- 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.
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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