level of antithrombin III decreases; protein S levels decrease; norepinephrine-induced platelet aggregation increases;

the concentration of thyroxine-binding globulin increases, which causes an increase in the concentration of total thyroid hormone, which is measured by the content of protein-bound iodine, T4 content (determined using chromatography or radioimmunoassay); The binding of free T3 by the ion exchange resin decreases, as evidenced by an increase in the concentration of thyroxine-binding globulin, the concentration of free T4 does not change. Serum concentrations of other binding proteins may be increased;

The concentrations of sex hormone-binding globulins increase, which leads to an increase in the concentrations of total circulating endogenous sex hormones. At the same time, the concentrations of free or biologically active sex steroids decrease or remain unchanged.

In women using TTC Evra, the concentrations of HDL-C, total cholesterol, LDL-C and TG may slightly increase, while the LDL-C/HDL-C ratio may remain unchanged.

Hormonal contraceptives may cause a decrease in serum folate concentrations. This may have potentially clinically significant consequences if a woman becomes pregnant soon after stopping hormonal contraception. It is currently recommended that all women take folic acid during and after stopping hormonal contraception.

Combined hormonal contraceptives may affect peripheral insulin resistance and glucose tolerance, but there is no evidence that changes in diabetes mellitus therapy are necessary while using combined hormonal contraceptives. At the same time, the condition of patients suffering from diabetes mellitus should be carefully monitored, especially at the early stage of using TTC Evra.

Exacerbation of endogenous depression, epilepsy, Crohn's disease and ulcerative colitis has been reported in women taking combined oral contraceptives.

Women who have experienced facial hyperpigmentation during pregnancy should avoid exposure to sunlight or artificial ultraviolet light while wearing the Evra TTC. Often this hyperpigmentation is not completely reversible.

Women should be informed that hormonal contraceptives do not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Women taking microsomal enzyme-inducing drugs (hydantoins, barbiturates, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin, modafinil and phenylbutazone) and antibiotics (except tetracyclines) should temporarily use a barrier method of contraception in addition to TTS Evra or choose another method of contraception. The barrier method must be used during the course of treatment with the above drugs, as well as within 28 days after discontinuation of microsomal enzyme inducers and within 7 days after stopping antibiotics. If the period of taking concomitant medications exceeds the 3-week cycle of using TTC Evra, then a new contraceptive cycle must be started immediately after the end of the previous one, i.e. without the usual period free from TTC use. Women receiving long-term therapy with drugs that induce liver enzymes should choose another method of contraception.

When prescribing drugs that are metabolized by isoenzymes CYP3A4, CYP2C19, especially those with a narrow therapeutic index (for example, cyclosporine), during the use of TTC Evra, the possibility of a clinically significant interaction should be excluded.

When using any combined hormonal contraceptives, the menstrual cycle may be disrupted (spotting or intermenstrual bleeding), especially in the first months of using these drugs. The duration of the adaptation period is about three cycles.

If, while using TTC Evra in accordance with the recommendations, persistence of intermenstrual bleeding is observed or such bleeding occurs after previous regular cycles, then reasons other than the use of TTC should be taken into account. One should keep in mind the possibility of non-hormonal causes of menstrual irregularities and, if necessary, conduct an adequate diagnostic examination to exclude organic disease or pregnancy.

In some women, menstruation may not occur during the period free from the use of TTC Evra. If a woman did not follow the instructions for use in the period preceding the first missed menstruation, or if she did not have two menstruation after breaks from using TTC, then pregnancy must be excluded before continuing to use TTC Evra.

In some women, discontinuation of hormonal contraceptives may provoke the occurrence of amenorrhea or oligomenorrhea, especially if they were present before starting hormonal contraception.

If the application of TTC Evra causes skin irritation, then you can glue a new TTC to another area of the skin and wear it until the next day of replacement.

In women weighing 90 kg or more, contraceptive effectiveness may be reduced.

If symptoms of liver dysfunction occur, the use of combined hormonal contraceptives should be discontinued until liver function markers normalize.

