No adverse effects were observed in studies carried out in rats and rabbits at an exposure greater than 16 times the recommended human dose. There are no controlled data in human pregnancy.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Physicians are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263.

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.

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not Assigned

Comment:
No data available on use of this drug in pregnant women to inform a drug-related risk.

See references

Breastfeeding is not recommended during use of this drug.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comment:
-The US Centers for Disease Control and Prevention advise HIV-infected women not to breastfeed to avoid postnatal transmission of HIV to a child who may not yet be infected.

Preclinical study reports presence of this drug in the plasma of nursing rat pups following administration to pregnant rats, however no effect on nursing pups was observed.

See references