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Ritonavir Pregnancy and Breastfeeding Warnings

Ritonavir is also known as: Norvir, Norvir Soft Gelatin

Ritonavir Pregnancy Warnings

FDA pregnancy category: B Potential benefit should outweigh the potential risk.

Animal studies have revealed evidence of developmental toxicity in rats (early resorption, decreased fetal body weight, ossification delays, developmental variations) and rabbits (resorptions, decreased litter size, decreased fetal weights) at maternally toxic dosages. Lower plasma levels have been reported when ritonavir was used alone in pregnant patients. There are no controlled data in human pregnancy. The US Public Health Service Task Force recommends the use of ritonavir during pregnancy as a low-dose booster to increase plasma levels of other protease inhibitors. To monitor maternal-fetal outcomes of pregnant women exposed to 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 2012, the APR has received prospective reports of 3860 exposures to ritonavir-containing regimens (1567 in the first trimester, 2293 in the second and third trimester). Birth defects occurred in 35 of 1567 live births with first trimester exposure and 59 of 2293 live births with second or third trimester exposure. The background rate of birth defects among pregnant women in the US reference population is 2.7%. There was no association between ritonavir and overall birth defects observed in the APR. FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Ritonavir Breastfeeding Warnings

There are no data on the excretion of 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 transmission and the potential for serious adverse reactions in nursing infants, mothers should not breast-feed if they are receiving ritonavir.

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