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REYATAZ ORAL POWDER
Viral infections
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Drug Name:

REYATAZ ORAL POWDER Rx

Generic Name and Formulations:
Atazanavir (as sulfate) 50mg; per packet; contains phenylalanine.

Company:
Bristol-Myers Squibb

Therapeutic Use:

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:

Drugs metabolized by CYP3A or UGT1A1 that may cause serious events if blood levels are elevated (eg, alfuzosin, rifampin, irinotecan, oral midazolam, triazolam, ergots, cisapride, St. John's wort, lovastatin, simvastatin, lurasidone (if Reyataz co-administered with ritonavir), pimozide, indinavir, nevirapine, sildenafil [Revatio; when used to treat PAH]).

Warnings/Precautions:

Cardiac conduction abnormalities. ESRD with hemodialysis in therapy-experienced or severe hepatic impairment: not recommended. Hepatic impairment. Hepatitis B and/or C or marked elevations in transaminases: monitor liver function tests before and during therapy. Consider alternative antivirals if jaundice, scleral icterus, or lactic acidosis occurs. Diabetes. Monitor for nephrolithiasis, hyperglycemia, fat redistribution, immune reconstitution syndrome, and hemophiliacs for spontaneous bleeding. Elderly. Pregnancy. Nursing mothers: not recommended.

Interactions:

See Contraindications. Concomitant other protease inhibitors (excluding ritonavir and saquinavir), salmeterol, or fluticasone (atazanavir + ritonavir): not recommended. Caution with drugs metabolized by UGT1A1 or CYP3A (eg, IV midazolam, calcium channel blockers, statins [eg, atorvastatin, rosuvastatin; use lowest dose necessary; max rosuvastatin dose is 10mg/day], immunosuppressants, PDE5 inhibitors: reduce doses of these to treat ED; max 25mg sildenafil in 48hrs; max 2.5mg vardenafil in 24hrs or 72hrs [atazanavir + ritonavir]; max 10mg tadalafil in 72hrs; tadalafil to treat PAH [see full labeling]), and CYP2C8 (eg, paclitaxel, repaglinide). Potentiated by CYP3A inhibitors, telaprevir. Antagonized by CYP3A inducers. Use cautiously and monitor diltiazem, antiarrhythmics, others that affect conduction (esp. if metabolized by CYP3A). Consider reducing diltiazem or clarithromycin dose by 50%; rifabutin dose by 75%. Variable effects on clarithromycin; consider other drugs. Plasma levels decreased by drugs that reduce gastric acidity (eg, H2-blockers, antacids). Give proton pump inhibitors 12hrs before atazanavir + ritonavir; avoid in therapy-experienced. Give 2hrs before or 1hr after buffered or enteric coated didanosine. Antagonized by efavirenz, bosentan, tenofovir (see dose). Increased risk of lactic acidosis with nucleoside analogues. Potentiates saquinavir, trazodone, fluticasone, oral contraceptives, ketoconazole, itraconazole, buprenorphine (reduce dose), colchicine (esp. renal or hepatic impaired; do not use), quetiapine (if co-administration needed, reduce quetiapine dose to 1/6 of current dose), lurasidone. Monitor warfarin, tricyclics, rifabutin, immunosuppressants.

See Also:

REYATAZ

Pharmacological Class:

HIV-1 protease inhibitor.

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, lab abnormalities, hyperglycemia, fat redistribution, immune reconstitution syndrome, hyperbilirubinemia, nephrolithiasis, 2nd- or 3rd-degree AV block, QT prolongation. 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

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