For Women Undergoing Controlled Ovarian Hyperstimulation

A Gondadotropin-Releasing Hormone (GnRH) Antagonist for the Inhibition of Premature Luteinizing Hormone (LH) Surges

  • Induces a rapid, reversible suppression of gonadotropin secretion.
  • The suppression of pituitary LH secretion by Ganirelix Acetate is more pronounced than that of follicle-stimulating hormone (FSH). An initial release of endogenous gonadotropins has not been detected with Ganirelix Acetate, which is consistent with an antagonist effect. Upon discontinuation of Ganirelix Acetate, pituitary LH and FSH levels are fully recovered within 48 hours.
  • Maximum serum concentrations reached approximately 1 hour after dosing.

Indication

Ganirelix Acetate Injection is indicated for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation.

Selected Safety Information About Ganirelix Acetate Injection
  • Ganirelix Acetate Injection is contraindicated in patients with a known hypersensitivity to Ganirelix Acetate or to any of its components, known hypersensitivity to gonadotropin-releasing hormone (GnRH) or any other GnRH analogue, and in patients with known or suspected pregnancy.
  • 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 packaging of this product contains natural rubber latex that 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.

WOMN-1075028-0003 12/14

Please orient your device to the portrait position to return to the site.

more less
Selected Safety Information About Ganirelix Acetate Injection
  • Ganirelix Acetate Injection is contraindicated in patients with a known hypersensitivity to Ganirelix Acetate or to any of its components, known hypersensitivity to gonadotropin-releasing hormone (GnRH) or any other GnRH analogue, and in patients with known or suspected pregnancy.
  • 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 packaging of this product contains natural rubber latex that 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.