Ovarian stimulation, hypogonadotropic hypogonadism - treatment with Gonal-F (instructions for use). Gonal F: instructions for use of injection

Dosage form: lyophilisate for preparing a solution for subcutaneous administration Compound:

1 bottle contains:

active substance: follitropin alpha (r-hFSH) 5.5 mcg (75 IU); Excipients: sucrose 30 mg, sodium hydrogen phosphate dihydrate 1.11 mg, sodium dihydrogen phosphate monohydrate 0.45 mg, methionine 0.1 mg, polysorbate 20 0.05 mg, phosphoric acid q.s., sodium hydroxide q.s.

Description:

White lyophilized powder or white lyophilized mass (lyophilisate).

Pharmacotherapeutic group:Follicle stimulating agent ATX:

G.03.G.A Gonadotropins

G.03.G.A.05 Follitropin alfa

Pharmacodynamics:

GONAL-f® - recombinant human follicle-stimulating hormone (r-hFSH) - is a drug that stimulates the growth and development of follicles. The drug is obtained by the method genetic engineering on a culture of Chinese hamster ovary cells. Has a gonadotropic effect: stimulates the growth and maturation of the follicle/follicles, promotes the development of several follicles during controlled ovarian hyperstimulation, including for assisted reproductive technology (ART) programs.

Comparative clinical researches r-hFSH () and y-FSH (urinary follicle-stimulating hormone) for ART and ovulation induction demonstrated greater effectiveness of GONAL-f® for initiating follicle maturation in terms of such indicators as a reduction in the cumulative dose and duration of treatment, compared with y-FSH and, thus reducing the risk of unwanted ovarian hyperstimulation. For ART, administration of GONAL-f® in a lower total dose with a shorter duration of treatment results in obtaining a larger number of retrieved oocytes compared to γ-FSH.

It has also been shown that in women with suppressed secretion of endogenous gonadotropins, it effectively stimulates follicular development and steroidogenesis, despite the low concentration of luteinizing hormone (LH) that is unmeasurable.

Pharmacokinetics:

After intravenous administration determined in extracellular fluids, with an initial half-life of approximately 2 hours, while a terminal half-life of approximately 24 hours. The equilibrium volume of distribution is 10 l, ground clearance - 0.6 l/hour. One-eighth of the administered dose of follitropin alfa is excreted in the urine.

Indications:

Anovulation (including polycystic ovary syndrome) in women if clomiphene therapy is ineffective.

Controlled ovarianhyperstimulation in ART programs.

Ovarian stimulation in women with severe deficiency of FGC and LH (in combination with LH drugs).

Stimulation of spermatogenesis with hypogonadotropic hypogonadism in men (in combination with human chorionic gonadotropin (hGC)).

Contraindications:

Hypersensitivity to the drug or excipients, hypothalamic-pituitary tumors.

In women: pregnancy, voluminous neoplasms or ovarian cysts (not due to polycystic ovary syndrome), uterine bleeding unknown etiology, ovarian carcinoma, uterine cancer, breast cancer.

The drug should not be prescribed:

in women: with abnormal development of the genital organs and uterine fibroids, incompatible with pregnancy, primary ovarian insufficiency, premature menopause.
in men: with primary testicular failure.

Pregnancy and lactation:During pregnancy and breastfeeding the drug GONAL-f® is not prescribed. Directions for use and dosage:

Treatment with GONAL-f® should be started under the supervision of a medical specialist with experience in the treatment of infertility.

The drug GONAL-f® is intended for subcutaneous administration.

The first injection of the drug GONAL-f® is carried out under the supervision of the attending physician or qualified medical personnel. Self-administration of GONAL-f® can only be carried out by well-motivated patients, trained and having the opportunity to receive expert advice.

The dry substance is dissolved in the supplied solvent immediately before use. The contents of up to three bottles of the drug are dissolved in 1 ml of solvent, which makes it possible to reduce the administered injection volume.

Women Anovulation (including polycystic ovary syndrome in women if clomiphene therapy is ineffective GONAL-f® should be prescribed as a course of daily injections. Treatment begins in the first 7 days of the cycle. Stimulation is carried out under the control of ultrasound of the ovaries (the size of the follicles is measured) and/or the concentration of estradiol in the blood plasma. Stimulation begins with a daily dose of 75-150 IU, increasing by 37.5-75 IU after 7-14 days until an adequate, but not excessive, response is obtained. Maximum dose daily injection should not exceed 225 IU. If there is no positive dynamics after 4 weeks, treatment is stopped. In the next cycle, stimulation can be started with a higher dose than in the previous cycle. After reaching the optimal follicle size, 24-48 hours after the last injection of GONAL-f®, 250 μg of recombinant human human chorionic gonadotropin(r-hGC) or 5000-10,000 IU human human chorionic gonadotropin (hGC). On the day of hCG injection and the next day, the patient is recommended to have sexual intercourse. As an alternative, intrauterine insemination may be performed.

If the ovaries respond excessively to stimulation, treatment with follitropin alfa should be discontinued and hHC discontinued. Stimulation is repeated in the next cycle, starting with a lower dose of GONAL-f® compared to the previous cycle.

Controlled ovarian hyperstimulation in ART programs GONAL-f® is prescribed daily at 150-225 IU, starting from days 2-3 of the cycle. Dose adjustment of GONAL-f® should be carried out no more than once every 3-5 days; a single dose can be increased by 75-150 IU. The daily dose may vary, but usually does not exceed 450 IU. Treatment is continued until the follicles reach adequate size according to ultrasound (5-20 days, on average by the 10th day of treatment).

24-48 hours after the last injection of GONAL-f®, a single dose of 250 μg of p-hGC or 5000-10,000 IU of hGC is administered to induce final maturation of the follicles.

To suppress the endogenous LH surge and maintain it at a low level, a gonadotropin-releasing hormone (GnRH) agonist or antagonist is used. In the usual protocol, GONAL-f® is started approximately two weeks after the start of GnRH agonist treatment, then both drugs are continued until follicles of adequate size are obtained. For example, after two weeks of treatment with a GnRH agonist, 150-225 IU GONAL-f® is prescribed for 7 days. Subsequently, the dose is adjusted depending on the development of follicles and the concentration of estradiol in the blood plasma. The existing experience with ART indicates that, in general, the likelihood successful treatment persists during the first 4 attempts and then gradually decreases.

Ovarian stimulation in women with severe FSH and LH deficiency (in combination with LH drugs)

The dose and treatment regimen are selected by the doctor individually.

Typically, GONAL-f® is administered daily subcutaneously for up to 5 weeks concomitantly with LH. Treatment with GONAL-f® begins with a dose of 75-150 IU simultaneously with lutropin alfa at a dose of 75 IU. If necessary, the dose of GONAL-f® can be increased by 37.5 - 75 IU every 7-14 days to her. If there is no adequate response to stimulation within 5 weeks, therapy should be stopped and resumed in a new cycle at a higher dose.

After reaching the optimal size of the follicle/follicles, 24-48 hours after the last injection of GONAL-f® and lutropin alfa, 250 μg of r-hGC or 5000-10,000 are administered once M.E. hGC. On the day of hCG injection and the next day, the patient is recommended to have sexual intercourse. As an alternative, intrauterine insemination may be performed.

If the ovaries respond excessively to stimulation, treatment should be discontinued and hHC discontinued. Stimulation is repeated in the next cycle, starting with a lower dose of GONAL-f® compared to the previous cycle.

Men

Stimulation of spermatogenesis in hypogonadotropic hypogonadism in men (in combination with hCG).

