Lumizyme® (alglucosidase alfa) treatment is administered to patients by intravenous (IV) infusion, a process that involves infusing the medicine into a vein so that it can get into your bloodstream. Like other protein-based medications, Lumizyme cannot be taken as an oral treatment because proteins are destroyed in the digestive system. Infusion into the bloodstream bypasses the body's digestive processes.
Talk to your healthcare provider for more details about what to expect during and after your infusions. The following information may help you prepare for the experience of receiving Lumizyme treatment.
Before you start Lumizyme treatment, be sure to discuss any general health or medical issues with your healthcare provider—even if you think they’re not related to your Pompe disease—as they may affect how your healthcare provider will plan your treatment. You should also alert your healthcare provider before each infusion if any of these change:
1. Lumizyme infusions are administered by a healthcare professional.
3. The infusion needle will be inserted into a vein, usually in your arm or hand. If your veins are difficult to access, or you are anxious about needles, there are options that can help.
4. It will take several hours to receive the entire infusion. During this time you can participate in many types of activities, for example: reading, watching television, sleeping, visiting with family and friends.
5. During your infusion a healthcare professional will monitor your vital signs to see how your body is reacting to Lumizyme and for potential life-threatening reactions. If you experience severe allergic reactions, the infusion should be stopped and you will receive appropriate medical treatment. Be sure to communicate to your healthcare provider about any reactions you experience or observe during or after your infusions.
Should you experience adverse reactions during your infusion, your healthcare provider will decide appropriate medical treatment.
LUMIZYME® (alglucosidase alfa) is an enzyme replacement therapy for patients with Pompe disease (acid α-glucosidase (GAA) deficiency).
WARNING: RISK OF ANAPHYLAXIS, HYPERSENSITIVITY AND IMMUNE-MEDIATED REACTIONS, AND RISK OF CARDIORESPIRATORY FAILURE
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.
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.