Index of drugs

Prevention of premature increases in luteinising hormone (LH) levels in women undergoing controlled ovarian hyperstimulation (COH) in assisted reproduction programs (ART). In clinical trials, the drug was used together with recombinant human folliculotropin (FSH) or corifollitropin alfa, a long-term follicle stimulant.

1 pre-filled syringe (0.5 ml) contains 0.25 mg of ganirelix.

GnRH antagonist, modulating the hypothalamic-pituitary-ovarian axis through competitive binding to GnRH receptors of the pituitary gland. As a result of this binding, rapid, deep and reversible suppression of endogenous gonadotropins occurs, without primary stimulation, as with the use of GnRH agonists. After multiple doses of 0.25 mg, serum LH, FSH and E2 concentrations were reduced by 74%, 32% and 25% respectively at 4, 16 h and 16 h after the injection. Serum hormone levels returned to pre-treatment values ​​within 2 days after the last injection. After a subcutaneous single dose of 0.25 mg, the concentration of ganirelix in the serum increases rapidly and reaches_max within 1-2 hours. T_0,5 It is about 13 hours. Excretion occurs primarily with faeces (about 75%) and urine (about 22%). Bioavailability after subcutaneous administration is about 91%. After repeated dosing of 0.25 mg daily, steady state was achieved within 2-3 days. Pharmacokinetic analysis indicates an inverse relationship between body weight and serum drug concentration.

Hypersensitivity to the active substance or to any of the excipients. Hypersensitivity to gonadotrophin releasing hormone (GnRH) or to any GnRH analogue. Moderate or severe kidney or liver failure. Pregnancy or breastfeeding.

Particular care should be taken in women with symptoms of active allergic conditions. Due to lack of clinical experience, it is not recommended for women with severe allergic conditions. Ovarian hyperstimulation syndrome (OHSS) may occur during or after ovarian stimulation. It should be treated as a naturally occurring risk associated with gonadotrophin stimulation. Ovarian hyperstimulation syndrome should be treated symptomatically, such as staying in bed, intravenous infusion of electrolyte solutions or colloids, and heparin. The risk of ectopic pregnancy can increase in infertile women treated with methods of assisted reproduction, especially IVF, as they often have tubal abnormalities. Therefore, early detection of intrauterine pregnancy in ultrasound is important. After the use of Assisted Reproduction Techniques (ART), the incidence of congenital malformations may be greater than after natural fertilization. This is probably related to the various characteristics of parents (eg mother's age, sperm parameters) and an increased risk of multiple pregnancy. The incidence of congenital malformations in children born as a result of controlled ovarian hyperstimulation after application is comparable to the incidence of these defects reported after controlled ovarian hyperstimulation with a GnRH agonist. The efficacy and safety of the preparation in women with less than 50 kg or over 90 kg. It is not appropriate to use the preparation in children and adolescents. The packaging of the preparation contains natural rubber (latex), which may cause allergic reactions.

The drug is contraindicated during pregnancy and breastfeeding.

Very common: skin irritation at the injection site (mainly redness, with or without edema) - local reactions usually disappear within 4 h after drug administration. Uncommon: headache, nausea, malaise. Very rare: cases of hypersensitivity (including symptoms such as rash, swelling of the face and shortness of breath). Other reported adverse reactions are associated with controlled ovarian hyperstimulation in assisted reproduction programs (ART), particularly pelvic pain and tension, ovarian hyperstimulation syndrome, ectopic pregnancy and miscarriage.

The drug should only be prescribed by a specialist who has experience in the treatment of fertility disorders. Controlled ovarian hyperstimulation with FSH or corifollitropin alfa can be started on the 2nd or 3rd day of menses. The product should be injected under the skin subcutaneously once daily, starting on the 5th or 6th day of FSH administration or on the 5th or 6th day when receiving corifollitropin alfa. The start of administration of the preparation depends on the response of the ovaries, i.e. the number and size of the growing ovarian follicles and / or the concentration of circulating estradiol. The initiation of administration may be delayed in the absence of follicular growth, although based on clinical experience, it is advisable to start administration on day 5 or day 6 of stimulation. The formulation and FSH should be administered at approximately the same time. However, they should not be mixed and other injection sites should be used. The FSH dose adjustment should be based on the number and size of the growing follicles rather than on the estradiol concentration. The daily administration of the preparation should be maintained until the day on which the bubbles have the right dimensions. Final follicular maturation can be achieved by administering human chorionic gonadotropin (hCG). Due to the half-life of the ganireliksu, the time between the two injections and the time between the last injection and the hCG injection should not exceed 30 hours, otherwise premature LH ejection may occur. Therefore, when taking an injection in the morning, treatment should be continued throughout the gonadotropin administration, including the day of triggering ovulation. If you are injecting this product in the afternoon, the last dose should be given in the afternoon of the day before the day of ovulation triggering. The preparation is safe and effective in women undergoing multiple therapeutic cycles. The need to support the luteal phase in the cycles in which the preparation is used has not been studied. Luteal phase support was used in clinical trials in accordance with the practical experience of the study center or according to the clinical protocol. The preparation should be administered subcutaneously, preferably in the thigh. Change the place of subcutaneous drug administration to avoid the loss of adipose tissue. A subcutaneous injection may be given by the patient or her partner, provided that the doctor has obtained the appropriate instructions and has access to expert advice.