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 RECOMMENDATIONS RELATED TO BLACK BOX 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 Information
Medication Guides
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Additional Information
Updated January 2018