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Umbralisib Pregnancy and Breastfeeding Warnings

Umbralisib is also known as: Ukoniq

Umbralisib Pregnancy Warnings

Animal studies have revealed evidence of malformations at doses comparable to those in patients at the recommended dose. Based on the findings of animal studies, this drug may impair male fertility. There are no controlled data in human pregnancy.

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.

This drug should be used during pregnancy only when clearly necessary.

US FDA pregnancy category: Not Assigned

Risk Summary: Based on animal studies and its mechanism of action, this drug can cause fetal harm.

Comments:
-Advise pregnant women of the potential risk to a fetus.
-Verify the pregnancy status of females of reproductive potential prior to treatment initiation.
-Advise females of reproductive potential or males with female partners of reproductive potential to use effective contraception during treatment and for one month after the last dose.
-Advise males of reproductive potential that this drug may impair fertility.

See references

Umbralisib Breastfeeding Warnings

Breastfeeding should be avoided.

Excreted into human milk: Data not available
Excreted into animal milk: Data not available

Comments:
-Advise women not to breastfeed during treatment and for one month following the last dose.
-There are no data regarding the secretion of this drug in human milk or its effects in the nursing infant or milk production.

See references

References for pregnancy information

  1. "Product Information. Ukoniq (umbralisib)." TG Therapeutics, New York, NY.

References for breastfeeding information

  1. "Product Information. Ukoniq (umbralisib)." TG Therapeutics, New York, NY.

Further information

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