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 adults with Type 1 Gaucher disease.

Adult Dose for ELELYSO:
Give by IV infusion over 60–120 minutes. Individualize. 60 Units/kg once every 2 weeks. Begin treatment with Elelyso at the same dose when switching from imiglucerase.

Children's Dose for ELELYSO:
Not established.

Pharmacological Class:
Lysosomal glucocerebroside-specific enzyme.

Warnings/Precautions:
Discontinue if anaphylaxis occurs and treat appropriately. Temporarily discontinue, decrease infusion rate, or administer antihistamines, corticosteroids and/or antipyretics if allergic or infusion reactions occur. Monitor for IgG antibody formation. Pregnancy (Cat.B). Nursing mothers.

Adverse Reactions:
Infusion or allergic reactions (eg, chest pain, discomfort, asthenia, fatigue, urticaria, erythema, increased blood pressure, back pain, flushing), URTI/nasopharyngitis, pharyngitis/throat infection, headache, arthralgia, influenza/flu, UTI/pyelonephritis, back pain, extremity pain.

How Supplied:
Single-use vials—1