In case of recurrence of cholestasis-related itching that occurred during a previous pregnancy or previous use of sex hormones, combined hormonal contraceptives should be discontinued.

The safety and effectiveness of TTC Evra are established only for women from 18 to 45 years of age.

Immediately after removing the TTS from the bag, it should be firmly glued to the skin. After TTS is removed, it still contains significant amounts of active ingredients. Residual hormones can be harmful to the environment if released into water, and therefore used TTCs should be disposed of carefully. To do this, separate a special sticky film from the outside of the bag. Place the used TTC in the bag so that its sticky side faces the colored area on the bag, and press lightly to seal. The sealed bag is thrown away. Used TTS should not be thrown into the toilet or sewer.

Overdose

Symptoms: nausea, vomiting, vaginal bleeding.
Treatment: there is no specific antidote. The TTS should be removed and symptomatic therapy performed.

Drug interactions

Hydantoins, barbiturates, primidone, carbamazepine and rifampicin, as well as oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin, modafinil and phenylbutazone, can cause an acceleration of the metabolism of sex hormones, which can cause intermenstrual bleeding or the ineffectiveness of hormonal contraception, i.e. the onset of unwanted pregnancy. The mechanism of interaction between these drugs and the active ingredients of TTS Evra is based on the ability of the above drugs to induce liver enzymes, with the participation of which sex hormones are metabolized. Maximum enzyme induction is usually achieved no earlier than 2-3 weeks, and may persist for at least 4 weeks after discontinuation of the corresponding drug.

Taking herbal preparations containing St. John's wort (Hypericum perforatum) simultaneously with the use of TTC Evra may lead to loss of contraceptive effect. Women who take such herbal remedies may experience intermenstrual bleeding and an unwanted pregnancy. This is due to the fact that St. John's wort induces enzymes that metabolize sex hormones. The inducing effect can last for 2 weeks. after discontinuation of a herbal preparation containing St. John's wort.

Antibiotics (including ampicillin and tetracyclines) can cause loss of contraceptive effect. A pharmacokinetic interaction study showed that oral administration of tetracycline hydrochloride 3 days before and for 7 days during use of TTC Evra does not have a significant effect on the pharmacokinetics of norelgestromin or ethinyl estradiol.

Storage conditions and periods

The drug should be stored out of the reach of children at a temperature of 15° to 25°C. Store in original packaging, do not store in refrigerator or freezer. Shelf life – 2 years.

The Evra patch is an easy way of reliable contraception. The patch itself is a thin and smooth plate of small size. Protection against pregnancy is provided due to the fact that after attaching the patch, substances that penetrate the skin from it block ovulation and change the mucus of the cervix. A prerequisite for using the patch is the presence of a permanent sexual partner, as well as the absence of sexually transmitted infections in the couple. Let's look at the disadvantages, side effects and contraindications of the Evra patch.

Disadvantages of the Evra patch

Despite the numerous advantages and disadvantages of the Evra patch, it also has some disadvantages, the main of which are:

the possibility of it peeling off, and you may not notice it right away. Approximately 4% of all women using the Evra patch face this unpleasant situation;
the likelihood of developing an allergic reaction in some women. At the time of gluing, skin irritation occurs in approximately 2% of women, which is why they have to stop using this method of contraception;
The patch does not affect menstruation, as does taking birth control pills.

The Evra patch as a contraceptive may interact poorly with some medications, so if you are taking medications, you should consult your doctor before using the patch.

Side effects of Evra patch

The Evra contraceptive patch contains the same substances as most oral contraceptives (a combination of estrogen and progestin). The Evra patch has the same side effects as with other forms of microdose hormonal contraception. The most unpleasant of them are those that arise from the circulatory system. These include the occurrence of venous insufficiency, accompanied by thrombosis. In addition, common side effects of the Evra patch are:

the occurrence of hemorrhoids;
increased blood pressure;
the occurrence of increased heartbeat;
the appearance of edema.

