Allergic Reactions Including Anaphylaxis and Immune-System Reactions:
Patients treated with enzyme replacement therapies have experienced allergic reactions, including severe or life-threatening hypersensitivity reactions (known as anaphylaxis), and reactions related to the immune system. Anaphylaxis has occurred during the early course and after repeated treatment with enzyme replacement therapy.

Your healthcare professional should initiate LUMIZYME in a healthcare setting with appropriate medical monitoring and support measures. If a severe hypersensitivity reaction (e.g. anaphylaxis) occurs, your healthcare provider will immediately slow or stop the infusion and provide appropriate medical treatment. Seek immediate medical care if signs and symptoms of any severe reactions occur. You may require close observation during and after the LUMIZYME infusion.

Risk of Acute Cardiorespiratory Failure:
Patients with compromised heart or breathing function due to Pompe disease, may be at risk of sudden worsening of their heart and/or lung function with LUMIZYME due to the fluid from the infusion. You may require close observation during and after your infusion.

Severe Allergic Reactions Including Anaphylaxis: see Boxed WARNING.

Signs of allergic reactions included cardiac and respiratory arrest (heart and lungs stop working), difficulty or shallow breathing; abnormal heart rate; low blood pressure; throat tightness; swelling of the tongue, lip, or face; and rash or hives.

Immune System Reactions: see Boxed WARNING.

Signs of an immune-system reaction included kidney dysfunction, elevated protein levels in urine, and severe skin lesions (tissue death).

Risk of Acute Cardiorespiratory Failure: see Boxed WARNING.

Infusion Associated Reactions (IARs)

Infusion Associated Reactions (IARs) have been observed in patients treated with Lumizyme. Your healthcare provider may decide to decrease the infusion rate, temporarily stop the infusion, or administer additional anti-fever and/or antihistamines medications that may treat the symptoms.

Risk of Irregular Heartbeat and Sudden Death during General Anesthesia for Central Venous Catheter Placement

Your healthcare provider should use caution when administering general anesthesia for the placement of a central venous catheter (a tubing line that can reach a large vein near your heart) for your LUMIZYME infusion.

Risk of Developing Anti-alglucosidase Alfa Antibodies

Patients with Infantile-onset Pompe disease (IOPD) should be managed by a specialist knowledgeable in immune tolerance induction (training the immune system to tolerate LUMIZYME) in Pompe disease to optimize treatment. Some patients who develop high and sustained IgG ADA antibody levels may have a reduced response to LUMIZYME treatment.

Your healthcare provider should monitor you for antibody formation before your first infusion and then regularly thereafter, depending on your response to treatment.