Dolutegravir

Dosing

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

General Information

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.

Common

  • Hyperglycemia

  • Increased serum lipase level

  • Headache

  • Insomnia

Serious

  • Increased liver enzymes

  • Hepatic failure

  • Drug-induced liver disease

  • Hepatitis

  • Hepatotoxicity

  • Hypersensitivity reaction

  • Immune reconstitution syndrome

  • Renal impairment

Contraindication:

  • Dofetilide

Major drug-drug interactions:

  • Etravirine

  • Carbamazepine

  • Fosamprenavir/Ritonavir

  • Rifampin

  • Tipranavir

  • Metformin

  • Select UGT enzyme inducers

  • CYP3A4 substrates

  • Efavirenz

  • Cabotegravir

  • Dasabuvir

  • Polyvalent cations containing products

  • Phenobarbital

  • St. John's wort

  • Nevirapine

  • Oxcarbazepine

  • Phenytoin

  • Dalfampridine

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.

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