Risk of Anaphylaxis (Myozyme, Lumizyme)

• Life threatening anaphylactic reactions, severe allergic reactions, and immune mediated reactions have been observed in some patients during alglucosidase-alfa infusions.
• Therefore, appropriate medical support should be readily available when alglucosidase alfa is administered.

Risk of Cardiorespiratory Failure (Myozyme)

• Patients with compromised cardiac or respiratory function may be at risk of serious acute exacerbation of their cardiac or respiratory compromise due to infusion reactions, and require additional monitoring.

Restricted Distribution Program (Lumizyme)

• Because of the potential risk of rapid disease progression in Pompe disease patients less than 8 yrs of age, Lumizyme is available through a restricted distribution program called the LUMIZYME ACE Program.
• Only prescribrs and healthcare facilities enrolled inthis program may prescribe, dispense, or administer Lumizyme.
• Lumizyme may be administered only to patietns who are enrolled in and meet all the conditions of the LUMIZYME ACE Program.
• To enroll in the LUMIZYME ACE Program call 1-800-745-4447.

FDA and Industry Communications

FDA Safety Alert Alglucosidase alfa

Approved Risk Evaluation and Mitigation Strategies (REMS)

Lumizyme (alglucosidase alfa) (PDF - 71KB)