Gonal-F is a recombinant human follicle-stimulating hormone.
Release form and composition
- Gonal-F solution for s / c administration in syringes with 0.5 ml, 0.75 ml and 1.5 ml handles containing the active ingredient - follitropin alfa - in the amount of 300 IU, 450 IU, 900 IU in 1 pen syringe respectively. Auxiliary substances of the drug are sucrose, phosphoric acid, poloxamer 188, sodium hydrogen phosphate dihydrate, water for injection, sodium hydroxide, sodium dihydrogen phosphate monohydrate, methionine, m-cresol;
- Lyophilisate for solution preparation for subcutaneous injection, in 3 ml vials containing 75 IU of follitropin alpha, as well as auxiliary components: sodium hydrogen phosphate dihydrate, sodium hydroxide, polysorbate 20, sucrose, sodium dihydrogen phosphate monohydrate, phosphoric acid, methionine.
Indications for use
According to the instructions, Gonal-F is indicated for use in women in the following cases:
- Lack of ovulation, including polycystic ovary syndrome (in case of treatment failure with clomiphene);
- Stimulation of ovulation in case of a lack of LH and FSH in the body (in combination with LH drugs);
- Controlled ovarian hyperstimulation during artificial insemination programs.
Men Gonal-F is prescribed to stimulate spermatogenesis in hypogonadotropic hypogonadism (in combination with human chorionic gonadotropin).
According to the instructions, Gonal-F is prohibited for use in the following cases:
- Hypersensitivity to the components of the drug;
- Hypothalamic-pituitary tumors;
- The period of pregnancy and breastfeeding;
- The presence of uterine bleeding of unknown origin;
- Ovarian cancer, uterine cancer, breast cancer;
- Ovarian cysts or other volumetric neoplasms not caused by polycystic ovary syndrome.
Also, Gonal-F is not prescribed in cases where its positive effect cannot be obtained, i.e. with:
- Premature menopause;
- Primary ovarian failure;
- Fibromyoma of the uterus or abnormal development of the genital organs, due to which pregnancy is impossible;
- Primary testicular failure (in men).
Dosing and Administration
The use of Gonal-F should be carried out only under the supervision of a physician engaged in the treatment of infertility. The medicine is intended for SC injection.
The first injection of the drug is done directly under the supervision of a physician or medical staff. Self-medication is allowed only if possible to get expert advice. The injection site should be changed daily.
Women in the absence of ovulation begin treatment in the first 7 days of the cycle. Stimulation should be carried out under ultrasound guidance to measure the size of the follicles and the level of estrogen. The daily dose in the first week is 75-150 IU, then it is increased by 37.5-75 IU once a week. The maximum daily dose should not exceed 225 IU. If during the month of therapy positive dynamics is absent, treatment with the drug is stopped. In the next cycle, the stimulation begins with a higher dose.
With controlled ovarian hyperstimulation during artificial insemination programs, Gonal-F is taken from 2-3 days of the cycle in a dose of 150-225 IU. The daily dose may increase, but not exceed 450 IU. Treatment continues until the appropriate size of the follicles is reached (ultrasound control). On average, this occurs on the 10th day of therapy. A day or two after the last injection of Gonal-F, r-hCG is administered once at a dose of 250 μg to induce the final maturation of the follicles.
When carrying out the stimulation of ovulation in women with deficiency of LH and WASH, the dose of Gonal-F is selected individually. As a rule, the drug is prescribed every day for 5 weeks simultaneously with the drugs LH. The initial dose is 75-150 IU. If necessary, the dose can be increased by 37.5-75 IU every 7-14 days. If after 5 weeks of therapy there is no adequate response to stimulation, treatment with the drug should be discontinued and resumed at a higher dose in the new cycle.
Men to stimulate spermatogenesis with hypogonadotropic hypogonadism take Gonal-F three times a week at a dose of 150 IU for 4 months in combination with hCG. If the treatment does not bring a positive result, an increase in the duration of Gonal-F up to 18 months is allowed.
The use of Gonal-F may cause the following side effects:
- Immune system: allergic reactions such as redness of the skin, urticaria, itching, difficulty breathing, as well as anaphylactic reactions and shock;
- Central nervous system: headache;
- Cardiovascular system: thromboembolism;
- Digestive system: heaviness, discomfort, abdominal pain, nausea, vomiting, diarrhea;
- Respiratory system: in bronchial asthma, an exacerbation or worsening of the course of the disease may occur;
- Reproductive system: ovarian cysts, OHSS, ectopic pregnancy, multiple pregnancy, gynecomastia, varicocele;
- Skin and subcutaneous tissue: acne (acne);
- Other: weight gain.
Since Gonal-F may cause serious adverse reactions, only a specialist can prescribe it. Before starting to use the medication, the patient must be examined by the body, in particular, to exclude hypothyroidism, hyperprolactinemia, adrenal insufficiency, hypothalamic-pituitary tumors. For the choice of assisted reproductive technology should be determined by the patency of the fallopian tubes.
Also, with Gonal-F treatment, it is necessary to evaluate the state of the ovaries using ultrasound, both separately and in combination with the determination of the plasma level of estradiol.
Structural analogue of the drug Gonal-F is Follitrop.
Terms and conditions of storage
According to the instructions, Gonal-F is stored in a dark place, out of reach of children, at a temperature of 2-8 ° C. Shelf life of the drug is 2 years.