Prevention of premature ovulation in patients undergoing controlled ovarian stimulation followed by oocyte collection and assisted reproduction techniques. In clinical studies, the preparation was used with human menopausal gonadotropin (HMG), but the experience with recombinant follicle stimulating hormone (FSH), although limited, suggested similar efficacy.
Composition:
1 vial contains 0.25 mg (as acetate).
Action:
Luteinizing hormone releasing hormone antagonist (LHRH). Binding to the pituitary receptors of pituitary cells, cetrorelix competes with endogenous LHRH. Depending on the dose used, it inhibits the secretion of LH and FSH by the pituitary gland. The onset of inhibition occurs immediately and persists during continued therapy without the initial stimulation effect. Cetrorelix delays LH ejection and consequently ovulation. In patients undergoing ovarian stimulation, the duration of action of the drug is dose-dependent. Repeated injections at a dose of 0.25 mg every 24 hours will support the effect of the drug. The effect of cetrorelix as an LHRH antagonist is fully reversible after treatment. The absolute bioavailability of the cetrorelix after subcutaneous administration is approximately 85%. Medium T0,5 in the final phase of elimination after intravenous and subcutaneous administration is respectively about 12 h and 30 h.
Contraindications:
Hypersensitivity to the active substance or any structural analogues of the gonadotrophin releasing hormone (GnRH), extrinsic peptide hormones or mannitol or to any of the excipients. Pregnancy and lactation. Menopausal women. Patients with moderate and severe kidney and liver problems.
Precautions:
Special precautions should be taken in women with signs and symptoms of active allergic conditions or with a history of allergy predisposition. Treatment with the preparation is not indicated in women with severe allergic conditions. During or after ovarian stimulation, ovarian hyperstimulation syndrome (OHSS) may occur. This event must be considered as a risk associated with the gonadotropin stimulation procedure. OHSS should be treated symptomatically, eg by recommending the patient to rest, intravenous administration of electrolytes or colloids and Heparin treatment. Support for the luteal phase should be carried out in accordance with the practice used in a given medical center. The previous experience in the use of the preparation during the repeated ovarian stimulation procedure is limited - the preparation can be used in repeated cycles only after a careful assessment of the risk-effectiveness ratio. It is not appropriate to use the preparation in children and adolescents.
Pregnancy and lactation:
The drug is contraindicated during pregnancy and breastfeeding. Animal studies have shown that cetrorelix has a dose-related effect on fertility, reproductive performance and pregnancy. No teratogenic effect was observed after drug administration during the sensitive phase of pregnancy.
Side effects:
Common: local injection site reactions, usually mild and transient (erythema, edema, pruritus), mild or moderate ovarian hyperstimulation syndrome - OHSS (Ist or II WHO), whose risk is related to the stimulation process. Uncommon: severe OHSS (WHO-III), headache, nausea, systemic allergic or pseudo allergic reactions, including life-threatening anaphylaxis.
Dosage:
The drug should only be prescribed by a specialist who has experience in this field of medicine. The first application should be made under the supervision of a physician, in conditions allowing immediate treatment of allergic or pseudo allergic reactions (including life-threatening anaphylaxis). It is recommended that after the first administration the patient is under medical care for 30 minutes. The Next injection may be self-administered by the patient, provided that she has been instructed on symptoms that may indicate hypersensitivity, the effects of these symptoms and the need for immediate medical attention. The content of 1 vial (0.25 mg cetrorelix) is given once a day, at 24 h intervals, in the morning or in the evening. The drug is intended for subcutaneous injection into the lower part of the abdominal wall.It is possible to minimize the reaction at the injection site by changing injection sites that delay injection at the same site and slow injections to facilitate gradual absorption of the drug.Morning delivery: treatment with the product should begin on the 5th or 6th day of ovarian stimulation (approximately 96-120 hours after initiation of stimulation) with urine or recombinant gonadotropins and continue for the duration of treatment with gonadotropins, including on the day of ovulation induction.Evening service: treatment should be started on the fifth day of ovarian stimulation (approximately 96-108 h after ovarian stimulation) with urinary gonadotrophins or recombinant gonadotropins and continued for the duration of gonadotropin treatment until the evening of the day preceding the day of ovulation induction.
(C)