Men are usually prescribed GONAL-f® at a dose of 150 IU three times a week for at least 4 months in combination with hCG. With absence positive effect during this time, treatment can be continued for up to 18 months.

Side effects:

When using medicinal product GONAL-f® development possible side effects, which, depending on the frequency of occurrence, are regarded as very frequent (≥1/10), frequent (≥1/100 and<1/10), нечастые (≥1/1000 и <1/100), редкие (≥1/10000 и <1/1000), очень редкие (<1/10000, включая single messages). The frequency of side effects in each group is listed in descending order.

Use in women

Immune system disorders: very rare - mild to moderate systemic allergic reactions (for example, redness of the skin, rash, swelling of the face, urticaria, difficulty breathing), the development of severe allergic reactions, including anaphylactic reactions and shock.

Nervous system disorders: often - headache.

Vascular disorders: very rarely - thromboembolism, usually associated with severe OHSS.

: very rarely - in patients with bronchial asthma there is a worsening of the course or exacerbation of the disease.

Gastrointestinal disorders: often - abdominal pain, heaviness, abdominal discomfort, nausea, vomiting, diarrhea, colic, belching.

Reproductive system and breast disorders: very often - ovarian cysts; often - ovarian hyperstimulation syndrome (OHSS) of mild or moderate severity (including associated symptoms); uncommon - severe form of OHSS (including accompanying symptoms); rarely - a complication of severe OHSS (see section "Special instructions").

very often - mild/moderate reactionsseverity at the injection site(pain, redness, hematoma, swelling).

Application at men

Immune system disorders: very rare - mild to moderatesystemic allergic reactions (egredness of the skin, rash, swelling of the face,hives, difficulty breathing),development of severe allergic reactions, inincluding anaphylactic reactions and shock.

Respiratory system disorders: very rarely - in patients with bronchialasthma worsening or exacerbation diseases.

Skin and subcutaneous disordersfiber: often - the appearance of acne (acne).

Disorders of the genital organs ormammary gland: often - gynecomastia, varicocele.

General disorders and disorders at the injection site: very often - a mild/moderate reaction at the injection site (for example, pain, redness, hematoma, swelling). often - weight gain.

If serious side effects or effects not described above occur, you should inform your doctor.

Overdose:

Currently, no cases of overdose of the drug GONAL-f® have been reported. Apparently, the development of ovarian hyperstimulation syndrome should be expected (see section "Special instructions").

Interaction:

When GONAL-f® is combined with other stimulating drugs (hHC, clomiphene), the ovarian response is enhanced; against the background of desensitization of the pituitary gland with a GnRH agonist or antagonist, it decreases (an increase in the dose of the drug is required). There is no data on the interaction of GONAL-f® with other drugs.

Special instructions:

Since the drug can cause various adverse reactions, GONAL-f® should be prescribed only by a specialist doctor who is directly involved in infertility problems.

The start of therapy should be preceded by an examination of the infertile couple, in particular, examinations should be carried out to exclude hypothyroidism, adrenal insufficiency, hyperprolactinemia, hypothalamic-pituitary tumors and, if necessary, appropriate therapy should be prescribed.

It is necessary to assess the patency of the fallopian tubes in order to select the ART method. Tubal obstruction should be excluded if the patient is not participating in an in vitro fertilization program.

In patients with porphyria, as well as in the presence of porphyria in relatives, careful monitoring is required during therapy with GONAL-f®. If the condition worsens or the first signs of this disease appear, you may need to cessation of therapy.

When treating with GONAL-f®, it is necessary to assess the condition of the ovaries using ultrasound (ultrasound), both separately and in combination with the determination of estradiol in the blood plasma. The response to FSH may vary between patients, so the minimum effective dose should be used in both women and men.

The drug GONAL-f® contains less than 1 mmol (23 mg) sodium in 1 dose, that is, it is not a significant source of sodium.

Ovarian hyperstimulation syndrome (OHSS)

OHSS must be differentiated from uncomplicated ovarian enlargement. Unlike uncomplicated ovarian enlargement, OHSS is a medical condition whose severity can vary.

A mild form of OHSS is accompanied by pain in the lower abdomen, an increase in its size, and an increase in the size of the ovaries. With OHSS of moderate severity, nausea, vomiting, and enlargement of the ovaries, including due to the formation of cysts, may additionally be observed. In severe forms of OHSS, shortness of breath, oliguria, a pronounced increase in the size of the ovaries, an increase in body weight, disorders of the gastrointestinal tract, high concentrations of sex hormones, an increase in vascular permeability, leading to the accumulation of fluid in the abdominal, pleural cavities and, less commonly, in pericardium.. In severe forms of OHSS, hypovolemia, hemoconcentration, electrolyte imbalance, ascites, hemoperitoneum, hydrothorax, and acute respiratory distress syndrome may occur. In very rare cases, severe OHSS may be complicated by torsion of an ovarian cyst or thromboembolic disorders such as pulmonary embolism, ischemic stroke, or myocardial infarction.

There is reason to believe that hHC plays a key role in the occurrence of OHSS. Therefore, in case of excessive ovarian response to stimulation, hCG is not prescribed, and patients are advised to abstain from coitus or use barrier methods

contraception for at least 4 days. OHSS can rapidly progress (from a day to several days) to a severe condition, therefore, after administration of hCG, patients must be monitored for at least two weeks.

Mild to moderate OHSS usually resolves spontaneously. If a severe form of OHSS develops, therapy with GONAL-f®, if it is still ongoing, should be discontinued. The patient should be hospitalized and appropriate treatment prescribed.

To minimize the risk of OHSS and multiple pregnancies, ultrasound and assessment of estradiol concentrations in blood plasma are regularly used. Risk factors for the development of OHSS are polycystic ovary syndrome, concentration estradiol >900 pg/ml (3300 pmol/l) andthe presence of more than 3 follicles in diameter is notless than 14 mm. With ART, the risk of developing OHSSincreases with estradiol concentrations >3000 pg/ml (1100 pmol/l) or the presence of 20 or more follicles with a diameter of 12 mm or more. When the estradiol concentration is >5500 pg/mL (20,200 pmol/L) or when there are 40 or more follicles, hCG should be avoided.

The likelihood of OHSS in patients undergoing controlled ovarian hyperstimulation for ART is reduced by aspiration of all follicles.

When pregnancy occurs, the severity of OHSS may worsen and its duration may increase. Most often, OHSS occurs after cessation of hormonal therapy and reaches its maximum after 7-10 days. As a rule, OHSS disappears spontaneously with the onset of menstruation.

Patients with polycystic ovary syndrome are at higher risk of developing OHSS.

Multiple pregnancy

The frequency of multiple pregnancies and births with ovulation induction is higher compared to natural conception, the most common option for Multiple pregnancy is twins.

Multiple pregnancies, especially those with a large number of embryos, increase the risk of adverse outcomes for the mother and fetus. To minimize the risk of multiple pregnancy, careful monitoring of the ovarian response is recommended. With ART, the risk of multiple pregnancy is associated mainly with the number of embryos transferred, their vitality and age of the patient.

Miscarriage

The incidence of miscarriage after ovulation induction and ART programs is higher than in the general population.

Ectopic pregnancy

Patients with a history of fallopian tube disease have an increased risk of ectopic pregnancy, regardless of whether the pregnancy occurred in the usual way or during infertility treatment. Probability ectopic pregnancy afterapplication of auxiliaryreproductive technologies are higher than in the general population.

Neoplasms of the reproductive system

There are reports of benign and malignant neoplasms of the ovary and other reproductive organs in women after multiple courses of infertility treatment with various medications. CurrentlyThe timing of the relationship between gonadotropin therapy and the increased risk of neoplasms in infertility has not been established.

Congenital malformations

The incidence of congenital anomalies after the use of ART programs may be slightly higher than during natural pregnancy and childbirth. However, it is unknown whether this is due to parental characteristics (eg, maternal age, sperm quality) and multiple pregnancies or directly to ART procedures.

Thromboembolic complications

In patients with recent or current thromboembolic diseases, as well as with a probable risk of their occurrence, in the presence of a history of the disease or in relatives, the use of the drug GONAL-f® may increase this risk or complicate the course of these diseases. For patients in this group, the benefits of therapy must be weighed against the possible risks. It should be noted that pregnancy itself, like OHSS, carries an increased risk of thromboembolic disorders.

Treatment for men

An increased concentration of FSH in the blood plasma of men may indicate primary testicular failure. In this case, treatment with r-hFSH/hHC is ineffective and GONAL-f® should not be prescribed. 4-6 months after the start of therapy, it is recommended to monitor the spermogram.

Patients should be aware of the above risks before starting therapy.

It is necessary to inform the doctor about all types of allergic reactions that the patient has, as well as about all drugs used before starting treatment with GONAL-f®.

If GONAL-f® is prescribed together with lutropin alfa, they can be mixed in one syringe.

1.Wash your hands. It is very important that your hands and all objects you use are as clean as possible.

2.Gather everything you need. Find a clean surface and lay out everything you will use:

Bottle with the drug

Pre-filled syringe with solvent

2 alcohol swabs

One needle for preparing the solution and a needle for subcutaneous administration

Container for disposal.

3. Prepare solution for injection. Remove the snap cap from the bottle and the protective cap from the syringe needle. Insert the needle of the syringe containing the solvent into the vial, piercing the rubber cap of the vial. Slowly inject the entire contents of the syringe into the vial. Rotate the bottle for better dissolution. Don't shake it.

4.After dissolving the lyophilisate, check whether the solution is clean and does not contain any particles. Turn the bottle upside down and draw the solution back into the syringe. Remove the syringe from the vial.

(If you are prescribed a dose contained in several bottles, slowly inject the contents of the syringe into the next bottle. Repeat the operation as described above until you receive the required dose. If you are prescribed, you can mix the two drugs in one syringe. Prepare a solution of lutropin alfa , draw it into a syringe, inject the solution into a bottle with GONAL-f®, dissolve the drug and draw the solution back into the syringe. Up to 3 bottles can be dissolved in 1 ml of solvent.

5.Change the needle to a hypodermic needle. If you see air bubbles in the syringe, turn the needle up and gently tap the syringe so that all the bubbles collect at the top of the syringe. Press the plunger until they all disappear.

6.Administer the solution immediately. Your doctor or nurse should have already advised you where to give the injection. This could be the stomach or thigh. Squeeze the skin and insert the needle sharply at an angle of 45 or 90°. Inject under the skin as you were taught. Do not inject into a vein. When injecting, press the plunger gently until the entire dose has been injected. After this, immediately remove the needle and wipe the injection site with an alcohol swab in a circular motion.

7.Immediately after finishing the injection, throw away the used syringes (preferably in a separate container) and the remaining drug solution.

Release form/dosage:Lyophilisate for the preparation of solution for subcutaneous administration, 5.5 μg (75 IU). Package: In a transparent, colorless glass bottle with a capacity of 3 ml, sealed with a rubber stopper and an aluminum ring with a protective removable cap. Solvent: water for injection 1 ml in a pre-filled clear glass syringe.

1, 5 or 10 bottles of lyophilisate, the same number of pre-filled syringes with solvent and 2,

10 or 20 sterile needles are respectively placed in a plastic container and then in a cardboard box along with Instructions for Use.

Storage conditions:

At a temperature not exceeding 25 °C in protected from light place.

Keep out of the reach of children.

Best before date:

2 years for lyophilisate.

3 years for solvent.

Do not use after the expiration date.

Conditions for dispensing from pharmacies: On prescription Registration number: LS-000200 Registration date: 15.03.2010 / 08.02.2017 Expiration date: Indefinite Owner of the Registration Certificate:Merck Serono S.A., Eaubonne Branch Switzerland Manufacturer: Representative office: MERK, LLC Russia Information update date: 05.05.2017 Illustrated instructions

So, now we will try to figure out with you what kind of reviews “Gonal-F” earns from its customers. This drug is very often mentioned in gynecology. And it is used there. But can it really be used? Maybe it's better to use some other drug? And in general, why exactly is Gonal-F needed? We have to find out about all this.

What it is

Let's start by figuring out what we're dealing with. Maybe we are looking at some kind of drug that is dangerous to the body as a whole? Or a strong antibiotic? Not at all.

"Gonal-F", reviews of which we are yet to find out, is nothing more than the most common solution for subcutaneous administration. A kind of injection. And it is used in female gynecology. So, there is no need to be afraid. We are dealing with the most common solution, which is not an antibacterial. But should he be trusted? When exactly is this medicine used? And why is it needed at all?

Who will need it

"Gonal-F 300" receives varied reviews from buyers and doctors. But in general they are positive. And all this because this injection is very useful in the modern world. We are dealing with a solution that is necessary in the treatment of infertility.

That is, the main indication for use is infertility. Next comes hormonal imbalance or menstrual irregularity. The action of the medicine is based solely on stimulating follicle growth. In other words, if you have problems conceiving and also suffer from irregular menstrual cycles, then your doctor may prescribe Gonal-F for subcutaneous administration. There is no need to be afraid of this. Many claim that the drug really works.

Contraindications

True, the medicine also has some contraindications. In fact, there are not so many of them as it might seem at first glance. Firstly, children are prohibited from taking injections. This also applies to teenagers under 18 years of age. Only in exceptional cases can a doctor prescribe this medicine to a young girl.

Secondly, during pregnancy and lactation you need to avoid Gonal-F. Reviews say that at these moments women should generally refrain from taking medications. Gonal does not pose any particular danger to the fetus, but a sufficient number of tests have not been carried out to confirm safety. So, it’s better not to take unnecessary risks.

Individual intolerance to the drug or a tendency to allergies are a few more reasons why you should not take Gonal-F. In principle, exceptions can sometimes be made. But only under the strict supervision of doctors. This is where all the contraindications end. Is it possible that Gonal-F stimulation does not receive the best reviews from girls who have obvious signs of a disorder in the structure of the genital organs. It’s unlikely that anything will help them at all. And for this reason, you should not inject yourself again. Violations of the structure of organs are the last contraindication. It occurs, as practice has shown, extremely rarely.

Doctors say

What kind of reviews does Gonal-F earn among doctors? As already mentioned, doctors quite often recommend this remedy to their patients for hormonal imbalances and problems with conception. This means there are reasons for this.

Firstly, gynecologists note that Gonal has a gentle effect on the body. Most patients do not experience any negative effects or side effects. And this, of course, makes me happy. Most hormonal drugs really don't work the best. And they can cause side effects.

Secondly, doctors assure the excellent effect of the drug. That is, it is considered extremely effective. In this regard, Gonal-F receives good reviews. IVF, for example, is now faster and easier. And even with less harm to the woman’s body. Among other things, doctors say that after 1-2 injections you will see results. More precisely, it will become noticeable on an ultrasound examination. And this, of course, makes me happy.

Thirdly, medical professionals often recommend Gonal-F because of its availability. A drug that is easy to buy at a pharmacy will be more popular than one that will have to be looked for throughout the city, or even beyond its borders. So it turns out that our medicine has a very good reputation among gynecologists. What can patients say about this?

