Spectrum Of Activity
HIV infection, Treatment-naïve or integrase strand inhibitor-naïve 50 mg PO once daily
HIV infection, INSTI-experienced with resistance substitutions 50 mg PO twice daily
HIV infection, In combination with Rilpivirine to replace current stable ARV regimen Dolutegravir 50 mg PO once daily + Rilpivirine 25 mg PO once daily
HIV infection, Non-occupational exposure, Prophylaxis Dolutegravir 50 mg PO once daily + Emtricitabine 200 mg/ Tenofovir disoproxil fumarate 300 mg PO once daily (for 28d) Tablets and tablets for oral suspension are not interchangeable
Age ≥4wBW 14 to <20 kg 40 mg (4 x 10-mg tabs) PO once daily
BW ≥20 kg 50 mg (1 x 50-mg tab) PO once daily
Age ≥4wBW 3 to <6 kg 5 mg PO once daily
BW 6 to <10 kg 15 mg PO once daily
BW 10 to <14 kg 20 mg PO once daily
BW 14 to <20 kg 25 mg PO once daily
BW ≥20 kg 30 mg PO once daily
Mild to moderate hepatic impairment No dose adjustment
Severe hepatic impairment Not recommended
Severe renal impairment in INSTI-experienced Use with caution
HIV infection HIV infection, In combination with Rilpivirine to replace current stable ARV regimen
Monitor viral load, CD4 cell counts, and hepatitis B screening at baseline and with modification of ARV treatment.
Perform hepatitis C antibody testing prior to initiation or modification of ARV treatment.
Monitor ALT, AST, total bilirubin, and urinalysis at baseline and with modification of ARV treatment.
Obtain fasting blood glucose or HbA1C, fasting lipid profile, and CBC with a differential.
Obtain basic chemistry including serum sodium, potassium, bicarbonate, chloride, BUN, creatinine, and creatinine-based estimated glomerular filtration rate.
Increased serum lipase level
Increased liver enzymes
Drug-induced liver disease
Immune reconstitution syndrome
Major drug-drug interactions:
Select UGT enzyme inducers
Polyvalent cations containing products
St. John's wort
Antimicrobial class: Antiretroviral agent, HIV integrase strand transfer inhibitor
Average serum half life: 14 hours
Precautions: Use with caution in patients with severe renal impairment who are also integrase strand transfer inhibitor (INSTI) experienced with certain INSTI-associated resistance substitutions or clinically suspected INSTI resistance; loss of therapeutic effect and development of resistance may occur due to decreased concentrations.
Monitor underlying hepatitis B or C, and hepatotoxicity.
Discontinue if hypersensitivity reactions develop.