Ganirelix Acetate Injection

 

Selected Safety Information

Contraindications

  • 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, including anaphylactoid reactions, have been reported as early as with the first dose, during postmarketing surveillance. 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.

Adverse Reactions

  • 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.

Copyright © 2018 Merck Sharp & Dohme B.V., a subsidiary of Merck & Co., Inc. All rights reserved.

WOMN-1075028-000707/18