Concise Prescribing Info
HIV-1 infection, co-administered w/ low dose ritonavir, & in combination w/ other antiretroviral drugs, in anti-retroviral treatment (ART)-experienced adults including those that have been highly pre-treated & ped patients 3 yr & at least 15 kg.
Dosage/Direction for Use
Always give w/ low dose ritonavir & in combination w/ other antiretroviral drugs. ART-experienced adult 600 mg bid w/ 100 mg ritonavir bid. Patients w/ prior exposure to antiretrovirals but w/o darunavir resistance associated mutations & who have plasma HIV-1 RNA <100,000 copies/mL & CD4+ cell count ≥100 cells x 106/L 800 mg once daily w/ cobicistat 150 mg once daily or ritonavir 100 mg once daily. ART-naïve adult 800 mg once daily w/ cobicistat 150 mg once daily or ritonavir 100 mg once daily. ART-naïve paed patients (3-17 yr) weighing ≥40 kg 800 mg darunavir w/ 100 mg ritonavir once daily, ≥30 to <40 kg 675 mg darunavir w/ 100 mg ritonavir once daily, ≥15 to <30 kg 600 mg darunavir w/ 100 mg ritonavir once daily. ART-experienced paed patients (3-17 yr) weighing ≥40 kg 800 mg darunavir w/ 100 mg ritonavir once daily, or 600 mg darunavir w/ 100 mg ritonavir bid, ≥30 to <40 kg 675 mg darunavir w/ 100 mg ritonavir once daily, or 450 mg darunavir w/ 60 mg ritonavir bid, ≥15  to <30 kg 600 mg darunavir w/ 100 mg ritonavir once daily, or 375 mg darunavir w/ 50 mg ritonavir bid.
Should be taken with food.
Hypersensitivity. Severe (Child-Pugh Class C) hepatic impairment. Concomitant use w/ rifampicin, lopinavir/ritonavir, herbal prep containing St. John's wort (Hypericum perforatum), active substances that are highly dependent on CYP3A for clearance & for which elevated plasma conc are associated w/ serious &/or life-threatening events [eg, alfuzosin, amiodarone, bepridil, dronedarone, quinidine, ranolazine, astemizole, terfenadine, colchicine when used in patients w/ renal &/or hepatic impairment; ergot derivatives (eg, dihydroergotamine, ergometrine, ergotamine, methylergonovine), elbasvir/grazoprevir, cisapride, lurasidone, pimozide, quetiapine, sertindole, triazolam, midazolam, sildenafil, avanafil, simvastatin, lovastatin & lomitapide, ticagrelor].
Special Precautions
Known sulphonamide allergy; discontinue use if signs & symptoms of severe skin reactions develop. Combination w/ optimised background regimen other than ≥2 NRTIs in ART-experienced patients. Patients w/ preexisting liver dysfunction, including chronic hepatitis B or C, or have an increased risk for liver function abnormalities including severe & potentially fatal hepatic adverse reactions. Conduct appropriate laboratory testing prior to initiating therapy & monitor patients during treatment. Consider increased AST/ALT monitoring in patients w/ underlying chronic hepatitis, cirrhosis, or in patients who have pre-treatment elevations of transaminases, especially during the 1st several mth of treatment; interrupt or discontinue treatment if evidence or worsening liver dysfunction occurs. Increased wt, blood lipid levels & glucose may occur during therapy. Osteonecrosis. Immune reconstitution inflammatory syndrome. Concomitant use w/ colchicine & strong CYP3A & P-gp inhibitors. Hemophiliac patients. Mild or moderate hepatic impairment. May affect ability to drive or operate machinery. Pregnancy & lactation. Paed patients <3 yr or weighing <15 kg. Elderly ≥65 yr
Adverse Reactions
Diarrhoea. DM, hypertriglyceridaemia, hypercholesterolaemia, hyperlipidaemia; insomnia; headache, peripheral neuropathy, dizziness; vomiting, nausea, abdominal pain, increased blood amylase, dyspepsia, abdominal distension, flatulence; increased alanine aminotransferase, rash (including macular, maculopapular, papular, erythematous & pruritic rash), pruritus; asthenia, fatigue.
Drug Interactions
Increase AUC, Cmin, Cmax of tenofovir disoproxil, simeprevir. Decreased AUC, Cmin, Cmax w/ efavirenz, saquinavir, boceprevir. Increased AUC, Cmin, Cmax w/ indinavir, clarithromycin. Decrease exposure w/ lopinavir/ritonavir combination. Increase plasma conc of alfuzosin; disopyramide, flecainide, lidocaine, mexiletine, propafenone, amiodarone, bepridil, dronedarone, quinidine, ranolazine; fluconazole, isavuconazole, itraconazole, posaconazole; clotrimazole; dasatinib, nilotinib, vinblastine, vincristine, everolimus; quetiapine, perphenazine, risperidone, thioridazine, lurasidone, pimozide, sertindole; carvedilol, metoprolol, timolol; amlodipine, diltiazem, felodipine, nicardipine, nifedipine, verapamil; bosentan; lovastatin, simvastatin; salmeterol; fentanyl, oxycodone, tramadol; sildenafil & tadalafil (for treatment of pulmonary arterial HTN). Increase conc of apixaban, dabigatran etexilate, rivaroxaban, paroxetine, sertraline, amitriptyline, desipramine, imipramine, nortriptyline, trazodone; buspirone, clorazepate, diazepam, estazolam, flurazepam, midazolam (parenteral), zolpidem, midazolam, triazolam. May affect conc of warfarin. Decreased plasma conc w/ phenobarb & phenytoin; dexamethasone (systemic); St. John's wort. Increase conc of clonazepam. Ritonavir may decrease plasma conc of voriconazole. Increased exposure of colchicine, lumefantrine, ticagrelor, grazoprevir, lomitapide, ciclosporin, sirolimus, tacrolimus, everolimus. Decreased conc w/ rifampicin, rifapentine. Increased systemic exposure w/ rifabutin. May increase risk of development of systemic corticosteroid effects including Cushing’s syndrome & adrenal suppression w/ corticosteroids primarily metabolized by CYP3A (including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone). Avanafil, sildenafil, tadalafil, vardenafil.
MIMS Class
ATC Classification
J05AE10 - darunavir ; Belongs to the class of protease inhibitors. Used in the systemic treatment of viral infections.
Darutab FC tab 600 mg
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