Index of drugs

The preparation is indicated for use in adult women undergoing induction of ovarian ovulation preceding the use of assisted reproduction techniques, such as in vitro fertilization: the preparation is given to induce final follicular maturation and luteinisation after stimulation of follicular growth. It is also indicated for women who are not ovulating or rare: the product is given to induce ovulation and luteinization in women who are not ovulating or rarely after stimulation of follicular growth.

1 pre-filled syringe (0.5 ml) contains 250 μg of choriogonadotropin alfa (equivalent to approximately 6,500 IU).

The preparation is choriogonadotropin alfa obtained by recombinant DNA. It has an analogous amino acid sequence like hCG isolated from urine. Chorionic gonadotropin binds to the transmembrane LH / CG receptor, the envelope (and granular layer) cells of the ovary, to which luteinizing hormone also attaches. The main pharmacodynamic activity in women is the resumption of meiosis in the egg cell, follicular rupture (ovulation), formation of the corpus luteum and production of Progesterone and estradiol by the corpus luteum. In women, the effect of chorionic gonadotropin corresponds to the release of luteinizing hormone, which triggers ovulation. After subcutaneous administration, the absolute bioavailability is 40%. T_0,5 choriogonadotropin alfa in the final phase of elimination is approx. 30 h.

Hypersensitivity to choriogonadotropin alfa or to any of the excipients. Neoplasms of the hypothalamus or pituitary gland. Enlargement of the ovaries or the appearance of cysts due to other reasons than polycystic ovary syndrome. Haemorrhages from the genital tract of unknown cause. Tumors of the ovaries, uterus or nipples. Ectopic pregnancy in the last 3 months. Active thromboembolism. Primary ovarian failure. Genital malformation that prevents the development of pregnancy. Uterine fibroids preventing the development of pregnancy. Menopausal women.

Before starting treatment, the causes of infertility and the existing and presumed contraindications to pregnancy should be determined. In particular, the patient should be examined for hypothyroidism, adrenal hormone deficiency, hyperprolactinemia and pituitary or hypothalamic tumors, and appropriate treatment should be given. There is no clinical experience in the use of the preparation for the treatment of other diseases (such as failure of corpus luteum or disease in men) - the preparation is not indicated for use in these diseases. Patients undergoing ovarian stimulation are at increased risk of developing ovarian hyperstimulation syndrome (OHSS) due to the growth of numerous follicles. Before starting treatment and then at regular intervals during treatment, ultrasound assessment of follicle development and / or determination of oestradiol concentration should be performed. For the treatment of non-ovulation, the risk of OHSS increases when the estradiol serum concentration is> 1500 pg / ml (5400 pmol / l) and more than 3 vesicles with a diameter of 14 mm or more are visible. When assisted reproduction techniques are used, the risk of OHSS increases when the estradiol serum concentration is> 3,000 pg / ml (11,000 pmol / l) and 18 or more bubbles with a diameter of 11 mm or more are visible. OHSS due to excessive ovarian response can be avoided by abandoning hCG. Therefore, if signs of ovarian overstimulation such as serum estradiol> 5500 pg / ml (20,000 pmol / l) and / or a total number of follicles of 30 or more occur, it is recommended to stop the administration of human chorionic gonadotropin and inform Patients should not have sexual intercourse or use contraception for at least 4 days. Compared to natural fertilization, the incidence of pregnancy and multiple births (mostly twin) is higher in patients undergoing ovulation induction.The risk of multiple pregnancy after assisted reproduction techniques depends on the number of embryos transferred. Adherence to the recommended dose, schedule of administration and the principles of careful monitoring of treatment reduces the risk of OHSS and multiple pregnancy. The rates of miscarriage in both ovulatory patients and women with assisted reproduction techniques are higher than in the normal population, but comparable to those observed in women with other fertility disorders. In infertile women undergoing ART procedures, and in particular IVF, the prevalence of ectopic pregnancy may be increased - it is important to perform an early ultrasound examination to confirm that the pregnancy is intrauterine and exclude an ectopic pregnancy. The incidence of congenital malformations after ART can be slightly higher compared to natural fertilization. It is believed that this is due to differences in the characteristics of parents (eg, mother's age, semen parameters) and the prevalence of multiple pregnancies. In women with recent or ongoing thromboembolism or women with generally recognized risk factors for thromboembolic complications, such as past medical history or family history, gonadotropin treatment may increase the risk of worsening or complications. In these women, the benefits of gonadotropin administration for risk should be considered. It should be noted, however, that pregnancy itself, similar to OHSS, may also carry an increased risk of thromboembolic complications, such as pulmonary embolism, ischemic stroke or myocardial infarction. During the treatment with the preparation it is possible to slightly stimulate the thyroid gland, whose clinical significance is unknown. The safety, efficacy and pharmacokinetics of the preparation have not been established in patients with impaired renal or hepatic function. Do not use the preparation in children and adolescents.

Do not use during pregnancy and breast-feeding.

Common: headache, vomiting, nausea, abdominal pain, mild or moderate OHSS, fatigue, reactions at the injection site. Uncommon: depression, irritability, anxiety, diarrhea, severe OHSS, breast pain. Very rare: mild or severe hypersensitivity reactions, including anaphylactic reactions and shock, thromboembolism, usually associated with severe OHSS, mild reversible skin reactions such as rash. After hCG administration, patients were diagnosed with ectopic pregnancy, ovarian torsion and other complications. It is recognized that the side effects listed above are related to the use of assisted reproduction techniques.

Subcutaneously. Treatment with the preparation should be carried out under the supervision of a physician experienced in the treatment of fertility disorders. The maximum dose is 250 μg. The following dosing regimens should be used:women subjected to the induction of multiple ovulation preceding the use of assisted reproduction techniques, such as in vitro fertilization (IVF): the content of 1 pre-filled syringe is given 24 to 48 hours after the last administration of follicle-stimulating hormone (FSH) or the human menopausal gonadotropin (hMG) product, i.e. when optimal follicular stimulation has been achieved;women who are not ovulating or rare: the content of 1 pre-filled syringe is given from 24 to 48 h after optimal stimulation of follicular growth. It is recommended that the patient have intercourse on the day of the injection and the Next day.
Self-injection of the preparation can only be performed by patients who are properly trained and have the possibility of obtaining specialist advice. The preparation is intended for single use.