Leniolisib Pregnancy and Breastfeeding Warnings

Brand names: Joenja

Medically reviewed by Drugs.com. Last updated on Oct 19, 2023.

Leniolisib Pregnancy Warnings

According to some authorities: This drug is not recommended during pregnancy or in women of childbearing potential not using contraception.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned

Risk summary: Based on animal studies, this drug may cause fetal harm when used during pregnancy. No data are available on the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Verify pregnancy status in females of reproductive potential prior to initiating treatment.
-Counsel female patients of childbearing potential to use highly effective methods of contraception during treatment and for 1 week after the last dose.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

Animal studies have revealed evidence of embryofetal toxicity. Administration of this drug during the period of organogenesis at exposures about 2 to 6 times the maximum recommended human dose based on AUC was associated with visceral and skeletal variations/malformations and decreased fetal weight in the presence of maternal toxicity. There are no controlled data in human pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

See references

Leniolisib Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for 1 week after the last dose.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-The effects on nursing infants are unknown; there is a potential for serious adverse reactions.
-There are no data on the presence of this drug in human milk or the effects of this drug on milk production.
-Because this drug is highly bound to plasma proteins (94.5%), the amount in milk is expected to be low.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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