Ganirelix Other names: Ganirelix acetate Ganirelix diacetate

Ovarian hyperstimulation syndrome (OHSS) may occur during or following ovarian stimulation. OHSS must be considered an intrinsic risk of gonadotrophin stimulation. OHSS should be treated symptomatically, e.g. with rest, intravenous infusion of electrolyte solutions or colloids and heparin.

Special care should be taken in women with signs and symptoms of active allergic conditions. Cases of hypersensitivity reactions (both generalised and local), have been reported with ganirelix, as early as with the first dose, during post-marketing surveillance. These events have included anaphylaxis (including anaphylactic shock), angioedema and urticaria. If a hypersensitivity reaction is suspected, ganirelix should be discontinued and appropriate treatment administered. In the absence of clinical experience, ganirelix treatment is not advised in women with severe allergic conditions.

There are no adequate data from the use of ganirelix in pregnant women. In animals, exposure to ganirelix at the time of implantation resulted in litter resorption. The relevance of these data for humans is unknown.

It is not known whether ganirelix is excreted in breast milk. The use of ganirelix is contraindicated during pregnancy and breast-feeding.

Fertility

Ganirelix is used in the treatment of women undergoing controlled ovarian hyperstimulation in assisted reproduction programmes. Ganirelix is used to prevent premature LH surges that might otherwise occur in these women during the ovarian stimulation.

No studies on the effects on the ability to drive and use machines have been performed.

Summary of the safety profile

The list below shows all adverse reactions in women treated with ganirelix in clinical studies using recFSH for ovarian stimulation. The adverse reactions with ganirelix using corifollitropin alfa for ovarian stimulation are expected to be similar.

Tabulated list of adverse reactions

The adverse reactions are classified according to MedDRA system organ class and frequency; very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100). The frequency of hypersensitivity reactions (very rare, <1/10,000) has been deduced from post-marketing surveillance.

Immune system disorders

Very rare: Hypersensitivity reactions (including rash, facial swelling, dyspnoea, anaphylaxis (including anaphylactic shock), angioedema and urticaria)¹, Worsening of a pre-existing eczema²

Nervous system disorders

Uncommon: Headache

Gastrointestinal disorders

Uncommon: Nausea

General disorders and administration site conditions

Very common: Local skin reaction at the site of injection (predominantly redness, with or without swelling)³

Uncommon: Malaise

¹ Cases have been reported, as early as with the first dose, among patients administered ganirelix.
² Reported in one subject after the first ganirelix dose.
³ In clinical studies, one hour after injection, the incidence of at least once a moderate or severe local skin reaction per treatment cycle, as reported by patients, was 12% in ganirelix treated patients and 25% in patients treated subcutaneously with a GnRH agonist. The local reactions generally disappear within 4 hours after administration. Description of selected adverse reactions Other reported adverse reactions are related to the controlled ovarian hyperstimulation treatment for ART, notably pelvic pain, abdominal distension, OHSS, ectopic pregnancy and spontaneous abortion.