Drugs A - Z

telbivudine Images

Generic Name: telbivudine

Brand Names: Tyzeka

There is an FDA Alert for this drug. Click here to view it.

  • Severe acute exacerbations of hepatitis reported in patients who have discontinued anti-hepatitis B virus (HBV) therapy, including telbivudine. (See Exacerbations of Hepatitis under Cautions.) Closely monitor hepatic function in patients who discontinue anti-HBV therapy; if appropriate, resumption of therapy may be warranted.
  • Lactic acidosis and severe hepatomegaly with steatosis (including some fatalities) reported in patients receiving nucleoside analogs alone or in conjunction with antiretroviral agents. (See Lactic Acidosis and Severe Hepatomegaly with Steatosis under Cautions.)

REMS:

FDA approved a REMS for telbivudine to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).

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