Lenacapavir Pregnancy and Breastfeeding Warnings

Brand names: Sunlenca

Medically reviewed by Drugs.com. Last updated on Feb 14, 2023.

Lenacapavir Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.
According to some authorities: This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B1
US FDA pregnancy category: Not Assigned

Risk Summary: Insufficient data available on use of this drug in pregnant women to inform a drug-related risk.

Comment: A pregnancy exposure registry is available.

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.

AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.

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

Lenacapavir Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug.
-According to some authorities: Safety has not been established. The manufacturer makes no recommendation regarding use during lactation.

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

Comments:
-The effects in the nursing infant are unknown.
-There is a potential for HIV transmission (in HIV-negative infants), developing viral resistance (in HIV-positive infants), and adverse reactions.
-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.
-LactMed recommends individuals with HIV who are on antiretroviral therapy with a sustained undetectable viral load and who choose to breastfeed should be supported in this decision.

A 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

Further information

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

Medical Disclaimer