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Dolutegravir Dosage

Medically reviewed on August 8, 2018.

Applies to the following strengths: 10 mg; 25 mg; 50 mg

Usual Adult Dose for HIV Infection

Therapy-naive or therapy-experienced integrase strand transfer inhibitor (INSTI)-naive patients or virologically-suppressed patients switching to this drug plus rilpivirine: 50 mg orally once a day

Therapy-naive or therapy-experienced INSTI-naive patients when coadministered with certain UGT1A or CYP450 3A inducers: 50 mg orally twice a day

INSTI-experienced patients with certain INSTI-associated resistance substitutions or clinically suspected INSTI resistance: 50 mg orally twice a day

Comments:
-Rilpivirine dose is 25 mg orally once a day for patients switching to this drug plus rilpivirine.
-The manufacturer product information should be consulted for relevant UGT1A or CYP450 3A inducers.
-In INSTI-experienced patients, alternative combinations that do not include metabolic inducers should be considered where possible.

Uses:
-In combination with other antiretroviral agents, for the treatment of HIV-1 infection
-In combination with rilpivirine, as a complete regimen for the treatment of HIV-1 infection to replace a stable antiretroviral regimen in patients who are virologically-suppressed (HIV-1 RNA less than 50 copies/mL) for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to either drug

Usual Adult Dose for Nonoccupational Exposure

US CDC Recommendations: 50 mg orally once a day
Duration of therapy: 28 days

Comments:
-This drug plus (emtricitabine-tenofovir disoproxil fumarate [DF] or lamivudine/zidovudine) is recommended as a preferred regimen for nonoccupational postexposure prophylaxis of HIV infection.
---This drug is not recommended in nonpregnant females of reproductive potential who are not using effective contraception or in pregnant women who are not at least 8 weeks from last menstrual period.
-Prophylaxis should be started as soon as possible, within 72 hours of exposure.
-Current guidelines should be consulted for additional information.

Usual Pediatric Dose for HIV Infection

30 to less than 40 kg: 35 mg orally once a day
At least 40 kg: 50 mg orally once a day

Comments:
-Recommended for therapy-naive or therapy-experienced INSTI-naive patients
-If certain UGT1A or CYP450 3A inducers are coadministered, the weight-based dose should be increased to twice a day; the manufacturer product information should be consulted for relevant inducers.
-Safety and efficacy not established in INSTI-experienced patients with documented or clinically suspected resistance to other INSTIs (raltegravir, elvitegravir).

Use: In combination with other antiretroviral agents, for the treatment of HIV-1 infection

Usual Pediatric Dose for Nonoccupational Exposure

US CDC Recommendations:
13 years or older and weighing at least 40 kg: 50 mg orally once a day
Duration of therapy: 28 days

Comments:
-This drug plus (emtricitabine-tenofovir DF or lamivudine/zidovudine) is recommended as a preferred regimen for nonoccupational postexposure prophylaxis of HIV infection.
---This drug is not recommended in nonpregnant females of reproductive potential who are not using effective contraception or in pregnant women who are not at least 8 weeks from last menstrual period.
-Prophylaxis should be started as soon as possible, within 72 hours of exposure.
-Current guidelines should be consulted for additional information.

Renal Dose Adjustments

Therapy-naive or therapy-experienced INSTI-naive patients:
-Mild, moderate, or severe renal dysfunction: No adjustment recommended.

INSTI-experienced patients (with certain INSTI-associated resistance substitutions or clinically suspected INSTI resistance):
-Mild or moderate renal dysfunction: No adjustment recommended.
-Severe renal dysfunction: Caution recommended.

Comments:
-INSTI-experienced patients with severe renal dysfunction: Reduced dolutegravir levels may lead to loss of therapeutic effect and development of resistance to this drug or other concomitant antiretroviral agents.

Liver Dose Adjustments

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

Precautions

CONTRAINDICATIONS:
-Hypersensitivity to the active component or any of the ingredients
-Coadministration with dofetilide

Safety and efficacy have not been established in pediatric patients weighing less than 30 kg or who are INSTI-experienced.

Consult WARNINGS section for dosing related precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-May administer without regard to food
-Administer products containing polyvalent cations (e.g., aluminum or magnesium) and supplements containing calcium or iron (including multivitamins containing calcium or iron) 6 hours before or 2 hours after this drug; may administer calcium or iron supplements and this drug together with food
-Consult the manufacturer product information regarding missed doses.

Storage requirements:
-For 10 mg tablets: Store and dispense in original bottle and protect from moisture; keep bottle tightly closed and do not remove desiccant.
-Store at 25C (77F); excursions permitted to 15C to 30C (59F to 86F).

General:
-The Department of Health and Human Services Antiretroviral Guidelines Panels provide the following interim recommendations regarding use of this drug in women who are pregnant or of reproductive potential:
---Women not known to be pregnant should have a negative pregnancy test before starting this drug.
---Women currently using a dolutegravir-containing regimen or who wish to be started on this drug should be apprised of the potential risk of neural tube defects when this drug is used near time of conception; neural tube defects occur within the first 28 days after conception or 6 weeks from the last menstrual period.
---Within 8 weeks from last menstrual period, pregnant women using this drug should consult healthcare providers regarding the risks and benefits of their current regimens; if good alternative options are available, then patients should be switched to a regimen without this drug.
---Pregnant women at least 8 weeks from last menstrual period may start or continue dolutegravir-containing regimens.
-Current HIV guidelines should be consulted for additional information.

Monitoring:
-Hepatic: For hepatotoxicity (during therapy), especially in patients with liver disease such as hepatitis B or C

Patient advice:
-Read the US FDA-approved patient labeling (Patient Information).
-Contact healthcare provider at once if rash develops; stop this drug and other suspect agents 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).
-Consult healthcare provider at once if 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.

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