WARNINGS
Ganirelix Acetate Injection should be prescribed by physicians who are experienced in infertility treatment. Before starting treatment with Ganirelix Acetate, pregnancy must be excluded. Safe use of Ganirelix Acetate during pregnancy has not been established (see CONTRAINDICTIONS and PRECAUTIONS).
PRECAUTIONS
General
Caution is advised in patients with hypersensitivity to GnRH. These patients should be carefully monitored after the first injection. Anaphylactic reactions or ganirelix antibody formation have not been reported in the clinical trials for Ganirelix Acetate Injection.
The packaging of this product contains natural rubber latex which may cause allergic reactions.
Information for Patients
Prior to therapy with Ganirelix Acetate Injection, patients should be informed of the duration of treatment and monitoring procedures that will be required. The risk of possible adverse reactions should be discussed (see ADVERSE REACTIONS).
Ganirelix Acetate should not be prescribed if the patient is pregnant.
Laboratory Tests
A neutrophil count ≥ 8.3 (x 109/L) was noted in 11.9% (up to 16.8 x 109/L) of all subjects treated within the adequate and well-controlled clinical trials. In addition, downward shifts within the Ganirelix Acetate Injection group were observed for hematocrit and total bilirubin. The clinical significance of these findings was not determined.
Drug Interactions
No formal drug-drug interaction studies have been performed.
Carcinogenesis and Mutagenesis and Impairment of Fertility
Long-term toxicity studies in animals have not been performed with Ganirelix Acetate Injection to evaluate the carcinogenic potential of the drug. Ganirelix Acetate did not induce a mutagenic response in the Ames test (S. typhimurium and E. coli) or produce chromosomal aberrations in in vitro assay using Chinese Hamster Ovary cells.
Pregnancy
Pregnancy Category X
Ganirelix Acetate Injection is contraindicated in pregnant women. When administered from Day 7 to near term to pregnant rats and rabbits at doses up to 10 and 30 µ g/day (approximately 0.4 to 3.2 times the human dose based on body surface area), Ganirelix Acetate increased the incidence of litter resorption. There was no increase in fetal abnormalities. No treatment-related changes in fertility, physical, or behavioral characteristics were observed in the offspring of female rats treated with Ganirelix Acetate during pregnancy and lactation.
The effects on fetal resorption are logical consequences of the alteration in hormonal levels brought about by the antigonadotrophic properties of this drug and could result in fetal loss in humans. Therefore, this drug should not be used in pregnant women (see CONTRAINDICTIONS).
Nursing Mothers
Ganirelix Acetate Injection should not be used by lactating women. It is not known whether this drug is excreted in human milk.
Geriatric Use
Clinical studies with Ganirelix Acetate Injection did not include a sufficient number of subjects aged 65 and over.
|