From the peripheral and central nervous system it is possible:

the occurrence of headaches (including migraines);
the appearance of dizziness;
the occurrence of increased sensitivity to loud sounds, bright light, pain;
development of sensitivity disorders in the form of crawling sensations throughout the body;
the appearance of seizures;
trembling of the limbs and whole body;
the occurrence of depression;
the appearance of anxiety;
mood swings;
sleep disturbance;
irritability.

Regarding the gastrointestinal tract it is possible:

the occurrence of inflammatory processes in the periodontal tissues (gingivitis, periodontitis);
increased or decreased appetite;
the appearance of inflammatory processes in the stomach and intestines;
the occurrence of nausea, vomiting, unstable stool (alternating constipation and diarrhea);
bloating;
the appearance of abdominal pain.

An infection may develop in the upper and lower respiratory tract due to decreased immunity, and bronchial asthma and shortness of breath may occur.

Regarding the female genital organs, the local immunity of the external genital organs may decrease and an infection may develop (colpitis, thrush), the nature of vaginal discharge and mucus secreted from the cervical canal may change, and pain may occur during sexual intercourse. In addition, it is possible:

the occurrence of ovarian dysfunction;
development of ovarian cysts;
decreased libido;
the appearance of discharge from the mammary glands;
enlargement of the mammary glands;
the occurrence of inflammatory processes and benign tumors of the mammary glands.

Infectious and inflammatory diseases may develop in the kidneys and urinary tract due to a general decrease in immunity.

In the musculoskeletal system the following may occur:

muscle cramps;
pain;
muscle weakness;
pain in joints and bones.

Skin side effects may include:

the occurrence of dry skin;
development of various types of skin rashes;
the appearance of a pustular rash on the face and upper body;
increased sweating;
change in complexion;
development of allergies to sunlight;
hair loss.

Regarding the sense organs, vision impairment and the development of conjunctivitis are possible. Metabolic processes may fail, resulting in a sharp weight gain and an increase in the level of “bad” cholesterol in the blood.

In addition to all of the above, a side effect of the Evra patch may be:

development of influenza-like syndrome (cough, runny nose, fever);
the appearance of a constant feeling of fatigue and weakness;
the occurrence of suppurative processes in soft tissues;
the appearance of pain in the heart;
swollen lymph nodes;
anemia;
fainting is rare.

Most of the side effects are mild to moderate, which does not limit the possibility of using the patch. In addition, side effects, as a rule, disappear 2-3 months after starting to use the patch, when the body has adapted to the substances contained in it.

Contraindications to the use of Evra patch

There are some contraindications to the use of Evra patch, including:

presence of thrombosis;
period of pregnancy and lactation;
history of myocardial infarction or stroke;
presence of a suspected or established diagnosis of a malignant tumor.

In addition, the patch is contraindicated in women who are over 35 years old and who smoke more than 15 cigarettes per day.

Disadvantages of the Evra patch

Despite the numerous advantages and disadvantages of the Evra patch, it also has some disadvantages, the main of which are:

the possibility of it peeling off, and you may not notice it right away. Approximately 4% of all women using the Evra patch face this unpleasant situation;
the likelihood of developing an allergic reaction in some women. At the time of gluing, skin irritation occurs in approximately 2% of women, which is why they have to stop using this method of contraception;
The patch does not affect menstruation, as does taking birth control pills.

The Evra patch as a contraceptive may interact poorly with some medications, so if you are taking medications, you should consult your doctor before using the patch.

Side effects of Evra patch

the occurrence of hemorrhoids;
increased blood pressure;
the occurrence of increased heartbeat;
the appearance of edema.

From the peripheral and central nervous system it is possible:

the occurrence of headaches (including migraines);
the appearance of dizziness;
the occurrence of increased sensitivity to loud sounds, bright light, pain;
development of sensitivity disorders in the form of crawling sensations throughout the body;
the appearance of seizures;
trembling of the limbs and whole body;
the occurrence of depression;
the appearance of anxiety;
mood swings;
sleep disturbance;
irritability.

