Dolutegravir And Lamivudine (1 brand name, 1 dosage form, 0 routes)
Available dosage forms: TABLET.
Brand Names
- DOLUTEGRAVIR AND LAMIVUDINE
Boxed Warning
All patients with HIV-1 should be tested for the presence of HBV prior to or when initiating DOVATO. Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens has been reported. If DOVATO is used in patients co-infected with HIV-1 and HBV, additional treatment should be considered for appropriate treatment of chronic HBV; otherwise, consider an alternative regimen. Severe acute exacerbations of HBV have been reported in patients who are co-infected with HIV-1 and HBV and have discontinued lamivudine, a component of DOVATO. Closely monitor hepatic function in these patients and, if appropriate, initiate anti-HBV treatment [see Warnings and Precautions (5.1)].
Indications and Usage
DOVATO is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 25 kg with no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of DOVATO.
Contraindications
DOVATO is contraindicated in patients: •with prior hypersensitivity reaction to dolutegravir or lamivudine [see Warnings and Precautions (5.2)]. •receiving dofetilide due to the potential for increased dofetilide plasma concentrations and the risk for serious and/or life-threatening events [see Drug Interactions (7.2)].
Adverse Reactions
The following adverse reactions are discussed in other sections of the labeling: •Patients co-infected with HIV-1 and HBV [see Warnings and Precautions (5.1)] •Hypersensitivity reactions [see Warnings and Precautions (5.2)] •Hepatotoxicity [see Warnings and Precautions (5.3)] •Lactic acidosis and severe hepatomegaly with steatosis [see Warnings and Precautions (5.4)] •Immune reconstitution syndrome [see Warnings and Precautions (5.6)]
Mechanism of Action
DOVATO is a fixed-dose combination of the HIV‑1 antiretroviral agents, dolutegravir and lamivudine [see Microbiology (12.4)].
Overdosage
There is no known specific treatment for overdose with DOVATO. If overdose occurs, the patient should be monitored, and standard supportive treatment applied as required. Dolutegravir As dolutegravir is highly bound to plasma proteins, it is unlikely that it will be significantly removed by dialysis. Lamivudine Because a negligible amount of lamivudine was removed via (4-hour) hemodialysis, continuous ambulatory peritoneal dialysis, and automated peritoneal dialysis, it is not known if continuous hemodialysis would provide clinical benefit in a lamivudine overdose event.