Raltegravir Pregnancy and Breast Feeding Warnings
Raltegravir is also known as: Isentress
Overview
If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Raltegravir while you are pregnant. It is not known if Raltegravir is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Raltegravir to the baby.
Raltegravir Pregnancy Warnings
Raltegravir has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of placental transfer resulting in fetal plasma levels approximately 1.5- and 2.5-fold greater than maternal plasma levels at 1 hour and 24 hours postdose, respectively, at a maternal dose of 600 mg/kg/day. There are no controlled data in human pregnancy. Raltegravir is only recommended for use during pregnancy when benefit outweighs risk.
A pregnancy registry has been established to monitor fetal outcomes of pregnant women exposed to raltegravir. Healthcare providers are encouraged to register patients by calling 1-800-258-4263 (USA).
Raltegravir Lactation Warnings
There are no data on the excretion of raltegravir into human milk; however, it is excreted into rat milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, mothers should not breast-feed while taking raltegravir. 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.
Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This drug information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information in contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.
