Ganirelix Acetate Injection is indicated for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation.
Selected Safety Information
- Ganirelix Acetate Injection is contraindicated in patients with a known hypersensitivity to Ganirelix Acetate or to any of its components including dry natural rubber/latex, known hypersensitivity to gonadotropin-releasing hormone (GnRH) or any other GnRH analogue, and in patients with known or suspected pregnancy.
Warnings and Precautions
- Ganirelix Acetate Injection should be prescribed by physicians who are experienced in infertility treatment. Before starting treatment with Ganirelix Acetate, pregnancy must be excluded.
- Special care should be taken in women with signs and symptoms of active allergic conditions. Cases of hypersensitivity reactions (both generalized and local), including anaphylaxis (including anaphylactic shock), angioedema and urticaria, have been reported with Ganirelix Acetate, as early as with the first dose, during post-marketing surveillance. If a hypersensitivity reaction is suspected, Ganirelix Acetate should be discontinued and appropriate treatment administered. In the absence of clinical experience, Ganirelix Acetate treatment is not advised in women with severe allergic conditions.
- Prior to therapy with Ganirelix Acetate Injection, patients should be informed of the duration of treatment and the monitoring procedures that will be required.
- The needle shield of this product contains dry natural rubber/latex which comes into contact with this product and may cause allergic reactions.
- Ganirelix Acetate should not be used by lactating women.
- The most common adverse events occurring in ≥1% of patients treated with Ganirelix Acetate Injection in clinical studies (N=794) include: abdominal pain (gynecological) (4.8%), fetal death (3.7%), headache (3.0%), ovarian hyperstimulation syndrome (OHSS) (2.4%), vaginal bleeding (1.8%), injection site reaction (1.1%), nausea (1.1%), and abdominal pain (gastrointestinal) (1.0%).
Before prescribing Ganirelix Acetate Injection, please read the accompanying Prescribing Information.