Price list

"Gonal-F" gets quite good reviews from customers. And you can verify this based on the fact that women very often advise each other to use our injection today if they have problems conceiving. True, there is one moment that is not particularly pleasing. We are talking about the cost of the drug. She plays not the least role. After all, few people would agree to pay a lot of money for a medicine that will have to be taken for a long period of time.

On average, a package of injections will cost 1,000 rubles. On the one hand, this is not so much. But on the other hand, if the average duration of a course of taking the drug is 3-4 months, then the price tag may affect your budget. This is the price of Gonal-F 75. Reviews about this drug, however, are often still encouraging. After all, if you have real problems with conception, then 1,000 rubles for a small package of a drug of similar effect is not so much. Analogues are several times more expensive. Many customers say that it is more profitable to buy large packages of Gonal-F. If you compare them by volume, it turns out that you will save about 2-3 thousand rubles. Especially if you have a long course of treatment ahead of you.

About efficiency

Now we know what the price of Gonal-F is. Customer reviews, as you can see, do not change much depending on the cost of the drug. After all, the main thing about it is efficiency. And there are no complaints here. All that can be found as opinions expressed about the medicine is the delight of the patients. Progress is visible after 2-3 applications.

Many girls assure that after just 1 course of taking the drug (lasting 1 month or 1 menstrual cycle), in the absence of other gynecological problems, you can successfully conceive a child. But such cases are rare. Practice shows that most often conception occurs after 2-3 months of injections. Considering that this process can occur in only 1 day out of 30, this is a very high indicator.

All this, of course, makes me happy. And that’s why many girls advise each other “Gonal-F”. But remember, it is better not to take it without medical supervision. Otherwise, some side effects may appear.

Negative influence

Reviews are left about Gonal-F as a safe product. And indeed it is. But with an overdose (which is extremely difficult to achieve), some not the best effects may appear.

For example, rashes or pimples on the face and body. Rather, all the effects of the drug will be reflected precisely in appearance. After all, it does not pose any danger to the body. In addition, in exceptional cases, as doctors and some patients believe, scabies may appear. Allergies in the form of redness are also a common occurrence. But there is no need to be afraid of all this. Firstly, all this does not affect the maturation of follicles. And secondly, an overdose of Gonal-F is such a rare occurrence that it is generally considered some kind of legend among patients.

Recombinant human follicle stimulating hormone

Active substance

Follitropin alfa

Release form, composition and packaging

Solution for subcutaneous administration

Excipients: poloxamer 188 - 0.05 mg, sucrose - 30 mg, - 0.05 mg, sodium dihydrogen phosphate monohydrate - 0.225 mg, sodium hydrogen phosphate dihydrate - 0.555 mg, m-cresol - 1.5 mg, phosphoric acid - q.s., sodium hydroxide - q.s., water d/i - up to 0.5 g.

0.5 ml - syringe pens (1) complete with disposable needles (5 pcs.) - plastic containers (1) - cardboard boxes.

Solution for subcutaneous administration transparent, colorless, slight opalescence is allowed.

Excipients: poloxamer 188 - 0.075 mg, sucrose - 45 mg, methionine - 0.075 mg, sodium dihydrogen phosphate monohydrate - 0.3375 mg, sodium hydrogen phosphate dihydrate - 0.8325 mg, m-cresol - 2.25 mg, phosphoric acid - q.s., sodium hydroxide - q.s., d/i water - up to 0.75 g.

0.75 ml - syringe pens (1) complete with disposable needles (7 pcs.) - plastic containers (1) - cardboard boxes.

Solution for subcutaneous administration transparent, colorless, slight opalescence is allowed.

Excipients: poloxamer 188 - 0.15 mg, sucrose - 90 mg, methionine - 0.15 mg, sodium dihydrogen phosphate monohydrate - 0.675 mg, sodium hydrogen phosphate dihydrate - 1.665 mg, m-cresol - 4.5 mg, phosphoric acid - q.s., sodium hydroxide - q.s., d/i water - up to 1.5 g.

1.5 ml - syringe pens (1) complete with disposable needles (14 pcs.) - plastic containers (1) - cardboard boxes.

pharmachologic effect

Recombinant human follicle-stimulating hormone (r-hFSH), which stimulates the growth and development of follicles. The drug is produced by genetic engineering using Chinese hamster ovary cell culture. Has a gonadotropic effect: stimulates the growth and maturation of the follicle/follicles, promotes the development of several follicles during controlled ovarian hyperstimulation for assisted reproductive technology (ART) programs.

Comparative clinical studies of r-hFSH (follitropin alfa) and y-FSH (urinary follicle-stimulating hormone) for ART and ovulation induction demonstrated the greater effectiveness of Gonal-f for initiating follicle maturation in terms of such indicators as a reduction in the cumulative dose and duration of treatment, compared with y-FSH and thus reducing the risk of unwanted ovarian hyperstimulation. For ART, the administration of Gonal-f in a lower total dose with a shorter duration of treatment leads to obtaining a larger number of retrieved oocytes compared to γ-FSH.

It has also been shown that in women with suppressed secretion of endogenous gonadotropins, follitropin alfa effectively stimulates follicular development and steroidogenesis, despite low measurable levels of luteinizing hormone (LH).

Pharmacokinetics

Suction

With subcutaneous administration, the absolute bioavailability is approximately 70%.

Distribution

After intravenous administration, follitropin alfa is distributed in extracellular fluids. V ss is 10 l.

After repeated injections of Gonal-f, a threefold accumulation of the drug in the blood is observed compared to a single injection. C ss in the blood is achieved within 3-4 days.

Removal

After intravenous administration of follitropin alfa, its initial T1/2 from the body is approximately 2 hours, the final T1/2 is approximately 24 hours. 1/8 of the administered dose of follitropin alfa is excreted in the urine. Total clearance - 0.6 l/h.

Indications

Among women:

- anovulation (including polycystic ovary syndrome) in women in case of ineffectiveness of clomiphene therapy;

— controlled ovarian hyperstimulation in assisted reproductive technology programs;

- ovarian stimulation in women with severe FSH and LH deficiency (in combination with LH medication).

For men:

- stimulation of spermatogenesis in hypogonadotropic hypogonadism (in combination with).

Contraindications

- hypothalamic-pituitary tumors;

- hypersensitivity to the components of the drug.

Among women:

- pregnancy;

- voluminous neoplasms or ovarian cysts (not caused by polycystic ovary syndrome);

- uterine bleeding of unknown etiology;

- ovarian cancer;

The drug should not be prescribed in cases where a positive effect cannot be obtained:

Among women:

- developmental anomalies of the genital organs and uterine fibroids, incompatible with pregnancy;

— primary ovarian insufficiency;

- premature menopause.

For men:

- primary testicular failure.

Dosage

Treatment with Gonal-f should be started under the supervision of a medical specialist with experience in treating infertility.

The drug Gonal-f is intended for subcutaneous administration.

The first injection of Gonal-f should be carried out under the supervision of the attending physician or qualified medical personnel. Self-administration of Gonal-f can only be carried out by patients who are well motivated, trained and have the opportunity to receive specialist advice. It is recommended to change the injection site daily.

Women

At anovulation (including polycystic ovary syndrome) in case of ineffectiveness of clomiphene therapy the drug should be prescribed in a course of daily injections. Treatment begins in the first 7 days of the cycle. Stimulation is carried out under ultrasound control (follicle sizes are measured) and/or estrogen levels. Stimulation begins with a daily dose of 75-150 IU, increasing it by 37.5 IU-75 IU after 7-14 days until an adequate but not excessive response is obtained. The maximum daily injection dose should not exceed 225 IU. If there is no positive dynamics after 4 weeks, treatment is stopped. In the next cycle, stimulation should begin with a higher dose than in the previous cycle.

