Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS 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.
WARNINGS 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).
Like all medications, Cetrorelix Acetate can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: