Cetrotide Special Precautions

Allergic conditions: Cases of allergic/pseudoallergic reactions, including life-threatening anaphylaxis with the first dose have been reported.
Special care should be taken in women with signs and symptoms of active allergic conditions or known history of allergic predisposition. Treatment with Cetrotide 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 ovarian hyperstimulation syndrome 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 Cetrotide 0.25 mg during a repeated ovarian stimulation procedure. Therefore, Cetrotide 0.25 mg should be used in repeated cycles only after a careful risk/benefit 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.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed. Due to its pharmacological profile cetrorelix is unlikely to impair the patient's ability to drive or to operate machinery.