Telbivudine: Difference between revisions

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{{Drugbox
__NOTOC__
| IUPAC_name        = 1-[(2''S'',4''R'',5''S'')-4-hydroxy-5-hydroxymethyltetrahydrofuran-2-yl]-<br>5-methyl-1''H''-pyrimidine-2,4-dione
{{Telbivudine}}
| image            = Telbivudine.svg
{{CMG}}
| CAS_number        = 3424-98-4
 
| ATC_prefix        = N03
==Overview==
| ATC_suffix        = AX17
| PubChem          = 159269
| DrugBank          =
| C=10|H=14|N=2|O=5
| molecular_weight  = 242.23 g/mol
| synonyms          = 1-(2-deoxy-β-<small>L</small>-ribofuranosyl)-5-methyluracil<br>β-<small>L</small>-2-deoxythymidine<br>β-<small>L</small>-thymidine (LdT)
| bioavailability  =
| protein_bound    = Low (3.3% ''[[in vitro]]'')
| metabolism        = Nil
| elimination_half-life = 40 to 49 hours (terminal phase)
| excretion        = [[Kidney|Renal]]
| pregnancy_AU      = <!-- A / B1 / B2 / B3 / C / D / X -->
| pregnancy_US      = B
| pregnancy_category= 
| licence_EU        = Sebivo
| licence_US        = TELBIVUDINE
| legal_AU          =  <!-- Unscheduled / S2 / S3 / S4 / S5 / S6 / S7 / S8 / S9 -->
| legal_CA          =  <!--            / Schedule I, II, III, IV, V, VI, VII, VIII -->
| legal_UK          =  <!-- GSL        / P      / POM / CD / Class A, B, C -->
| legal_US          = Rx-only
| legal_status      =
| routes_of_administration = Oral
}}
'''Telbivudine''' is an [[antiviral drug]] used in the treatment of [[hepatitis B]] infection. It is marketed by Swiss pharmaceutical company [[Novartis]] under the trade names '''Sebivo''' (Europe) and '''Tyzeka''' (United States). [[Clinical trial]]s have shown it to be [[statistical significance|significantly]] more effective than [[lamivudine]] or [[adefovir]], and less likely to cause resistance.<ref name=Lai1>{{cite journal |author=Lai CL, Leung N, Teo EK, ''et al.'' |title=A 1-year trial of telbivudine, lamivudine, and the combination in patients with hepatitis B e antigen-positive chronic hepatitis B |journal=Gastroenterology |volume=129 |issue=2 |pages=528–36 |year=2005 |pmid=16083710 |doi=10.1016/j.gastro.2005.05.053}}</ref><ref name=NEJM>{{cite journal |author=Lai CL, Gane E, Liaw YF, ''et al.'' |title=Telbivudine versus lamivudine in patients with chronic hepatitis B |journal=[[New England Journal of Medicine|N Engl J Med]] |volume=357 |issue=25 |pages=2576–88 |year=2007 |pmid=18094378 |doi=10.1056/NEJMoa066422}}</ref><ref>{{cite journal |author=Chan HL, Heathcote EJ, Marcellin P, ''et al'' |title=Treatment of hepatitis B e antigen positive chronic hepatitis with telbivudine or adefovir: a randomized trial |journal=[[Annals of Internal Medicine|Ann Intern Med]] |volume=147 |issue=11 |pages=745–54 |year=2007 |pmid=17909201 |url=http://www.annals.org/cgi/content/full/147/11/745}}</ref>
'''Telbivudine''' is an [[antiviral drug]] used in the treatment of [[hepatitis B]] infection. It is marketed by Swiss pharmaceutical company [[Novartis]] under the trade names '''Sebivo''' (Europe) and '''Tyzeka''' (United States). [[Clinical trial]]s have shown it to be [[statistical significance|significantly]] more effective than [[lamivudine]] or [[adefovir]], and less likely to cause resistance.<ref name=Lai1>{{cite journal |author=Lai CL, Leung N, Teo EK, ''et al.'' |title=A 1-year trial of telbivudine, lamivudine, and the combination in patients with hepatitis B e antigen-positive chronic hepatitis B |journal=Gastroenterology |volume=129 |issue=2 |pages=528–36 |year=2005 |pmid=16083710 |doi=10.1016/j.gastro.2005.05.053}}</ref><ref name=NEJM>{{cite journal |author=Lai CL, Gane E, Liaw YF, ''et al.'' |title=Telbivudine versus lamivudine in patients with chronic hepatitis B |journal=[[New England Journal of Medicine|N Engl J Med]] |volume=357 |issue=25 |pages=2576–88 |year=2007 |pmid=18094378 |doi=10.1056/NEJMoa066422}}</ref><ref>{{cite journal |author=Chan HL, Heathcote EJ, Marcellin P, ''et al'' |title=Treatment of hepatitis B e antigen positive chronic hepatitis with telbivudine or adefovir: a randomized trial |journal=[[Annals of Internal Medicine|Ann Intern Med]] |volume=147 |issue=11 |pages=745–54 |year=2007 |pmid=17909201 |url=http://www.annals.org/cgi/content/full/147/11/745}}</ref>


