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