Tisotumab vedotin Pregnancy and Breastfeeding Warnings

Brand names: Tivdak

Medically reviewed by Drugs.com. Last updated on Oct 4, 2023.

Tisotumab vedotin Pregnancy Warnings

No embryofetal development studies in animals have been performed with this drug. In pregnant rats, administration of 2 IV doses of MMAE, the small molecule component, gestational days 6 and 13 caused embryofetal mortality and structural abnormalities, including protruding tongue, malrotated limbs, gastroschisis, and agnathia compared to controls at a dose of 0.2 mg/kg (approximately 0.5-fold 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.

Use should be avoided.

US FDA pregnancy category: Not assigned.

Risk Summary: Based on its mechanism of action and findings in animals, this drug can cause fetal harm when administered during pregnancy. In animal reproduction studies, administration of the small molecule component to pregnant rats during organogenesis caused embryofetal mortality and structural abnormalities at exposures below the clinical exposure at the recommended human dose.

Comments:
-This drug can harm a developing fetus.
-Adequate methods of contraception should be encouraged.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-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.
-Advise females of reproductive potential to use effective contraception during therapy and for 2 months after.
-Advise male patients with female partners of reproductive potential to use effective contraception during therapy and for 4 months after.
-Based on findings from animal studies, this drug may impair male fertility.

See references

Tisotumab vedotin Breastfeeding Warnings

Use should be avoided.

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

Comments:
-This drug can harm a nursing infant.
-Because of the potential for serious adverse reactions in a breastfed child, lactating women should not breastfeed during therapy and for 3 weeks after.

See references

Further information

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