Cobicistat / elvitegravir / emtricitabine / tenofovir Pregnancy and Breastfeeding Warnings

Cobicistat / elvitegravir / emtricitabine / tenofovir is also known as: Stribild

Cobicistat / elvitegravir / emtricitabine / tenofovir Pregnancy Warnings

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

Animal studies have failed to reveal evidence of teratogenicity or embryofetal toxicity. There are no controlled data in human pregnancy. To monitor fetal outcomes of pregnant women exposed to cobicistat/elvitegravir/emtricitabine/tenofovir, an Antiretroviral Pregnancy Registry has been established. Healthcare providers are encouraged to register patients by calling 1-800-258-4263 (USA). 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.

Cobicistat / elvitegravir / emtricitabine / tenofovir Breastfeeding Warnings

The manufacturer recommends that due to the potential for HIV transmission and the potential for serious adverse reactions in nursing infants, mothers should not breastfeed while taking cobicistat/elvitegravir/emtricitabine/tenofovir. The Centers for Disease Control and Prevention advise HIV-infected women not to breastfeed to avoid postnatal transmission of HIV to a child who may not yet be infected. Samples of breast milk obtained from 5 HIV-1 infected women show that emtricitabine is secreted in human milk. Breastfeeding infants whose mothers are being treated with emtricitabine may be at risk for developing viral resistance to emtricitabine. Other emtricitabine-associated risks in such infants are unknown. Samples of breast milk obtained from 5 HIV-1 infected mothers show that tenofovir is secreted in human milk. Tenofovir-associated risks, including the risk of viral resistance to tenofovir, in infants breastfed by mothers being treated with tenofovir are unknown.

Use of cobicistat/elvitegravir/emtricitabine/tenofovir is not recommended. Excreted into human milk: Unknown (cobicistat and elvitegravir); Yes (emtricitabine and tenofovir) Excreted into animal milk: Yes (cobicistat, elvitegravir, and tenofovir); Unknown (emtricitabine) The effects in the nursing infant are unknown.

See Also...

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and 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 material 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 combination thereof in no way should be construed to indicate that the drug or 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 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.