Index of drugs

Treatment of prostate cancer responding to hormonal treatment. Treatment of breast cancer in women in the pre- and perimenopausal period, in whom endocrine therapy is appropriate. Treatment of endometriosis - the drug relieves the symptoms of the disease (including pain) and reduces the size and number of endometrial changes. Initial thinning of the endometrium before planned endometrial ablation or resection. Uterine fibroids - in combination with iron preparations before the surgery leads to improvement of hematological parameters. Assisted reproduction - to suppress pituitary function in preparation for superovulation.

1 subcutaneous implant contains 3.6 mg of goserelin (as acetate).

Goserelin is a synthetic analogue of a naturally occurring hormone - gonadoliberin (LHRH). As a result of long-term administration, goserelin inhibits pituitary release of luteinizing hormone (LH), which leads to a decrease in blood testosterone levels in men and estradiol in women's blood. In men, approximately 21 days after the first injection of the subcutaneous implant, the testosterone concentration decreases to the concentration values ​​characteristic of the castration state. The administration of subsequent doses supports this suppression. In women, estradiol levels decrease after 21 days from the first injection, suppression can be sustained by administering the Next dose every 28 days, and the estradiol concentration is comparable to the concentration observed in menopausal women. The biological availability of the drug is almost total. The administration of the implant every 28 days ensures the maintenance of therapeutic concentration without drug accumulation in the tissues. Goserelin is poorly bound by plasma proteins. T_0,5 in the elimination phase ranges from 2-4 hours in patients with normal renal function; in patients with renal failure is prolonged, but if given once a month, this difference is of minor importance.

Hypersensitivity to goserelin or other LHRH analogues or other components of the preparation. Pregnancy and breastfeeding.

Do not use in children.Men. In patients who are at increased risk of ureteral obstruction or vertebral compression with compression of the spinal cord, the drug should be used with caution and during the first month. Patients should be closely monitored. The use of an antiandrogen (eg cyproterone acetate 300 mg daily) should be considered 3 days before goserelin treatment and 3 weeks after the first implant injection - this prevents the occurrence of increased testosterone levels in the initial period of use of LHRH analogues. If there are or symptoms of compression of the spinal cord or renal failure due to ureteral obstruction, standard treatment of these complications should be introduced.Women. Special care should be taken in patients with known metabolic disorders affecting the skeletal system (the drug may cause a decrease in bone mineral density). In patients with endometriosis treated with goserelin, the use of hormone replacement therapy (daily dose of estrogen with progestogen) reduces the loss of bone mineral density and vasomotor symptoms. Women may experience difficulty in opening the cervix (increase in resistance of the cervix) after using the drug in women. When goserelin is used in combination with gonadotropin, ovulation suppression syndrome (OHSS) and the need to stop administering human placental gonadotropin may occur. In patients with polycystic ovary syndrome, the preparation should be used in assisted reproduction with extreme caution due to the possibility of stimulation of more oocytes. There are no clinical data on glyphological treatment of benign glioblastic disease for more than 6 months.

Do not use during pregnancy, due to the theoretical risk of miscarriage or disorders in fetal development. Women of childbearing age should be carefully examined before starting treatment to rule out pregnancy.Non-hormonal contraceptives should be used during treatment, and in the case of endometriosis, they should be used until normal menstruation. Before using the preparation in assisted growth, it should be stated that the patient is not pregnant. It is not recommended to use the product during breastfeeding.

The following may occur: joint pain, paresthesia, mild skin rashes. Rare: hypersensitivity reactions (including anaphylaxis), slight bruising at the injection site. Very rare: hemorrhage to the pituitary gland. Occasional: changes in blood pressure (hypotension or hypertension, generally transient, rarely requiring medical intervention or discontinuation of goserelin treatment).Men. Pharmacological action in men is expressed by the attacks of redness of the face and reduction of potency. Occasional cases of nipple swelling and pain are reported. Initially, patients with prostate cancer may experience an increase in bone pain (receding after symptomatic treatment). There have been isolated cases of ureteral obstruction and compression of the spinal cord. The use of LHRH analogues in men may reduce bone mineral density.Women. Pharmacological action in women is expressed by hot flushes and sweating, decreased sex drive. The following may occur: headache, mood changes (including depression), vaginal dryness, changes in the size of the nipples, bleeding from the genital tract of varying severity and duration. Initially, patients with breast cancer may experience a transient increase in symptoms associated with underlying disease, which should be treated symptomatically. In women with fibromas these degenerations may degenerate. In patients with breast cancer who have metastases to the bone, an increase in the level of Calcium in the blood is rarely observed at the beginning of treatment. The use of LHRH analogues in women may reduce bone mineral density. Very rarely, women who are treated with LHRH analogues have menopause and the monthly cycle does not return after treatment. After administration of goserelin and gonadotrophin in assisted reproduction, ovulation hyperplasia (OHSS) may occur. After treatment with LHRH agonists, Graaff follicular cysts and ovarian cysts were observed (cysts were usually asymptomatic, of varying size, most of them undergo spontaneous resorption).

Subcutaneously (in the front wall of the abdomen). Adults: 1 implant every 28 days. There is no need to change the dose in patients with renal or hepatic impairment or in elderly patients. Treatment of endometriosis should be carried out for 6 months; repetition of therapy is not recommended; use of HRT (daily dose of estrogen with progestogen) reduces the loss of bone mineral density and vasomotor symptoms. In order to thin the endometrium, two doses of the drug are used (1 injection every 4 weeks), surgery should be performed within 2 weeks of the second dose. In patients with anemia due to uterine fibroids, the drug is used in combination with iron preparations up to 3 months before the planned surgery. In assisted medicine, the drug is used to suppress the pituitary function, until the concentration of estradiol in the blood corresponds to the concentration in the early follicular phase (about 150 pmol / l, it is reached after about 7-21 days); after suppression of the pituitary function, superovulation begins; Pituitary suppression occurring after the use of LHRH agonists in the form of long-acting preparations is more constant, which may sometimes lead to the need for a higher dose of gonadotropin to induce ovulation; at the appropriate time of the follicular phase, gonadotropin should be discontinued and human placental gonadotropin (hCG) administered to induce ovulation; subsequent medical procedures, such as egg cell procurement or fertilization techniques, should be carried out in accordance with the experience of the specialist clinic.