REYATAZ Rx

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REYATAZ

Viral infections
Only 4 drugs may be compared at once

Generic Name and Formulations:

Atazanavir (as sulfate) 150mg, 200mg, 300mg; caps.

Select therapeutic use:

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 (must also give ritonavir): consider giving atazanavir 300mg + tenofovir 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: 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, H2-blockers, or PPIs: give atazanavir with ritonavir.

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 ORAL POWDER

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

REYATAZ 300mg capsules (Qty:30)

appx. price $1488.00