CEZIBOE

Cetrorelix should only be prescribed by a specialist experienced in this field Posology The first administration of cetrorelix 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.

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 cetrorelix in the geriatric population. Paediatric population There is no relevant use of cetrorelix in the paediatric population. Method of administration Cetrorelix is for 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 medicinal product.

Administration in the morning:

Treatment with cetrorelix 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.

e. the number and size of growing follicles and/or the amount of circulating oestradiol. The start of cetrorelix may be delayed in absence of follicular growth, although clinical experience is based on starting cetrorelix on day 5 or day 6 of stimulation.

Administration in the evening:

Treatment with cetrorelix 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.

Summary of the safety profile 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. 25 mg. 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.

Inversely, severe OHSS remains uncommon. Uncommonly, cases of hypersensitivity reactions including pseudo-allergic/anaphylactoid reactions have been reported. Tabulated list of adverse reactions The adverse reactions reported below are classified according to frequency of occurrence as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).

MedDRA system organ class (SOC) Common Uncommon Immune system disorders Systemic allergic/pseudo- allergic reactions including life- threatening anaphylaxis. 4). g. erythema, swelling and pruritus) Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

8). 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. 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. 3).

1 - during pregnancy and lactation - patients with severe renal impairment