Orgalutran Adverse Reactions

General disorders and administration site conditions: Orgalutran may cause a local skin reaction at the site of injection (predominantly redness, with or without swelling). In clinical studies, one hour after injection, the incidence of at least one moderate or severe local skin reaction per treatment cycle, as reported by patients, was 12% in Orgalutran treated patients and 25% in patients treated subcutaneously with a GnRH agonist. The local reactions generally disappear within 4 hours after administration. Malaise was reported in 0.3% of patients.
Immune system disorders: Very rarely, post-marketing cases of hypersensitivity reactions (including rash, facial swelling, dyspnea, anaphylaxis (including anaphylactic shock), angioedema, and urticaria) have been reported, as early as with the first dose among patients administered Orgalutran.
Nervous system disorders: Headache (0.4%).
Gastrointestinal disorders: Nausea (0.5%).
Other reported undesirable effects are related to the controlled ovarian hyperstimulation treatment for ART, notably pelvic pain, abdominal distension, OHSS, ectopic pregnancy and spontaneous abortion.
The incidence of congenital malformations after Assisted Reproductive Technologies (ART) may be slightly higher than after spontaneous conceptions. This slightly higher incidence is thought to be related to differences in parental characteristics (e.g., maternal age, sperm characteristics) and to the higher incidence of multiple gestations after ART. In clinical trials investigating more than 1000 newborns, it has been demonstrated that the incidence of congenital malformations in children born after COH treatment using Orgalutran is comparable with that reported after COH treatment using a GnRH agonist.