Viral infections:

Indications for REYATAZ ORAL POWDER:

HIV-1 infection, in combination with other antiretroviral agents.

Adult:

Use other form.

Children:

See full labeling. Mix with food (eg, applesauce, yogurt) or beverage (eg, milk, infant formula, water). <3mos (<5kg): not recommended. ≥3mos (5 to <15kg): atazanavir 200mg (4 packets) + ritonavir oral solution 80mg; (15 to <25kg): atazanavir 250mg (5 packets) + ritonavir oral solution 80mg; (≥25kg who are unable to swallow caps): atazanavir 300mg (6 packets) + ritonavir oral solution 100mg; all: single daily dose.

Contraindications:

Concomitant alfuzosin, amiodarone (with ritonavir), rifampin, irinotecan, lurasidone (with ritonavir), pimozide, quinidine (with ritonavir), triazolam, oral midazolam, ergots, cisapride, elbasvir/grazoprevir, glecaprevir/pibrentasvir, St. John's wort, lomitapide, lovastatin, simvastatin, sildenafil (for PAH), indinavir, nevirapine.

Warnings/Precautions:

Cardiac conduction abnormalities; consider ECG monitoring if preexisting marked 1st-degree AV block or 2nd/3rd-degree AV block. Preexisting or at high risk for renal disease: consider alternatives. Assess CrCl, SCr, urinalysis with microscopic exam prior to initiation and during therapy; consider discontinuing if progressive kidney disease develops. ESRD with hemodialysis in treatment-experienced or severe hepatic impairment: not recommended. Liver disease, hepatitis B and/or C, marked elevations in transaminases: monitor LFTs before and during therapy. Consider interruption or discontinuation if nephrolithiasis or cholelithiasis occurs. Consider alternative if jaundice or scleral icterus occurs. Diabetes. Hemophilia. Fat redistribution. Immune reconstitution syndrome. Oral pwd: phenylketonuria. Elderly. Pregnancy: see full labeling. Nursing mothers: not recommended.

See Also:

Pharmacologic Class:

HIV-1 protease inhibitor.

Interactions:

See Contraindications. Concomitant other protease inhibitors (excluding ritonavir and saquinavir), sofosbuvir/velpatasvir/voxilaprevir, colchicine (in those with renal or hepatic impairment), salmeterol: not recommended. Avoid atazanavir + ritonavir with boceprevir, fluticasone, rivaroxaban, voriconazole. Concomitant paclitaxel, repaglinide, carbamazepine, phenytoin, phenobarbital, bosentan, or buprenorphine without ritonavir: not recommended. Caution with UGT1A1 or CYP3A substrates (eg, IV midazolam, CCBs, statins [eg, atorvastatin, rosuvastatin (max 10mg/day); use lowest dose necessary], PDE5 inhibitors: reduce doses of these to treat ED; max 25mg sildenafil in 48hrs; max 2.5mg vardenafil in 24hrs [atazanavir] or 72hrs [atazanavir + ritonavir]; max 10mg tadalafil in 72hrs; tadalafil to treat PAH [see full labeling]). May be antagonized by CYP3A inducers. Consider reducing diltiazem or clarithromycin dose by 50%; rifabutin dose by 75%. Antagonized by H2-blockers (see full labeling). Give PPIs 12hrs before atazanavir + ritonavir; avoid in therapy-experienced. Give 2hrs before or 1hr after antacids, didanosine buffered formulations. Antagonized by efavirenz, bosentan, tenofovir DF (see dose). Potentiates saquinavir, tenofovir DF, trazodone (caution), fluticasone, ketoconazole, itraconazole, buprenorphine (reduce dose), quetiapine (if co-administration needed, reduce quetiapine dose to 1/6 of current dose). Atazanavir + ritonavir may potentiate direct-acting oral anticoagulants (eg, betrixaban, dabigatran, edoxaban). Caution with oral contraceptives (eg, ethinyl estradiol + norgestimate or norethindrone). Concomitant other hormonal contraceptives (eg, patches, vaginal rings, injectables, other progestogen-containing products, or <25mcg ethinyl estradiol): use alternative methods. Monitor with antiarrhythmics, warfarin, tricyclics, rifabutin, apixaban, rivaroxaban, immunosuppressants. See full labeling.

Adverse Reactions:

Nausea, vomiting, diarrhea, abdominal pain, jaundice, scleral icterus, rash (may be severe; discontinue if occurs), headache, insomnia, peripheral neuropathy, dizziness, myalgia, depression, fever; hyperglycemia, hyperbilirubinemia, chronic kidney disease, 2nd- or 3rd-degree AV block. Children: also cough, peripheral edema, extremity pain, nasal congestion, oropharyngeal pain, wheezing, rhinorrhea.

Note:

Register pregnant patients exposed to atazanavir by calling (800) 258-4263. See Norvir entry in this section for more information on ritonavir.

How Supplied:

Caps 150mg, 200mg—60; 300mg—30; Oral powder—30