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ELELYSO
Inborn errors of metabolism
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Drug Name:

ELELYSO Rx

Generic Name and Formulations:
Taliglucerase alfa (recombinant) 200 Units; per vial; lyophilized pwd; for IV infusion after reconstitution; preservative-free.

Company:
Pfizer Inc.

Therapeutic Use:

Indications for ELELYSO:

Long-term enzyme replacement therapy (ERT) for patients with confirmed Type 1 Gaucher disease.

Adults and Children:

<4yrs: not established. Give by IV infusion over 60–120 minutes. ≥4yrs: 60 Units/kg once every 2 weeks. Begin treatment with Elelyso at the same dose when switching from imiglucerase.

Warnings/Precautions:

Have appropriate medical support available. Closely monitor patients during and after the infusion. Discontinue if anaphylaxis occurs and treat appropriately. Reduce or temporarily interrupt infusion, or administer antihistamines, corticosteroids and/or antipyretics if hypersensitivity reactions occur. Monitor for development of anti-drug antibodies. Pregnancy (Cat.B). Nursing mothers.

Pharmacological Class:

Lysosomal glucocerebroside-specific enzyme.

Adverse Reactions:

Headache, arthralgia, fatigue, nausea, dizziness, abdominal pain, pruritus, flushing, vomiting, urticaria, extremity pain.

Generic Availability:

NO

How Supplied:

Single-use vials—1

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