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Lopinavir / ritonavir Pregnancy and Breastfeeding Warnings

Lopinavir / ritonavir is also known as: Kaletra

Lopinavir / ritonavir Pregnancy Warnings

Lopinavir-ritonavir has been assigned to pregnancy category C by the FDA. Embryonic and fetal developmental toxicities were observed in rats at maternally toxic dosages (early resorption, decreased fetal viability, decreased fetal body weight, increased incidence of skeletal variations and ossification delays, and decrease in survival between birth and postnatal day 21). There are no controlled data in human pregnancy; however, pharmacokinetic studies suggest a dosage increase may be necessary. According to the manufacturer, lopinavir-ritonavir is only recommended for use during pregnancy when benefit outweighs risk.

To monitor maternal-fetal outcomes of pregnant women exposed to lopinavir-ritonavir, an Antiretroviral Pregnancy Registry (APR) has been established. Physicians are encouraged to register patients by calling 1-800-258-4263 (USA). As of January 2011, the APR has received prospective reports of 2458 exposures to lopinavir containing regimens (738 exposed in the first trimester and 1720 exposed in the second and third trimester). Birth defects occurred in 16 of the 738 (2.2%) live births with first trimester exposure and 41 of the 1720 (2.4%) live births with second or third trimester exposure. Among pregnant women in the U.S. reference population, the background rate of birth defects is 2.7%. There was no association between lopinavir and overall birth defects observed in the APR. The Department of Health and Human Services (DHHS) Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission consider lopinavir-ritonavir a preferred agent for use during pregnancy. Pharmacokinetic studies suggest the dose should be increased to lopinavir 600 mg-ritonavir 150 mg twice a day in the second and third trimester, especially in protease inhibitor-experienced patients. If standard dosing is used, virologic response and lopinavir drug levels should be monitored. The DHHS Panel does not recommend once-daily dosing during pregnancy.

Lopinavir / ritonavir Breastfeeding Warnings

There are no data on the excretion of lopinavir-ritonavir into human milk. The U.S. Public Health Service Centers for Disease Control and Prevention advise HIV-infected women not to breast-feed to avoid postnatal transmission of HIV to a child who may not yet be infected. The manufacturer recommends that due to the potential for HIV-1 transmission and the potential for serious adverse reactions in nursing infants, mothers should be instructed not to breast-feed if they are receiving lopinavir-ritonavir.

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