GANIRELIX ACETATE

Pharmacokinetics The pharmacokinetic parameters of single and multiple injections of ganirelix acetate in healthy adult females are summarized in Table I . Steady-state serum concentrations are reached after 3 days of treatment. The pharmacokinetics of ganirelix acetate are dose-proportional in the dose range of 125 to 500 mcg. TABLE I: Mean (SD) pharmacokinetic parameters of 250 mcg of ganirelix acetate following a single subcutaneous (SC) injection (n=15) and daily SC injections (n=15) for sev...

Clinical Studies The efficacy of ganirelix acetate was established in two adequate and well-controlled clinical studies which included women with normal endocrine and pelvic ultrasound parameters. The studies intended to exclude subjects with polycystic ovary syndrome (PCOS) and subjects with low or no ovarian reserve. One cycle of study medication was administered to each randomized subject. For both studies, the administration of exogenous recombinant FSH [Follistim ® (follitropin beta for injection)] 150 IU daily was initiated on the morning of Day 2 or 3 of a natural menstrual cycle. Ganir...

ADVERSE REACTIONS The safety of ganirelix acetate was evaluated in two randomized, parallel-group, multicenter controlled clinical studies. Treatment duration for ganirelix acetate ranged from 1 to 14 days. Table IV represents adverse events (AEs) from first day of ganirelix acetate administration until confirmation of pregnancy by ultrasound at an incidence of ≥ 1% in ganirelix acetate-treated subjects without regard to causality. TABLE IV: Incidence of common adverse events (Incidence ≥ 1% in ...

CONTRAINDICATIONS Ganirelix acetate is contraindicated under the following conditions: Known hypersensitivity to ganirelix acetate or to any of its components including dry natural rubber/latex (see HOW SUPPLIED ). Known hypersensitivity to GnRH or any other GnRH analog. Known or suspected pregnancy (see PRECAUTIONS ).

Drug Interactions No formal drug-drug interaction studies have been performed.