Gonal-f
Instructions for use:
- 1. Release form and composition
- 2. Indications for use
- 3. Contraindications
- 4. Method of application and dosage
- 5. Side effects
- 6. Special instructions
- 7. Drug interactions
- 8. Analogs
- 9. Terms and conditions of storage
- 10. Terms of dispensing from pharmacies
Prices in online pharmacies:
from 1069 rub.
Buy
Gonal-f is a recombinant human follicle-stimulating hormone.
Release form and composition
Dosage forms:
- Lyophilisate for the preparation of a solution for subcutaneous (s / c) administration: powder or white mass (glass vials of 3 ml, in a cardboard box 1, 3, 5 or 10 vials complete with a solvent in syringes or vials 1, 3, 5 or 10 pcs respectively);
- Solution for subcutaneous administration: clear, colorless liquid, slight opalescence is possible (syringe pen 0.5 ml, 0.75 ml, 1.5 ml, in a plastic container 1 syringe pen complete with 5, 7 or 14 disposable needles, respectively, in a cardboard box 1 container).
The active substance of Gonala-f is follitropin alpha:
- 1 bottle - 5.5 mcg, or 75 international units (IU);
- 1 syringe pen - 22 μg (300 IU), 33 μg (450 IU), 66 μg (900 IU).
Excipients:
- Lyophilisate: sodium hydrogen phosphate dihydrate, sucrose, sodium dihydrogen phosphate monohydrate, sodium hydroxide, phosphoric acid, polysorbate 20, methionine;
- Solution: sucrose, poloxamer 188, methionine, sodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate monohydrate, m-cresol, sodium hydroxide, phosphoric acid, water for injection.
Solvent: water for injection.
Indications for use
The use of Gonala-f is indicated in the treatment of infertility in women:
- Ovarian stimulation with the ineffectiveness of clomiphene therapy and the absence of growth and maturation of follicles, including against the background of polycystic ovary syndrome;
- Controlled ovarian increased stimulation in the assisted reproductive technology program;
- Ovarian stimulation for hypogonadotropic pathologies (in combination with a luteotropin drug).
In addition, the drug is used in the treatment of hypogonadotropic hypogonadism in men to stimulate spermatogenesis (in combination with chorionic gonadotropin).
Contraindications
- Tumors of the pituitary gland or hypothalamus;
- Hypersensitivity to drug components.
In addition, contraindications for use in women:
- Bulky tumors or ovarian cysts, not caused by polycystic ovary syndrome;
- Uterine cancer;
- Ovarian carcinoma;
- Breast cancer;
- Uterine bleeding of unknown etiology;
- Ovarian primary insufficiency;
- Fibroids of the uterus and genital anomalies incompatible with pregnancy;
- The period of pregnancy and breastfeeding;
- Premature menopause.
Do not prescribe the drug to men with primary testicular insufficiency.
Method of administration and dosage
Gonal-F is administered sc, changing the injection site daily.
The dosage regimen and the period of use are prescribed by the doctor based on clinical indications.
