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Ganirelix (Ganirelix Acetate) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

Carcinogenesis and Mutagenesis, 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 mcg/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 antigonadotropic properties of this drug and could result in fetal loss in humans. Therefore, this drug should not be used in pregnant women (see CONTRAINDICATIONS).

OVERDOSAGE

There have been no reports of overdosage with Ganirelix Acetate Injection in humans.

CONTRAINDICATIONS

Ganirelix Acetate Injection is contraindicated under the following conditions:

  • Known hypersensitivity to Ganirelix Acetate or to any of its components.
  • Known hypersensitivity to GnRH or any other GnRH analog.
  • Known or suspected pregnancy (see PRECAUTIONS).

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