HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ELELYSO safely and effectively. See full prescribing information for ELELYSO.
ELELYSO® (taliglucerase alfa) for injection, for intravenous use
Initial U.S. Approval: 2012
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
ELELYSO is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for the treatment of patients 4 years and older with a confirmed diagnosis of Type 1 Gaucher disease (1).
DOSAGE AND ADMINISTRATION
Recommended Dosage in Patients 4 Years and Older (2.1):
DOSAGE FORMS AND STRENGTHS
For injection: 200 units lyophilized powder in a single-dose vial for reconstitution (3)
WARNINGS AND PRECAUTIONS
The most common adverse reactions are:
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION.
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