Alacovir Use In Pregnancy & Lactation

abacavir + lamivudine




Full Prescribing Info
Use In Pregnancy & Lactation
Pregnancy: US Pregnancy category: C.
There are no adequate and well-controlled studies of abacavir/lamivudine in pregnant women. Use abacavir/lamivudine during pregnancy only if the potential benefits outweigh the risks. The updated guidelines for the use of antiretroviral agents in HIV-1-infected patients recommended that therapy, with the exception of efavirenz, should be continued during pregnancy.
Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.
Labor and delivery: Data is not available.
Lactation: The Centers for Disease Control and Prevention recommends that HIV-1-infected mothers not breast-feed their infants to avoid risking postnatal transmission of HIV-1. Abacavir is secreted in the milk of lactating rats. The molecular weight (about 671) suggests that abacavir may be excreted in human breast milk. Lamivudine is excreted in human breast milk and into the milk of lactating rats. Because of the potential for HIV-1 transmission and the potential for serious adverse reactions in breast-fed infants, instruct mothers not to breast-feed if they are receiving abacavir/lamivudine.
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