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Elelyso Generic Name & Formulations
Legal Class
Rx
General Description
Taliglucerase alfa (recombinant) 200 Units; per vial; lyophilized pwd; for IV infusion after reconstitution; preservative-free.
Pharmacological Class
Lysosomal glucocerebroside-specific enzyme.
How Supplied
Single-use vial—1
Manufacturer
Generic Availability
NO
Elelyso Indications
Indications
Long-term enzyme replacement therapy (ERT) for patients with confirmed Type 1 Gaucher disease.
Elelyso Dosage and Administration
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.
Elelyso Contraindications
Not Applicable
Elelyso Boxed Warnings
Not Applicable
Elelyso Warnings/Precautions
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. Nursing mothers.
Elelyso Pharmacokinetics
See Literature
Elelyso Interactions
Elelyso Adverse Reactions
Adverse Reactions
Headache, arthralgia, fatigue, nausea, dizziness, abdominal pain, pruritus, flushing, vomiting, urticaria, extremity pain.
Elelyso Clinical Trials
See Literature
Elelyso Note
Not Applicable
Elelyso Patient Counseling
See Literature
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