IMPORTANT SAFETY INFORMATION:
WARNING: RISK OF ANAPHYLAXIS, HYPERSENSITIVITY AND IMMUNE-MEDIATED REACTIONS, and RISK OF CARDIORESPIRATORY FAILURE Life-threatening anaphylactic reactions and severe hypersensitivity reactions, presenting as respiratory distress, hypoxia, apnea, dyspnea, bradycardia, tachycardia, bronchospasm, throat tightness, hypotension, angioedema (including tongue or lip swelling, periorbital edema), and urticaria, have occurred in some patients during and after alglucosidase alfa infusions. Immune-mediated reactions presenting as proteinuria, nephrotic syndrome, and necrotizing skin lesions have occurred in some patients following alglucosidase alfa treatment. View more

ORDERING LUMIZYME

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 58468-0160-1 (Carton of one single-use vial)

NDC 58468-0160-2 (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.

Ordering Direct from Sanofi Genzyme

Lumizyme_Vial

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.

Lumizyme_Vial

Sanofi Genzyme Customer Operations

To get Lumizyme pricing information, set up your account, or place an order, contact Sanofi Genzyme Customer Operations at

800-745-4447, 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.

Shipping & Delivery

General Terms and Conditions

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

Returned Goods

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 (800-745-4447, option 1). The Lumizyme Return Goods Authorization Policy is available upon request.

Resources

Full Prescribing Information (PDF)

Lumizyme Fact Sheet (PDF)

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 or severe hypersensitivity reactions, and other severe reactions related to the immune system may occur during and after Lumizyme treatment. Reactions may include, for example, kidney dysfunction, extreme difficulty breathing, shallow breathing, abnormal heart rate, low blood pressure, or throat tightness (including face, tongue and lip swelling) and skin lesions.
  • If you or your child experiences these severe reactions, you may require close observation during and after Lumizyme administration. You should discuss with your physician the signs and symptoms of anaphylaxis and hypersensitivity reactions and seek immediate medical care should they occur. Anaphylaxis or severe hypersensitivity reactions are potentially very dangerous. 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 when you are being infused with Lumizyme.
  • If your child has a current respiratory condition or illness and has compromised breathing or heart function due to Pompe disease, there may be risk of acute worsening of heart and/or lung function with Lumizyme due to the fluid of 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: 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.

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.

Special populations

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.