Lumizyme® (alglucosidase alfa) 50 mg vials are supplied as a sterile, nonpyrogenic, white to off-white lyophilized cake or powder in single-use vials. Lumizyme can be ordered directly from Sanofi Genzyme or through one of our distributors.
NDC(Carton of one single-use vial)
NDC(Carton of ten single-use vials)
Please note that a patient's insurance coverage may dictate how Lumizyme should be ordered (i.e., directly by the physician, by a treatment center pharmacy, etc.), so be sure to understand your patient's benefits.
If you plan to order directly from Sanofi Genzyme, please contact our Customer Operations group well in advance of your patient's first infusion to establish your account. You'll be assigned an Account Manager dedicated to making your Lumizyme ordering as seamless as possible.
To get Lumizyme pricing information, set up your account, or place an order, contact Sanofi Genzyme Customer Operations at
, option 1.
Our Account Managers are available Monday through Friday, 8AM to 6PM EST. An after-hours Account Manager is also on call through our answering service to assist with emergency situations.
Execution of a payment agreement is required prior to the purchase of Lumizyme; thereafter, the following terms apply:
Net 60 days, FOB destination, freight pre-paid, effective January 1, 2012
Lumizyme is a non-returnable product, except in cases of Sanofi Genzyme shipping error, product defect, or untreated patient. Sanofi Genzyme reserves the right to review other return requests on a case-by-case basis and may subsequently allow returns at its sole discretion. All returns require prior authorization from Sanofi Genzyme. For return authorization, call your Account Manager at Sanofi Genzyme Customer Operations (, option 1). The Lumizyme Return Goods Authorization Policy is available upon request.
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: Since Lumizyme is a protein, it is possible that patients receiving it develop antibodies. Some patients who develop high IgG antibody levels that last for a while may have reduced response to Lumizyme. 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.
If you are pregnant, you should use Lumizyme only if your doctor has determined that its use outweighs any risks to your unborn child.
Please see the Full Prescribing Information for complete details, including boxed WARNING.