Changes to Label for Atripla (Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate) Tablets
April 18, 2013
FDA recently approved updates to the Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) tablet label to include the following changes:
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.
Efavirenz reduces plasma concentrations of raltegravir. The clinical significance of this interaction has not been directly assessed.
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.
Atripla is a product of Gilead Sciences and Bristol-Myers Squibb.
The complete, revised labeling will be available soon at Drugs@FDA.
This article was provided by U.S. Food and Drug Administration. Visit the FDA's website to find out more about their activities and publications.
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