Cetrotide

/ Merck

This medicinal product should only be prescribed by a specialist experienced in this field.
The first administration should be performed under the supervision of a physician and under conditions where treatment of possible allergic/pseudo-allergic reactions (including life-threatening anaphylaxis) is immediately available. The following injections may be self-administered as long as the patient is made aware of the signs and symptoms that may indicate hypersensitivity, the consequences of such a reaction and the need for immediate medical intervention.
The contents of 1 vial (0.25 mg cetrorelix) are to be administered once daily, at 24 h intervals, either in the morning or in the evening. Following the first administration, it is advised that the patient be kept under medical supervision for 30 minutes to ensure there is no allergic/pseudo-allergic reaction to the injection.
Elderly: There is no relevant use of the drug in the geriatric population.
Paediatric population: There is no relevant use of the drug in the paediatric population.
Method of administration: subcutaneous injection into the lower abdominal wall.
The injection site reactions may be minimised by rotating the injection sites, delaying injection at the same site and injecting the product in a slow rate to facilitate the progressive absorption of the product.
Administration in the morning: Treatment should commence on day 5 or 6 of ovarian stimulation (approximately 96 to 120 hours after start of ovarian stimulation) with urinary or recombinant gonadotropins and is to be continued throughout the gonadotropin treatment period including the day of ovulation induction.
Administration in the evening: Treatment should commence on day 5 of ovarian stimulation (approximately 96 to 108 hours after start of ovarian stimulation) with urinary or recombinant gonadotropins and is to be continued throughout the gonadotropin treatment period until the evening prior to the day of ovulation induction.
See prescribing information for full details.

Prevention of premature ovulation in patients undergoing a controlled ovarian stimulation, followed by oocyte pick-up and assisted reproductive techniques.

Hypersensitivity to the active substance or any structural analogues of gonadotropin-releasing hormone (GnRH), extrinsic peptide hormones or to any of the excipient. See prescribing information for full details.
During pregnancy and lactation.
Patients with severe renal impairment.

Allergic conditions: Cases of allergic/pseudoallergic reactions, including life-threatening anaphylaxis with the first dose have been reported. See prescribing information for full details.
Special care should be taken in women with signs and symptoms of active allergic conditions or known history of allergic predisposition. Treatment with cetrorelix is not advised in women with severe allergic conditions.
Ovarian Hyperstimulation Syndrome (OHSS): During or following ovarian stimulation an ovarian hyperstimulation syndrome can occur. This event must be considered as an intrinsic risk of the stimulation procedure with gonadotropins.
An OHSS should be treated symptomatically, e.g. with rest, intravenous electrolytes/colloids and heparin therapy.
Luteal phase support should be given according to the reproductive medical centre´s practice.
Repeated ovarian stimulation procedure: There is limited experience up to now with the administration of cetrorelix during a repeated ovarian stimulation procedure. Therefore cetrorelix should be used in repeated cycles only after a careful benefit/risk evaluation.
Congenital anomalies: The prevalence of congenital anomalies after the use of assisted reproductive technologies (ART) with or without GnRH antagonists may be slightly higher than after spontaneous conceptions although it is unclear whether this is related to factors inherent to the couple’s infertility or the ART procedures.
Limited data from clinical follow-up studies in 316 newborns of women administered cetrorelix for infertility treatments suggest that cetrorelix does not increase the risk of congenital anomalies in the offsprings.
Hepatic impairment: Cetrorelix has not been studied in patients with hepatic impairment and caution is therefore warranted.
Renal impairment: Cetrorelix has not been studied in patients with renal impairment and caution is therefore warranted.
Cetrorelix is contraindicated in patients with severe renal impairment.
see prescribing information for full details.

The most commonly reported adverse reactions are local injection site reactions such as erythema, swelling and pruritus that are usually transient in nature and mild in intensity. Mild to moderate OHSS (WHO grade I or II) have been commonly reported and should be considered as an intrinsic risk of the stimulation procedure. See prescribing information for full details

No formal drug-drug interaction studies have been performed with cetrorelix. In vitro investigations have shown that interactions are unlikely with medicinal products that are metabolised by cytochrome P450 or glucuronised or conjugated in some other way. However, the possibility of interactions with gonadotropins or medicinal products that may induce histamine release in susceptible individuals, cannot be totally excluded.

This product is not intended to be used during pregnancy and lactation. Studies in animals have indicated that cetrorelix exerts a dose related influence on fertility, reproductive performance and pregnancy. No teratogenic effects occurred when the medicinal product was administered during the sensitive phase of gestation.
See prescribing information for full details.

Overdose in humans may result in a prolonged duration of action but is unlikely to be associated with acute toxic effects. In acute toxicity studies in rodents non-specific toxic symptoms were observed after intraperitoneal administration of cetrorelix doses more than 200 times higher than the pharmacologically effective dose after subcutaneous administration.
See prescribing information for full details.

Store in a refrigerator (2°C – 8°C); in the original package in order to protect from light. After dispensing to the patient, the unopened product may be stored in the original package at room temperature (not above 30°C) for up to three months.
This product must be at room temperature prior to injection. Remove from the refrigerator approximately 30 minutes before use.
Do not freeze or place next to the freezer compartment or a freezer pack.
See prescribing information for full details.