Phallietropin alfa - instructions for use, dose, side effects, contraindications

Clinical and pharmacological group: & nbsp

Hormones of the hypothalamus, pituitary gland, gonadotropins and their antagonists

Included in the formulation

GONAL-f®

solution PC

Merck Serono Juorope Limited United Kingdom

GONAL-f®

lyophilizate PC

Merk Serono SA, Oborn Branch Switzerland

Foliotrop®

lyophilizate w / m PC

Al Gee Life Senses Ltd The Republic of Korea

Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):

VED

АТХ:

G.03.G.A Gonadotropins

G.03.G.A.05 Foliotropin alfa

Pharmacodynamics:

Recombinant FSH, obtained by genetic engineering from Chinese hamster ovary cells. Binding to FSH receptors. In men - the effect on Sertoli cells testes. In women - the effect on the cells and cells of the granular layer of the ovary.

It binds to receptors in target cells, increases the level of estrogens and increases the proliferation of the endometrium. Stimulates the development of follicles and ovulation in women with dysfunction of the hypothalamic-pituitary system, manifested by oligomenorrhea or amenorrhea. Promotes development of multiple follicles if superovulation is necessary in case of using artificial reproduction technologies: in vitro fertilization, gamete or zygote transplantation inside the fallopian tube.

Pharmacokinetics:After intravenous administration, it is distributed in extracellular fluids. The half-life in the first phase is 2 hours, in the second - 1 day. The values of the volume distribution and total clearance are respectively equal to 10 liters and 0.6 liters / hour.1/8 of the administered dose is excreted in the urine. With subcutaneous and intramuscular injections, absolute bioavailability is 70%. With repeated administration, it accumulates for 3-4 days. The equilibrium concentration is three times higher than the level after a single application.

Indications:

Anovulatory infertility (including polycystic ovary syndrome) in women in case of ineffective clomiphene therapy.
Hypothalamic-HypophicIlar disorders - oligomenorrhea, amenorrhea (including polycystic ovaries).
Stimulation of superovulation (stimulation of growth of multiple follicles) with technology of assisted methods of reproduction.
Ovarian stimulation in women with severe follicle-stimulant deficiencyand luteinizing hormones (in combination with luteinizing hormone preparations).
Stimulation of spermatogenesis with hypogonadotropicm hypogonadism in men (in combination with chorionic gonadotropin).

ICD-10

IV.E20-E35.E28.2 Polycystic ovary syndrome

XIV.N80-N98.N91 Absence of menstruation, meager and rare menstruation

XIV.N80-N98.N97 Female infertility

XXI.Z30-Z39.Z31.1 Artificial insemination

Contraindications:Hypersensitivityincrease in the ovary or ovarian cyst, not related to polycystic ovary, gynecological bleeding of unknown etiology, ovarian carcinoma, uterus or breast, hypothalamus or pituitary tumor, absence of ovary, obstruction of fallopian tubes (possible development of ectopic pregnancy), pregnancy, breast-feeding. The drug should not be prescribed in cases where a positive effect can not be obtained: in women - malformations of the genital organs and tumors of the uterus, incompatible with pregnancy, primary ovarian failure, premature menopause; in men - with primary testicular failure.

Carefully:Diseases of the adrenal cortex, thyroid gland; tumors (intracranial or hormone-dependent), bronchial asthma.

Pregnancy and lactation:

Recommendations for FDA - Category X. High risk of ovarian hyperstimulation syndrome. Do not apply!

There is no information on the penetration into breast milk. Use with caution!

Dosing and Administration:

Women

Subcutaneously, intramuscularly (the powder is dissolved in distilled water immediately before use, in 1 ml it is possible to dissolve up to 450 IU, which allows to reduce the introduced volume).With anovulatory infertility with a saved menstrual cycle, treatment begins in the first 7 days of the cycle. The course should be coordinated with an individual response, determined by measuring the size of the follicles on ultrasound and / or estrogen secretion. Daily dose - 75-150 IU, if necessary, after 7-14 days increase by 37.5-75 IU. If after 5 weeks there is no positive dynamics, the treatment stops. 24-48 hours after the last injection, a single dose of the chorionic gonadotropin is administered, up to 10,000 IU. On the day of injection of chorionic gonadotropin and the next day it is recommended to have coitus. When performing assisted reproductive techniques, daily 150-225 IU is prescribed starting from 2-3 days of the cycle until adequate follicles are formed (controlled by serum estrogen concentration and / or ultrasound). The dose (maximum - 450 IU) is regulated in accordance with the response to treatment. Twenty-four hours after the last injection, a single dose of human chorionic gonadotropin is administered, up to 10,000 IU, which helps induce the finally mature follicles.

Men's

Stimulation of spermatogenesis in hypogonadotropic hypogonadism in men (in combination with chorionic gonadotropin).150 IU three times a week for at least 4 months in combination with human chorionic gonadotropin. In the absence of a positive effect during this time, treatment can be continued up to 18 months.

Side effects:

Among women

Ovarian hyperstimulation syndrome (lower abdominal pain, nausea, vomiting, weight gain, ovarian enlargement, cyst or ovarian cyst rupture), ectopic pregnancy (in women with fallopian tube diseases in history), multiple ovulation.

Pain and hyperemia at the injection site, fever, arthralgia, ascites, hydrothorax, thromboembolism, allergic reactions.

Diarrhea, flatulence, flu-like syndrome, pharyngitis, sinusitis, upper respiratory tract infections, intermenstrual bleeding, acne, pain and tension in the mammary gland, dizziness, dysmenorrhea, leukorrhea (white discharge from the vagina), drowsiness, non-menstrual vaginal bleeding, dyspepsia, hypotension, erosion of the cervix, migraine, nervousness, anorexia, chest pain, palpitation, unusual thirst.

In men

Local reaction: pain, redness, bruising, swelling at the injection site.

Skin and subcutaneous tissue: the appearance of blackheads.

Reproductive system and mammary glands: gynecomastia, varicocele.

Other: increase in body weight.

Overdose:

Symptoms: Ovarian hyperstimulation syndrome - the formation of large ovarian cysts with the risk of their rupture (perforation), ascites and circulatory disorders.

Treatment: cancellation of the drug. You should refrain from sexual intercourse or use barrier methods of contraception for 4 days or more.

Interaction:

When combined use of foliotropin alfa with clomiphene, chorionicadotropin alfa the response of the ovaries increases.

Special instructions:

Before the treatment should be established 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 tumor).

With the appointment of human chorionic gonadotropin, the possibility of a syndrome of ovarian hyperstimulation increases, so when an excessive estrogenic reaction occurs human chorionic gonadotropin Do not appoint, and patients are recommended to refrain from coitus for at least 4 days. The likelihood of hyperstimulation can be reduced by aspirating all follicles before ovulation.

The risk of multiple pregnancy during artificial reproduction is related to the number of substituted oocytes / embryos; while most cases of multiple pregnancies gave twins.

Impact on the ability to drive vehicles and manage mechanismsnot found.

Instructions

Foliotropin alfa (Follitropinum alfa)