Polatuzumab vedotin Pregnancy and Breastfeeding Warnings

Brand names: Polivy

Medically reviewed by Drugs.com. Last updated on Dec 25, 2023.

Polatuzumab vedotin Pregnancy Warnings

Use is not recommended.

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

Risk Summary: Based on findings from animal studies and its mechanism of action this drug can cause fetal harm. Administration of the small molecule component of this drug, MMAE, to pregnant animals during organogenesis at exposures below the clinical exposure at the recommended dose in humans every 21 days resulted in embryofetal mortality and structural abnormalities.

Comments:
-This drug can harm a developing fetus.
-Adequate methods of contraception should be encouraged.
-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.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-Advise females of reproductive potential to use effective contraception during therapy and for at least 3 months after.
-Based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during therapy and for at least 5 months after.
-Based on findings from animal studies, this drug may impair male fertility. The reversibility of this effect is not known.

Animal studies have revealed evidence of caused embryofetal mortality and structural abnormalities including protruding tongue, malrotated limbs, gastroschisis, and agnathia. 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

Polatuzumab vedotin Breastfeeding Warnings

Use is not recommended.

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

Comments:
-The effects in the nursing infant are unknown.
-Because of the potential for serious adverse reactions in the breastfed child, women should not breastfeed during therapy and for at least 2 months after the last dose.

See references

Further information

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