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

RECENT MAJOR CHANGES

Dosage and Administration, Pretreatment to Reduce Risk of Subsequent Hypersensitivity Reactions (2.1)

5/2023

Dosage and Administration, Administration Instructions (2.5)

8/2022

Warnings and Precautions, Hypersensitivity Reactions Including Anaphylaxis (5.1)

5/2023

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 (2.2):

•
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

Hypersensitivity Reactions Including Anaphylaxis: Observe patients during and after the infusion; immediately discontinue infusion if anaphylaxis occurs and initiate appropriate treatment. Reduction in the infusion rate and/or pre-medication may prevent subsequent reactions (5.1, 6.2).

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: 5/2023

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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

RECENT MAJOR CHANGES

Dosage and Administration, Pretreatment to Reduce Risk of Subsequent Hypersensitivity Reactions (2.1)

5/2023

Dosage and Administration, Administration Instructions (2.5)

8/2022

Warnings and Precautions, Hypersensitivity Reactions Including Anaphylaxis (5.1)

5/2023

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 (2.2):

•
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

Hypersensitivity Reactions Including Anaphylaxis: Observe patients during and after the infusion; immediately discontinue infusion if anaphylaxis occurs and initiate appropriate treatment. Reduction in the infusion rate and/or pre-medication may prevent subsequent reactions (5.1, 6.2).

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: 5/2023
Prescribing Information
Download Prescribing Information

Health Professional Information

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

RECENT MAJOR CHANGES

Dosage and Administration, Pretreatment to Reduce Risk of Subsequent Hypersensitivity Reactions (2.1)

5/2023

Dosage and Administration, Administration Instructions (2.5)

8/2022

Warnings and Precautions, Hypersensitivity Reactions Including Anaphylaxis (5.1)

5/2023

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 (2.2):

•
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

Hypersensitivity Reactions Including Anaphylaxis: Observe patients during and after the infusion; immediately discontinue infusion if anaphylaxis occurs and initiate appropriate treatment. Reduction in the infusion rate and/or pre-medication may prevent subsequent reactions (5.1, 6.2).

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: 5/2023

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