Label Changes for:

Baraclude (entecavir) Tablets and Oral Solution

July 2008

Changes have been made to the BOXED WARNING, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- July 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 Summary of Changes to Contraindications and Warnings

BOXED WARNING

  • WARNINGS: SEVERE ACUTE EXACERBATIONS OF HEPATITIS B, PATIENTS CO-INFECTED WITH HIV AND HBV, and LACTIC ACIDOSIS AND HEPATOMEGALY

WARNINGS AND PRECAUTIONS

  • Severe Acute Exacerbations of Hepatitis B (new header)
  • Patients Co-infected with HIV and HBV (new header)
  • Lactic Acidosis and Severe Hepatomegaly with Steatosis (new subsection)

ADVERSE REACTIONS

  • Clinical Trial Experience
    • The most common adverse reactions of any severity (>3%) with at least a possible relation to study drug for Baraclude-treated subjects were headache, fatigue, dizziness, and nausea...
  • Postmarketing Experience
    • Immune system disorders
      • Anaphylactoid reaction

USE IN SPECIFIC POPULATIONS

  • Pregnancy
  • Nursing Mothers

PATIENT COUNSELING INFORMATION

  • Information about Treatment
    • Patients using the oral solution should be instructed to hold the dosing spoon in a vertical position and fill it gradually to the mark corresponding to the prescribed dose. Rinsing of the dosing spoon with water is recommended after each daily dose.

BOXED WARNING (the following headed added)

WARNINGS: SEVERE ACUTE EXACERBATIONS OF HEPATITIS B, PATIENTS CO-INFECTED WITH HIV AND HBV, and LACTIC ACIDOSIS AND HEPATOMEGALY

WARNINGS AND PRECAUTIONS

Lactic Acidosis and Severe Hepatomegaly with Steatosis (new subsection)

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

A majority of these cases have been in women. Obesity and prolonged nucleoside exposure may be risk factors. Particular caution should be exercised when administering nucleoside analogues to any patient with known risk factors for liver disease; however, cases have also been reported in patients with no known risk factors. 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).

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