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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

INDICATIONS AND USAGE

ELELYSO is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for the treatment of patients with a confirmed diagnosis of Type 1 Gaucher disease (1).

DOSAGE AND ADMINISTRATION

Recommended Dosage in Patients 4 Years and Older (2.1)

  • Treatment-naïve: 60 units/kg administered every other week as a 60 to 120 minute intravenous infusion
  • Patients switching from imiglucerase: Begin ELELYSO at the same unit/kg dose as the patient's previous imiglucerase dose. Administer ELELYSO every other week as a 60 to 120 minute intravenous infusion. Dosage adjustments can be based on achievement and maintenance of each patient's therapeutic goals.

Preparation and Administration (2.2, 2.3)

  • 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 single-use vials 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, 6.3).

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 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: 10/2019

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