HIV-1-infected patient w/o resistance to the integrase class (documented or clinically suspected) 50 mg once daily. Administer bd in this population when co-administered w/ other medicines (eg, efavirenz, nevirapine, tipranavir/ritonavir, or rifampicin). HIV-1-infected patient w/ resistance to the integrase class (documented or clinically suspected) 50 mg bd. HIV-1-infected adolescent (12 to <18 yr & weighing at least 40 kg) w/o resistance to the integrase class 50 mg once daily.
View Tivicay overdosage for action to be taken in the event of an overdose.
Administration
May be taken with or without food.. HIV-infected patients w/ resistance to the integrase class (particularly in patients w/ Q148 mutations): Should be taken with food.
Contraindications
Hypersensitivity. Co-administration w/ medicinal products w/ narrow therapeutic windows that are substrates of organic cation transporter 2 (OCT2), including but not limited to fampridine (also known as dalfampridine).
Residual risk of HIV transmission. Presence of integrase class resistance. Discontinue immediately if signs or symptoms of hypersensitivity reactions develop. Risk of immune reactivation syndrome. Monitor liver biochemistries in patients w/ hepatitis B &/or C co-infection. Opportunistic infections & other complications of HIV infection may still develop. Reports of osteonecrosis in patients w/ advanced HIV disease &/or long-term exposure to CART. Increases in wt & in levels of blood lipids & glucose may occur during antiretroviral therapy. Factors that decrease dolutegravir exposure should be avoided in the presence of integrase class resistance, including co-administration w/ medicinal products that reduce dolutegravir exposure. Monitor renal function when co-administered w/ metformin; combination may increase risk for lactic acidosis in patients w/ moderate renal impairment. Dolutegravir 50 mg once daily + lamivudine 300 mg once daily drug regimen is only suitable for the treatment of HIV-1 infection where there is no known or suspected resistance to the integrase inhibitor class, or to lamivudine. Contains <1 mmol Na (23 mg) per tab (essentially Na-free). May affect ability to drive or operate machinery. Patients w/ severe hepatic impairment (Child-Pugh grade C). Potential risk of neural tube defects. Pregnancy. HIV-infected women should not breast-feed to avoid HIV transmission. Safety & efficacy have not yet been established in childn <12 yr or weighing <40 kg.
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