FDA Hepatitis Update - Changes to the Baraclude (entecavir) package and label

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Changes have been made to the Baraclude (entecavir) label to reflect a new protective outer cardboard carton added as secondary packaging for 0.5 and 1 mg tablets, intended to help avoid exposure to light.  The container has been updated with the wording "Protect from Light."

The label reflects the change under 16 HOW SUPPLIED/STORAGE AND HANDLING as follows:

Storage
BARACLUDE Tablets should be stored in a tightly closed container at 25° C (77° F); excursions
permitted between 15–30° C (59–86° F) [see USP Controlled Room Temperature]. Store in the
outer carton to protect from light.

BARACLUDE Oral Solution should be stored in the outer carton at 25° C (77° F); excursions
permitted between 15–30° C (59–86° F) [see USP Controlled Room Temperature]. Protect from light. After opening, the oral solution can be used up to the expiration date on the bottle. The bottle and its contents should be discarded after the expiration date.

The Patient Product Information similarly summarizes the storage information as follows:

How should I store BARACLUDE?

• Store BARACLUDE Tablets or Oral Solution at room temperature, between 59° F to 86° F (15° C to 30° C).

• Keep BARACLUDE Tablets in a tightly closed container.

• Do not store BARACLUDE Tablets in a damp place such as a bathroom medicine cabinet or near the kitchen sink.

• Store BARACLUDE Tablets or BARACLUDE Oral Solution in the original carton, and keep the carton out of the light.

The complete revised label will be posted at Drugs@FDA.

Baraclude is a nucleoside analogue indicated for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

Baraclude is a product of the Bristol-Myers Squibb Company

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

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