Dovato

Dolutegravir 50 mg, lamivudine 300 mg

HIV infection in adults & adolescents from 12 yr weighing at least 40 kg w/ no known or suspected resistance to either antiretroviral component.

Adult & adolescent weighing at least 40 kg 1 tab once daily.

May be taken with or without food.

Hypersensitivity. Not to be administered concurrently w/ medicinal products w/ narrow therapeutic windows that are substrates of organic cation transporter 2 (OCT2) eg, dofetilide, pilsicainide or fampridine.

Discontinue immediately if signs or symptoms of hypersensitivity reactions develop. Suspend treatment in patient who develops clinical or lab findings suggestive of lactic acidosis w/ or w/o hepatitis. Lactic acidosis & severe hepatomegaly w/ steatosis. Inflammatory reaction to asymptomatic or residual opportunistic infections in HIV-infected patients w/ severe immune deficiency at the time of therapy initiation. Autoimmune disorders eg, Graves' disease, polymyositis & Guillain-Barre syndrome. Opportunistic infections & other HIV infection complications. Residual risk of sexual transmission. Hepatitis B co-infected patients; patients w/ chronic HBV disease. Not recommended in patients w/ integrase inhibitor resistance. Monitor clinical status including liver aminotransferases; liver chemistries in patients w/ hepatitis B &/or C co-infection. Periodically monitor LFTs & markers of HBV replication. Concomitant use w/ medications reducing dolutegravir & lamivudine exposure, or may have their exposure changed by the treatment. Not to be coadministered w/ polyvalent cation-containing antacids. Administer 2 hr before or 6 hr after taking polyvalent cation-containing antacids; Ca or Fe supplements. Consider dose adjustment of metformin prior to initiation, or upon discontinuation of treatment. Not to be co-administered w/ polyvalent cation-containing antacids. Administer 2 hr before or 6 hr after taking polyvalent cation-containing antacids; Ca or Fe supplements or alternatively administer w/ food. Increased metformin conc. Not recommended in patients w/ integrase inhibitor resistance. Not recommended in patients w/ CrCl <30 mL/min. Patients w/ known risk factors for liver disease; w/ severe hepatic impairment (Child-Pugh grade C). Women of childbearing potential should be informed about the risk of neural tube defects w/ dolutegravir & use effective contraception. Conduct pregnancy testing prior to initiation of treatment. Pregnancy. Not to breastfeed infants to avoid HIV transmission. Mild, transient elevations in serum lactate levels due to mitochondrial dysfunction in neonates & infants exposed in utero &/or peri-partum to NRTIs. Not recommended in childn <12 yr.

Headache; nausea, diarrhoea, vomiting, upper abdominal pain; rash; fatigue. Dolutegravir: Suicidal ideation (particularly in patients w/ pre-existing history of depression or psychiatric illness), depression, anxiety, insomnia, abnormal dreams; dizziness; flatulence, abdominal pain & discomfort; pruritus. Lamivudine: Malaise, fever. Hyperlactataemia; alopecia; arthralgia, muscle disorders.

Dolutegravir: Increased plasma conc of drugs in which excretion is dependent upon OCT2 &/or MATE1 eg, dofetilide, pilsicainide, fampridine or metformin. Decreased plasma conc w/ UGT1A1, UGT1A3, UGT1A9, CYP3A4, P-gp inducers &/or BCRP; rifampicin, carbamazepine, phenytoin, phenobarb, St. John's wort, etravirine (w/o boosted PIs), efavirenz, nevirapine or tipranavir/ritonavir; fosamprenavir/ritonavir; antacids containing polyvalent cations (eg, Mg, Al); Ca & Fe supplements. Increased plasma conc w/ UGT1A1, UGT1A3, UGT1A9, CYP3A4 &/or P-gp inhibitors; atazanavir; atazanavir/ritonavir. Increased dofetilide or pilsicainide, fampridine plasma conc. Lamivudine: Inhibited intracellular phosphorylation of emtricitabine. Concomitant use w/ sorbitol-containing medicines.

Antivirals

J05AR25 - lamivudine and dolutegravir ; Belongs to the class of antivirals for treatment of HIV infections, combinations.

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