Telbivudine is a synthetic [[thymidine]] [[nucleoside analogue]]; it is the [[Stereoisomerism|<small>L</small>-isomer]] of thymidine. It is taken once daily.
==Category==
Antiviral


==References==
==US Brand Names==
{{reflist|2}}
TYZEKA<sup>®</sup>


==External links==
==FDA Package Insert==
*[http://www.tyzeka.com/ Tyzeka official website] run by [[Novartis]] Pharmaceuticals Corporation
'''  [[Telbivudine description|Description]]'''
*[http://www.rxlist.com/cgi/generic/tyzeka.htm Telbivudine] entry in RxList
'''| [[Telbivudine clinical pharmacology|Clinical Pharmacology]]'''
*[http://www.emea.europa.eu/humandocs/PDFs/EPAR/sebivo/H-713-PI-en.pdf Sebivo Summary of Product Characteristics] (from the EMEA website)
'''| [[Telbivudine microbiology|Microbiology]]'''
'''| [[Telbivudine indications and usage|Indications and Usage]]'''
'''| [[Telbivudine contraindications|Contraindications]]'''
'''| [[Telbivudine warnings and precautions|Warnings and Precautions]]'''
'''| [[Telbivudine adverse reactions|Adverse Reactions]]'''
'''| [[Telbivudine overdosage|Overdosage]]'''
'''| [[Telbivudine clinical studies|Clinical Studies]]'''
'''| [[Telbivudine dosage and administration|Dosage and Administration]]'''
'''| [[Telbivudine compatibility reconstitution and stability|Compatibility, Reconstitution, and Stability]]'''
'''| [[Telbivudine directions for use|Directions For Use]]'''
'''| [[Telbivudine how supplied|How Supplied]]'''
'''| [[Telbivudine labels and packages|Labels and Packages]]'''


{{Antivirals}}
==Mechanism of Action==


{{pharma-stub}}
==References==
{{Reflist|2}}


[[Category:Antivirals]]
[[Category:Antibiotics]]
{{WikiDoc Sources}}
[[Category:Wikinfect]]

Revision as of 18:58, 31 December 2013

Telbivudine
TYZEKA® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Overdosage
Clinical Studies
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Overview

Telbivudine is an antiviral drug used in the treatment of hepatitis B infection. It is marketed by Swiss pharmaceutical company Novartis under the trade names Sebivo (Europe) and Tyzeka (United States). Clinical trials have shown it to be significantly more effective than lamivudine or adefovir, and less likely to cause resistance.[1][2][3]

Category

Antiviral

US Brand Names

TYZEKA®

FDA Package Insert

Description | Clinical Pharmacology | Microbiology | Indications and Usage | Contraindications | Warnings and Precautions | Adverse Reactions | Overdosage | Clinical Studies | Dosage and Administration | Compatibility, Reconstitution, and Stability | Directions For Use | How Supplied | Labels and Packages

Mechanism of Action

References

  1. Lai CL, Leung N, Teo EK; et al. (2005). "A 1-year trial of telbivudine, lamivudine, and the combination in patients with hepatitis B e antigen-positive chronic hepatitis B". Gastroenterology. 129 (2): 528–36. doi:10.1016/j.gastro.2005.05.053. PMID 16083710.
  2. Lai CL, Gane E, Liaw YF; et al. (2007). "Telbivudine versus lamivudine in patients with chronic hepatitis B". N Engl J Med. 357 (25): 2576–88. doi:10.1056/NEJMoa066422. PMID 18094378.
  3. Chan HL, Heathcote EJ, Marcellin P; et al. (2007). "Treatment of hepatitis B e antigen positive chronic hepatitis with telbivudine or adefovir: a randomized trial". Ann Intern Med. 147 (11): 745–54. PMID 17909201.