Regarding the gastrointestinal tract it is possible:

the occurrence of inflammatory processes in the periodontal tissues (gingivitis, periodontitis);
increased or decreased appetite;
the appearance of inflammatory processes in the stomach and intestines;
the occurrence of nausea, vomiting, unstable stool (alternating constipation and diarrhea);
bloating;
the appearance of abdominal pain.

An infection may develop in the upper and lower respiratory tract due to decreased immunity, and bronchial asthma and shortness of breath may occur.

the occurrence of ovarian dysfunction;
development of ovarian cysts;
decreased libido;
the appearance of discharge from the mammary glands;
enlargement of the mammary glands;
the occurrence of inflammatory processes and benign tumors of the mammary glands.

Infectious and inflammatory diseases may develop in the kidneys and urinary tract due to a general decrease in immunity.

In the musculoskeletal system the following may occur:

muscle cramps;
pain;
muscle weakness;
pain in joints and bones.

Skin side effects may include:

the occurrence of dry skin;
development of various types of skin rashes;
the appearance of a pustular rash on the face and upper body;
increased sweating;
change in complexion;
development of allergies to sunlight;
hair loss.

In addition to all of the above, a side effect of the Evra patch may be:

development of influenza-like syndrome (cough, runny nose, fever);
the appearance of a constant feeling of fatigue and weakness;
the occurrence of suppurative processes in soft tissues;
the appearance of pain in the heart;
swollen lymph nodes;
anemia;
fainting is rare.

Contraindications to the use of Evra patch

There are some contraindications to the use of Evra patch, including:

presence of thrombosis;
period of pregnancy and lactation;
history of myocardial infarction or stroke;
presence of a suspected or established diagnosis of a malignant tumor.

In addition, the patch is contraindicated in women who are over 35 years old and who smoke more than 15 cigarettes per day.

The Evra patch is a square-shaped transdermal therapeutic system (TTS), with a beige matte backing, rounded corners, a colorless adhesive layer and a transparent protective film; the inscription "EVRA" is embossed on the backing. Pack of 3 pieces.

Active substance:
1 TTC contains norelgestromin 6 mg, ethinyl estradiol 600 mcg (releases norelgestromin 203 mcg, ethinyl estradiol 33.9 mcg within 24 hours).

Excipients:
Composition of the TTC base: an outer layer of pigmented low-density polyethylene and an inner layer of polyester. Composition of the TTC middle layer: adhesive mixture of polyisobutylene-polybutene, crospovidone, polyester non-woven material, lauryl lactate. Composition of the removable protective layer of TTS: polyethylene terephthalate film, polydimethylsiloxane coating.

pharmachologic effect

Contraceptive agent for transdermal use. Inhibits the gonadotropic function of the pituitary gland, suppresses the development of the follicle and interferes with the ovulation process. The contraceptive effect is enhanced by increasing the viscosity of cervical mucus and reducing the susceptibility of the endometrium to the blastocyte. Pearl index – 0.90.

The pregnancy rate does not depend on factors such as age, race and increases in women weighing more than 90 kg.

Pharmacokinetics

After application of the Evra patch, norelgestromin and ethinyl estradiol quickly appear in the serum, reaching a plateau after approximately 48 hours, and remain in equilibrium concentrations throughout the period of wearing the patch. This eliminates the daily rise and fall in serum hormone levels that occurs with oral contraceptives. The study examined the pharmacokinetics of norelgestromin and ethinyl estradiol in 37 women when the Evra patch was applied to the skin of the abdomen, buttocks, arms or back for 7 days. In all three studies, serum concentrations of norelgestromin and ethinyl estradiol remained within the target range throughout the entire period of wearing the Evra patch, regardless of application site. Absorption of norelgestromin when applied to all sites - buttocks, arm and torso - was therapeutically equivalent.

