Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Allergic conditions
Cases of allergic/pseudoallergic reactions, including life-threatening anaphylaxis with the first dose have been reported (see section 4.8).

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 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 section 4.3).

Effects on Driving

4.7   Effects on ability to drive and use machines

Cetrotide has no or negligible influence on the ability to drive and use machines.