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PREZCOBIX
Viral infections
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Drug Name:

PREZCOBIX Rx

Generic Name and Formulations:
Darunavir, cobicistat; 800mg/150mg; tabs.

Company:
Janssen Therapeutics

Therapeutic Use:

Indications for PREZCOBIX:

In combination with other antiretroviral agents for treatment of HIV-1 infection in adults with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M T74P, L76V, I84V, L89V).

Adult:

Take with food. 1 tab daily.

Children:

<18yrs: not established.

Contraindications:

Concomitant alfuzosin, ranolazine, dronedarone, carbamazepine, phenobarbital, phenytoin, colchicine (in renal/hepatic impaired), rifampin, lurasidone, pimozide, ergots, cisapride, St. John's wort, elbasvir/grazoprevir, lovastatin, simvastatin, oral midazolam, triazolam, sildenafil (for PAH).

Warnings/Precautions:

Conduct HIV genotypic testing prior to initiation in antiretroviral treatment-experienced; if not feasible, do not initiate in protease inhibitor-experienced patients. Assess CrCl prior to initiation. Renal impairment: consider alternatives that do not require dose adjustments. Monitor closely if confirmed SCr >0.4mg/dL from baseline. When concomitant tenofovir DF: assess baseline CrCl, urine glucose, urine protein and monitor during treatment; if CrCl <70mL/min: not recommended; monitor serum phosphorus if risk of renal impairment. Hepatic impairment (eg, chronic hepatitis, cirrhosis, pre-treatment elevated transaminases): monitor liver enzymes; interrupt or discontinue therapy if liver dysfunction occurs or worsens. Severe hepatic impairment: not recommended. Sulfonamide allergy. Diabetes (may need insulin or oral hypoglycemics dose adjusted). Hemophilia. Elderly. Pregnancy. Nursing mothers: not recommended.

Interactions:

See Contraindications. Concomitant tenofovir DF with concomitant or recent nephrotoxic agents, darunavir- or cobicistat-containing products, ritonavir, or other antiretrovirals that require PK boosting (eg, another protease inhibitor, elvitegravir), efavirenz, etravirine, nevirapine, apixaban, dabigatran etexilate, rivaroxaban, voriconazole, rifapentine, simeprevir, everolimus, salmeterol, avanafil: not recommended. May need to adjust dose of dasatinib, nilotinib, colchicine, sildenafil, tadalafil, vardenafil, perphenazine, risperidone, thioridazine, buprenorphine, buprenorphine/naloxone, methadone, tramadol, bosentan, rifabutin, and sedatives/hypnotics. Concomitant maraviroc: give maraviroc 150mg twice daily. Concomitant quetiapine: consider alternative antiretrovirals; if necessary, reduce quetiapine to ⅙ of current dose and monitor. Monitor with antiarrhythmics, digoxin, warfarin, clonazepam, SSRIs, TCAs, trazodone, antimalarials (eg, artemether, lumefantrine), antifungals, fentanyl, oxycodone, immunosuppressants, other statins, β-blockers, calcium channel blockers. Concomitant antibacterials (eg, clarithromycin, erythromycin, telithromycin), CYP3A-inducing anticonvulsants that are not contraindicated (eg, eslicarbazepine, oxcarbazepine), corticosteroids: consider alternatives. Concomitant vincristine, vinblastine: consider temporarily withholding cobicistat-containing regimen if significant hematologic or GI adverse events develop. Concomitant hormonal contraceptives: consider additional or alternative (non-hormonal) contraception. Separate dosing of didanosine at least 1hr before or 2hrs after. See full labeling.

Pharmacological Class:

HIV-1 protease inhibitor + CYP3A inhibitor.

Adverse Reactions:

Diarrhea, nausea, rash, headache, abdominal pain, vomiting; severe skin reactions (discontinue if occurs), fat redistribution, immune reconstitution syndrome.

Note:

Register pregnant patients exposed to Prezcobix by calling (800) 258-4263.

Generic Availability:

NO

How Supplied:

Tabs—30

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