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Enfortumab vedotin Pregnancy and Breastfeeding Warnings

Brand names: Padcev

Medically reviewed by Drugs.com. Last updated on Oct 2, 2023.

Enfortumab vedotin Pregnancy Warnings

Animal studies have revealed evidence of maternal toxicity, embryotoxicity, and embryolethality at doses equal to the recommended human dose. Structural malformations included gastroschisis, hindlimb malrotation, absent forepaw, malpositioned internal organs and fused cervical arch, skeletal anomalies (e.g., asymmetric, fused, incompletely ossified, and misshapen sternebra, misshapen cervical arch, and unilateral ossification of the thoracic centra) and decreased fetal weight. 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.

Use is not recommended.
-According to some authorities: Use is contraindicated.

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

Risk Summary:
Based on its mechanism of action and findings in animal models, this drug can cause fetal harm when administered during pregnancy. No data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-This drug can harm a developing fetus.
-Pregnancy status of patients of childbearing potential should be verified within 7 days before starting this drug.
-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.
-Monomethyl auristatin E (MMAE), the main cytotoxic moiety of this drug was shown to cross the placenta in rats; therefore, this drug has the potential to be transmitted from the mother to the developing fetus.
-Advise females of reproductive potential to use effective contraception during therapy and for about 12 months after the last dose.
-This drug may impair male fertility. Male patients may freeze and store sperm samples before treatment.
-Advise male patients with female partners of reproductive potential to use effective contraception during therapy and for 4 months after the last dose.
-Advise male patients not to father a child during and for 9 months after the last dose.

See references

Enfortumab vedotin Breastfeeding Warnings

Since this drug is a large protein molecule (molecular weight about 152 kilodalton's), the amount in milk is likely to be very low. It is also likely to be partially destroyed in the infant's gastrointestinal tract; absorption by the infant is probably minimal.

Breastfeeding is not recommended during use of this drug and for at least 3 weeks after the last dose. Some authorities recommend waiting for at least 6 months after the last dose to resume therapy.

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

Comments:
-No information is available on the clinical use of this drug during breastfeeding.
-The effects in the nursing infant are unknown; there is the potential for serious adverse reactions.

See references

References for pregnancy information

  1. Product Information. Padcev (enfortumab vedotin). Seattle Genetics Inc. 2019.
  2. Product Information. Padcev (enfortumab vedotin). Astellas Pharma Australia Pty Ltd. 2023.
  3. Product Information. Padcev (enfortumab vedotin). Astellas Pharma Ltd. 2022.

References for breastfeeding information

  1. Product Information. Padcev (enfortumab vedotin). Seattle Genetics Inc. 2019.
  2. Product Information. Padcev (enfortumab vedotin). Astellas Pharma Australia Pty Ltd. 2023.
  3. Product Information. Padcev (enfortumab vedotin). Astellas Pharma Ltd. 2022.

Further information

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