Ganirelix (Orgalutran)
Ganirelix Acetate (N-acetyl-3-(2-naphthyl)-D-alanyl-4-chloro-D-phenylalanyl-3-(3-pyridyl)-D-alanyl-L-seryl-L-tyrosyl-N9,N10-diethyl-D-homoarginyl-L-leucyl-N9,N10-diethyl-L-homoarginyl-L-prolyl-D-alanylamide acetate)
Approved status applies to specific products, routes, and indications, not every use context discussed online.
Its effectiveness has been confirmed in multiple large clinical trials.
Safety Summary
The overall safety profile of ganirelix is well-established from two pivotal RCTs (N=794 ganirelix-treated subjects) and extensive post-marketing surveillance. FDA label Table IV lists adverse events at ≥1% incidence without regard to causality, including fetal death (3.7%) which reflects the IVF population baseline rather than drug-attributable events. The most frequent drug-related events were abdominal pain (4.8%), headache (3.0%), OHSS (2.4%), vaginal bleeding (1.8%), injection site reaction (1.1%), and nausea (1.1%). Post-marketing pharmacovigilance identified shared signals with cetrorelix for OHSS-related events (ascites, pleural effusion, abdominal distension) that are attributable to the underlying infertility treatment rather than ganirelix specifically (PMC12016398). A 1000-fetus neonatal safety study found no increase in major malformations with ganirelix versus GnRH agonist protocols (5.0% vs 5.4%, OR 0.94, 95% CI 0.62-1.42) (PMID 20378616).
Clinical check-in
If real-world use or exposure is being considered, review potential interactions, contraindications, and monitoring needs with a licensed clinician rather than relying on summary copy alone.
Sources: [1-14]