Durart

Durart

darunavir

Manufacturer:

Viatris

Distributor:

Atlanta Medicare

Marketer:

Atlanta Medicare
Concise Prescribing Info
Contents
Darunavir
Indications/Uses
In combination w/ low dose ritonavir & other antiretrovirals for HIV infection in adults, & HIV-1 infection in treatment-experienced ped patients weighing ≥40 kg.
Dosage/Direction for Use
Antiretroviral treatment-naive adult 800 mg darunavir once daily w/ 100 mg ritonavir. Antiretroviral treatment-experienced adult No darunavir resistance associated mutation: 800 mg darunavir once daily w/ 100 mg ritonavir. W/ at least 1 darunavir resistance associated mutation: 600 mg darunavir bid w/ 100 mg ritonavir. Antiretroviral treatment-experienced ped patient weighing ≥40 kg 600 mg darunavir w/ 100 mg ritonavir bid.
Administration
Should be taken with food.
Contraindications
Hypersensitivity. Concomitant use w/ drugs highly dependent on CYP3A for clearance & for which increased plasma conc are associated w/ narrow therapeutic index eg, alfuzosin, astemizole, cisapride, colchicine (in patients w/ renal &/or hepatic impairment), dronedarone, elbasavir/grazoprevir, ergot alkaloids (eg, ergotamine, dihydroergotamine, ergonovine & methylergonovine), lomitapride, lovastatin, lurasidone, oral midazolam, pimozide, ranolazine, sildenafil (when used for treatment of pulmonary arterial HTN), simvastatin, terfenadine & triazolam. Drugs containing rifampicin or St. John's wort.
Special Precautions
Not for cure for HIV & not proven for prevention of HIV transmission. Immediately discontinue treatment if signs & symptoms of severe skin reactions develop. Patients w/ a known sulphonamide allergy. Severe hepatic impairment. Patients w/ preexisting liver dysfunction, including chronic active hepatitis B or C. Perform appropriate laboratory testing prior to initiation of therapy & monitor patients during treatment. Consider increased AST/ALT monitoring in patients w/ underlying chronic hepatitis, cirrhosis, or who have pre-treatment elevations of transaminases. Prompt consideration of interruption or discontinuation of treatment in evidence of new or worsening liver dysfunction. Hemophiliac patients. New onset DM, hyperglycemia, or exacerbation of existing DM. Risk of lipodystrophy. Evaluate patients for physical signs of fat redistribution. Measure fasting serum lipids & blood glucose. Immune reconstitution inflammatory syndrome. Concomitant use w/ drugs metabolized by CYP3A, CYP2D6 or transported by P-gp, & CYP3A inhibitors. Severe hepatic impairment. May affect ability to drive or operate machinery. Pregnancy & lactation. Childn <3 yr. Elderly ≥65 yr.
Adverse Reactions
Diarrhea, headache & abdominal pain. Abdominal pain, acute pancreatitis, dyspepsia, flatulence, nausea; angioedema, lipodystrophy, pruritus, rash, Stevens-Johnson syndrome, urticaria; myalgia, osteonecrosis; anorexia, DM, asthenia, fatigue; hypersensitivity, immune reconstitution inflammatory syndrome; acute hepatitis; abnormal dreams; gynecomastia. Toxic epidermal necrolysis, acute generalized exanthematous pustulosis.
Drug Interactions
Concomitant use w/ other antiretrovirals that also require pharmacokinetic boosting w/ ritonavir; drugs primarily metabolized by CPY3A, CYP2D6 or by transported by P-gp; elvitegravir. Increase systemic exposure of tenofovir. Increased conc w/ delavirdine. Decreased exposure of etravirine. Increased systemic exposure w/ ritonavir & rifabutin. May increase plasma conc w/ antifungals eg, itraconazole, ketoconazole, posaconazole & voriconazole. Increased exposure w/ indinavir. May increase conc w/ clotrimazole & fluconazole. Decreased exposure w/ lopinavir/ritonavir, saquinavir; rifampin & rifapentin; systemic dexamethasone. May increase exposure of maraviroc, alfuzosin, ranolazine, antiarrhythmics (eg, amiodarone, bepridil, disopyramide, dronedarone, flecainide, mexiletine, propafenone, systemic lidocaine & quinidine); clarithromycin; colchicine; astemizole, terfenadine; lumefantrine; lurasidone, pimozide, risperidone, thioridazine, ergot alkaloids (eg, ergotamine, ergonovine, dihydroergotamine, methylergonovine); cisapride; grazoprevir; quetiapine, lomitapide; immunosuppressants eg, cyclosporin, everolimus, sirolimus, tacrolimus; buprenorphine/naloxone. Increased AUClast of digoxin. May increase conc of neuroleptic w/ perphenazine. May increase conc of clonazepam; anticoagulants eg, apixaban, dabigatran etexilate, rivaroxaban; antidepressants eg, amitriptyline, desipramine, imipramine, nortriptyline & trazodone; β-blockers eg, carvedilol, metoprolol, timolol; Ca-channel blockers eg, amlodipine, diltiazem, felodipine, nicardipine, nifedipine, verapamil; clonazepam, antineoplastics eg, dasatinib, everolimus, nilotinib, vinblastine, vincristine; corticosteroids; bosentan; simeprevir; HMG-CoA reductase inhibitors eg, atorvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin; fentanyl, oxycodone, tramadol; ticagrelor; sedatives/hypnotics (buspirone, clorazepate, diazepam, estazolam, flurazepam, midazolam, triazolam). May affect conc of warfarin. Decrease systemic exposure of ethinylestradiol & norethindrone. May increase plasma conc of corticosteroids (betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone). May decrease plasma conc w/ phenobarb & phenytoin; St. John's wort. Decrease exposure of paroxetine, sertraline; boceprevir, telaprevir. May increase risk of CV adverse events w/ salmeterol. Decrease AUC of methadone. PDE-5 inhibitors eg, avanafil, sildenafil, tadalafil, vardenafil.
MIMS Class
Antivirals
ATC Classification
J05AE10 - darunavir ; Belongs to the class of protease inhibitors. Used in the systemic treatment of viral infections.
Presentation/Packing
Form
Durart FC tab 600 mg
Packing/Price
60's
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