Recommended dosage for women:
- Anovulatory infertility with a preserved menstrual cycle, including in violation of its periodicity: the initial dose is 75-150 IU once a day, every 7 or (preferably) 14 days the dose should be increased by 37.5-75 IU until the desired effect is obtained. Treatment should be started in the first 7 days of the menstrual cycle. Stimulation is carried out under the supervision of an ultrasound examination (ultrasound), measuring the level of estrogen in the blood and / or the size of the follicles. The dose of one injection should not exceed 225 IU. The therapy is discontinued in the absence of positive dynamics after 4 weeks of using the drug, resuming in the next cycle with a higher dose. When an optimal response is achieved 24-48 hours after the last SC injection of the drug, the patient needs a single administration of recombinant human choriogonadotropin (r-hCG) at a dose of 250 μg or human chorionic gonadotropin (hCG) at a dose of 5-10 thousand IU. On the day of hCG administration and the next day, the woman is recommended to have sexual intercourse. If the ovaries respond excessively to stimulation, hCG should be discontinued. In the next cycle, stimulation should be carried out at a lower dose;
- Controlled ovarian hyperstimulation in the program of assisted reproductive technology (ART): 150-225 IU once a day, starting from 2-3 days of the cycle. The daily dose may vary, but should not exceed 450 IU. Treatment continues from 5 to 20 days, usually by the 10th day of drug administration, according to ultrasound data, the follicles reach adequate size. 24-48 hours after the last injection, a single injection of 250 μg r-hCG or 5-10 thousand IU hCG follows to accelerate the final maturation of follicles. Suppression of the endogenous release of luteinizing hormone (LH) and its maintenance at a low level is achieved by the administration of an agonist or antagonist of gonadotropin-releasing hormone (GnRH) for 2 weeks. Then the therapy is continued for 7 days in combination with Gonal-f at a dose of 150-225 IU until the follicles reach an adequate size. In the future, the dose can be adjusted taking into account the response of the ovaries. The likelihood of successful therapy remains during the first 4 attempts;
- Ovarian stimulation for hypogonadotropic pathologies in combination with a luteotropin drug (LH): the dose and regimen are selected individually. Usually, the initial dose is 75-150 IU 1 time per day for no more than 35 days at the same time as 75 IU of lutropin alfa. If necessary, the dose of Gonal-f can be increased every 7-14 days by 37.5-75 IU. If during the indicated course the stimulation does not give an adequate response, the treatment is stopped and resumed at a higher dose in the next cycle. When the follicles reach their optimal size 24-48 hours after the last injection of the drug and lutropin alfa, 250 μg r-hCG or 5-10 thousand IU hCG is injected once. Sexual intercourse is required on the day of hCG injection and the next day, or alternatively, intrauterine insemination can be performed. If there is an excessive ovarian response to stimulation, therapy should be discontinued and resumed in the next cycle with a lower dose of Gonal-f.
For men, the drug is prescribed for hypogonadotropic hypogonadism to stimulate spermatogenesis, 150 IU once every 2 days. The course of treatment in combination with hCG is 4 months or more. If there is no clinical effect, the treatment can be extended up to 18 months.
Side effects
Very often, the use of Gonala-f causes local reactions in the form of bruising, redness, pain, swelling at the injection site of mild to moderate severity.
In women, both forms of the drug can cause side effects:
- Reproductive system: very often - ovarian cysts; often - mild to moderate ovarian hyperstimulation syndrome (OHSS); rarely - in women with a history of fallopian tube disease - ectopic pregnancy, complication of OHSS in the form of torsion of the ovarian cyst, multiple pregnancies;
- Digestive system: often - abdominal pain, nausea, vomiting, diarrhea;
- Cardiovascular system: very rarely - increased blood clotting (thromboembolism);
- From the respiratory system: very rarely - in patients with bronchial asthma, exacerbation or worsening of the course of the disease;
- Allergic reactions: very rarely - mild skin redness, rash, swelling of the face, hives, shortness of breath, severe allergic reactions, including anaphylaxis and shock.
In addition, undesirable effects against the background of the use of lyophilisate in women can be:
- Nervous system: often - headache;
- Cardiovascular system: very rarely - ischemic stroke, pulmonary embolism, myocardial infarction;
- Digestive system: often - belching, colic;
- Reproductive system: rarely - severe OHSS, ovarian apoplexy;
- Others: arthralgia, fever, acute pulmonary insufficiency.
Also, the use of Gonala-f solution in women can cause side effects:
- Nervous system: very often - headache;
- Digestive system: often - abdominal discomfort, heaviness;
- Reproductive system: infrequently - severe OHSS.
In men, the use of the drug can cause side effects:
- Dermatological reactions: often - acne;
- Endocrine system: often - gynecomastia;
- Reproductive system: often - varicocele;
- Others: often - an increase in body weight.
In addition, the use of the solution in men causes side reactions:
- Immune system: very rarely - systemic allergic reactions of mild to moderate severity (redness of the skin, hives, swelling of the face, rash, shortness of breath), anaphylactic reactions, shock;
- Respiratory system: very rarely - worsening of the course or exacerbation of bronchial asthma.
special instructions
The drug should be used under the supervision of a physician with experience in infertility treatment.
The first injection of the drug is carried out by a qualified specialist. Self-administration is allowed only if the patient is well trained, motivated and has the opportunity to seek specialist advice.
