WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS, IMMUNE-MEDIATED REACTIONS, AND RISK OF ACUTE CARDIORESPIRATORY FAILURE
Hypersensitivity Reactions Including AnaphylaxisPatients treated with enzyme replacement therapies he experienced life-threatening hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. Initiate LUMIZYME in a healthcare setting with appropriate medical monitoring and support measures, including cardiopulmonary resuscitation equipment. If a severe hypersensitivity reaction (e.g. anaphylaxis) occurs, discontinue LUMIZYME immediately and initiate appropriate medical treatment, including the use of epinephrine.
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 ReactionsImmune-mediated reactions presenting as proteinuria, nephrotic syndrome, and necrotizing skin lesions he occurred in some patients following LUMIZYME treatment. Monitor patients for the development of systemic immune-mediated reactions involving skin and other organs while receiving LUMIZYME.
Risk of Acute Cardiorespiratory FailureInfantile-onset Pompe disease (IOPD) patients with compromised cardiac or respiratory function may be at risk of serious acute exacerbation of their cardiac or respiratory compromise due to fluid overload and require additional monitoring.
WARNINGS AND PRECAUTIONSInfusion Associated Reactions (IARs)Infusion Associated Reactions (IARs) he 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 he experienced IARs when re-administering LUMIZYME.
Risk of Cardiac Arrhythmia and Sudden Cardiac Death during General Anesthesia for Central Venous Catheter PlacementCaution 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 he 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 REACTIONSThe 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.
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