Evra allows for continuous delivery of norelgestromin and ethinyl estradiol into the systemic circulation and inhibits follicular development for an additional two full days after completion of the recommended 7-day period of wearing the patch. Even after a 2-day delay in patch replacement, serum concentrations of the two hormones remained within the target range. Because norelgestromin and ethinyl estradiol continue to provide contraceptive effect during this 2-day period, additional contraception is not necessary if up to 2 days are missed. During each of Evra's three 7-day attachment periods, 30 women wore the patch on their abdomen in one of six different conditions: normal activity, sauna, hydromassage, treadmill, cool water immersion, or a combination of these. During the study, under the influence of elevated temperature, humidity, cold and/or exercise in a fitness club, only one (1.1%) of 87 patches completely came off on its own. The values of the maximum serum concentrations of norelgestromin and ethinyl estradiol indicate that in none of these conditions there was a sudden release of excess amounts of hormones.

Indications for use

contraception (prevention of unwanted pregnancy) in women.

Mode of application

The patient should be informed that in order to achieve maximum contraceptive effect, it is necessary to strictly follow the instructions for use of TTC Evra. Only one TTS can be used at a time.

Each used TTC is removed and immediately replaced with a new one on the same day of the week (“replacement day”) on days 8 and 15 of the menstrual cycle (weeks 2 and 3). TTS can be changed at any time on the day of replacement. During the 4th week, from the 22nd to 28th day of the cycle, TTC is not used. A new contraceptive cycle begins the day after the end of the 4th week; the next TTS should be stuck on, even if there was no menstruation or it has not ended.

Under no circumstances should a break in the application of TTC Evra be longer than 7 days, otherwise the risk of pregnancy increases. In such situations, it is necessary to simultaneously use a barrier method of contraception for 7 days, because the risk of ovulation increases with each day the recommended duration of the period free from TTC use is exceeded. In case of sexual intercourse during such an extended period, the probability of conception is very high.

Starting to use the Evra patch

If the woman did not use hormonal contraception during the previous menstrual cycle
Contraception with TTC Evra begins on the first day of menstruation. One TTC Evra is glued to the skin and used for the whole week (7 days). The day of gluing the first TTS Evra (1st day/start day) determines the subsequent days of replacement. The replacement day will fall on the same day of each week (8th and 15th days of the cycle). On the 22nd day of the cycle, TTC is removed, and from the 22nd to 28th day of the cycle the woman does not use TTC Evra. The next day is considered the first day of the new contraceptive cycle. If a woman does not start using TTC Evra from the first day of the cycle, then she should simultaneously use barrier methods of contraception during the first 7 days of the first contraceptive cycle.
If a woman switches from using a combined oral contraceptive to using TTC Evra
TTC Evra should be applied to the skin on the 1st day of menstruation, which began after stopping the combined oral contraceptive. If menstruation does not begin within 5 days after taking the contraceptive pill, then pregnancy must be ruled out before starting to use TTC Evra.
If the use of Evra begins after the 1st day of menstruation, then for 7 days it is necessary to simultaneously use barrier methods of contraception. If more than 7 days have passed since the last contraceptive pill, a woman may be ovulating and should therefore consult a doctor before starting to use TTC Evra. Sexual intercourse during this extended period without taking contraceptive pills can lead to pregnancy.
If a woman switches from using progestogen-only medications to using TTC Evra
A woman can switch from using a drug containing only a progestogen at any day (on the day the implant is removed, on the day the next injection is due), but during the first 7 days of using TTC Evra, a barrier method should be used to enhance the contraceptive effect.
After an abortion or miscarriage
After an abortion or miscarriage before the 20th week of pregnancy, you can immediately begin using TTC Evra. If a woman begins to use TTC Evra immediately after an abortion or miscarriage, then no additional methods of contraception are required. A woman should know that ovulation can occur within 10 days after an abortion or miscarriage. After an abortion or miscarriage in the 20th week of pregnancy or later, the use of TTC Evra can be started on the 21st day after the abortion or miscarriage, or on the 1st day of the first menstrual period.
After childbirth
Women who are not breastfeeding should start using TTC Evra no earlier than 4 weeks after birth. If a woman starts using TTC Evra later, then during the first 7 days she must additionally use a barrier method of contraception. If sexual intercourse has taken place, pregnancy must be excluded before starting the use of TTC Evra, or the woman must wait until her first menstruation.

