Elelyso

— THERAPEUTIC CATEGORIES —
  • Inborn errors of metabolism
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • 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

    Pfizer Inc.

    Generic Availability

    NO

    Mechanism of Action

    Elelyso, a long term enzyme replacement therapy, is a recombinant analog of human lysosomal glucocerebrosidase that catalyzes the hydrolysis of glucocerebroside to glucose and ceramide, reducing the amount of accumulated glucocerebroside. Elelyso uptake into cellular lysosomes is mediated by binding of Elelyso mannose oligosaccharide chains to specific mannose receptors on the cell surface leading to internalization and subsequent transport to the lysosomes.

    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. Consider premedication with antihistamines and/or corticosteroids. 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 immediately if severe hypersensitivity reactions including anaphylaxis occur 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

    Elimination

    Half-life: Pediatric: 37.1 minutes (range: 22.5–56.8); Adult: 18.9 minutes (range: 9.20–57.9).

    Elelyso Interactions

    Not Applicable

    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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