Indicated for the treatment of chronic hepatitis B in adult patients with evidence of viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
Thymidine nucleoside analogue; Antiviral
Telbivudine is a synthetic thymidine nucleoside analogue with activity against hepatitis B virus (HBV). Telbivudine is the unmodified β–L enantiomer of the naturally occurring nucleoside, thymidine. It undergoes phosphorylation via interaction with cellular kinases to form the active metabolite, telbivudine 5'-triphosphate.
Telbivudine 5'–triphosphate inhibits HBV DNA polymerase (reverse transcriptase) by competing with the natural substrate, thymidine 5'–triphosphate. This leads to the chain termination of DNA synthesis, thereby inhibiting viral replication. Incorporation of telbivudine 5'–triphosphate into viral DNA also causes DNA chain termination, resulting in inhibition of HBV replication. Telbivudine inhibits anticompliment or second-strand DNA.
ORAL Chronic hepatitis B: Adult: 600 mg once daily. Child: 16 yr: 600 mg once daily.
Altered plasma concentration with drugs that affect renal function (e.g. aminoglycosides, loop diuretics, platinum compounds, vancomycin, amphotericin B). May increase risk of myopathy with other drugs associated with myopathy (e.g. azole antifungals, ciclosporin, corticosteroids, erythromycin, fibrates, HMG-CoA reductase inhibitors, penicillamine, zidovudine).
Hypersensitivity. Patients w/ risk factors for liver disease (especially in female gender, obesity, pregnancy or prolonged exposure). Discontinue treatment in patients who develop clinical/laboratory findings suggestive of lactic acidosis or hepatotoxicity. Interrupt therapy if myopathy is suspected; discontinue if myopathy is diagnosed. Monitor LFTs several mth after discontinuation of treatment due to risk of severe acute exacerbation of hepatitis B. Renal impairment. Safety & efficacy have not been established in patients <16 yr, liver transplant patients or those coinfected w/ HIV, HCV or hepatitis D virus. Caution in patients who have failed previous lamivudine treatment due to risk of cross- resistance development. Pregnancy, lactation.
Fatigue, malaise, headache, abdominal pain. Dizziness, insomnia, fever, rash, increased lipase, nausea & vomiting, diarrhoea, dyspepsia. cough, flu-like symptoms. Lactic acidosis & severe hepatomegaly.
This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. An alternative agent may be preferred, particularly while breastfeeding newborn or preterm infants.
Store Telbivudine Tablets and Oral Solution in the original bottle at room temperature (15° to 30°C)
.png&w=384&q=75)