(taliglucerase alfa)

Prescribing Information
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Highlights

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

WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS

See full prescribing information for complete boxed warning.

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Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. (5.1)
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Initiate ELELYSO in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment. (5.1)
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If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue ELELYSO and immediately initiate appropriate medical treatment, including use of epinephrine. (5.1)

RECENT MAJOR CHANGES

Boxed Warning

7/2024

Dosage and Administration (2.1)

7/2024

Warnings and Precautions (5.1)

1/2025

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

Recommendations Prior to ELELYSO Treatment (2.1):

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Administration of ELELYSO should be supervised by a healthcare provider knowledgeable in the management of hypersensitivity reactions including anaphylaxis.

Recommended Dosage in Patients 4 Years and Older (2.2):

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Treatment-naïve: 60 units/kg administered every other week as a 60- to 120-minute intravenous infusion.
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Patients switching from imiglucerase: Initiate ELELYSO intravenous treatment (60- to 120-minute infusion) with the same units/kg imiglucerase dosage and subsequently administer ELELYSO every other week. Dosage adjustments can be based on achievement and maintenance of each patient’s therapeutic goals.

Preparation and Administration (2.3, 2.4, 2.5):

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Reconstitute, dilute and administer under the supervision of a healthcare professional.
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See Full Prescribing Information for complete instructions. 

DOSAGE FORMS AND STRENGTHS

For injection: 200 units lyophilized powder in a single-dose vial for reconstitution (3)

CONTRAINDICATIONS

None (4)

WARNINGS AND PRECAUTIONS

See boxed warning (5.1)

ADVERSE REACTIONS

The most common adverse reactions are:

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Treatment-Naïve Adults (≥5%): headache, arthralgia, fatigue, nausea, dizziness, abdominal pain, pruritus, flushing, vomiting, urticaria (6.1).
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Patients who Switched from Imiglucerase, after 9 Months on Treatment (≥10%): arthralgia, headache, pain in extremity (6.1).

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.

Revised: 1/2025

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