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Ganirelix Acetate Inj Generic Name & Formulations
Legal Class
Rx
General Description
Ganirelix acetate 250mcg per 0.5mL; soln for SC inj.
Pharmacological Class
GnRH antagonist.
How Supplied
Prefilled syringe—1
Manufacturer
Mechanism of Action
Ganirelix acetate acts by competitively blocking the gonadotropin-releasing hormone (GnRH) receptors on the pituitary gonadotroph and subsequent transduction pathway. It induces a rapid, reversible suppression of gonadotropin secretion. The suppression of pituitary LH secretion by ganirelix acetate is more pronounced than that of FSH. An initial release of endogenous gonadotropins has not been detected with ganirelix acetate, which is consistent with an antagonist effect.
Ganirelix Acetate Inj Indications
Indications
Inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation.
Ganirelix Acetate Inj Dosage and Administration
Adult
After initiating FSH on day 2 or 3 of the cycle: 250mcg once daily SC during the mid to late follicular phase. Continue until the day of hCG.
Children
Not applicable.
Ganirelix Acetate Inj Contraindications
Contraindications
Pregnancy. Nursing mothers.
Ganirelix Acetate Inj Boxed Warnings
Not Applicable
Ganirelix Acetate Inj Warnings/Precautions
Warnings/Precautions
Do complete gynecological and endocrinological exam first. Latex allergy.
Ganirelix Acetate Inj Pharmacokinetics
Absorption
Maximum serum concentrations reached approximately 1 hour after dosing. Mean absolute bioavailability: 91.1%.
Distribution
Mean (SD) volume of distribution: 43.7 (11.4) L. In vitro plasma protein bound: 81.9%.
Elimination
Fecal (75.1%), renal (22.1%). Half-life: 12.8 hours.
Ganirelix Acetate Inj Interactions
Not Applicable
Ganirelix Acetate Inj Adverse Reactions
Adverse Reactions
Abdominal pain (gynecological), fetal death, headache, ovarian hyperstimulation syndrome, vaginal bleeding, inj site reactions, nausea, GI pain; hypersensitivity reactions.
Ganirelix Acetate Inj Clinical Trials
See Literature
Ganirelix Acetate Inj Note
Not Applicable
Ganirelix Acetate Inj Patient Counseling
See Literature
