> ## Content Index > Fetch the complete content index at: https://www.foodconsumer.org/llms.txt > Use this file to discover other available public pages before exploring further. # HIV/AIDS Update - Changes to label for Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) tablets - URL: https://www.foodconsumer.org/hiv_update-0417130703/ - Published: 2013-04-17T20:02:00.000Z - Updated: 2026-09-22T16:18:30.000Z - Description: FDA approved label changes for Atripla. Stribild joins the drugs that should not be co-administered, interaction data for raltegravir, boceprevir and telaprevir is added, and the rash warning now advises considering alternative therapy for patients who had life-threatening skin reactions. - Author: Food Consumer - Tags: Drug, Health News, #vivvo-import FDA recently approved changes to the Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) tablet label to include the following changes: - Lists Stribild as one of the drugs that should not be coadministered with Atripla - Adds drug interaction information for raltegravir, boceprevir and telaprevir - Strengthens Warnings and Precautions: Rash section - Updates the Use in Specific Populations: Nursing Mothers section - Updates Tables 7 and 8 with didanosine drug interaction data based upon recent changes to the prescribing information for Sustiva, Truvada and Viread. The specific changes are as follows: Section 5 *Warnings and Precautions, subsection 5.9 Rash:* the following text was added For patients who have had a life-threatening cutaneous reaction (eg, Stevens-Johnson syndrome), alternative therapy should be considered. Section 7 *Drug Interactions Table 4* was revised as follows: Lopinavir/Ritionavir: Do not use once daily administration of lopinavir/ritonavir. Dose adjustment of lopinavir/ritonavir is recommended when coadministered with efavirenz. Refer to the full prescribing information for lopinavir/ritonavir for guidance on coadministration with efavirenz- or tenofovir-containing regimens, such as ATRIPLA. Patients should be monitored for tenofovir-associated adverse reactions. Saquinavir: Appropriate doses of the combination of efavirenz and saquinavir/ritonavir with respect to safety and efficacy have not been established. Section 12.3 *Pharmacokinetics* was updated to provide the magnitude of interaction with raltegravir, boceprevir and telaprevir.Raltegravir: Efavirenz reduces plasma concentrations of raltegravir. The clinical significance of this interaction has not been directly assessed. Boceprevir: Plasma trough concentrations of boceprevir were decreased when boceprevir was coadministered with efavirenz, which may result in loss of therapeutic effect. The combination should be avoided. Telaprevir: Concomitant administration of telaprevir and efavirenz resulted in reduced steady-state exposures to telaprevir and efavirenz. Section 8.3 *Nursing Mothers* was revised as follows: The Centers for Disease Control and Prevention recommend that HIV-1 infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV-1\. Studies in rats have demonstrated that efavirenz is secreted in milk. Studies in humans have shown that both tenofovir and emtricitabine are excreted in human milk. Because the risks of low level exposure to emtricitabine and tenofovir to infants are unknown, and because of the potential for HIV-1 transmission, mothers should be instructed not to breastfeed if they are receiving ATRIPLA. Emtricitabine Samples of breast milk obtained from five HIV-1 infected mothers 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 infants breastfed by mothers being treated with emtricitabine are unknown. Tenofovir Disoproxil Fumarate Samples of breast milk obtained from five 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 disoproxil fumarate are unknown. Atripla is a product of Gilead Sciences and Bristol-Myers Squibb. The complete, revised labeling will be available soon at [Drugs@FDA](http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTMwNDE3LjE3ODU4MDQxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDEzMDQxNy4xNzg1ODA0MSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE2Nzk1MzkyJmVtYWlsaWQ9Zm9vZGNvbnN1bWVyLm9yZ0BnbWFpbC5jb20mdXNlcmlkPWZvb2Rjb25zdW1lci5vcmdAZ21haWwuY29tJmZsPSZleHRyYT1NdWx0aXZhcmlhdGVJZD0mJiY=&&&100&&&http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label%5FApprovalHistory&source=govdelivery#labelinfo). Richard Klein Office of Health and Constituent Affairs Food and Drug Administration Kimberly Struble Division of Antiviral Products Food and Drug Administration Steve Morin Office of Health and Constituent Affairs Food and Drug Administration If you are interested in receiving information about a broader range of FDA topics, consider subscribing to the FDA [Patient Network News](http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTMwNDE3LjE3ODU4MDQxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDEzMDQxNy4xNzg1ODA0MSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE2Nzk1MzkyJmVtYWlsaWQ9Zm9vZGNvbnN1bWVyLm9yZ0BnbWFpbC5jb20mdXNlcmlkPWZvb2Rjb25zdW1lci5vcmdAZ21haWwuY29tJmZsPSZleHRyYT1NdWx0aXZhcmlhdGVJZD0mJiY=&&&101&&&http://service.govdelivery.com/service/subscribe.html?code=USFDA%5F203&ref=foodconsumer.org), a twice monthly newsletter containing FDA-related information on a variety of topics, including new product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings, proposed regulatory guidances and opportunity to comment, and other information of interest to patients and patient advocates.