Ritonavir Pregnancy and Breast Feeding Warnings

Ritonavir is also known as: Norvir, Norvir Soft Gelatin

Overview

If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Ritonavir Solution while you are pregnant. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Ritonavir Solution to the baby.

Ritonavir Pregnancy Warnings

Ritonavir has been assigned to pregnancy category B by the FDA. Reproduction studies in rats and rabbits demonstrated some developmental toxicities (e.g. early resorption, decreased fetal body weight, ossification delays) 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. Ritonavir should only be given during pregnancy when benefit outweighs risks. The U.S. 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 has been established. Physicians are encouraged to register patients by calling 1-800-258-4263 (USA).

Ritonavir Lactation Warnings

There are no data on the excretion of ritonavir into human milk. In addition, HIV-infected mothers should not breast-feed their infants due to the risk of transmission of HIV via breast milk.

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