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Abacavir / Dolutegravir / Lamivudine Dosage

Applies to the following strength(s): 600 mg-50 mg-300 mg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult 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

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

With concomitant efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir, 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.
-LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS: Lactic acidosis and severe hepatomegaly with steatosis (including fatalities) reported with use of nucleoside analogs alone or in combination (including abacavir, lamivudine, and other antiretrovirals). This drug should be discontinued if clinical or laboratory findings suggest lactic acidosis or pronounced hepatotoxicity.
-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.

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:
-May administer without regard to food
-Administer products containing polyvalent cations and supplements containing calcium or iron 6 hours before or 2 hours after this drug; calcium or iron supplements 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; do not remove desiccant.

General:
-Screening for HLA-B*5701 allele is recommended before starting this drug.
-Before starting this drug, medical history should be reviewed for prior exposure to any abacavir-containing product.
-This drug should not be used alone in patients with history of resistance to any of the active components.
-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.

Monitoring:
-Hepatic: Appropriate laboratory testing (before starting therapy) and for hepatotoxicity (during therapy) in patients with underlying hepatic disease such as hepatitis B or C; 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:
-Always read the Medication Guide and Warning Card (with information about abacavir hypersensitivity reaction) dispensed with each new and refill prescription; carry the Warning Card.
-Contact physician immediately if signs/symptoms of hypersensitivity develop; do not restart this or any other abacavir-containing product after a hypersensitivity reaction.
-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.

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