REYATAZ

The pharmacokinetics of atazanavir were evaluated in adult participants who either were healthy, or with HIV-1, after administration of REYATAZ 400 mg once daily and after administration of REYATAZ 300 mg with ritonavir 100 mg once daily (see Table 17).

Table 17Steady-State Pharmacokinetics of Atazanavir in Healthy Participants or Participants with HIV-1 in the Fed State a n=26. b n=12. 400 mg once daily 300 mg with ritonavir 100 mg once daily Parameter Healthy Participants (n=14) Participants...

14.1 Adult Participants without Prior Antiretroviral Therapy Study AI424-138: a 96-week study comparing the antiviral efficacy and safety of either REYATAZ or lopinavir/ritonavir, each in combination with fixed-dose tenofovir DF-emtricitabine in treatment-naive participants with HIV-1 infection. Study AI424-138 (NCT00272779) was a 96-week, open-label, randomized, multicenter study, comparing REYATAZ (300 mg once daily) with ritonavir (100 mg once daily) to lopinavir/ritonavir (400/100 mg twice daily as fixed-dose product), each in combination with the fixed-dose product, tenofovir DF/emtricita...

The following adverse reactions are discussed in greater detail in other sections of the labeling:

• cardiac conduction abnormalities [see Warnings and Precautions (5.1) ]
• rash [see Warnings and Precautions (5.2) ]
• hyperbilirubinemia [see Warnings and Precautions (5.8) ]
• chronic kidney disease [see Warnings and Precautions (5.5) ]
• nephrolithiasis and cholelithiasis [see Warnings and Precautions (5.6) ] Most common adverse reactions (≥2%) are nausea, jaundice/scleral icterus, rash, headac...

REYATAZ is contraindicated:

• in patients with previously demonstrated clinically significant hypersensitivity (eg, Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of REYATAZ capsules or REYATAZ oral powder [see Warnings and Precautions (5.2) ] .
• when coadministered with drugs that are highly dependent on CYP3A or UGT1A1 for clearance, and for whi...

• Cardiac conduction abnormalities: PR interval prolongation may occur in some patients. ECG monitoring should be considered in patients with preexisting conduction system disease or when administered with other drugs that may prolong the PR interval. (5.1 , 7.3 , 12.2 , 17)
• Severe Skin Reactions: Discontinue if severe rash develops. (5.2 , 17)
• Hyperbilirubinemia: Most patients experience asymptomatic increases in indirect bilirubin, which is reversible upon discontinuation. Do not dose redu...

7 DRUG INTERACTIONS 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 , 7 , 12.3) 7.1 Potential for REYATAZ to Affect Other Drugs Atazanavir is an inhibitor of CYP3A and UGT1A1. Coadministration of REYATAZ and drugs primarily metabo...