1 tablet orally once a day
Use: For the treatment of HIV-1 infection
CrCl less than 50 mL/min: Not recommended; individual components should be used.
Mild liver dysfunction (Child-Pugh A): Not recommended; individual components should be used.
Moderate or severe liver dysfunction (Child-Pugh B or C): Contraindicated
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.
US BOXED WARNINGS:
-HYPERSENSITIVITY REACTIONS: Serious and sometimes fatal hypersensitivity reactions (with multiple organ involvement) have been associated with abacavir. Patients with the HLA-B*5701 allele are at increased risk of abacavir hypersensitivity reaction; such reactions have occurred in HLA-B*5701-negative patients. All patients should be screened for the HLA-B*5701 allele before starting or restarting this drug unless they have had an HLA-B*5701 allele assessment. This drug should be discontinued if hypersensitivity reaction is suspected. This drug is contraindicated in patients with the HLA-B*5701 allele and in patients with prior hypersensitivity reaction to abacavir. Restarting this or any other abacavir-containing product can result in life-threatening or fatal hypersensitivity reactions, even in patients with no history of abacavir hypersensitivity; such reactions can occur within hours.
-LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY: Lactic acidosis and severe hepatomegaly with steatosis (including fatalities) reported with nucleoside analogs alone or in combination with other antiretrovirals. This drug should be discontinued if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur.
-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.
Data not available
-May be taken 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.
-Store and dispense in original container; protect from moisture; keep bottle tightly closed; do not remove desiccant.
-Screening for HLA-B*5701 allele is recommended before starting this drug.
-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.
-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)