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Prezista Oral Suspension Generic Name & Formulations
Legal Class
Rx
General Description
Darunavir (as ethanolate) 100mg/mL; strawberry-cream flavor.
Pharmacological Class
Protease inhibitor.
See Also
How Supplied
Tabs 75mg—480; 150mg—240; 600mg—60; 800mg—30; Oral susp—200mL (w. dosing syringe)
Manufacturer
Generic Availability
NO
Prezista Oral Suspension Indications
Indications
HIV-1 infection in combination with ritonavir and with other antiretroviral agents.
Prezista Oral Suspension Dosage and Administration
Adult
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.
Children
<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.
Prezista Oral Suspension Contraindications
Contraindications
Concomitant drugs that are highly dependent on CYP3A for clearance and for which elevated plasma levels are associated with serious and/or life-threatening events (narrow therapeutic index) (eg, alfuzosin, colchicine [in renal and/or hepatic impairment], dronedarone, ivabradine, ranolazine, rifampin, lurasidone, pimozide, ergots, cisapride, oral midazolam, triazolam, St. John's wort, elbasvir/grazoprevir, lomitapide, lovastatin, simvastatin, naloxegol, sildenafil [for PAH]).
Prezista Oral Suspension Boxed Warnings
Not Applicable
Prezista Oral Suspension Warnings/Precautions
Warnings/Precautions
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. Elderly. Pregnancy. Nursing mothers: not recommended.
Prezista Oral Suspension Pharmacokinetics
See Literature
Prezista Oral Suspension Interactions
Interactions
See Contraindications. Concomitant voriconazole, salmeterol, boceprevir, glecaprevir/pibrentasvir, simeprevir, apixaban (see full labeling), rivaroxaban, rifapentine, everolimus, irinotecan (unless no alternatives), avanafil, ticagrelor, clopidogrel, 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, fesoterodine (max 4mg/day), solifenacin (max 5mg/day), corticosteroids (consider alternatives [eg, beclomethasone, prednisone, prednisolone] for long-term use). Potentiates, and is potentiated by, indinavir, ketoconazole, itraconazole, isavuconazole; 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.
Prezista Oral Suspension Adverse Reactions
Adverse Reactions
Diarrhea, headache, abdominal pain, rash, nausea, vomiting; skin reactions (may be severe; discontinue if occurs), drug-induced hepatitis, new onset diabetes, hyperglycemia, fat redistribution, immune reconstitution syndrome.
Prezista Oral Suspension Clinical Trials
See Literature
Prezista Oral Suspension Note
Notes
See Norvir entry for more information on ritonavir. To register pregnant patients exposed to darunavir/ritonavir call (800) 258-4263.
Prezista Oral Suspension Patient Counseling
See Literature
