Viral infections:

Indications for REYATAZ:

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

Adult:

See full labeling. Take with food. Treatment-naive: atazanavir 300mg + ritonavir 100mg, both once daily; or atazanavir 400mg once daily if unable to tolerate ritonavir. Treatment-experienced: atazanavir 300mg + ritonavir 100mg; both once daily. Concomitant efavirenz (must also give ritonavir; not for treatment-experienced): atazanavir 400mg + ritonavir 100mg (both as a single daily dose) + efavirenz 600mg (on an empty stomach at bedtime). Concomitant tenofovir DF (must also give ritonavir): consider giving atazanavir 300mg + tenofovir DF 300mg + ritonavir 100mg; all as a single daily dose; see full labeling. Concomitant H2-blockers or PPIs: see full labeling. ESRD with hemodialysis in treatment-naive: atazanavir 300mg + ritonavir 100mg. Hepatic impairment in treatment-naive: (mild): 400mg once daily; (moderate): 300mg once daily; (severe): not recommended. Pregnancy (2nd or 3rd trimester) in treatment-experienced plus concomitant H2-blocker or tenofovir DF: atazanavir 400mg + ritonavir 100mg, both once daily. All other pregnant patients: no dose adjustments needed. Postpartum period: no dose adjustments needed; monitor for adverse events during first 2 months after delivery.

Children:

See full labeling. Take with food. <6yrs: not recommended. 6–18yrs (15 to <35kg): atazanavir 200mg + ritonavir 100mg; ≥35kg: atazanavir 300mg + ritonavir 100mg; all: single daily dose. Treatment-naive: ≥13yrs and ≥40kg who are unable to tolerate ritonavir: atazanavir 400mg once daily. For patients ≥13yrs and ≥40kg receiving concomitant tenofovir DF, H2-blockers, or PPIs: give atazanavir with ritonavir.

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.

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

Pricing for REYATAZ

300mg capsule (Qty: 30)
Appx. price $178
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