Telbivudine

Acute Exacerbation of Heptatitis B; Lactic Acidosis; Severe Hepatomegaly

Acute Exacerbation of Hepatitis B

  • Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including telbivudine.
  • Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy.
  • If appropriate, resumption of anti-hepatitis B therapy may be warranted. (see WARNINGS)

Lactic Acidosis/Severe Hepatomegaly

  • Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogues alone or in combination with other antiretrovirals.

Monitoring data

  • Closely monitor liver function after stopping therapy with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, resumption of anti-hepatitis B therapy may be warranted.
  • Suspend treatment in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity.

Patient counseling

Medical guidelines

Package inserts

Additional information

Updated: January 2018