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

Company:
Pfizer Inc.
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:
Pruritus, flushing, headache, arthralgia, extremity pain, abdominal pain, vomiting, fatigue, back pain, dizziness, nausea, rash.

How Supplied:
Single-use vials—1