• Inborn errors of metabolism

Lumizyme Generic Name & Formulations

General Description

Alglucosidase alfa 50mg/vial; lyophilized pwd for IV infusion after reconstitution and dilution; preservative-free.

Pharmacological Class

Hydrolytic lysosomal glycogen-specific enzyme.

How Supplied

Single-use vial—1, 10


Generic Availability


Lumizyme Indications


Pompe disease (GAA deficiency).

Lumizyme Dosage and Administration

Adults and Children

Give by IV infusion over 4hrs. 20mg/kg every 2 weeks. Initial infusion rate: max 1mg/kg/hr; may increase by 2mg/kg/hr every 30mins, if tolerated, to max 7mg/kg/hr.

Lumizyme Contraindications

Not Applicable

Lumizyme Boxed Warnings

Boxed Warning

Risk of anaphylaxis, hypersensitivity, and immune-mediated reactions. Risk of cardiorespiratory failure.

Lumizyme Warnings/Precautions


Risk of anaphylaxis or severe hypersensitivity reactions; discontinue immediately if develop. Have appropriate medical support available and during rechallenge. Monitor for systemic immune-mediated reactions; consider discontinuing and treat if occur. Obtain urinalysis periodically. Acute underlying respiratory illness or compromised cardiac and/or respiratory function: risk of acute cardiorespiratory failure. Cardiac hypertrophy (increased risk of cardiac arrhythmia when given general anesthesia for central venous catheter placement). Infants with cardiac dysfunction may require prolonged observation times. Risk of antibody development. Infantile-onset disease: perform cross-reactive immunologic material (CRIM) assessment early in the disease course. Monitor for IgG antibody formation every 3 months for 2 years, then annually. Labor & delivery. Pregnancy. Nursing mothers (consider interrupting breastfeeding, pumping and discarding breast milk during and for 24hrs after therapy).

Lumizyme Pharmacokinetics

See Literature

Lumizyme Interactions

Not Applicable

Lumizyme Adverse Reactions

Adverse Reactions

Hypersensitivity reactions (including anaphylaxis, rash, pyrexia, flushing/feeling hot, urticaria, headache, hyperhidrosis, nausea, cough, decreased oxygen saturation, tachycardia, tachypnea, chest discomfort, dizziness, muscle twitching, agitation, cyanosis, erythema, hypertension, pallor, rigors, tremor, vomiting, fatigue, myalgia).

Lumizyme Clinical Trials

See Literature

Lumizyme Note


To enroll in the Pompe registry call (800) 745-4447.

Lumizyme Patient Counseling

See Literature