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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.
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
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