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 10
6/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.