Telbivudine


Concise Prescribing Info
Indications/Uses
Chronic hepatitis B.
Dosage/Direction for Use
Adult : PO 600 mg once daily.
Dosage Details
Oral
Chronic hepatitis B
Adult: 600 mg once daily.
Renal Impairment
ESRD: 600 mg 96 hrly, after dialysis session.
CrCl (mL/min) Dosage
<30 (not requiring dialysis) 600 mg 72 hrly.
30-49 600 mg 48 hrly.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Lactation. Concurrent use w/ peginterferon alfa-2a.
Special Precautions
Patient w/ cirrhosis, hepatomegaly or other risk factors for liver disease. Renal impairment. Pregnancy.
Adverse Reactions
Cough, dizziness, fatigue, GI effects (e.g. abdominal pain, diarrhoea, nausea, vomiting, dyspepsia), rash, arthralgia, myalgia, myopathy, malaise, back pain, nasopharyngitis, headache, flu or flu-like symptoms, insomnia; increased serum amylase, lipase, creatine phosphokinase, alanine aminotransferase levels; peripheral neuropathy, rhabdomyolysis.
Potentially Fatal: Lactic acidosis, severe hepatomegaly w/ steatosis.
MonitoringParameters
Monitor hepatic function (e.g. AST and ALT) periodically during therapy and for several mth following discontinuation of therapy; renal function; signs and symptoms of peripheral neuropathy or myopathy; serum creatine kinase; hepatitis B virus (HBV) DNA 3-6 mthly during therapy; HBeAg and anti-HBe signs/symptoms of HBV relapse/exacerbation after discontinuation of therapy.
Drug Interactions
Altered plasma concentration w/ drugs that affect renal function (e.g. aminoglycosides, loop diuretics, platinum compounds, vancomycin, amphotericin B). May increase risk of myopathy w/ other drugs associated w/ myopathy (e.g. azole antifungals, ciclosporin, corticosteroids, erythromycin, fibrates, HMG-CoA reductase inhibitors, penicillamine, zidovudine).
Potentially Fatal: Increased risk of peripheral neuropathy w/ peginterferon alfa-2a.
Action
Description: Telbivudine is phosphorylated intracellularly to the active triphosphate form, which competes w/ thymidine 5'-triphosphate, the natural substrate of hepatitis B virus (HBV) reverse transcriptase, resulting to DNA chain termination and inhibition of HBV replication.
Pharmacokinetics:
Absorption: Absorbed from the GI tract. Time to peak plasma concentration: Approx 3 hr.
Distribution: Widely distributed into tissues. Plasma protein binding: Approx 3.3%.
Metabolism: Undergoes phosphorylation by cellular kinases to form the active metabolite, telmivudine-5'-triphosphate.
Excretion: Via urine, as unchanged drug. Terminal elimination half-life: 30-53.6 hr.
Chemical Structure

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Storage
Store at 25°C.
MIMS Class
ATC Classification
J05AF11 - telbivudine ; Belongs to the class of nucleoside and nucleotide reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.
Disclaimer: This information is independently developed by MIMS based on Telbivudine from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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