ELELYSO® Highlights

(taliglucerase alfa)

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.

•
Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. (5.1)
•
Initiate ELELYSO in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment. (5.1)
•
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)

7/2024

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):

•
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):

•
Treatment-naïve: 60 units/kg administered every other week as a 60- to 120-minute intravenous infusion.
•
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):

•
Reconstitute, dilute and administer under the supervision of a healthcare professional.
•
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:

•
Treatment-Naïve Adults (≥5%): headache, arthralgia, fatigue, nausea, dizziness, abdominal pain, pruritus, flushing, vomiting, urticaria (6.1).
•
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: 7/2024

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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.

•
Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. (5.1)
•
Initiate ELELYSO in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment. (5.1)
•
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)

7/2024

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):

•
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):

•
Treatment-naïve: 60 units/kg administered every other week as a 60- to 120-minute intravenous infusion.
•
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):

•
Reconstitute, dilute and administer under the supervision of a healthcare professional.
•
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:

•
Treatment-Naïve Adults (≥5%): headache, arthralgia, fatigue, nausea, dizziness, abdominal pain, pruritus, flushing, vomiting, urticaria (6.1).
•
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: 7/2024
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