After achieving the optimal response, 24-48 hours after the last injection of the drug Gonal-f, a single dose of recombinant human chorionic gonadotropin (r-hCG) is administered at a dose of 250 mcg or human chorionic gonadotropin (hCG) at a dose of 5000-10,000 IU. On the day of hCG injection and the next day, the patient is recommended to have sexual intercourse. As an alternative, intrauterine insemination may be performed.

If the ovaries respond excessively to stimulation, treatment with follitropin alfa should be discontinued and hCG should be discontinued. Stimulation is repeated in the next cycle, starting with a lower dose of Gonal-f compared to the previous cycle.

At conducting controlled ovarian hyperstimulation in assisted reproductive technology programs Gonal-f is prescribed daily at a dose of 150-225 IU, starting from days 2-3 of the cycle. The daily dose may vary, but usually does not exceed 450 IU. Treatment is continued until the follicles reach adequate size according to ultrasound (5-20 days, on average by the 10th day of treatment). 24-48 hours after the last injection of the drug Gonal-f, r-hCG is administered once at a dose of 250 mcg or hCG at a dose of 5000-10,000 IU to induce the final maturation of follicles.

To suppress the endogenous LH surge and maintain it at a low level, a GnRH agonist or antagonist is used. In the usual protocol, Gonal-f administration begins approximately 2 weeks after the start of agonist treatment, then both drugs are continued until follicles of adequate size are obtained. For example, after 2 weeks of treatment with an agonist, Gonal-f is prescribed at a dose of 150-225 IU for 7 days. Subsequently, the dose is adjusted depending on the response of the ovaries. The existing experience of ART indicates that, in general, the probability of successful treatment remains during the first 4 attempts and then gradually decreases.

At conducting ovarian stimulation in women with severe FSH and LH deficiency (in combination with LH drugs) The dose and treatment regimen are selected by the doctor individually.

Gonal-f is usually prescribed daily for up to 5 weeks concurrently with LH. Treatment with Gonal-f begins with a dose of 75-150 IU simultaneously with lutropin alfa at a dose of 75 IU. If necessary, the dose of Gonal-f can be increased by 37.5-75 IU every 7-14 days.

If there is no adequate response to stimulation within 5 weeks, therapy should be stopped and resumed in a new cycle at a higher dose.

After reaching the optimal size of the follicle/follicles, 24-48 hours after the last injection of the drug Gonal-f and lutropin alfa, r-hCG is administered once at a dose of 250 mcg or hCG at a dose of 5000-10,000 IU. On the day of hCG injection and the next day, the patient is recommended to have sexual intercourse. As an alternative, intrauterine insemination may be performed.

If the ovaries respond excessively to stimulation, treatment should be discontinued and hCG should be discontinued. Stimulation is repeated in the next cycle, starting with a lower dose of Gonal-f compared to the previous cycle.

Men

For stimulation of spermatogenesis in hypogonadotropic hypogonadism in men (in combination with human chorionic gonadotropin) Gonal-f is prescribed, as a rule, at a dose of 150 IU 3 times a week for at least 4 months in combination with hCG. If there is no positive effect during this time, treatment can be continued for up to 18 months.

Rules for administering the drug

When using the drug independently, patients should carefully study the instructions. The doctor prescribes the drug in doses in International Units (IU). One package of the drug is intended for use by only one patient. The patient should prepare a prefilled pen and administer the injection. The next injection should be given the next day at the same time.

1. The patient should wash their hands. It is very important that his hands and all objects he uses are as clean as possible.

To carry out the injection, you need to lay out 2 alcohol-soaked swabs, a pre-filled syringe pen and an injection needle on a clean surface.

2. Preparation of a pre-filled syringe pen of the drug Gonal-f for the first use: remove the cap of the pen, put on the needle as described in paragraph 3. Then fill the syringe pen by placing the dose indicator arrow opposite point 37.5 on the black scale to set the dose. Pull out the injection button until it stops, remove the outer needle cap, then the inner needle cap, while holding the syringe pen with the needle vertically (the needle should be pointing up). Gently tap the cartridge location so that any air bubbles collect at the base of the needle. While pointing the needle vertically upward, release the injection button completely. A drop may appear at the tip of the needle. This means the pre-filled pen is ready to be injected. The loss of a small amount of fluid at the tip of the needle does not matter, because... the syringe pen is specially filled with some excess. If liquid does not appear at the tip of the needle, then the preparation process should be repeated. Then the dose should be set as described in paragraph 4.

For the next injection, attach the needle and set the dose as described in paragraphs. 3 and 4 respectively.

3. Attaching the needle. Get a new needle. If the needle packaging is broken, you should throw the needle away and get a new one. Remove the protective membrane from the outer needle cap. Holding the needle firmly by the outer cap, insert the needle into the pen onto the threaded tip and turn clockwise until it clicks into place. Only use the needles included with the pen or supplied separately for this pen.

4. Dose setting. Set the required dose by turning the dose setting dial with a black scale until the dose value is opposite the arrow. The dose dial allows you to set the dose in 37.5 IU intervals. The minimum dose and maximum dose range from 37.5 IU to 300 IU. After establishing the required dose, dial it by pulling the injection button all the way. The button should be lifted straight up and not rotated, because this may change the prescribed dose. It is necessary to carefully monitor the set dose on the disk, because Once the injection button is pressed, it can no longer be changed. If, after pressing the injection button and dialing the dose, it turns out that the dose was dialed incorrectly, then the injection should not be given. It is necessary to remove the erroneously dialed dose and repeat the dialing again.

The red scale of the dose control dial should be checked to ensure that the correct dose is dialed: when the injection button is pulled out, the number on the red scale of the control dial indicating the dose dialed is opposite the dose set on the black dial of the dose dial against the arrow. If the dialed dose is less than the required one, then dosing is not completed. In this case, you must act in accordance with clause 2.

If the same dose is required each time, the dose indicator arrow should remain in the same position.

5. Administration of the drug. The injection site chosen on the doctor's recommendation should be treated with an alcohol swab. The patient should use the subcutaneous injection technique as recommended by a doctor or nurse. Insert the needle into the skin and press the injection button. Make sure that the gray full dose indicator is no longer visible. This position of the indicator indicates delivery of the full dose. You should hold the needle in the skin and keep the button pressed for at least 10 seconds. When removing the needle from the skin, you must continue to hold the button down.

6. Removing the needle. The needle should be thrown away after each injection. Holding the syringe pen firmly by the drug reservoir, carefully place the outer cap on the needle. Clamp the outer needle cap and unscrew the needle by turning it counterclockwise. Throw away the used needle. Place the protective cap on the syringe pen.

7. Storing a pre-filled pen. After injection, remove used needles as described in step 6. Place the protective cap on the syringe pen. The pen syringe should be stored in a safe place, preferably in its original packaging. Once the pen is empty, you should throw it away.

Note: The scale that can be seen through the drug reservoir serves as an indicator of the amount of drug remaining in the reservoir. It cannot be used to set the dose.

8. The dose control dial with a red scale on the injection button serves to monitor whether the last dose has been fully injected. It changes its position, indicating the amount of drug in the reservoir. If the collected dose is not sufficient to complete the injection, there are two options: a) inject the dose remaining in the pen, and then take a new pen, set the remainder of the required dose on it and inject it; b) throw away the old syringe pen, take a new one and administer the required dose.

Patients should be warned to consult a physician if a larger dose than required is administered or if a dose is missed; Do not administer a double dose of the drug.

