Daru-Rito

Darunavir 400 mg, ritonavir 50 mg

In combination w/ other antiretroviral medicinal products for HIV-1 infection in adult & paed patients ≥3 yr, & weighing at least 40 kg who are antiretroviral therapy (ART)-naïve, ART-experienced w/ no darunavir resistance associated mutations (DRV-RAMs) & have plasma HIV-1 RNA <100,000 copies/mL & CD4+ cell count ≥100 cells x 10⁶/L.

ART-naïve & ART-experienced adult & ped patient 3-17 yr weighing at least 40 kg w/ no DRV-RAMs & have plasma HIV-1 RNA <100,000 copies/mL & CD4+ cell count ≥100 cells x 10⁶/L 800 mg darunavir & 100 mg ritonavir once daily. All other ART-experienced patients or if HIV-1 genotype testing is not available 600 mg darunavir & 100 mg ritonavir bid.

Should be taken with food: Take w/in 30 min after meal.

Hypersensitivity. Concomitant use w/ lopinavir/ritonavir; strong CYP3A inducers, rifampicin, & herbal prep containing St. John's wort (Hypericum perforatum); alfuzosin; amiodarone, bepridil, dronedarone, quinidine, ranolazine, systemic lidocaine; astemizole, terfenadine; colchicine when used in patients w/ renal &/or hepatic impairment; ergot derivatives (eg, dihydroergotamine, ergometrine, ergotamine, methylergonovine); cisapride; pimozide, quetiapine, sertindole; triazolam, oral midazolam; sildenafil when used for pulmonary arterial HTN, avanafil; simvastatin, lovastatin; ticagrelor. Severe (Child-Pugh class C) hepatic impairment.

Discontinue treatment if signs or symptoms of severe skin reactions develop. DRESS, SJS, TEN, acute generalised exanthematous pustulosis. Known sulphonamide allergy. Consider interruption or discontinuation of treatment if there is evidence of new or worsening liver dysfunction. Once daily dosing in ART-experienced patients should not be used in patients w/ ≥1 DRV-RAMs or HIV-1 RNA ≥100,000 copies/mL or CD4+ cell count <100 cells x 10⁶/L. May continue to develop opportunistic infections & other complications of HIV infection. Increased bleeding including spontaneous skin haematomas & haemarthrosis in patients w/ haemophilia type A & B. Drug-induced hepatitis eg, acute hepatitis, cytolytic hepatitis. Osteonecrosis. Cytomegalovirus retinitis, generalised &/or focal mycobacterial infections & pneumonia caused by Pneumocystis jirovecii; autoimmune disorders eg, Graves' disease. Patients w/ preexisting liver dysfunction including chronic active hepatitis B or C. Patients experiencing joint aches, pain & stiffness or difficulty in movement. Perform regular assessment of virological response. Conduct appropriate lab testing prior to treatment initiation. Consider increased ALT/AST monitoring in patients w/ underlying chronic hepatitis, cirrhosis, or those who have pre-treatment elevations of transaminases, especially during 1st several mth of darunavir used in combination w/ low dose ritonavir treatment. Monitor blood lipids & glucose. Concomitant use w/ cobicistat; efavirenz; colchicine, strong CYP3A inhibitors & P-gp. May affect ability to drive & use machines. Mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment. Not to be used in severe hepatic impairment (Child-Pugh class C). Pregnant women w/ concomitant medications that may further decrease darunavir exposure. Not to breastfeed during treatment. Alternative, effective & safe method of contraception should be used during treatment. Not recommended in paed patients <3 yr or weighing <15 kg. Elderly.

Diarrhoea. Lipodystrophy including lipohypertrophy & lipoatrophy, DM, hypertriglyceridaemia, hypercholesterolaemia, hyperlipidaemia; insomnia; headache, peripheral neuropathy, dizziness; vomiting, nausea, abdominal pain, increased blood amylase, dyspepsia, abdominal distension, flatulence; increased ALT; rash including macular, maculopapular, papular, erythematous & pruritic rash, pruritus; asthenia, fatigue. DRESS, SJS, TEN.

Lowered plasma conc w/ CYP3A inducers. Increased plasma conc w/ CYP3A inhibitors. Increased systemic exposure w/ medicinal products primarily metabolised by CYP3A &/or CYP2D6 or transported by P-gp; medicinal products that are highly dependent on CYP3A for clearance. Enhanced darunavir pharmacokinetic parameters w/ cobicistat. Increased plasma conc of medicinal products primarily metabolised by CYP2D6 eg, flecainide, propafenone, metoprolol; P-gp, OATP1B1 & OATP1B3 substrates eg, dabigatran etexilate, digoxin, statins, bosentan. Decreased systemic exposure to medicinal products primarily metabolised by CYP2C9 (eg, warfarin), CYP2C19 (eg, methadone), CYP2C8 eg, paclitaxel, rosiglitazone, repaglinide.

Antivirals

J05AE - Protease inhibitors ; Used in the systemic treatment of viral infections.

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