Nogapendekin alfa inbakicept Pregnancy and Breastfeeding Warnings

Brand names: Anktiva

Medically reviewed by Drugs.com. Last updated on Jun 18, 2024.

Nogapendekin alfa inbakicept Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not Assigned

Risk Summary: Based on its mechanism of action, this drug may cause fetal harm when administered to a pregnant woman if systemic exposure occurs.

Comments:
-There is no data on use in pregnant women to know this drugs risks, including the risk of fetal harm or reproductive effects.
-Systemic exposure in patients receiving intravesical administration of the approved dosage of this drug was below the quantitation limit.
-Verify the pregnancy status in females of reproductive potential prior to initiating treatment and advise them of the potential risk to a fetus.
-Advise females of reproductive potential to use effective contraception during treatment and for 1 week after the last dose.

Animal reproductive and developmental toxicity studies have not been conducted. 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.

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Nogapendekin alfa inbakicept Breastfeeding Warnings

Benefit should outweigh risk.

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

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Systemic exposure in patients receiving intravesical administration of the approved dosage of this drug was below the quantitation limit suggesting that any amount in breast milk will be low.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.

See references

Further information

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