Cetrorelix Acetate

Cetrorelix acetate for injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian stimulation.

Cetrorelix acetate for injection is contraindicated under the following conditions: 1. Hypersensitivity to cetrorelix acetate, extrinsic peptide hormones or mannitol. 2. Known hypersensitivity to GnRH or any other GnRH analogs. 3. Known or suspected pregnancy, and lactation (see PRECAUTIONS). 4. Severe renal impairment.

Cetrorelix acetate for injection should be prescribed by physicians who are experienced in fertility treatment. Before starting treatment with cetrorelix acetate for injection, pregnancy must be excluded (see CONTRAINDICATIONS and PRECAUTIONS).

The safety of cetrorelix acetate for injection in 949 patients undergoing controlled ovarian stimulation in clinical studies was evaluated. Women were between 19 and 40 years of age (mean: 32). 94.0% of them were Caucasian. Cetrorelix acetate for injection was given in doses ranging from 0.1 mg to 5 mg as either a single or multiple dose. Table 3 shows systemic adverse events, reported in clinical studies without regard to causality, from the beginning of cetrorelix acetate for injection treatment until confirmation of pregnancy by ultrasound at an incidence ≥ 1% in cetrorelix acetate for injection treated subjects undergoing COS.

Table 3: Adverse Events in ≥1% (WHO preferred term) Cetrorelix Acetate for Injection N=949 % (n) Ovarian Hyperstimulation Syndrome* 3.5 (33) Nausea 1.3 (12) Headache 1.1 (10) * Intensity moderate or severe, or WHO Grade II or III, respectively Local site reactions (e.g. redness, erythema, bruising, itching, swelling, and pruritus) were reported. Usually, they were of a transient nature, mild intensity and short duration.

During post-marketing surveillance, cases of mild to moderate Ovarian Hyperstimulation syndrome and cases of hypersensitivity reactions including anaphylactoid reactions have been reported. Two stillbirths were reported in Phase 3 studies of cetrorelix acetate for injection. Congenital Anomalies Clinical follow-up studies of 316 newborns of women administered cetrorelix acetate for injection were reviewed. One infant of a set of twin neonates was found to have anencephaly at birth and died after four days.