Ganirelix Acetate (ganirelix acetate)

The recommended dosage of ganirelix acetate for the inhibition of premature LH surges in adult women undergoing controlled ovarian hyperstimulation (with an exogenous form of FSH) is 250 mcg once daily during the mid- to late-follicular phase of the menstrual cycle. FSH therapy (e.g., follitropin beta) usually is initiated on the morning of day 2 or 3 of the menstrual cycle and ganirelix acetate on the morning of day 7 or 8 of the cycle (day 6 of FSH therapy) and continued until an adequate follicular response is achieved, at which time human chorionic gonadotropin (hCG) is administered and FSH therapy and ganirelix are discontinued. Oocyte retrieval, followed by in vitro fertilization or intracytoplasmic sperm injection, is then performed, with subsequent attempts at implantation and pregnancy.

Ganirelix acetate is administered by subcutaneous injection once daily. The currently available formulation is for subcutaneous use only.

No formal drug interaction studies have been performed.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

Known hypersensitivity to ganirelix or any ingredient in the formulation. Known hypersensitivity to GnRH or any other GnRH analog. Known or suspected pregnancy.

• Lactation
• Pregnancy

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Adverse effects of ganirelix occurring in at least 1% of treated individuals include neutrophil count of 8.3/mm3 or greater, gynecologic abdominal pain, fetal death, headache, ovarian hyperstimulation syndrome, vaginal bleeding, injection site reactions, nausea, and GI abdominal pain.

Less Frequent

• Ovarian hyperstimulation syndrome

Rare or Very Rare

• Anaphylaxis
• Angioedema
• Facial edema
• Hypersensitivity drug reaction

Less Frequent

• Abnormal vaginal bleeding
• Acute abdominal pain
• Drug-induced hot flash
• Dyspnea
• Fatigue
• Headache disorder
• Injection site sequelae
• Nausea
• Pain
• Rhinitis
• Upper respiratory infection

Rare or Very Rare

• Dizziness
• Urticaria

No enhanced messaging available.

Not indicated.

Category X. (See Users Guide.) May result in fetal loss due to antigonadotropic properties. (See Cautions: Contraindications and also Major Toxicities.)

It is unknown whether ganirelix is distributed in breast milk; use in nursing women is not recommended.

Clinical studies did not include sufficient numbers of geriatric adults 65 years of age or older.