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

NEEDLE ACCEPTANCE

Lumizyme® (alglucosidase alfa) treatment is administered by intravenous (IV) infusion, which requires inserting a needle into the patient’s vein at each infusion. However, some people’s veins can be difficult to access, or they may have a fear of needles, making repeated needle insertions a stressful experience. Following are some options and alternatives that can help make the experience easier; you may wish to discuss these with your healthcare team.

Needle Tolerance

Before your infusions, be sure to keep warm and drink plenty of fluids, which can help make your veins more accessible to the healthcare provider inserting the needle. Try to relax and get comfortable before starting. You can also ask about having a numbing medicine applied to your skin to lessen the pain of the needle.

Your provider may also do the following to help make needle insertion easier:

  • Look for a vein in your arm or hand that is below the level of your heart
  • Gently tap the skin over the vein to make it easier to get into the vein
  • Have you wear an armband that pushes the vein out to make it easier to see
  • Have you make a fist several times
  • Put a warm compress or cloth over the vein, or put your arm in warm water, for 2 to 3 minutes

During your infusion, you might want to lie down and elevate your legs to increase blood flow to your infusion site. To stay relaxed, try turning your attention to something else, like listening to your favorite music, reading a book, or watching a DVD.

Alternative Devices

If vein access, needle insertion, or fears and anxieties continue to be an issue, your doctor may suggest that an implanted catheter, or similar device, be inserted. An implanted catheter is a device that is placed in the chest area under the skin surface using local or general anesthetics. An advantage of this device is that it provides predictable, direct access to veins without repeated needle injections. There may be a higher risk of infections compared to accessing a new vein site at each infusion. You may wish to discuss this option with your physician.

 

Resources

Product Information

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

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.