Lopinavir/ritonavir Pregnancy and Breast Feeding Warnings
Lopinavir/ritonavir is also known as: Kaletra
Overview
If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Lopinavir/Ritonavir Capsules while you are pregnant. It is not known if Lopinavir/Ritonavir Capsules is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Lopinavir/Ritonavir Capsules to the baby.
Lopinavir/ritonavir Pregnancy Warnings
Lopinavir-ritonavir has been assigned to pregnancy category C by the FDA. Reproduction studies in rats demonstrated some developmental toxicities at maternally toxic dosages (e.g. 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). Lopinavir-ritonavir should only be given during pregnancy if the potential benefit outweighs the potential risks. Studies to evaluate the pharmacokinetics of standard dose of lopinavir-ritonavir capsules (3 capsules twice daily) during 3rd trimester revealed significantly lower levels than during postpartum period and in nonpregnant adults. An increased dosage of 4 capsules twice daily starting in the 3rd trimester resulted in sufficient lopinavir exposure. By 2 weeks postpartum, standard dosing was again appropriate. Optimal dosages of the tablet formulation have not been established but studies to evaluate the pharmacokinetics are underway.
To monitor maternal-fetal outcomes of pregnant women exposed to lopinavir-ritonavir, an Antiretroviral Pregnancy Registry has been established. Physicians are encouraged to register patients by calling 1-800-258-4263 (USA).
Lopinavir/ritonavir Lactation Warnings
There are no data on the excretion of lopinavir-ritonavir into human milk. HIV-infected mothers should not breast-feed their infants due to the risk of transmission of HIV via breast milk.
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