Leniolisib Pregnancy and Breastfeeding Warnings
Brand names: Joenja
Medically reviewed by Drugs.com. Last updated on Oct 19, 2023.
Leniolisib Pregnancy Warnings
Safety has not been established during pregnancy.
US FDA pregnancy category: Not assigned.
Risk summary: No data on this drug's use in pregnant women is available to inform a drug-related risk.
Comments:
-Highly effective contraception is required during treatment with this drug and for one week after the last dose.
-Advise pregnant patients of the potential risk to a fetus.
Animal studies have revealed evidence of embryofetal toxicity, including visceral and skeletal variations, malformations, and decreased fetal and maternal body weight. This drug was toxic to animals and caused malformations at 2-6 times higher than the maximum recommended human dose (MRHD). There are no controlled data in human pregnancy.
Leniolisib Breastfeeding Warnings
Breastfeeding is not recommended during the use of this drug.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-The effects on nursing infants are unknown.
-Advise women not to breastfeed during treatment and for 1 week after the last dose.
See also
References for pregnancy information
- (2023) "Product Information. Joenja (leniolisib)." Pharming Healthcare Inc.
References for breastfeeding information
- (2023) "Product Information. Joenja (leniolisib)." Pharming Healthcare Inc.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.