Indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection for patients 3 months and older weighing at least 5 kg.

REYATAZ is not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus.

Use of REYATAZ/ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions.

REYATAZ capsules without ritonavir are not recommended for treatment experienced adult or pediatric patients with prior virologic failure.

Efficacy and safety of REYATAZ with ritonavir when ritonavir is administered in doses greater than 100 mg once daily have not been established. The use of higher ritonavir doses may alter the safety profile of atazanavir (cardiac effects, hyperbilirubinemia) and, therefore, is not recommended.

REYATAZ is not recommended in HIV-treatment-experienced patients with end stage renal disease managed with hemodialysis.

The use of REYATAZ in patients with severe hepatic impairment (Child-Pugh  Class C) is not recommended. The co-administration of REYATAZ with ritonavir in patients with any degree of hepatic impairment is not recommended.

REYATAZ is contraindicated:

• When co-administered with drugs that are highly dependent on CYP3A or UGT1A1 for clearance, and for which elevated plasma concentrations of the interacting drugs are associated with serious and/or life-threatening events 
• When co-administered with drugs that strongly induce CYP3A and may lead to lower exposure and loss of efficacy of REYATAZ 

Most patients taking REYATAZ experience asymptomatic elevations in indirect (unconjugated) bilirubin related to inhibition of UDP-glucuronosyltransferase (UGT).

Alternative antiretroviral therapy to REYATAZ may be considered if jaundice or scleral icterus associated with bilirubin elevations presents cosmetic concerns for patients. Dose reduction of atazanavir is not recommended since long-term efficacy of reduced doses has not been established.

Cases of nephrolithiasis and/or cholelithiasis have been reported during postmarketing surveillance in HIV-infected patients receiving REYATAZ therapy.

New-onset diabetes mellitus, exacerbation of preexisting diabetes mellitus, and hyperglycemia have been reported.

Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and “cushingoid appearance” have been observed in patients receiving antiretroviral therapy.

There have been reports of increased bleeding, including spontaneous skin hematomas and hemarthrosis, in patients with hemophilia type A and B treated with protease inhibitors.

Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including REYATAZ.

Cases of Stevens-Johnson syndrome, erythema multiforme, and toxic skin eruptions, including drug rash,eosinophilia, and systemic symptoms (DRESS) syndrome, have been reported in patients receiving REYATAZ.

REYATAZ is contraindicated with Alfuzosin, Amiodarone (with ritonavir), quinidine (with ritonavir), Rifampin, Irinotecan, Lurasidone (with ritonavir), pimozide, Triazolam, orally administered midazolam, Dihydroergotamine, ergotamine, ergonovine, methylergonovine, Cisapride, Elbasvir/grazoprevir; glecaprevir/pibrentasvir, St. John’s wort (Hypericum perforatum), Lovastatin, simvastatin, lomitapide, Sildenafil when dosed as REVATIO for the treatment of pulmonary arterial hypertension, Indinavir and Nevirapine.

Risk of significant adverse drug-drug interactions between the antipsychotic medication LATUDA (lurasidone hydrochloride) and strong CYP3A4 inhibitors.

REYATAZ has been shown to prolong the PR interval of the electrocardiogram in some patients.

REYATAZ must be administered with ritonavir in pregnant women. Advise pregnant women of the potential risks of lactic acidosis syndrome and hyperbilirubinemia. All infants, including neonates exposed to REYATAZ in utero, should be monitored for the development of severe hyperbilirubinemia during the first few days of life.

Cases of lactic acidosis syndrome, sometimes fatal, and symptomatic hyperlactatemia have occurred in pregnant women using REYATAZ in combination with nucleoside analogues, which are associated with an increased risk of lactic acidosis syndrome.

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.

GoToSource

• Use in patients under the age of 3 months. GoToSource

• Post-exposure prophylaxis. GoToSource

Gastrointestinal upset, rash, hypersensitivity reactions, hyperbilirubinemia (elevated level of the pigment bilirubin), hyperlipidemia (elevated lipid (fat) levels in the blood), lipodystrophy (fat redistribution), acute liver injury, exacerbation of underlying chronic viral hepatitis and jaundice. GoToSource

Use with certain statins increases risk of myopathy (disorder of the skeletal muscles) and rhabdomyolysis (breakdown of muscle tissue). GoToSource

Atrioventricular block and ventricular tachycardia (heart rhythm disorder). GoToSource

Cholelithiasis (gallstones), cholecystitis (gallbladder inflammation) and cholestasis (decrease in bile flow). GoToSource

Toxic skin eruptions (stevens-johnson syndrome and drug rash with eosinophilia and systemic symptoms syndrome). GoToSource

Crystalluria (cloudy urine due to crystals found in the urine), urolithiasis (formation of stones in the urinary tract), chronic kidney disease and interstitial nephritis (swelling between kidney tubules). GoToSource

Kidney stones. GoToSource

No major injury lawsuits reported.