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Dolutegravir / Lamivudine Dosage

Medically reviewed by Drugs.com. Last updated on Sep 29, 2020.

Applies to the following strengths: 50 mg-300 mg

Usual Adult Dose for HIV Infection

1 tablet orally once a day

Uses: As a complete regimen, for the treatment of HIV-1 infection in patients with no antiretroviral treatment history or to replace a stable antiretroviral regimen in patients who are virologically-suppressed (HIV-1 RNA less than 50 copies/mL) with no history of treatment failure and no known substitutions associated with resistance to the individual components

Renal Dose Adjustments

CrCl less than 50 mL/min: Not recommended.

Liver Dose Adjustments

Mild or moderate liver dysfunction (Child-Pugh A or B): No adjustment recommended.
Severe liver dysfunction (Child-Pugh C): Not recommended.

Dose Adjustments

Coadministration with carbamazepine or rifampin: An additional 50 mg/day of dolutegravir is recommended, separated from this combination product by 12 hours.

Precautions

US BOXED WARNINGS:
PATIENTS COINFECTED WITH HBV AND HIV-1:
-EMERGENCE OF LAMIVUDINE-RESISTANT HBV: All patients with HIV-1 should be tested for HBV before/when starting this drug. Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens reported. If this drug is used in HBV/HIV-1-coinfected patients, additional treatment should be considered to appropriately treat chronic HBV; otherwise, an alternative regimen should be considered.
-EXACERBATIONS OF HBV: Severe acute exacerbations of HBV reported in HBV/HIV-1-coinfected patients who have stopped lamivudine, a component of this drug. Hepatic function of HBV/HIV-1-coinfected patients should be monitored closely; if appropriate, anti-HBV therapy should be started.

CONTRAINDICATIONS:
Prior hypersensitivity reaction to either active component; coadministration with dofetilide

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Before/when starting this drug, test patients for HBV infection.
-Perform pregnancy testing before starting this drug in patients of childbearing potential (to exclude use during the first trimester of pregnancy).
-Administer with or without food.
-Administer products containing polyvalent cations (e.g., aluminum or magnesium) and oral supplements containing calcium or iron (including multivitamins containing calcium or iron) 6 hours before or 2 hours after this drug; may administer supplements/multivitamins containing calcium or iron and this drug at the same time with food
-Consult the manufacturer product information regarding missed doses.

Storage requirements:
-Store below 30C (86F).

General:
-Each combination tablet contains dolutegravir 50 mg and lamivudine 300 mg.
-Current HIV guidelines should be consulted regarding use of dolutegravir in patients who are pregnant or of childbearing potential.

Monitoring:
-General: Pregnancy testing in patients of childbearing potential (before starting therapy)
-Hepatic: For hepatotoxicity (during therapy); hepatic function of HBV/HIV-1-coinfected patients with clinical and laboratory follow-up (for at least several months after stopping this drug)

Patient advice:
-Read the US FDA-approved patient labeling (Patient Information).
-Contact healthcare provider at once if rash develops; stop this drug immediately and seek medical attention if rash associated with any of the following symptoms develop: fever, general ill feeling, extreme tiredness, muscle/joint aches, blisters/peeling of skin, oral blisters/lesions, eye inflammation, facial swelling, swelling of eyes/lips/tongue/mouth, difficulty breathing, and/or signs/symptoms of liver problems (e.g., yellowing of skin/whites of eyes, dark/tea-colored urine, pale-colored stools/bowel movements, nausea, vomiting, loss of appetite, pain/aching/sensitivity on right side below ribs).
-Monitor for hepatotoxicity during therapy.
-Patients of childbearing potential: Consider an alternative regimen at time of conception through the first trimester of pregnancy. Contact healthcare provider if you plan to become pregnant, become pregnant, or suspect you are pregnant during therapy; consistently use effective contraception.
-Notify healthcare provider at once of any signs/symptoms of infection.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.