IMPORTANT SAFETY INFORMATION:
WARNING: RISK OF ANAPHYLAXIS, HYPERSENSITIVITY AND IMMUNE-MEDIATED REACTIONS, AND RISK OF CARDIORESPIRATORY FAILURE If you or your child is taking Lumizyme, you should know that severe and potentially life-threatening allergic-type reactions known as anaphylaxis, severe hypersensitivity reactions, and reactions related to the immune system may occur during and after Lumizyme treatment. These reactions may include extreme difficulty breathing, shallow breathing, abnormal heart rate, low blood pressure, throat tightness, face and tongue swelling, kidney dysfunction, and severe skin lesions. You should seek immediate medical care if signs and symptoms of anaphylaxis, hypersensitivity reactions, and immune system reactions occur. View more

POSSIBLE SIDE EFFECTS

Following is a summary of some of the important warnings and precautions associated with Lumizyme® (alglucosidase alfa) treatment, as well as the adverse reactions (side effects) most frequently reported during clinical trials. Additional "Important Safety Information" can be found at the bottom of this page. If you have any questions or concerns, you should review and discuss this information with your doctor.

Important Warnings and Precautions

  • Life-threatening severe allergic (anaphylactic) and hypersensitivity reactions have occurred in some patients during Lumizyme infusions and up to 3 hours after Lumizyme infusion. Your doctor should have appropriate medical support measures, including cardiopulmonary (heart/lung) resuscitation equipment readily available during your Lumizyme infusion.
    • If such a reaction is severe enough, your doctor may decide to immediately discontinue the infusion and provide you with immediate medical care.
  • Severe skin-related (cutaneous) and other immune system-related reactions can occur within several weeks to 3 years after starting treatment with Lumizyme. Your doctor should monitor you for the development of reactions involving skin and other organs.
  • There is a risk of worsening heart or lung function during Lumizyme infusions in patients with an acute respiratory illness or reduced heart and/or breathing function due to Pompe disease.
    • Medical support should be available and additional monitoring may be used, depending on the needs of the individual patient. Acute difficulty has been seen in infantile patients, possibly associated with excess fluid with the administration of Lumizyme.
  • Caution is required with the use of general anesthesia due to potential complications of underlying severe muscle weakness of the heart and breathing muscles. Irregular heart beat (arrhythmias) requiring urgent medical intervention have occurred in infantile-onset Pompe patients with enlarged hearts.
  • Development of IgG antibody (an immune response) occurs in the majority of patients, typically within 3 months of starting Lumizyme infusions. Patients should be tested for IgG antibody every 3 months for 2 years and then once a year; this is done by a test on a blood sample.
    • There is evidence that high levels of antibody over a period of time may be associated with a lower effectiveness of Lumizyme; additional testing may be ordered by your/ your child’s doctor.

Most Frequently Reported Adverse Reactions

The most frequently reported adverse reactions during Lumizyme studies in patients were allergy (hypersensitivity) reactions and included:

  • Anaphylaxis
  • Rash
  • Fever
  • Flushing/feeling hot
  • Hives
  • Headache
  • Excessive sweating
  • Nausea
  • Cough
  • Less oxygen in the blood
  • Fast heart rate
  • Rapid breathing
  • Chest discomfort
  • Dizziness
  • Muscle twitching
  • Agitation
  • Bluish or purple skin
  • Redness of skin
  • High blood pressure/increased blood pressure
  • Facial paleness
  • Chills
  • Tremor
  • Vomiting
  • Fatigue
  • Muscle pain

If an infusion reaction occurs, your doctor may temporarily stop the infusion, and/or administer antihistamines (drugs to combat an allergic reaction) and/or anitpyretics (drugs to reduce fever) to help the symptoms.

 

Resources

Product Information

Download this document for more details on Lumizyme, its indication, safety information, and its usage:

Report Side Effects

If you suspect you might be having side effects from your Lumizyme treatment, or any other medication, it's important that you report these experiences to your doctor immediately. You can also report them to Sanofi Genzyme by calling our Medical Information group at 800-745-4447, option 2.

Indication

LUMIZYME® (alglucosidase alfa) is an enzyme replacement therapy for patients with Pompe disease (acid α-glucosidase (GAA) deficiency).

Important Safety Information

WARNING: RISK OF ANAPHYLAXIS, HYPERSENSITIVITY AND IMMUNE-MEDIATED REACTIONS, AND RISK OF CARDIORESPIRATORY FAILURE 

  • If you or your child is taking Lumizyme, you should know that severe and potentially life-threatening allergic-type reactions known as anaphylaxis, severe hypersensitivity reactions, and reactions related to the immune system may occur during and after Lumizyme treatment. These reactions may include extreme difficulty breathing, shallow breathing, abnormal heart rate, low blood pressure, throat tightness, face and tongue swelling, kidney dysfunction, and severe skin lesions. You should seek immediate medical care if signs and symptoms of anaphylaxis, hypersensitivity reactions, and immune system reactions occur. If such a reaction is severe enough, your doctor may decide to immediately discontinue the infusion and provide immediate medical care. Appropriate medical support measures may be administered during your infusion, and you may require close observation during and after Lumizyme administration.
  • If your child has compromised breathing or heart function due to Pompe disease, there may be a risk of acute worsening of heart and/or lung function with Lumizyme due to the fluid from the infusion, and your doctor may decide that close observation during and after Lumizyme administration may be necessary.

Warnings and Precautions

Anaphylaxis and Hypersensitivity Reactions: Life-threatening anaphylaxis and hypersensitivity reactions have been observed in some patients during and after treatment with alglucosidase alfa. If such a reaction is severe enough, your doctor may decide to immediately discontinue the infusion and provide you with immediate medical care. Appropriate medical support and monitoring measures should be available during infusion.

Immune-Mediated Reactions: You or your child may be monitored for the development of systemic immune-mediated reactions while receiving Lumizyme. If these reactions occur, your doctor may discontinue the infusion and initiate appropriate medical treatment.

Risk of Acute Cardiorespiratory Failure: Infant Pompe patients with heart or breathing problems who are experiencing an acute respiratory condition may be at risk for increasing the seriousness of these problems as a result of Lumizyme administration due to the infusion fluid, and your child’s doctor may require additional monitoring for these infants.

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. Ventricular arrhythmias and slow heart rate resulting in cardiac arrest or death have been observed in infant Pompe patients with cardiac hypertrophy during general anesthesia for central venous catheter placement. Appropriate medical support and monitoring measures should be available during infusion.

Risk of Antibody Development: Patients with infantile-onset Pompe disease (IOPD) should be managed by a clinical specialist knowledgeable in immune tolerance induction in Pompe disease to optimize treatment. Some patients who develop high and sustained IgG antibody levels, including certain IOPD patients, may have a reduced response to Lumizyme.

Monitoring: Laboratory Tests: Patients should be monitored for IgG antibody formation every 3 months for 2 years and then annually thereafter.

Adverse Reactions

The most frequently reported adverse reactions during Lumizyme studies in patients were allergy reactions and included: anaphylaxis, rash, fever, flushing/feeling hot, hives, headache, excessive sweating, nausea, cough, less oxygen in the blood, fast heart rate, rapid breathing, chest discomfort, dizziness, muscle twitching, agitation, bluish or purple skin, redness of skin, high blood pressure/increased blood pressure, facial paleness, chills, tremor, vomiting, fatigue, and muscle pain.

Please see the Full Prescribing Information for complete details, including boxed WARNING.