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Indication
LUMIZYME® (alglucosidase alfa) is a hydrolytic lysosomal glycogen-specific enzyme indicated for patients with Pompe disease (GAA deficiency).
Important Safety Information
WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS, IMMUNE-MEDIATED REACTIONS, AND RISK OF ACUTE CARDIORESPIRATORY FAILURE Hypersensitivity Reactions Including Anaphylaxis Consider risks and benefits of re-administering LUMIZYME following severe hypersensitivity reactions. If a mild or moderate hypersensitivity reaction occurs, the infusion rate may be slowed or temporarily stopped. Prior to LUMIZYME administration, consider pretreating with antihistamines, antipyretics, and/or corticosteroids. Immune-Mediated Reactions Risk of Acute Cardiorespiratory Failure |
WARNINGS AND PRECAUTIONS
Infusion Associated Reactions (IARs)
Infusion Associated Reactions (IARs) have been observed in patients treated with Lumizyme. Discontinue immediately or adjust the infusion rate and provide medical treatment based on the severity of the reaction. Closely monitor patients who have experienced IARs when re-administering LUMIZYME.
Risk of Cardiac Arrhythmia and Sudden Cardiac Death during General Anesthesia for Central Venous Catheter Placement
Caution should be used when administering general anesthesia for the placement of a central venous catheter intended for LUMIZYME infusion.
Risk of Developing Anti-alglucosidase Alfa Antibodies (ADA)
Patients with IOPD should have a cross-reactive immunologic material (CRIM) assessment early in their disease course and be managed by a specialist knowledgeable in immune tolerance induction in Pompe disease to optimize treatment. Evidence suggests that patients who develop high and sustained IgG ADA antibody titers may experience reduced clinical efficacy.
Patients should be monitored for IgG ADA antibody formation beginning at baseline, then regularly during the first year of treatment with subsequent monitoring as clinically warranted. Patients who experience hypersensitivity reactions, including anaphylaxis, may also be tested for IgE antibodies to LUMIZYME and other mediators of anaphylaxis.
ADVERSE REACTIONS
The most frequently reported adverse reactions (≥ 5%) in clinical trials were hypersensitivity reactions and included: 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/increased blood pressure, pallor, rigors, tremor, vomiting, fatigue, and myalgia.
Please see full Prescribing Information, including Boxed WARNING.
