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).

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.

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

None (4)

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).

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.