Side effects

When using Gonal-f, side effects may develop, the frequency of which is determined as follows: very often (≥1/10), often (≥1/100,<1/10), нечасто (≥1/1000, <1/100), редко (≥1/10 000, <1/1000), очень редко (<1/10 000, включая единичные сообщения). Частота побочных эффектов в каждой группе указана в порядке убывания.

Use in women

From the immune system: very rarely - mild to moderate systemic allergic reactions (for example, redness of the skin, rash, swelling of the face, urticaria, difficulty breathing), severe allergic reactions (including anaphylactic reactions and shock).

From the side of the central nervous system: very often - headache.

From the cardiovascular system: very rarely - thromboembolism, usually associated with a severe form of ovarian hyperstimulation syndrome (OHSS).

From the digestive system: often - heaviness, abdominal discomfort, nausea, vomiting, diarrhea.

very often - ovarian cysts; often - (OHSS of mild or moderate severity (including corresponding symptoms); infrequently - severe form of OHSS (including corresponding symptoms); rarely - complication of OHSS (see "Special Instructions"), ectopic pregnancy (in women with a history of uterine diseases tubes), multiple pregnancy.

Local reactions:

Usage men

From the respiratory system: very rarely - in patients with bronchial asthma, worsening or exacerbation of the disease.

Local reactions: very often - mild/moderate reactions at the injection site (pain, redness, bruising, swelling).

From the skin and subcutaneous tissue: often - the appearance of acne (acne).

From the reproductive system and mammary glands: often - gynecomastia, varicocele.

Others: often - weight gain.

If serious side effects or effects not described above occur, you should inform your doctor.

Overdose

Currently, no cases of overdose of Gonal-f have been reported. When using the drug in excessive doses, the development of OHSS should apparently be expected.

Drug interactions

When Gonal-f is combined with other stimulating drugs (hCG, clomiphene citrate), the ovarian response is enhanced; against the background of desensitization of the pituitary gland with GnRH analogues, it decreases (an increase in the dose of the drug Gonal-f is required).

There is no data on the interaction of the drug Gonal-f with other drugs.

special instructions

Since Gonal-f can cause serious side effects, it should only be prescribed by a specialist doctor who is directly involved in infertility problems. The start of therapy should be preceded by an examination of the infertile couple, in particular, studies should be carried out to exclude hypothyroidism, hyperprolactinemia, hypothalamic-pituitary tumors, and, if necessary, appropriate therapy should be prescribed.

It is necessary to assess the patency of the fallopian tubes in order to select a method of assisted reproductive technology. Fallopian tube obstruction should be excluded if the patient is not participating in an in vitro fertilization program.

In patients with porphyria, as well as in the presence of porphyria in relatives, careful monitoring is required during therapy with Gonal-f. If the condition worsens or the first signs of this disease appear, it may be necessary to discontinue therapy.

When treating with the drug, it is necessary to assess the condition of the ovaries using ultrasound, both separately and in combination with the determination of estradiol in the blood.

The response to the administration of follicle-stimulating hormone may differ in different patients, so the drug should be used in the minimum effective doses in both women and men.

The drug Gonal-f contains less than 1 mmol (23 mg) sodium in 1 dose, that is, it is not a significant source of sodium.

Ovarian hyperstimulation syndrome

OHSS must be differentiated from uncomplicated ovarian enlargement. Clinical symptoms of OHSS may appear with increasing severity. Characterized by a significant increase in the size of the ovaries, high levels of sex hormones, increased vascular permeability, leading to the accumulation of fluid in the abdominal, pleural and, less commonly, pericardial cavities.

The following symptoms are most typical for severe OHSS: pain and a feeling of fullness in the abdomen, a marked increase in the size of the ovaries, increased body weight, shortness of breath, oliguria, gastrointestinal symptoms (nausea, vomiting, diarrhea); hypovolemia, hemoconcentration, electrolyte imbalance, ascites, hemoperitonium, pleural effusion, hydrothorax, acute respiratory distress syndrome may occur. In very rare cases, severe OHSS may be complicated by ovarian torsion, pulmonary embolism, ischemic stroke, or myocardial infarction.

In order to minimize the risk of OHSS and multiple pregnancies, it is recommended to regularly use ultrasound and evaluate the concentration of estradiol in the blood plasma for early identification of risk factors. Independent risk factors for the development of OHSS are polycystic ovary syndrome or high concentrations of estradiol in the blood plasma. During anovulation, the risk of developing OHSS increases with estradiol concentrations > 900 pg/ml (3300 pmol/l) and the presence of more than 3 follicles with a diameter of 14 mm or more. With ART, the risk of developing OHSS increases with estradiol concentrations > 3000 pg/ml (11,000 pmol/l) or the presence of 20 or more follicles with a diameter of 12 mm or more.

There is reason to believe that hCG plays a key role in the occurrence of OHSS. When pregnancy occurs, the severity of OHSS may worsen and its duration may increase. When estradiol levels are >5500 pg/mL (20,200 pmol/L) or when there are 40 or more follicles, hCG should be avoided.

OHSS can progress quickly (from a day to several days) to a severe condition. Most often, OHSS occurs after cessation of hormonal therapy and reaches its maximum after 7-10 days, therefore, after the introduction of hCG, observation for at least 2 weeks is necessary.

The likelihood of OHSS in patients undergoing controlled ovarian hyperstimulation for ART is reduced by aspiration of all follicles.

Mild to moderate OHSS resolves spontaneously. If severe OHSS develops, gonadotropin therapy, if still ongoing, should be discontinued. The patient should be hospitalized and given OHSS-specific therapy.

Multiple pregnancy

The frequency of multiple pregnancies and births during ovulation induction is higher compared to natural conception. The most common option for multiple pregnancy is twins. Multiple pregnancies, especially those with a large number of embryos, increase the risk of adverse outcomes for the mother and fetus. To minimize the risk of multiple pregnancies, careful monitoring of the ovarian response is necessary. With ART, the risk of multiple pregnancy is mainly related to the number of embryos transferred, their viability and the age of the patient.

Miscarriage

The incidence of miscarriage or spontaneous abortions (miscarriages) after ovulation induction and ART programs is higher than in the general population.

Ectopic pregnancy

Patients with a history of fallopian tube disease have an increased risk of ectopic pregnancy. The likelihood of ectopic pregnancy after the use of assisted reproductive technologies is higher than in the general population.

Neoplasms of the reproductive system

There are reports of benign and malignant neoplasms of the ovary and other reproductive organs in women after repeated courses of infertility treatment with various drugs. Currently, no connection has been established between gonadotropin therapy and an increased risk of neoplasms in infertility.

Congenital malformations

Thromboembolic complications

In patients with recent or current thromboembolic diseases, as well as at a probable risk of their occurrence, the use of gonadotropins may increase this risk or complicate the course of these diseases. For patients in this group, the benefits of therapy must be weighed against the possible risks. It should be noted that pregnancy itself carries an increased risk of thromboembolic disorders.

Treatment for men

An increased concentration of follicle-stimulating hormone in the blood serum of men may indicate primary testicular failure. In this case, treatment with r-hFSH/hCG is ineffective and Gonal-f should not be prescribed. 4-6 months after the start of therapy, it is recommended to monitor the spermogram.

Patients should be aware of the above risks before starting therapy.

It is necessary to inform the doctor about all types of allergic reactions that the patient has, as well as about all drugs used before starting treatment with Gonal-f.

It is necessary to mark the date of first use on the handle with the drug.

After the first use, the drug can be stored for no more than 28 days at a temperature not exceeding 25°C. Do not use the drug after this period.