Before starting therapy, the infertile couple should be examined to exclude adrenal insufficiency, hypothyroidism, hypothalamic-pituitary neoplasms, hyperprolactinemia.
An assessment of the patency of the fallopian tubes is required.
In case of porphyria, including in close relatives, treatment should be carried out under close monitoring of the patient's condition, in case of its deterioration or the first signs of illness appear, therapy can be discontinued.
The use of the drug requires a regular assessment of the state of the ovaries using ultrasound, including the determination of estradiol in the blood plasma.
Treatment for men and women should be carried out using the lowest effective dose.
Ovarian hyperstimulation syndrome (OHSS) should be differentiated from uncomplicated ovarian enlargement. A significant increase in the size of the ovaries and vascular permeability, a significant level of sex hormones causes the accumulation of fluid in the abdominal, pleural or pericardial cavities, which is characteristic of the clinical symptoms of OHSS.
In severe OHSS, there is a feeling of bloating and abdominal pain, shortness of breath, a significant increase in the size of the ovaries, oliguria, weight gain, nausea, vomiting, diarrhea, hemoconcentration, hypovolemia, electrolyte imbalance, hemoperitonium, ascites, pleural effusion, acute respiratory distress syndrome, hydrothorax. Very rarely, OHSS can cause ovarian torsion, pulmonary embolism, ischemic stroke, or myocardial infarction.
High plasma levels of estradiol and polycystic ovary disease are risk factors for the development of OHSS.
With strict adherence to the dosing regimen and careful monitoring of therapy, the risk of developing OHSS and multiple pregnancy is minimized.
Patients with an excessive ovarian response to hCG stimulation should not be prescribed and unprotected sexual intercourse should be prohibited for 4 days.
With controlled ovarian hyperstimulation for ART, the risk of developing OHSS is reduced by aspiration of all follicles.
The frequency of multiple pregnancies, spontaneous abortions and ectopic pregnancies after ART and ovulation induction programs is higher than with natural conception. The likelihood of multiple pregnancies with ART depends on the number of embryos transferred, their viability and the woman's age.
Repeated courses of therapy in women can cause benign and malignant tumors of the reproductive organs, including the ovary.
Since pregnancy increases the likelihood of thromboembolic disorders, women who have recently undergone or with current thromboembolic pathology need to balance the benefits of therapy with the possible risks.
Elevated serum follicle-stimulating hormone levels in men may indicate primary testicular insufficiency. The use of Gonal-f is not effective in this case. Semen analysis to assess the response to stimulation is recommended after 4-6 months of therapy.
Before prescribing the drug, the doctor should be informed about all the patient's allergic pathologies and the drugs used before starting treatment.
Gonal-f does not affect the patient's ability to drive vehicles and mechanisms.
Drug interactions
The ovarian response is enhanced by the combination of the drug with hCG, clomiphene citrate. When the pituitary gland is desensitized with GnRH analogs, the dose of Gonal-f must be increased, since the ovarian response to stimulation decreases.
Analogs
Analogs of the drug Gonal-F are: Follitrop, Follitropin Alpha.
Terms and conditions of storage
Keep out of the reach of children.
Store in a dark place at a temperature: lyophilisate up to 25 ° C, solution - 2-8 ° C, after opening the syringe pen - no more than 28 days at a temperature not higher than 25 ° C, do not freeze.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Gonal-f: prices in online pharmacies
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Drug name Price Pharmacy |
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Gonal-f 5.5 mcg lyophilisate for the preparation of a solution for subcutaneous administration complete with a solvent of 3 ml 1 pc. 1069 RUB Buy |
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Gonal-f 22 μg / 0.5 ml solution for subcutaneous administration of 0.5 ml 1 pc. RUB 5345 Buy |
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Gonal-f 33 μg / 0.75 ml solution for subcutaneous administration with 12 needles 0.75 ml 1 pc. RUB 7895 Buy |
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Gonal-f 33 μg / 0.75 ml solution for subcutaneous administration 0.75 ml 1 pc. 7939 RUB Buy |
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Gonal-f 66 mcg / 1.5 ml solution for subcutaneous administration 1.5 ml 1 pc. RUB 16210 Buy |
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
