These highlights do not include all the information needed to use EVOTAZ safely and effectively. See full prescribing information for EVOTAZ.
EVOTAZ™ (atazanavir and cobicistat) tablet, for oral use
Initial U.S. Approval: 2015
RECENT MAJOR CHANGES
Warnings and Precautions,
Risk of Serious Adverse Reactions or Loss of Virologic
Response Due to Drug Interactions (5.7) 5/2015
INDICATIONS AND USAGE
EVOTAZ is a combination human immunodeficiency virus (HIV-1) protease inhibitor and CYP3A inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. (1)
DOSAGE AND ADMINISTRATION
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Recommended dosage in adults: One tablet once daily, taken orally with food. (2.1)
DOSAGE FORMS AND STRENGTHS
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Tablets: 300 mg of atazanavir and 150 mg of cobicistat. (3, 16)
CONTRAINDICATIONS
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EVOTAZ is contraindicated in patients with previously demonstrated hypersensitivity (e.g., Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of this product. (4)
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Coadministration with certain drugs for which altered plasma concentrations are associated with serious and/or life-threatening events or loss of therapeutic effect. (4)
WARNINGS AND PRECAUTIONS
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Cardiac conduction abnormalities: PR interval prolongation may occur in some patients. Consider ECG monitoring in patients with preexisting conduction system disease or when administered with other drugs that may prolong the PR interval. (5.1, 6.2, 7.3, 12.2, 17)
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Rash: Discontinue if severe rash develops. (5.2, 6.2, 17)
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Assess creatinine clearance (CLcr) before initiating treatment. Consider alternative medications that do not require dosage adjustments in patients with renal impairment. (5.3)
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When cobicistat, a component of EVOTAZ, is used in combination with a tenofovir disoproxil fumarate (tenofovir DF)-containing regimen, cases of acute renal failure and Fanconi syndrome have been reported. (5.4)
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When used with tenofovir DF, assess urine glucose and urine protein at baseline and monitor CLcr, urine glucose, and urine protein. Monitor serum phosphorus in patients with or at risk for renal impairment. Coadministration with tenofovir DF is not recommended in patients with CLcr below 70 mL/min or in patients also receiving a nephrotoxic agent. (5.4)
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Nephrolithiasis and cholelithiasis have been reported. Consider temporary interruption or discontinuation. (5.5, 6.2)
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Hepatotoxicity: Patients with hepatitis B or C coinfection are at risk of increased transaminases or hepatic decompensation. Monitor hepatic laboratory tests prior to therapy and during treatment. (2.4, 5.6, 8.7)
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The concomitant use of EVOTAZ and certain other medications may result in known or potentially significant drug interactions. Consult the full prescribing information prior to and during treatment for potential drug interactions. (5.7, 7.3)
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Antiretrovirals that are not recommended: EVOTAZ is not recommended for use with atazanavir or cobicistat, with ritonavir or products containing ritonavir, or in combination with other antiretroviral drugs that require CYP3A inhibition to achieve adequate exposures (e.g., other protease inhibitors and elvitegravir). (5.8)
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Hyperbilirubinemia: Most patients experience asymptomatic increases in indirect bilirubin, which is reversible upon discontinuation. If a concomitant transaminase increase occurs, eva luate for alternative etiologies. (5.9, 6.1)
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Patients receiving EVOTAZ may develop immune reconstitution syndrome (5.10), new onset or exacerbations of diabetes mellitus/hyperglycemia (5.11, 6.2), and redistribution/accumulation of body fat (5.12).
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Hemophilia: Spontaneous bleeding may occur and additional factor VIII may be required. (5.13)
ADVERSE REACTIONS
Most common adverse reactions seen with atazanavir coadministered with cobicistat (greater than 2%, Grades 2-4) are jaundice, ocular icterus, and nausea. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Coadministration of EVOTAZ can alter the concentration of other drugs and other drugs may alter the concentration of EVOTAZ. The potential drug-drug interactions must be considered prior to and during therapy. (4, 7, 12.3)
USE IN SPECIFIC POPULATIONS
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Pregnancy: Use only if the potential benefit justifies the potential risk. (8.1)
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Nursing mothers should be instructed not to breastfeed due to the potential for postnatal HIV transmission. (8.3)
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Renal impairment: EVOTAZ is not recommended for use in treatment-experienced patients with end-stage renal disease managed with hemodialysis. (2.3, 8.6)
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Hepatic impairment: EVOTAZ is not recommended in patients with hepatic impairment. (2.4, 8.7)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 5/2015
