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 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 ganirelix acetate-treated subjects).
Completed controlled clinical studies (All-subjects-treated group).
Adverse Events Occurring in ≥ 1% Ganirelix Acetate N=794 % (n) Abdominal Pain (gynecological) 4.8 (38) Death Fetal 3.7 (29) Headache 3.0 (24) Ovarian Hyperstimulation Syndrome 2.4 (19) Vaginal Bleeding 1.8 (14) Injection Site Reaction 1.1 (9) Nausea 1.1 (9) Abdominal Pain (gastrointestinal) 1.0 (8) During post-marketing surveillance, rare cases of hypersensitivity reactions, including anaphylaxis (including anaphylactic shock), angioedema and urticaria have been reported with ganirelix acetate, as early as with the first dose (see PRECAUTIONS ).
Congenital Anomalies An observational study in more than 1,000 newborns compared the incidence of congenital anomalies in newborns of women administered ganirelix acetate to historical controls of a GnRH agonist.
This study demonstrated that the incidence of congenital anomalies in children born after COH treatment in women using ganirelix acetate was comparable with that reported after a COH treatment cycle using a GnRH agonist.
The incidence of congenital malformations after some Assisted Reproductive Technologies (ART) [specifically in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI)] may be slightly higher than after spontaneous conception.
This slightly higher incidence is thought to be related to differences in parental characteristics (e.g., maternal age, maternal and paternal genetic background, sperm characteristics) and to the higher incidence of multi-fetal gestations after IVF or ICSI.
WARNINGS Ganirelix acetate injection should be prescribed by physicians who are experienced in infertility treatment.
Before starting treatment with ganirelix acetate, pregnancy must be excluded.
Safe use of ganirelix acetate during pregnancy has not been established (see CONTRAINDICATIONS and PRECAUTIONS ).
Like all medications, Ganirelix 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: