Instruction for use: Follitropin alfa (Follitropinum alfa)

Chemical name:

R-hFSH-Agglutinin antiresus follicle-stimulating hormone

Pharmacological group

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

Nosological classification (ICD-10)

N91 Lack of menstruation, meager and rare menstruation

Amenorrhea, Amenorrhea hypogonadotropic, Amenorrhea is prolactin-dependent, Oligomenorrhoea, Shortening of the secretory phase of the menstrual cycle, Menstrual disorders, Menstruation disorders, Prolactin-dependent amenorrhea without galactorrhea

N97 Female infertility

Female infertility in anovulation, Hyperprolactinemic infertility, Hyperprolactinaemia with infertility, Endocrine infertility, Infertility due to hypothalamic-pituitary dysfunction, Infertility infertility, Infertility, Infertility on the background of hyperprolactinaemia, Functional infertility, Marriage is infertile, Infertility of ovarian genesis, Stimulation of the growth of a single follicle

Z31.2 In Vitro Fertilization

Support of the luteal phase in the spontaneous or induced menstrual cycle, Support of the luteal phase during preparation for in vitro fertilization, Reproductive technologies, Superovulation, ECO, In Vitro Fertilization, Controlled superovulation in in vitro fertilization

Characteristics of the substance Phallitropin alfa

A white, sterile powder that does not contain pyrogens.

Pharmacology

The pharmacological action is estrogen-like.

It binds to receptors in target cells, increases the level of estrogens and increases the proliferation of the endometrium.

After intravenous administration is distributed in extracellular fluids, T1 / 2 in the first phase is 2 hours, in the second - 1 day. The values of the volume of distribution and total Cl are respectively equal to 10 liters and 0.6 liters / hour. 1/8 of the administered dose is excreted in the urine. With n / k and / m injections, absolute bioavailability is 70%. With repeated administration, it accumulates within 3-4 days. The equilibrium concentration is three times higher than the level after a single application.

Stimulates the development of follicles and ovulation in women with dysfunction of the hypothalamic-pituitary system, manifested by oligomenorrhea or amenorrhoea. Promotes the development of multiple follicles if superovulation is necessary in the case of artificial reproduction techniques: in vitro fertilization, gamete or zygote transplantation inside the fallopian tube.

Indications

Infertility due to hypothalamic-pituitary dysfunction, accompanied by oligo- or amenorrhea (in combination with chorionic gonadotropin); Procedure of superovulation (in vitro fertilization and other reproductive technologies).

Contraindications

Hypersensitivity, an increase in the ovary or ovarian cyst not associated with polycystic ovary, gynecological bleeding of unknown etiology, carcinoma of the ovary, uterus or breast, tumors of the hypothalamus or pituitary gland, absence of the ovary, malformation of the reproductive organs and tumors of the uterus, incompatible with pregnancy, (Development of an ectopic pregnancy is possible), pregnancy, breast-feeding.

Side effects

Ovarian hyperstimulation syndrome: lower abdominal pain, nausea, vomiting, weight gain; Increase or formation of ovarian cysts, ascites, hydrothorax, thromboembolic events, fever and arthralgia, pain and hyperemia at the injection site.

Routes of administration

P / to, in / m (intramuscularly).

Precautions

Before the treatment should be excluded possible causes of infertility, hypothyroidism, adrenocortical insufficiency, hyperprolactinemia, pituitary and hypothalamic tumors.