When the Evra patch comes off completely or partially

If partial peeling occurs for more than 24 hours (24 hours or longer), and if the woman does not know exactly when the TTC Evra partially or completely peeled off, pregnancy may occur. The woman should immediately start a new cycle by gluing a new Evra TTC and consider this day the first day of the contraceptive cycle. Barrier methods of contraception should be used simultaneously only in the first 7 days of a new cycle.

If the next days of replacing the Evra patch are missed

At the beginning of any contraceptive cycle (1st week/1st day)

In the middle of the cycle (2nd week/8th day or 3rd week/15th day):

if 1 or 2 days have passed since the date of replacement (up to 48 hours): the woman should immediately glue a new TTS. The next TTS must be glued on the usual “replacement day”. If during the 7 days preceding the first missed day of TTC attachment, the use of TTC was correct, then additional contraception is not required;
if more than 2 days (48 hours or more) have passed since the date of replacement: there is an increased risk of pregnancy. The woman should stop the current contraceptive cycle and immediately begin a new 4-week cycle with a new Evra TTC. This day is considered the new "1st day" and a new "replacement day" is counted. Barrier contraception should be used simultaneously during the first 7 days of a new cycle;
at the end of the cycle (4th week/22nd day): if the TTC is not removed at the beginning of the 4th week (22nd day), then it should be removed as quickly as possible. The next contraceptive cycle should begin on the usual “replacement day,” which is the day after the 28th day. Additional contraception is not required.

Changing the replacement day

How to apply the Evra patch correctly

To avoid possible irritation, each subsequent TTC Evra must be glued to a different area of the skin; this can be done within the same anatomical area.

TTC Evra must be pressed tightly so that its edges are in good contact with the skin. To prevent a decrease in the adhesive properties of TTC Evra, you should not apply makeup, creams, lotions, powders and other local products to those areas of the skin where it is or will be glued.

A woman should inspect the Evra TTC daily to ensure that it is firmly attached.

Used TTS must be disposed of carefully according to instructions.

Side effect

When using TTC Evra, the following side effects may occur:

From the central nervous system and peripheral nervous system
dizziness, migraine, paresthesia, hypoesthesia, convulsions, tremor, emotional lability, depression, anxiety, insomnia, drowsiness.

From the cardiovascular system
increased blood pressure, palpitations, edema syndrome, varicose veins.

From the digestive system
gingivitis, anorexia or increased appetite, gastritis, gastroenteritis, dyspepsia, abdominal pain, vomiting, diarrhea, flatulence, constipation, hemorrhoids.

From the respiratory system
upper respiratory tract infections, shortness of breath, bronchial asthma.

From the reproductive system
pain during sexual intercourse (dyspareunia), vaginitis, dysmenorrhea, decreased libido, enlarged mammary glands, menstrual irregularities (including intermenstrual bleeding, hypermenorrhea), changes in vaginal secretion, changes in cervical mucus, lactation not occurring in connection with childbirth , ovarian dysfunction, mastitis, breast fibroadenomas, ovarian cysts.

From the urinary system
urinary tract infections.

From the musculoskeletal system
muscle cramps, myalgia, arthralgia, ostalgia (including back pain, pain in the lower extremities), tendinosis (tendon changes), muscle weakness.

Dermatological reactions
itching, urticaria, skin rash, contact dermatitis, bullous rash, acne, skin discoloration, eczema, increased sweating, alopecia, photosensitivity, dry skin.

From the side of the organ of vision
conjunctivitis, visual impairment.

Metabolism
weight gain, hypertriglyceridemia, hypercholesterolemia.

Others
flu-like syndrome, feeling tired, allergic reactions, chest pain, asthenic syndrome, fainting, anemia, abscesses, lymphadenopathy.

