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Important new information about atazanavir drug interaction

New drug interaction information has led to the following changes in the CLINICAL PHARMACOLOGY section of the REYATAZ (atazanavir sulfate) label:

Table 2: Drug Interactions: Pharmacokinetic Parameters for Atazanaivr in the Presence of Coadministered Drugs and Table 3: Drug Interactions: Pharmacokinetic Parameters for Coadministered Drugs in the Presence of REYATAZ were revised to include results from the tenofovir interaction studies.

The following information was added to the PRECAUTION: Drug Interaction section:

Table 9: Established and Other Potentially Significant Drug Interactions. Specifically the following statement was included

Tenofovir decreases the AUC (area under the curve) and Cmin (minimum concentration) of REYATAZ. When coadministered with tenofovir, it is recommended that REYATAZ 300 mg is given with ritonavir 100 mg and tenofovir 300 mg (all as a single daily dose with food). REYATAZ without ritonavir should not be coadministered with tenofovir.

REYATAZ increases tenofovir concentrations. The mechanism of this interaction is unknown. Higher tenofovir concentrations could potentiate tenofovir-associated adverse events, including renal disorders. Patients receiving REYATAZ and tenofovir should be monitored for tenofovir-associated adverse events.

The following information was added to the DOSAGE AND ADMINISTRATION section:

When coadministered with tenofovir, it is recommended that REYATAZ 300 mg is given with ritonavir 100 mg and tenofovir 300 mg (all as a single daily dose with food). REYATAZ without ritonavir should not be coadministered with tenofovir.

Further, information regarding PDE5 inhibitors (sildenafil [Viagra], tadalafil [Cialis] and vardenafil [Levitra]) was added to the WARNINGS and PRECAUTION sections. The information included is consistent with the recently approved Invirase and Fortovase label.

In addition, the patient package insert was revised to include information regarding tenofovir and PDE5 inhibitors (sildenafil, tadalafil, vardenafil).

A pdf file containing the revised label is attached. A free copy of Adobe Acrobat Reader 5.0 can be downloaded.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration
 

Page Last Updated: 08/01/2014
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