Treatment of chronic hepatitis B in patients with evidence of viral replication and either evidence of persistent elevations of ALT/AST or histologically active disease.
Adult Dose for TYZEKA:
HBeAg-positive: HBV DNA should be <9 log10 copies/mL and ALT should be ≥2xULN prior to treatment. HBeAg-negative: HBV DNA should be <7 log10 copies/mL prior to treatment. ≥16yrs (CrCl ≥50mL/min): 600mg once daily. Renal impairment: CrCl 30–49mL/min: 600mg once every 48hrs; CrCl <30mL/min (not on dialysis): 600mg once every 72hrs; end-stage renal disease: 600mg every 96hrs (give after dialysis session). If detectable HBV DNA after 24 weeks of treatment, initiate alternate therapy.
Concomitant pegylated interferon alfa-2a (increased risk of peripheral neuropathy).
Renal impairment. Monitor for lactic acidosis, hepatotoxicity, myopathy, peripheral neuropathy; suspend therapy if suspected, discontinue if confirmed. Risk of hepatitis B reactivation (monitor after discontinuing therapy). Monitor HBV DNA every 6 months; if positive at any time after initial response, alternate treatment should be initiated. Elderly. Pregnancy (Cat.B). Nursing mothers: not recommended.
See Contraindications. Risk of myopathy may be increased with statins, fibrates, corticosteroids, chloroquine, hydroxychloroquine, penicillamine, zidovudine, cyclosporine, erythromycin, niacin, azole antifungals. Caution with drugs that affect renal elimination (may need to extend telbuvidine dosing interval); monitor renal function with cyclosporine, tacrolimus.
Fatigue, malaise, fever, joint pain, upper respiratory symptoms, headache, abdominal pain, myalgia/myopathy, peripheral neuropathy, elevated CPK levels, GI upset, dizziness, insomnia, post-treatment exacerbation of hepatitis B; lactic acidosis, severe hepatomegaly with steatosis.
Note: Register pregnant patients exposed to telbivudine by calling (800) 258-4263.