Viral infections:
Indications for: PREZCOBIX
In combination with other antiretroviral agents for treatment of HIV-1 infection in patients weighing ≥40kg with no darunavir resistance-associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V).
Adults and Children:
<40kg: not established. ≥40kg: Take with food. 1 tab daily.
PREZCOBIX Contraindications:
Concomitant drugs that are highly dependent on CYP3A for clearance and for which altered plasma levels are associated with serious and/or life-threatening events (narrow therapeutic index) or loss of therapeutic effect (eg, alfuzosin, colchicine [in renal/hepatic impaired], dronedarone, ivabradine, ranolazine, carbamazepine, phenobarbital, phenytoin, rifampin, lurasidone, pimozide, ergots, cisapride, St. John's wort, elbasvir/grazoprevir, lomitapide, lovastatin, simvastatin, oral midazolam, triazolam, naloxegol, sildenafil [for PAH]).
PREZCOBIX 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 (monitor). Diabetes (may need insulin or oral hypoglycemics dose adjusted). Hemophilia. Elderly. Pregnancy (use alternatives), nursing mothers: not recommended.
PREZCOBIX Classification:
HIV-1 protease inhibitor + CYP3A inhibitor.
PREZCOBIX 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 (see full labeling), rivaroxaban, voriconazole, rifapentine, glecaprevir/pibrentasvir, simeprevir, everolimus, irinotecan (unless no alternatives), salmeterol, avanafil, ticagrelor, clopidogrel: not recommended. May need to adjust dose of dasatinib, nilotinib, colchicine, sildenafil, tadalafil, vardenafil, perphenazine, risperidone, thioridazine, buprenorphine, buprenorphine/naloxone, methadone, tramadol, bosentan, rifabutin (give 150mg every other day), and other sedatives/hypnotics. Concomitant maraviroc (give 150mg twice daily), fesoterodine (max 4mg/day), solifenacin (max 5mg/day). Concomitant quetiapine: consider alternative antiretrovirals or reduce quetiapine to ⅙ of current dose; monitor. Monitor with antiarrhythmics, digoxin, dabigatran, edoxaban, warfarin, clonazepam, SSRIs, TCAs, trazodone, antimalarials (eg, artemether, lumefantrine), itraconazole (max 200mg/day), ketoconazole (max 200mg/day), isavuconazole, posaconazole, fentanyl, oxycodone, immunosuppressants, β-blockers, calcium channel blockers. Concomitant other statins (eg, atorvastatin (max 20mg/day), fluvastatin, pitavastatin, pravastatin, rosuvastatin (max 20mg/day): start at low dose, titrate and monitor. Concomitant antibacterials (eg, clarithromycin, erythromycin, telithromycin), CYP3A-inducing anticonvulsants that are not contraindicated (eg, eslicarbazepine, oxcarbazepine): consider alternatives. Potentiate corticosteroids; consider alternatives (eg, beclomethasone, prednisone, prednisolone) for long-term use. Antagonized by CYP3A-inducing corticosteroids (eg, systemic dexamethasone or others); consider alternatives. Concomitant vincristine, vinblastine: consider temporarily withholding cobicistat-containing regimen if significant hematologic or GI adverse events develop. Concomitant hormonal contraceptives (eg, drosperinone): monitor for hyperkalemia; estrogen-containing contraceptives: consider additional or alternative (non-hormonal) contraception. Separate dosing of didanosine at least 1hr before or 2hrs after. See full labeling.
Adverse Reactions:
Diarrhea, nausea, rash, headache, abdominal pain, vomiting; severe skin reactions (discontinue if occurs), fat redistribution, immune reconstitution syndrome.
Note:
To register pregnant patients exposed to Prezcobix, call (800) 258-4263.
Generic Drug Availability:
NO
How Supplied:
Tabs—30
