REMS
Absorption: Well absorbed following oral administration.
Distribution: Extensive tissue distribution.
Half-Life: Plasma: 128149 hr; intracellular: 15 hr.
Contraindicated in:
Use Cautiously in:
Patients coinfected with HIV (unless receiving highly active antiretroviral therapy; at ↑ risk for resistance)
;Drug-drug:
Renal Impairment
Monitor signs of HBV (jaundice, fatigue, anorexia, pruritus) during and for several months following discontinuation of therapy. Exacerbations may occur when therapy is discontinued.
Monitor patient for signs of lactic acidosis and severe hepatomegaly with steatosis (↑ serum lactate levels, ↑ liver enzymes, liver enlargement on palpation). Suspend therapy if clinical or laboratory signs occur.
Lab Test Considerations:
Monitor liver function tests closely during and for several months following discontinuation of therapy. May ↑ serum AST, ALT, bilirubin, amylase, lipase, creatinine, and glucose. May ↓ albumin.
Do not stop taking without consulting health care provider. Discontinuing therapy may lead to severe exacerbations.
Advise patient to notify health care provider promptly if signs of lactic acidosis (weakness or tiredness; unusual muscle pain; trouble breathing; stomach pain with nausea and vomiting; feeling cold, especially in arms or legs; dizziness; fast or irregular heartbeat) or hepatotoxicity (jaundice, dark urine, light-colored bowel movements, anorexia, nausea, lower stomach pain) occur.
NDC Code