Based on findings in animal studies and mechanism of action, ELIGARD® may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology].
There is no available data in pregnant women to inform the drug-associated risk. Expected hormonal changes that occur with ELIGARD treatment increase the risk for pregnancy loss.
In animal developmental and reproductive studies, major fetal abnormalities were observed after administration of leuprolide acetate throughout gestation.
There were increased fetal mortality and decreased fetal weights in rats and rabbits.
The effects of fetal mortality are expected consequences of the alterations in hormonal levels brought about by this drug.
The safety and efficacy of ELIGARD have not been established in females.
There is no information regarding the presence of ELIGARD in human milk, the effects on the breastfed child, or the effects on milk production.
Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in a breastfed child from ELIGARD, a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
Individuals of reproductive potential
ELIGARD® may impair fertility for males of reproductive potential.
Based on mechanism of action, ELIGARD may impair fertility in males of reproductive potential [see Clinical Pharmacology].
Safety and effectiveness in pediatric patients have not been established.
The majority of the patients (approximately 70%) studied in the clinical trials were age 70 and older.