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Generic Name and Formulations:
Darunavir (as ethanolate) 75mg, 150mg, 600mg, 800mg; tabs.
Indications for PREZISTA:
Treatment of HIV-1 infection in combination with ritonavir and with other antiretroviral agents.
Take with food. Use oral susp if unable to swallow tabs. ≥18yrs: Treatment-naive or treatment-experienced with no darunavir resistance associated substitutions: 800mg once daily with ritonavir 100mg once daily. Treatment-experienced with at least one darunavir resistance associated substitution or with no baseline resistance information: 600mg twice daily with ritonavir 100mg twice daily. Pregnancy: 600mg twice daily with ritonavir 100mg twice daily; may consider 800mg once daily with ritonavir 100mg once daily only if stable on dose prior to pregnancy and virologically suppressed (HIV-1 RNA <50copies/mL). Severe hepatic impairment: not recommended.
<3yrs: not recommended. Take with food. Use oral susp if unable to swallow tabs. Treatment-naive or treatment-experienced with no darunavir resistance associated substitutions: ≥3yrs to <18yrs: ≥10kg–<11kg: 350mg once daily with ritonavir 64mg once daily; ≥11kg–<12kg: 385mg once daily with ritonavir 64mg once daily; ≥12kg–<13kg: 420mg once daily with ritonavir 80mg once daily; ≥13kg–<14kg: 455mg once daily with ritonavir 80mg once daily; ≥14kg–<15kg: 490mg once daily with ritonavir 96mg once daily; ≥15–<30kg: 600mg once daily with ritonavir 100mg once daily; ≥30kg–<40kg: 675mg once daily with ritonavir 100mg once daily; ≥40kg: 800mg once daily with ritonavir 100mg once daily. Treatment-experienced with at least one darunavir resistance associated substitution: ≥3yrs to <18yrs: ≥10kg–<11kg: 200mg twice daily with ritonavir 32mg twice daily; ≥11kg–<12kg: 220mg twice daily with ritonavir 32mg twice daily; ≥12kg–<13kg: 240mg twice daily with ritonavir 40mg twice daily; ≥13kg–<14kg: 260mg twice daily with ritonavir 40mg twice daily; ≥14kg–<15kg: 280mg twice daily with ritonavir 48mg twice daily; ≥15–<30kg: 375mg twice daily with ritonavir 48 mg twice daily; ≥30kg–<40kg: 450mg twice daily with ritonavir 60mg twice daily; ≥40kg: 600mg twice daily with ritonavir 100mg twice daily. Severe hepatic impairment: not recommended.
Concomitant alfuzosin, ranolazine, dronedarone, colchicine (in renal and/or hepatic impairment), rifampin, lurasidone, pimozide, ergots, cisapride, oral midazolam, triazolam, St. John's wort, elbasvir/grazoprevir, lomitapide, lovastatin, simvastatin, sildenafil (for PAH).
Perform genotypic/phenotypic testing, treatment history in treatment-experienced patients prior to initiation. Sulfonamide allergy. Hepatic impairment (eg, chronic hepatitis, cirrhosis, pre-treatment elevated transaminases): monitor liver enzymes esp. during 1st few months; interrupt or discontinue therapy if liver dysfunction occurs or worsens. Severe renal impairment. Diabetes: may need insulin or oral hypoglycemics dose adjusted. Hemophilia: monitor for spontaneous bleeding. Elderly. Pregnancy. Nursing mothers: not recommended.
See Contraindications. Concomitant voriconazole, salmeterol, boceprevir, simeprevir, apixaban (see full labeling), rivaroxaban, rifapentine, everolimus, avanafil, ticagrelor, protease inhibitors (eg, lopinavir/ritonavir, saquinavir, others): not recommended. Potentiates carbamazepine, antipsychotics (eg, perphenazine, risperidone, thioridazine), TCAs, trazodone, IV midazolam, rifabutin, digoxin, HMG-CoA reductase inhibitors (eg, pravastatin, atorvastatin, rosuvastatin; use lowest dose necessary; max atorvastatin dose is 20mg/day), sildenafil, vardenafil, tadalafil (adjust doses), other sedatives/hypnotics, bosentan (see full labeling), maraviroc (max 150mg twice daily), colchicine (dose adjustments: see full labeling), quetiapine (reduce quetiapine dose by ⅙ or consider alternative antiretrovirals), dasatinib, nilotinib, vinca alkaloids. Potentiates, and is potentiated by, indinavir, ketoconazole, itraconazole; monitor. Antagonizes sertraline, paroxetine, phenytoin, phenobarbital (monitor levels), omeprazole (max 40mg/day). Antagonized by CYP3A-inducing corticosteroids (eg, systemic dexamethasone or others); consider alternatives. Caution with antimalarials (artemether, lumefantrine). Monitor carbamazepine, antiarrhythmics (eg, amiodarone, bepridil, disopyramide, flecainide, systemic lidocaine, mexiletine, propafenone, quinidine), calcium channel blockers, β-blockers, warfarin, digoxin, clonazepam, immunosuppressants (eg, tacrolimus, sirolimus, cyclosporine), fentanyl, oxycodone, tramadol, buprenorphine, buprenorphine/naloxone, methadone. Reduce concomitant clarithromycin dose in renal impairment. 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.
Diarrhea, nausea, vomiting, abdominal pain, headache; skin reactions (may be severe; discontinue if occurs), drug-induced hepatitis, new onset diabetes, hyperglycemia, fat redistribution, immune reconstitution syndrome.
See Norvir entry for more information on ritonavir. To register pregnant patients exposed to darunavir/ritonavir call (800) 258-4263.
Hepatic (CYP3A); 95% protein bound.
Fecal (primary), renal.
Tabs 75mg—480; 150mg—240; 600mg—60; 800mg—30; Oral susp—200mL (w. dosing syringe)