Within the expiration date, the drug can be stored at a temperature not exceeding 25°C for up to 3 months. The drug should be destroyed if it has not been used after 3 months. Re-refrigeration is not permitted.

Impact on the ability to drive vehicles and operate machinery

The drug Gonal-f does not affect the ability to drive a car or operate other mechanisms.

Pregnancy and lactation

The drug is not prescribed during pregnancy and breastfeeding.

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, protected from light, in its original packaging at a temperature of 2° to 8°C; do not freeze. Shelf life - 2 years.

Merck Serono S.p.A.

Country of origin

Italy

Product group

Hormonal drugs

Follicle stimulating agent.

Release forms

1 pre-filled drug pen
12 disposable injection needles

Description of the dosage form

Transparent colorless solution. Light opalescence is acceptable.

Pharmacokinetics

When administered subcutaneously, the absolute bioavailability is approximately 70%. After repeated injections of GONAL-f®, a threefold accumulation of the drug in the blood is observed compared to a single injection. Steady-state equilibrium concentration in the blood is achieved within 3-4 days. It has also been shown that in women with suppressed secretion of endogenous gonadotropins, follitropin alfa effectively stimulates follicular development and steroidogenesis, despite low measurable levels of luteinizing hormone (LH). Following intravenous administration, follitropin alfa is detected in extracellular fluids with an initial half-life of approximately 2 hours and a terminal half-life of approximately 24 hours. The equilibrium volume of distribution is 10 l, the total clearance is 0.6 l/hour. One-eighth of the administered dose of follitropin alfa is excreted in the urine.

Special conditions

The start of therapy should be preceded by an examination of the infertile couple to identify contraindications to pregnancy. In particular, they diagnose hypothyroidism, adrenal insufficiency, hyperprolactinemia, hypothalamic-pituitary tumors, and, if necessary, prescribe appropriate therapy. When hCG is prescribed, the likelihood of ovarian hyperstimulation syndrome and multiple superovulation increases, which can lead to ovarian rupture. Therefore, if the ovaries have an excessive response to stimulation, hCG is not prescribed, and patients are advised to abstain from coitus for at least 4 days or use barrier methods of contraception. The likelihood of ovarian hyperstimulation syndrome in patients undergoing controlled ovarian hyperstimulation for assisted reproductive technologies is reduced by aspiration of all follicles. The degree of risk of multiple pregnancy with assisted reproductive technologies depends on the number of embryos transferred; twin pregnancies are more common. After the ovulation induction protocol, the incidence of multiple pregnancies and births is increased compared to natural conception. The rate of pregnancy loss after ovulation induction protocols and assisted reproductive technology programs is slightly higher than in the population, but comparable to rates for women suffering from other forms of infertility. Tell your doctor about all types of allergic reactions you have to medications. Inform your doctor about all medications that you are taking or have taken before starting treatment with GONAL-f®. High levels of follicle-stimulating hormone in the blood serum of men may indicate primary testicular failure. In this case, treatment with GONAL-f® is not effective. To assess the response to Gonal-F stimulation, it is recommended to monitor spermograms 4-6 months after the start of therapy. Be sure to mark the date of the first day of use on the handle with the drug. Do not use the drug solution after 28 days from the date of first use. Within the expiration date, the drug can be stored without refrigeration for 28 days at a temperature not exceeding 25°C. The drug must be destroyed if it is not used during this period. Use during pregnancy and lactation During pregnancy and lactation, the drug GONAL-f® is not prescribed. Effect of the drug on driving a car and operating other mechanisms The drug GONAL-f® does not affect the patient’s ability to drive a car or control other mechanisms.

Compound

1 pre-filled syringe pen contains: follitropin alfa 33 mcg (450 IU) and excipients: poloxamer 188, sucrose, methionine, sodium dihydrogen phosphate monohydrate, sodium hydrogen phosphate dihydrate, m-cresol, phosphoric acid, sodium hydroxide, water for injection.

Gonal-F indications for use

-Ovarian stimulation in the absence of growth and maturation of follicles (including with polycystic ovary syndrome) and in case of ineffectiveness of therapy with clomiphene citrate;
-Controlled ovarian hyperstimulation in assisted reproductive technology programs;
-Ovarian stimulation in hypogonadotropic conditions in women (in combination with a luteinizing hormone drug);
-Stimulation of spermatogenesis in hypogonadotropic hypogonadism in men (in combination with human chorionic gonadotropin).

Gonal-F contraindications

Hypersensitivity to the drug or excipients, hypothalamic-pituitary tumors.
In women: pregnancy, voluminous neoplasms or ovarian cysts (not caused by polycystic ovary syndrome), uterine bleeding of unknown etiology, ovarian carcinoma, uterine cancer, breast cancer. The drug should not be prescribed:
-in women: with abnormal development of the genital organs and uterine fibroids, incompatible with pregnancy, primary ovarian insufficiency, premature menopause.
-in men: with primary testicular failure.

Gonal-F dosage

33 mcg/0.75 ml

Gonal-F side effects

Local reaction: pain and hyperemia at the injection site. Fever, headache and arthralgia may occur.
From the endocrine and reproductive systems: ectopic pregnancy (more often in women with a history of diseases of the fallopian tubes), multiple pregnancy. Possible development of ovarian hyperstimulation syndrome (mild form - pain in the lower abdomen, nausea, vomiting, weight gain, enlarged ovaries, formation of ovarian cysts, severe form (in rare cases) - the occurrence of large ovarian cysts prone to rupture, ascites, hydrothorax) .
In rare cases, thromboembolism, allergic reactions.
In men - gynecomastia, acne and weight gain.

Drug interactions

When GONAL-f® is combined with other stimulating drugs (hCG, clomiphene citrate), the ovarian response is enhanced; against the background of desensitization of the pituitary gland with gonadotropin-releasing hormone analogues, it decreases (an increase in the dose of the drug is required). There is no data on the incompatibility of GONAL-f® with other drugs.

Overdose

Currently, no cases of overdose of the drug GONAL-f® have been reported. Apparently, one should expect the appearance of ovarian hyperstimulation syndrome, which is described in more detail in the “Special Instructions” section.

Storage conditions

Store refrigerated (t 2 - 5)
keep away from children
store in a place protected from light

Information provided

Increasing the reproductive functions of the female body is given great attention in the development of modern gynecology, and ovulation stimulation plays an important role in this direction. To carry out stimulation, various methods are used, including surgical, therapeutic (hCG injections and tablets) treatment, which allows accelerating the development of the egg in women with infertility. Unfortunately, the use of ovulation stimulation can help achieve a positive result only for those patients who have retained the ability to form a healthy egg, but for a number of reasons it does not mature.

A decrease in estrogen has a negative impact on female reproductive functions and often causes infertility. To restore and stimulate the functioning of the ovaries, doctors recommend using effective hormonal drugs, for example, the French drug Proginova. Before an IVF procedure or for polycystic ovary syndrome, the use of ovulation stimulation is also indicated. To stimulate the ovaries, spouses need to be examined in detail and only in the absence of contraindications, under the strict supervision of a doctor, with regular ultrasound monitoring, they are given a course of stimulation.

To avoid hyperstimulation, it is especially important to adhere to the indicated dose of drugs and avoid overdose. Stimulation of ovulation using medications is not carried out more than six times throughout life.

