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U.S. Department of Health and Human Services

Safety

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Baraclude (entecavir) Tablets and Oral Solution

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – June 2008, December 2010 and October 2012

 

October 2012

Summary View

 

USE IN SPECIFIC POPULATIONS

Racial/Ethnic Groups
  • There are no significant racial differences in entecavir pharmacokinetics. The safety and efficacy of Baraclude 0.5 mg once daily were assessed in a single-arm, open-label trial of HBeAgpositive or -negative, nucleoside-naïve, Black/African American (n=40) and Hispanic (n=6) subjects with chronic HBV infection. In this trial, 76% of subjects were male, the mean age was 42 years, 57% were HBeAg-positive, the mean baseline HBV DNA was 7.0 log10 IU/mL, and...
 
Liver Transplant Recipients
  • The safety and efficacy of BARACLUDE were assessed in a single-arm, open-label trial in 65 subjects who received a liver transplant for complications of chronic HBV infection. Eligible subjects who had HBV DNA less than 172 IU/mL (approximately 1000 copies/mL) at the time of transplant were treated with BARACLUDE 1 mg once daily in addition to usual posttransplantation management, including hepatitis B immune globulin. The trial population was 82% male, 39% Caucasian, and 37% Asian, with a mean age of 49 years; 89% of subjects had
HBeAg-negative disease at the time of transplant.
  • Four of the 65 subjects received 4 weeks or less of BARACLUDE (2 deaths, 1 retransplantation, and 1 protocol violation) and were not considered evaluable. Of the 61 subjects who received more than 4 weeks of BARACLUDE, 60 received hepatitis B immune globulin post-transplant. Fifty-three subjects (82% of all 65 subjects treated) completed the trial and had HBV DNA measurements at or after 72 weeks treatment post-transplant.All 53 subjects had HBV DNA…

 

December 2010

Summary View

 

Warnings and Precautions

Lactic Acidosis and Severe Hepatomegaly with Steatosis
  • Lactic acidosis with Baraclude use has been reported, often in association with hepatic decompensation, other serious medical conditions, or drug exposures. Patients with decompensated liver disease may be at higher risk for lactic acidosis. Treatment with Baraclude should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations).

ADVERSE REACTIONS

Postmarketing Experience
  • Metabolism and nutrition disorders: lactic acidosis
  • Hepatobiliary disorders: increased transaminases

Patient Package Insert

Baraclude can cause serious Side effects including
  • Lactic Acidosis...Reports of lactic acidosis with Baraclude generally involved patients who were seriously ill due to their liver disease or other medical condition.

 

June 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


 

Summary View

Sections Modified

ADVERSE REACTIONS

  • Postmarketing Experience (new subsection)
    • Skin and subcutaneous tissue disorders
      • Rash

PATIENT PACKAGE INSERT

  • What are the possible side effects of Baraclude?
    • There have also been occasional reports of rash (added)
  • How should I store Baraclude?
    • Keep Baraclude and all medicines out of the reach of children and pets at all times. Do not keep medicine that is out of date or that you no longer need. Dispose of unused medicines through community take-back disposal programs when available or place Baraclude in an unrecognizable closed container in the household trash.

 

Label approved 06/03/2008 is not available on Drugs@FDA