Generic Name and Formulations:
Taliglucerase alfa (recombinant) 200 Units; per vial; lyophilized pwd; for IV infusion after reconstitution; preservative-free.
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.
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.
Lysosomal glucocerebroside-specific enzyme.
Headache, arthralgia, fatigue, nausea, dizziness, abdominal pain, pruritus, flushing, vomiting, urticaria, extremity pain.