Monograph Details
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Infections & Infestations
> Viral infections
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TYZEKA |
| Manufacturer |
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Idenix and Novartis |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Nucleoside analogue reverse transcriptase inhibitor. |
| Generic Name |
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Telbivudine 600mg; tabs. |
| Indications |
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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. |
| Children |
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<16yrs: not recommended. |
| Adults |
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≥16yrs (CrCl ≥50mL/min): 600mg once daily. Renal impairment: CrCl 30–49mL/min: 600mg once every 48 hrs; CrCl <30mL/min (not on dialysis): 600mg once every 72 hrs; end-stage renal disease: 600mg every 96 hrs (give after dialysis session). |
| Precautions |
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Renal impairment. Monitor for lactic acidosis and for myopathy; suspend therapy if myopathy is suspected, discontinue if confirmed. Risk of hepatitis B reactivation (monitor after discontinuing therapy). Elderly. Pregnancy (Cat.B). Nursing mothers: not recommended. |
| Interactions |
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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. |
| Adverse Reactions |
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Fatigue, malaise, fever, joint pain, upper respiratory symptoms, headache, abdominal pain, myalgia/myopathy, elevated CPK levels, GI upset, dizziness, insomnia, post-treatment exacerbation of hepatitis B; lactic acidosis, severe hepatomegaly with steatosis. |
| Extra Text |
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Note: Register pregnant patients exposed to telbivudine by calling (800) 258-4263. |
| How Supplied |
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Tabs—30 |
| Additional Resources |
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• Related Prescribing Note |
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