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/o antiretroviral treatment history & w/o known substitutions associated w/ resistance to the individual components of Dovato.
Dosage/Direction for Use
Administration
May be taken with or without food.
Contraindications
Special Precautions
Discontinue in case of hypersensitivity reactions. Increase in wt & in blood lipid & glucose levels may occur. Patients co-infected w/ HBV. If Dovato is discontinued in patients co-infected w/ HBV, periodically monitor liver function tests & markers of HBV replication. Monitor patients w/ pre-existing liver dysfunction according to standard practice. Immune reactivation syndrome. Mitochondrial dysfunction in HIV-negative infants exposed in utero &/or post-natally to nucleoside analogues. Osteonecrosis. Opportunistic infections may still develop. Co-administration w/ polyvalent cation-containing antacids; metformin; cladribine; other medicinal products containing dolutegravir or lamivudine. Severe hepatic impairment. Not recommended in patients w/ CrCl <50 mL/min. Pregnancy & lactation. Paed population.
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, creatine phosphokinase (CPK) elevations, ALT &/or AST elevations.
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 MATE-1 (eg, metformin). Decreased dolutegravir AUC & Cmax w/ Mg/Al-containing antacids; supplements or multivit containing Ca, Fe or Mg (in fasted state).
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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