Telbivudine indications and usage: Difference between revisions

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__NOTOC__
__NOTOC__
{{Telbivudine}}
{{Telbivudine}}
{{CMG}}
{{CMG}}; {{AE}} {{SS}}


==Indications And Usage==
==Indications and Usage==


=== Chronic Hepatitis B===
=== Chronic Hepatitis B===


Tyzeka is 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.
Tyzeka is indicated for the treatment of [[chronic hepatitis B]] in adult patients with evidence of viral replication and either evidence of persistent elevations in serum [[aminotransferase]]s ([[ALT]] or [[AST]]) or histologically active disease.


The following points should be considered when initiating therapy with Tyzeka:
The following points should be considered when initiating therapy with Tyzeka:


*This indication is based on virologic, serologic, biochemical and histologic responses in nucleoside treatment naïve adult patients with HBeAg positive and HBeAg negative chronic hepatitis B with compensated liver disease [see Clinical Studies (14)].
* This indication is based on virologic, serologic, biochemical and histologic responses in nucleoside treatment naïve adult patients with HBeAg positive and HBeAg negative chronic hepatitis B with compensated liver disease [see Clinical Studies (14)].
*For HBeAg-positive patients, Tyzeka should only be initiated in patients with HBV DNA less than 9 log10 copies per mL and ALT greater than or equal to 2x Upper Limit of Normal (ULN) prior to treatment.
 
*For HBeAg-negative patients, Tyzeka should only be initiated in patients with HBV DNA less than 7 log10 copies per mL prior to treatment.
* For HBeAg-positive patients, Tyzeka should only be initiated in patients with HBV DNA less than 9 log10 copies per mL and ALT greater than or equal to 2x Upper Limit of Normal (ULN) prior to treatment.
*On-treatment response should guide continued therapy [see Dosage and Administration (2.1) and Microbiology (12.4)].
 
*Tyzeka has not been evaluated in patients co-infected with [[HIV]], [[HCV]], or [[HDV]].
* For HBeAg-negative patients, Tyzeka should only be initiated in patients with HBV DNA less than 7 log10 copies per mL prior to treatment.
*Tyzeka has not been evaluated in liver transplant recipients or in patients with decompensated liver disease.
 
*Tyzeka has not been studied in well-controlled trials for the treatment of patients with established nucleoside analog reverse transcriptase inhibitor-resistant [[hepatitis B virus]] infection, but is expected to be cross-resistant to [[lamivudine]] [see Microbiology (12.4)].
* On-treatment response should guide continued therapy [see Dosage and Administration (2.1) and Microbiology (12.4)].
 
* Tyzeka has not been evaluated in patients co-infected with [[HIV]], [[HCV]], or [[HDV]].
 
* Tyzeka has not been evaluated in liver transplant recipients or in patients with decompensated liver disease.
 
* Tyzeka has not been studied in well-controlled trials for the treatment of patients with established nucleoside analog reverse transcriptase inhibitor-resistant [[hepatitis B virus]] infection, but is expected to be cross-resistant to [[lamivudine]] [see Microbiology (12.4)].
*The safety and efficacy of Tyzeka have not been evaluated in Black/African American or Hispanic patients [see Use in Specific Populations (8.9)].<ref>{{Cite web | last = | first =|title = http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022011s013lbl.pdf | url =http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022011s013lbl.pdf | publisher = |date = | accessdate = }}</ref>
*The safety and efficacy of Tyzeka have not been evaluated in Black/African American or Hispanic patients [see Use in Specific Populations (8.9)].<ref>{{Cite web | last = | first =|title = http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022011s013lbl.pdf | url =http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022011s013lbl.pdf | publisher = |date = | accessdate = }}</ref>


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{{FDA}}
{{FDA}}


[[Category:Antiviral]]
[[Category:Antibiotics]]
[[Category:Wikinfect]]
[[Category:Wikinfect]]

Latest revision as of 20:42, 2 January 2014

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]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]

Indications and Usage

Chronic Hepatitis B

Tyzeka is 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.

The following points should be considered when initiating therapy with Tyzeka:

  • This indication is based on virologic, serologic, biochemical and histologic responses in nucleoside treatment naïve adult patients with HBeAg positive and HBeAg negative chronic hepatitis B with compensated liver disease [see Clinical Studies (14)].
  • For HBeAg-positive patients, Tyzeka should only be initiated in patients with HBV DNA less than 9 log10 copies per mL and ALT greater than or equal to 2x Upper Limit of Normal (ULN) prior to treatment.
  • For HBeAg-negative patients, Tyzeka should only be initiated in patients with HBV DNA less than 7 log10 copies per mL prior to treatment.
  • On-treatment response should guide continued therapy [see Dosage and Administration (2.1) and Microbiology (12.4)].
  • Tyzeka has not been evaluated in patients co-infected with HIV, HCV, or HDV.
  • Tyzeka has not been evaluated in liver transplant recipients or in patients with decompensated liver disease.
  • Tyzeka has not been studied in well-controlled trials for the treatment of patients with established nucleoside analog reverse transcriptase inhibitor-resistant hepatitis B virus infection, but is expected to be cross-resistant to lamivudine [see Microbiology (12.4)].
  • The safety and efficacy of Tyzeka have not been evaluated in Black/African American or Hispanic patients [see Use in Specific Populations (8.9)].[1]

References

  1. ↑ "http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022011s013lbl.pdf" (PDF). External link in |title= (help)

Adapted from the FDA Package Insert.

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