Action from applications

One of the safest drugs to use, and also the most effective for stimulating ovulation, is Gonal-F, produced in the form of an injection. Since it contains hormones, should gonal be taken only as strictly prescribed by a doctor and in accordance with the dosage? specified in the recipe. The hormonal compounds that determine the effect of the drug are created using artificial synthesis and have properties identical to those of hormones produced in the pituitary gland to stimulate the formation of follicles. The effect of using gonal is close to the effect obtained from the influence of these hormones, and also regulates menstrual cycles and the occurrence of ovulation. The composition of the drug Gonal includes the current active substance and several auxiliary components that increase its effectiveness and reduce the possibility of adverse reactions. Treatment with gonal is carried out using intramuscular injections on the prescribed days of the cycle and if all recommendations are followed, conception can occur as a result of the first course of use.

The use of gonal injections causes such changes in the female body as:

stimulation of formation and full maturation of the follicle;
normalization of the menstrual cycle;
regulation of the fertilization process;
restoration of the endometrium;
increased estrogen hormone;
normalization of hormonal levels.

The changes that have occurred under the influence of gonal allow for full ovulation to occur, and the fertilized egg has the opportunity to strengthen in the uterus on the endometrium that is sufficiently prepared for this.

Injections used

Intramuscular injections are often used for treatment with gonadotropins. For this purpose, menopausal or recombinant gonadotropins, such as gonal, are used. They are made in a laboratory, contain no impurities, and their effect on the ovaries is close to natural follicle stimulating hormone. Preparations for injections of hCG (human chorionic gonadotropin) are produced in an outpatient clinic and are used in cases where the follicle is able to develop normally, reaching the desired size, but is not able to rupture on its own.

Clostilbegit and hCG injections for stimulation

As a means of stimulating the ovaries, in addition to gonal, clostilbegit is also used, which also promotes the production of necessary hormones. In order to prevent the occurrence of follicular cysts, hCG (gonadotropin) injections are prescribed together with the drug clostilbegit. During the entire course of taking the tablets, ultrasound monitors the growth of follicles until they reach a size of 20 mm.

The course of treatment with clostilbegit is carried out according to the following scheme: 1 tablet for five days, with monitoring of the condition of the ovaries with ultrasound. Pregnancy after treatment with clostilbegit occurs between days 110 and 15 of the cycle. If pregnancy does not occur after taking the drug clostilbegit, use another regimen with an increase in dose to 2 tablets over five days. In cases where the second scheme does not bring the expected result, the course is completely repeated.

Situations arise when clostilbegit does not affect the patient’s reproductive organs, then the use of this drug must be stopped and other methods of stimulating ovulation must be tried. One treatment regimen with clostilbegit should not exceed 750 mg of the drug.

To prevent the formation of cysts from empty follicles that have not undergone ovulation, injections of hCG are given, which can activate the maturation of follicles within a day after application. According to experts, hCG injections can lead to conception immediately after the first injection.

Stimulation of ovulation using the drug Gonal

Stimulating ovulation with Gonal has significant differences from stimulation with clostilbegit. It is in many ways superior to clostilbegit in terms of effectiveness and safety, since it does not cause the formation of cysts. Gonal injections are used in the initial seven days of the cycle, and the duration of administration is determined by the doctor and depends on the estrogen level.

Stimulation with increasing doses of the drug continues until a significant effect appears. Two to three days after the injection, the patient receives hCG (gonadotropin). For successful conception, sexual intercourse is recommended to be carried out on these and the next day. If the course according to the given scheme does not bring a positive result, when used in the next cycle, the dose of the drug is increased.

Reasons for use

The need to use gonal arises in the following situations:

Methods of using drugs

The drug Gonal is produced in capsules as powders intended for injections by dilution immediately before use, or in special syringe pens intended for injection with a composition of a certain concentration that is completely ready for use. The second option is more convenient to use and is increasingly being used. The syringe pen can be produced in various dosages required in each specific case, which makes it easy to control the dose required for the injection, does not require dilution and is completely painless to use, since it is injected under the skin. When using powder, the dosage of follitropin directly depends on the volume of the dissolving composition, so it is best to have this portion accurately calculated by a specialist.

Gonal is used using conventional technology intended for subcutaneous injections, and is no different from conventional procedures that require certain antiseptic rules:

Hand hygiene using soap or alcohol-containing compounds before the injection.
Preparing for use of a syringe pen and setting the prescribed dosage. The powder is diluted in a bottle to the required concentration, and the amount of the drug prescribed by the doctor for one injection is drawn into the syringe.
The skin is treated with an antiseptic composition, and a puncture is made with a needle directed perpendicular to the injection site. The injection is almost painless, as it is performed with a thin short needle.
Injecting the solution, removing the needle and treating the puncture site with a napkin containing alcohol.

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Efficacy of the drug

When using gonal, you can achieve the desired pregnancy and normalize many physiological processes occurring in a woman’s body. For example, it is possible to increase the level of hormones belonging to the estrogen series and normalize the menstrual cycle. Increase the formation of follicles in the ovaries, stimulate their growth and cause full ovulation, as well as prepare the endometrium to receive a fertilized egg and attach it to it.

As a result of taking gonal, it is possible to completely regulate hormonal dysfunction and restore the ability of the ovaries to ovulate eggs exactly in the middle of the cycle. By reuniting all the links in the chain necessary for the regulation of reproductive functions, there is a real opportunity for the development of full-fledged embryos. With correct diagnosis and timely use in accordance with the recommendations, pregnancy as a result of the use of gonal can occur after just one treatment course.

Carrying out stimulation for IVF

The use of IVF can often be the only way for an infertile couple to have offspring. The technique uses the fertilization of eggs in the laboratory with the implantation of fertilized embryos into the uterus. IVF is used for obstruction of the fallopian tubes, low-quality sperm and other abnormalities. Before IVF, an examination is carried out to prevent the risk of undesirable consequences. Since for IVF it is necessary to have several mature eggs available at the same time, ovulation stimulation is used using the drug gonal. When carrying out IVF with artificial ovarian stimulation, it is necessary to take into account that the use of gonal often provokes the occurrence of multiple births.

Contraindications for stimulation

The substances that make up gonal can, like any other medicine, have undesirable effects and limit its use. All possible side effects must be taken into account when prescribing ovulation stimulation with gonal. In this case, you need to pay attention to the following points:

formation of large follicular ovarian cysts;
individual intolerance and manifestation of allergic reactions to the administered drug;
unknown cause of uterine bleeding;
tumors in the ovary and uterine cavity that are malignant;
mastopathy in a precancerous state;
the presence of tumor processes of the pituitary gland;
disruption of the primary processes of follicle formation in the ovaries;
a common manifestation of infertility resulting from obstruction of the fallopian tubes.

Possible side effects

In case of individual intolerance to gonal, the following symptoms may appear:

skin rashes;
formation of follicular cysts;
reaction to the injection of gonal at the injection site, manifested by redness and inflammation;
the occurrence of multiple births;
miscarriage;
development of tumors in the mammary gland.

In the absence of contraindications and the drug is well tolerated, it is indispensable for stimulating ovulation in solving problems associated with infertility, especially if the use of another means of stimulation does not bring a positive effect. An important condition for obtaining a good result is the correct dosage according to the regimen and taking gonal under the constant supervision of a doctor with an ultrasound. Monitoring the patient allows you to monitor the condition of the ovaries and timely apply methods that promote full conception.

After a course of treatment, you need to take into account that pregnancy may not occur the first time. This serves as a reason for undergoing additional examination, which allows us to determine the cause of the failure and which is an obstacle to conception. According to the observations of doctors, after stimulation of ovulation, which seems unsuccessful, after a few months the patients achieve the desired pregnancy. This occurs as a result of the fact that the internal functions of the body return to the appropriate norm and trigger the correct functioning of the reproductive organs.