Residual risk of HIV transmission. High risk of abacavir hypersensitivity reactions (HSR) in patients +ve for HLA-B*5701 allele. Do not initiate treatment in patients w/ +ve HLA-B*5701 status, nor in patients w/ -ve HLA-B*5701 status who had a suspected abacavir HSR on a previous abacavir-containing regimen. Discontinue treatment if HSR is suspected. Increases in wt & in levels of blood lipids & glucose may occur during antiretroviral therapy. Increased risk of severe & potentially fatal hepatic adverse reactions in patients w/ chronic hepatitis B or C treated w/ combination antiretroviral therapy (CART). Periodic monitoring of both LFTs & markers of HBV replication is recommended if discontinuing treatment in patients co-infected w/ HBV. Risk of immune reactivation syndrome. Monitor liver chemistries in patients w/ hepatitis B &/or C co-infection. Reports of mitochondrial dysfunction in HIV -ve infants exposed
in utero &/or post-natally to nucleoside analogues. Risk of MI. Reports of osteonecrosis particularly in patients w/ advanced HIV disease &/or long-term exposure to CART. Opportunistic infections & other complications of HIV infection may still develop. Not recommended for patients w/ integrase inhibitor resistance. Not recommended for patients taking etravirine (w/o boosted PIs), efavirenz, nevirapine, rifampicin, tipranavir/ritonavir, carbamazepine, phenytoin, phenobarb or St. John's wort. Do not co-administer w/ polyvalent cation-containing antacids. Administer Triumeq 2 hr before or 6 hr after polyvalent cation-containing antacids; Ca-, Fe-, or Mg-containing supplements/multivit. Monitor renal function when co-administered w/ metformin; combination may increase risk for lactic acidosis in patients w/ moderate renal impairment. Combination of lamivudine w/ cladribine is not recommended. Do not take w/ any other medicinal products containing dolutegravir, abacavir, lamivudine or emtricitabine. May impair ability to drive or operate machinery. Not recommended in patients w/ CrCl <50 mL/min, or in patients w/ moderate or severe hepatic impairment. Close monitoring is required in patients w/ mild hepatic impairment (Child-Pugh score 5-6). Potential risk of neural tube defects w/ dolutegravir. Pregnancy. HIV-infected women should not breast-feed to avoid HIV transmission. Special care in elderly ≥65 yr due to age-associated changes. Safety & efficacy in childn <12 yr have not yet been established.
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