NEW
Dovato

Dovato

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Dolutegravir 50 mg, lamivudine 300 mg
Indications/Uses
HIV-1 infection in adults w/ no known or suspected resistance to the integrase inhibitor class, or lamivudine.
Dosage/Direction for Use
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Co-administration w/ medicinal products w/ narrow therapeutic windows that are substrates of organic cation transporter (OCT) 2 eg, fampridine/dalfampridine.
Special Precautions
Discontinue in case of hypersensitivity reactions. Increase in wt & in blood lipid & glucose levels may occur. Periodically monitor liver function tests & markers of HBV replication if Dovato is discontinued in patients co-infected w/ HBV. Monitor patients w/ pre-existing liver dysfunction according to standard practice. Immune reactivation syndrome. Monitor liver chemistries in patients w/ hepatitis B &/or C co-infection. Mitochondrial dysfunction in HIV-negative infants exposed in utero &/or post-natally to nucleoside analogues. Osteonecrosis. Opportunistic infections may still develop. Should not be co-administered w/ polyvalent cation-containing antacids. Should not be taken w/ any other medicinal product containing dolutegravir, lamivudine or emtricitabine. Not recommended w/ cladribine. Co-administration w/ metformin may increase risk for lactic acidosis in patients w/ moderate renal impairment. Supplements or multivit containing Ca, Fe or Mg should be taken 2 hr after or 6 hr before treatment (in fasted state). Not recommended in patients w/ CrCl <50 mL/min. Patients w/ severe hepatic impairment (Child-Pugh grade C). Counsel women of childbearing potential about the risk of neural tube defects w/ dolutegravir & to consider effective contraception. Pregnancy & lactation. Paed patients.
Adverse Reactions
Headache; nausea, diarrhoea. Depression, anxiety, insomnia, abnormal dreams; dizziness, somnolence; vomiting, flatulence, abdominal pain/discomfort; rash, pruritus, alopecia; arthralgia, muscle disorders (including myalgia); fatigue; elevated creatine phosphokinase (CPK), elevated ALT &/or AST.
Drug Interactions
Increased dolutegravir plasma conc w/ UGT1A1, UGT1A3, UGT1A9, CYP3A4, &/or P-gp inhibitors. Decreased dolutegravir plasma conc w/ UGT1A1, UGT1A3, UGT1A9, CYP3A4, &/or P-gp inducers. Dolutegravir may increase plasma conc of medicinal products in which excretion is dependent upon OCT2 &/or MATE1 (eg, fampridine/dalfampridine, metformin). Decreased lamivudine AUC & Cmax w/ sorbitol or other osmotic acting poly- or monosaccharide alcohols (eg, xylitol, mannitol, lactitol, maltitol). Decreased dolutegravir AUC & Cmax w/ Mg/Al-containing antacids; supplements or multivit containing Ca, Fe or Mg (in fasted state). Potential risk of cladribine loss of efficacy. Risk of intracellular interactions w/ emtricitabine.
MIMS Class
ATC Classification
J05AR25 - lamivudine and dolutegravir ; Belongs to the class of antivirals for treatment of HIV infections, combinations.
Presentation/Packing
Form
Dovato FC tab
Packing/Price
30's
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