Rarely (with frequency from >0.01% to<0.1%)
hypertonicity or hypotonicity of muscles, impaired coordination of movements, dysphonia, hemiplegia, neuralgia, stupor, increased libido, depersonalization, apathy, paranoia, benign tumors of the mammary glands, cervical cancer in situ, pain in the perineum, ulceration of the genitals, atrophy of the mammary glands, decreased blood pressure , enanthema, dry mouth or increased salivation, colitis, pain when urinating, hyperprolactinemia, melanosis, skin pigmentation disorders, chloasma, xerophthalmia, weight loss or obesity, inflammation of the subcutaneous tissue, alcohol intolerance, cholecystitis, cholelithiasis, liver dysfunction, purpura , "flushes" of blood to the face, thrombosis (including deep vein thrombosis, pulmonary artery thrombosis), thrombophlebitis of the superficial veins, pain in the veins, pulmonary embolism.

Contraindications for use

venous thrombosis, incl. history (including deep vein thrombosis, pulmonary embolism);
arterial thrombosis, incl. history (including acute cerebrovascular accident, myocardial infarction, retinal artery thrombosis) or precursors of thrombosis (including angina pectoris or transient ischemic attack);
the presence of serious or multiple risk factors for arterial thrombosis: severe arterial hypertension (more than 160/100 mmHg), diabetes mellitus with vascular damage;
hereditary dyslipoproteinemia;
hereditary predisposition to venous or arterial thrombosis (eg, activated protein C resistance, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies - anticardiolipin antibodies, lupus anticoagulant);
migraine with aura;
confirmed or suspected breast cancer;
endometrial cancer and confirmed or suspected estrogen-dependent tumors;
liver adenoma and carcinoma;
genital bleeding;
postmenopausal period;
age under 18 years;
postpartum period (4 weeks);
lactation period;
hypersensitivity to the components of the drug.

Do not use on the mammary glands, as well as on hyperemic, irritated or damaged areas of the skin.

Carefully should be used when there is a family history of venous or arterial thromboembolism in brothers, sisters or parents at a relatively young age; with prolonged immobilization; obesity (body mass index more than 30 kg/m2, calculated as the ratio of body weight in kilograms to the square of height in meters); thrombophlebitis of superficial veins and varicose veins; dyslipoproteinemia; arterial hypertension; lesions of the heart valve apparatus; atrial fibrillation; diabetes mellitus; systemic lupus erythematosus; hemolytic-uremic syndrome; Crohn's disease; ulcerative colitis; liver dysfunction; hypertriglyceridemia (including family history); acute impairment of liver function during a previous pregnancy or previous use of sex hormones; for menstrual irregularities; renal dysfunction.

Use of the drug Evra during pregnancy and lactation

The drug Evra is contraindicated during pregnancy and lactation.

Use for liver and kidney dysfunctions

Evra should be used with caution in case of liver dysfunction; acute impairment of liver function during a previous pregnancy or previous use of sex hormones.
Use with caution in case of impaired renal function.

Use in children under 12 years of age

The transdermal contraceptive patch Evra is contraindicated in children and adolescents under 18 years of age.

special instructions

There is no clinical evidence that the transdermal contraceptive system is in any way safer than oral contraceptives.

The risk of vascular complications is increased in women with thrombophlebitis of the superficial veins and varicose veins, as well as in obesity (body mass index more than 30 kg/m2).

Some epidemiological studies have found an increased risk of cervical cancer in women who use combined oral contraceptives for a long time.

Women with hypertriglyceridemia or a family history of this disease may have an increased risk of pancreatitis when using combined hormonal contraceptives.

concentrations of prothrombin and coagulation factors VII, VIII, IX and X increase; the level of antithrombin III decreases; protein S levels decrease; norepinephrine-induced platelet aggregation increases;
the concentration of thyroxine-binding globulin increases, which causes an increase in the concentration of total thyroid hormone, which is measured by the content of protein-bound iodine, T4 content (determined using chromatography or radioimmunoassay); The binding of free T3 by the ion exchange resin decreases, as evidenced by an increase in the concentration of thyroxine-binding globulin, the concentration of free T4 does not change. Serum concentrations of other binding proteins may be increased;
The concentrations of sex hormone-binding globulins increase, which leads to an increase in the concentrations of total circulating endogenous sex hormones. At the same time, the concentrations of free or biologically active sex steroids decrease or remain unchanged.