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Abacavir / Dolutegravir / Lamivudine Dosage

Medically reviewed on July 20, 2018.

Applies to the following strengths: 600 mg-50 mg-300 mg

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for HIV Infection

1 tablet orally once a day

Use: For the treatment of HIV-1 infection

Usual Pediatric Dose for HIV Infection

At least 40 kg: 1 tablet orally once a day

Use: For the treatment of HIV-1 infection

Renal Dose Adjustments

CrCl less than 50 mL/min: Not recommended; individual components should be used.

Liver Dose Adjustments

Mild liver dysfunction (Child-Pugh A): Not recommended; individual components should be used.
Moderate or severe liver dysfunction (Child-Pugh B or C): Contraindicated

Dose Adjustments

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

Precautions

US BOXED WARNINGS:
-HYPERSENSITIVITY REACTIONS: Serious and sometimes fatal hypersensitivity reactions (with multiple organ involvement) reported with abacavir. Patients with the human leukocyte antigen subtype B*5701 (HLA-B*5701) allele are at higher risk of abacavir hypersensitivity reactions; however, such reactions have occurred in patients without the HLA-B*5701 allele. This drug is contraindicated in patients with prior hypersensitivity reaction to abacavir and in HLA-B*5701-positive patients. All patients should be screened for the HLA-B*5701 allele before starting or restarting treatment with this drug (unless HLA-B*5701 allele assessment previously documented). Regardless of HLA-B*5701 status, this drug should be discontinued without delay if hypersensitivity reaction is suspected, even if other diagnoses are possible. After hypersensitivity reaction to this drug, NEVER restart this or any other abacavir-containing product as more severe symptoms (including death) can occur within hours. Similar severe reactions also reported after restarting abacavir-containing products in patients with no history of abacavir hypersensitivity
-EXACERBATIONS OF HEPATITIS B: Severe acute exacerbations of hepatitis B reported in patients coinfected with HBV and HIV-1 after stopping lamivudine. Hepatic function of coinfected patients should be closely monitored with clinical and laboratory follow-up for at least several months after stopping this drug. If appropriate, initiation/resumption of antihepatitis B therapy may be necessary.

CONTRAINDICATIONS:
-Presence of the HLA-B*5701 allele
-Prior hypersensitivity to any active component or to any of the ingredients
-Coadministration with dofetilide
-Moderate or severe liver dysfunction

Safety and efficacy have not been established in patients weighing less than 40 kg.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Before starting this drug, screen for the HLA-B*5701 allele.
-Before starting this drug, review medical history for prior exposure to any abacavir-containing product.
-May administer with or without food
-Administer products containing polyvalent cations and supplements containing calcium or iron 6 hours before or 2 hours after this drug; oral calcium or iron supplements (including multivitamins containing calcium or iron) and this drug may be administered together with food.
-Consult the manufacturer product information regarding missed doses.

Storage requirements:
-Store and dispense in original container.
-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:
-Each combination tablet contains abacavir 600 mg, dolutegravir 50 mg, and lamivudine 300 mg.
-Limitations of use: This drug should not be used alone in patients with resistance-associated integrase substitutions or clinically suspected integrase strand transfer inhibitor resistance; the dose of dolutegravir in this product is insufficient in such patients. The manufacturer product information for dolutegravir should be consulted.
-The Department of Health and Human Services Antiretroviral Guidelines Panels provide the following interim recommendations regarding use of dolutegravir in women who are pregnant or of reproductive potential:
---Women not known to be pregnant should have a negative pregnancy test before starting dolutegravir.
---Women currently using a dolutegravir-containing regimen or who wish to be started on dolutegravir should be apprised of the potential risk of neural tube defects when dolutegravir 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 dolutegravir 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 dolutegravir.
---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); hepatic function of HIV-1/HBV 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 (Medication Guide); read the Medication Guide and Warning Card (dispensed with each new and refill prescription) every time; carry the Warning Card with you.
-Contact healthcare provider immediately if signs/symptoms of hypersensitivity develop; do not restart this or any other abacavir-containing product after a hypersensitivity reaction (dispose of unused product).
-If this drug is stopped for any reason besides hypersensitivity, do not restart it (or any other abacavir-containing product) without consulting physician; medical care must be readily accessible.
-Notify healthcare provider at once of any symptoms of infection.
-Notify healthcare provider if any unusual symptom develops or if any known symptom persists/worsens.

Further information

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

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