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REYATAZ ® (atazanavir sulfate) Capsules
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use REYATAZ safely and effectively. See full prescribing information for REYATAZ.
REYATAZ ® (atazanavir sulfate) Capsules
Initial U.S. Approval: 2003
INDICATIONS AND USAGE
REYATAZ is a protease 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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Treatment-naive patients: REYATAZ 300 mg with ritonavir 100 mg once daily with food or REYATAZ 400 mg once daily with food. When coadministered with tenofovir, the recommended dose is REYATAZ 300 mg with ritonavir 100 mg. (2.1)
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Treatment-experienced patients: REYATAZ 300 mg with ritonavir 100 mg once daily with food. (2.1)
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Pediatric patients (6 to less than 18 years of age): Dosage is based on body weight not to exceed the adult dose. (2.2)
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Pregnancy: REYATAZ 300 mg with ritonavir 100 mg once daily with food, with dosing modifications for some concomitant medications. (2.3)
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Concomitant therapy: Dosing modifications may be required. (2.1, 7)
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Renal impairment: Dosing modifications may be required. (2.4)
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Hepatic impairment: Dosing modifications may be required. (2.5)
DOSAGE FORMS AND STRENGTHS
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Capsules: 150 mg, 200 mg, 300 mg. (3, 16)
CONTRAINDICATIONS
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REYATAZ is contraindicated in patients with previously demonstrated hypersensitivity (eg, Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of this product. (4)
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Coadministration with alfuzosin, triazolam, orally administered midazolam, ergot derivatives, rifampin, irinotecan, lovastatin, simvastatin, indinavir, cisapride, pimozide, St. John’s wort, and sildenafil when dosed as REVATIO ®. (4)
WARNINGS AND PRECAUTIONS
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Cardiac conduction abnormalities: PR interval prolongation may occur in some patients. Use with caution in patients with preexisting conduction system disease or when administered with other drugs that may prolong the PR interval. (5.2, 6.4, 7.3, 12.2, 17.3)
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Rash: Discontinue if severe rash develops. (5.3, 6.4, 17.4)
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Hyperbilirubinemia: Most patients experience asymptomatic increases in indirect bilirubin, which is reversible upon discontinuation. Do not dose reduce. If a concomitant transaminase increase occurs, eva luate for alternative etiologies. (5.4, 6.2)
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Hepatotoxicity: REYATAZ should be used with caution in patients with hepatic impairment (5.5). Patients with hepatitis B or C infection are at risk of increased transaminases or hepatic decompensation. Monitor hepatic laboratory tests prior to therapy and during treatment. (2.5, 5.5, 6.3, 6.4, 8.8)
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Nephrolithiasis and cholelithiasis have been reported. Consider temporary interruption or discontinuation. (5.6, 6.4)
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Patients receiving REYATAZ may develop new onset or exacerbations of diabetes mellitus/hyperglycemia (5.7, 6.4), immune reconstitution syndrome (5.8), and redistribution/accumulation of body fat (5.9).
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Hemophilia: Spontaneous bleeding may occur and additional factor VIII may be required. (5.10)
ADVERSE REACTIONS
Most common adverse reactions (≥2%) are nausea, jaundice/scleral icterus, rash, headache, abdominal pain, vomiting, insomnia, peripheral neurologic symptoms, dizziness, myalgia, diarrhea, depression, and fever. (6.1, 6.2)
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 REYATAZ can alter the concentration of other drugs and other drugs may alter the concentration of atazanavir. The potential drug-drug interactions must be considered prior to and during therapy. (4, 5.1, 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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Hepatitis B or C co-infection: Monitor liver enzymes. (5.5, 6.3)
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Renal impairment: Do not use in treatment-experienced patients with end stage renal disease managed with hemodialysis. (2.4, 8.7)
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Hepatic impairment: REYATAZ should be used with caution in patients with mild to moderate hepatic impairment. Do not use REYATAZ in patients with severe hepatic impairment. REYATAZ/ritonavir is not recommended. (2.5, 8.8)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 6/2014
FULL PRESCRIBING INFORMATION: CONTENTS*
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