Gonal-f powder for injection 5.5 μg №1

Dosage form

Lyophilisate for preparation of solution for subcutaneous injection as a white powder or white lyophilized mass

Composition

1 bottle contains: follitropin alfa 5.5 mcg (75 IU).
Excipients: sucrose, sodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate monohydrate, phosphoric acid, sodium hydroxide, methionine, polysorbate 20.
Solvent: water d / and - 1 ml.

Packing

In packing 1 bottle with lyophilisate, 1 syringe with solvent, 2 sterile needles.

Mechanism of action

Gonal-F is a recombinant human follicle-stimulating hormone obtained by genetic engineering on a Chinese hamster ovary cell culture. Stimulates the growth of follicles. It has gonadotropic (stimulates endometrial proliferation, ovulation in women with suppressed endogenous gonadotropin secretion) and estrogenic (stimulates the growth and maturation of ovarian follicles, promotes the development of multiple follicles during controlled ovarian hyperstimulation programs for assisted reproductive technologies) action.

Indications and usage

Among women: lack of ovulation and in case of treatment failure with clomiphene,lack of ovulation as a result of deficiency of FSH and LH (in combination with LH), to stimulate superovulation (stimulate the growth of multiple follicles) when using the technology of auxiliary methods of reproduction.
In men: to activate the process of spermatogenesis in hypogonadotropic hypogonadism (in combination with chronic hepatitis).

Contraindications

- Tumors of the hypothalamus or pituitary.
- Hypersensitivity to the drug.
- In women: ovarian cysts (not due to the presence of polycystic ovary syndrome); uterine bleeding of unknown etiology; ovarian carcinoma; uterine cancer; mammary cancer; violation of the reproductive system (the absence of ovocytes of the 1st order); conditions incompatible with pregnancy (premature menopause, abnormal development of the genital organs, or uterine fibroids); pregnancy.
- In men: primary testicular failure.

Pregnancy and Breastfeeding

The drug is not prescribed during pregnancy and lactation (breastfeeding).

Dosage and administration

Gonal-F is administered s / c.
For women in case of anovulatory infertility with a preserved menstrual cycle or in violation of its periodicity, treatment begins in the first 7 days of the cycle. The course of stimulation is carried out under the control of ultrasound (measure the size of the follicles) and / or by the concentration of estrogen in the serum. Treatment begins with the introduction of the drug in a dose of 75-150 IU daily, increasing the dose by 37.5 IU (75 IU) in 7-14 days to obtain the desired effect. In the absence of positive dynamics, therapy is stopped after 4 weeks.In the next cycle, stimulation should start with a higher dose.
After the optimal reaction is reached, 24-48 hours after the last injection of Gonal-F, hCG (human chorionic gonadotropin) is administered once. Coitus is recommended on the day of hCG injection and the next day.
With the development of ovarian hyperstimulation syndrome, treatment should be discontinued and hCG should be discontinued. In the next cycle, treatment should be resumed with the appointment of the drug in a lower (compared to the previous cycle) dose.
When conducting auxiliary methods of reproduction Gonal-F is prescribed daily in a dose of 150-225 IU, starting from 2-3 days of the cycle. The daily dose of the drug may vary, but should not exceed 450 IU. Treatment is continued until the follicles are of adequate size (on average after 5–20 days), which is controlled by the concentration of estrogen in the serum and / or by ultrasound. After the last injection of the drug Gonal-F, after 24-48 hours, a single injection of hCG is prescribed, which induces the final maturation of the follicles.
To suppress the endogenous release of LH and maintain it at a low level, gonadotropin releasing factor agonists are commonly used. In the commonly used scheme, Gonal-F is prescribed approximately 2 weeks after the start of treatment with an agonist. Courses of both drugs are held to achieve the desired level of follicle development.
In case of anovulatory infertility with the absence of the menstrual cycle as a result of FSH and LH deficiency, the dose and treatment regimen is selected individually.
Gonal-F is prescribed daily for 3 weeks n / a simultaneously with LH.The initial dose is 75-150 IU simultaneously with lutropin alpha at a dose of 75 ME. If necessary, the dose of Gonal-F can be increased by 37.5-75 ME in 7-14 days.
If no positive effect is observed within 3 weeks, treatment 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 alpha, hCG is administered once. Coitus is recommended on the day of hCG injection and the next day. Alternatively, intrauterine insemination of sperm can be performed.
In the presence of ovarian hyperstimulation syndrome, treatment should be discontinued and hCG should be discontinued. Treatment should be resumed in the next cycle with the appointment of the drug at a lower dose compared with the previous cycle.
For men with hypogonadotropic hypogonadism, Gonal-F is usually prescribed at a dose of 150 ME 3 times a week in combination with hCG for 4 months. If there is no positive effect during this time, treatment can be continued up to 18 months.
Terms of preparation of the solution for injection: To prepare the solution for injection, the contents of the vial should be dissolved in the supplied solvent immediately before use. The contents of 3 vials can be dissolved in 1 ml of solvent, which allows to reduce the volume of the solution during injection.

Adverse reactions

Among women: ectopic pregnancy (in womenhaving a history of fallopian tube disease); multiple pregnancy; possible development of ovarian hyperstimulation syndrome (mild form is characterized by pain in the lower abdomen, nausea, vomiting, weight gain, ovarian enlargement, ovarian cysts; severe form (rare) - the occurrence of large ovarian cysts prone to rupture, ascites, hydrothorax); pain and hyperemia; headache, fever, arthralgia, thromboembolism, allergic reactions.
In men: on the part of the endocrine and reproductive systems: When used in combination with hCG - swelling of the mammary glands, the appearance of acne, weight gain.

Special notes

Prior to the appointment of a course of treatment should establish the presence of marital infertility and possible contraindications to pregnancy. It is necessary to exclude concomitant endocrine diseases (hypothyroidism, adrenal insufficiency, hyperprolactinemia, hypothalamic and pituitary tumors). When hCG is prescribed, the likelihood of ovarian hyperstimulation syndrome and multiple super ovulation increases, which can lead to ovarian rupture. Therefore, in case of excessive ovarian response to hCG stimulation, they are not prescribed, and patients are recommended to abstain from coitus for at least 4 days. The likelihood of ovarian hyperstimulation syndrome in patients after stimulating follicle growth can be reduced by aspirating all follicles before ovulation.The degree of risk of multiple pregnancies in the application of assisted reproductive technologies depends on the number of transferred embryos; however, in most cases there are twins. In men, an elevated level of FSH in the blood indicates damage to the testes. In this case, treatment with Gonalom-F is not effective. Therefore, 4-6 months after the start of the course of therapy, a sperm analysis should be done. If Gonala-F is prescribed with lutropin alpha, they can be mixed in one syringe.
Influence on ability to drive motor transport and control mechanisms: Gonal-F does not affect the ability to drive vehicles and control other mechanisms.

With simultaneous use of the drug Gonal-F along with other means to stimulate ovulation, an increase in the growth of follicles is possible, whereas simultaneous desensitization of the pituitary by the GnRH agonist can lead to a decrease in the reaction of follicle formation and the need to increase the dose of Gonal-F.

Currently, no cases of overdose of the drug Gonal-F have been reported. Perhaps the development of ovarian hyperstimulation syndrome.

The drug should be stored in a dark, out of reach of children at a temperature not higher than 25 ° C.

2 years.