An Antiretroviral Pregnancy Registry has been established to monitor maternal-fetal outcome of enfuvirtide exposures during pregnancy. To register patients, physicians should call 800-258-4263 (USA).

Enfuvirtide has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy. Enfuvirtide is only recommended for use during pregnancy when benefit outweighs risk.

See references

There are no data on the excretion of enfuvirtide into human milk. Due to the potential for serious adverse reactions in nursing infants mothers should be advised not to breast-feed during enfuvirtide therapy. In addition, HIV-infected mothers should not breast-feed their infants due to the risk of transmission of HIV via breast milk.

See references