FDA approves label update for atazanavir in pregnant women with HIV

The United States Food and Drug Administration (FDA) has approved updated labeling for the protease inhibitor atazanavir sulfate (Reyataz) that includes dose recommendations for pregnant women infected with human immunodeficiency virus 1 (HIV-1). The drug was approved to treat HIV-1 infection in 2003.

The updated labeling supports the recommended adult dose of 300 mg of atazanavir boosted with 100 mg of ritonavir. The combination achieved minimum plasma concentrations during the third trimester of pregnancy that were comparable to concentrations observed in historical data on HIV-infected adults. The update is based on data from a multicenter, open-label, prospective, single arm, pharmacokinetic study (Study 182) of 41 HIV-infected pregnant women between 12 and 32 weeks’ gestation.

Available human and animal data suggest that atazanavir doesn’t increase the overall risk of major birth defects compared with the background rate. Because studies in humans can’t rule out the risk of harm, atazanavir should be used during pregnancy only if the benefit outweighs the risk. Patients should be monitored for adverse effects for 2 months postpartum because atazanavir concentrations may rise during this period. Atazanavir should not be used without ritonavir in pregnant or postpartum women.

In patients taking atazanavir, including pregnant women, hyperbilirubinemia often occurs. Neonates exposed to atazanavir in utero should be monitored for severe hyperbilirubinemia during the first few days of life. The drug is not indicated for preventing maternal-fetal transmission of HIV-1.