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Talazoparib Pregnancy and Breastfeeding Warnings

Talazoparib is also known as: Talzenna

Medically reviewed by Drugs.com. Last updated on Nov 20, 2018.

Talazoparib Pregnancy Warnings

Use should be avoided.

US FDA pregnancy category: Not assigned.

Risk Summary: Based on findings from animal studies and its mechanism of action, this drug can cause embryofetal harm when administered to a pregnant woman. Administration to pregnant animals during the period of organogenesis caused fetal malformations and structural skeletal variations and embryofetal death at maternal exposures that were 0.24 times the equivalent recommended human dose.

Comments:
-Advise females of reproductive potential to use effective contraception during therapy and for at least 7 months after.
-Based on genotoxicity and animal reproduction studies, advise male patients with female partners of reproductive potential and pregnant partners to use effective contraception during therapy and for at least 4 months after.
-This drug may impair fertility in males of reproductive potential.
-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 fetal malformations (e.g., depressed eye bulge, small eye, split sternebra, and fused cervical vertebral arch) and structural variations (e.g., misshapen or incomplete ossification of the sternebra, skull, rib, and vertebra) and fetal death at doses 0.24 times the equivalent recommended human dose. 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.

See references

Talazoparib Breastfeeding Warnings

Use should be avoided.

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

Comments: Because of the potential for serious adverse reactions in breastfed infants, advise lactating women not to breastfeed during therapy and for at least 1 month after.

See references

References for pregnancy information

  1. "Product Information. Talzenna (talazoparib)." Pfizer U.S. Pharmaceuticals Group, New York, NY.

References for breastfeeding information

  1. "Product Information. Talzenna (talazoparib)." Pfizer U.S. Pharmaceuticals Group, New York, NY.

Further information

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

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