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, and contact a Sanofi Genzyme Case Manager (800-745-4447, option 3) if you have questions.

Ordering Direct from Sanofi Genzyme

Lumizyme vial and packaging

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.

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.

INDICATION

LUMIZYME® (alglucosidase alfa) is a hydrolytic lysosomal glycogen-specific enzyme indicated for patients with Pompe disease (GAA deficiency).

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 face 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. Closely observe patients during and after alglucosidase alfa administration and be prepared to manage anaphylaxis and hypersensitivity reactions. Inform patients of the signs and symptoms of anaphylaxis, hypersensitivity reactions, and immune-mediated-reactions and have them seek immediate medical care should signs and symptoms occur.
  • Infantile-onset Pompe disease patients with compromised cardiac or respiratory function may be at risk of serious acute exacerbation of their cardiac or respiratory compromise due to fluid overload, and require additional monitoring.

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 anaphylaxis or severe hypersensitivity reactions occur, immediately discontinue infusion and institute appropriate medical treatment. Appropriate medical support and monitoring measures should be available during infusion.

Immune-Mediated Reactions: Monitor patients for the development of systemic immunemediated reactions involving skin and other organs.

Risk of Acute Cardiorespiratory Failure: Patients with acute underlying respiratory illness and compromised cardiac and/or respiratory function may be at risk of acute cardiorespiratory failure. Caution should be exercised when administering alglucosidase alfa to patients susceptible to fluid volume overload. Appropriate medical support and monitoring measures should be available during infusion and some patients may require longer observation times.

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 alglucosidase alfa infusion.

Risk of Antibody Development: As with all therapeutic proteins, there is potential for immunogenicity. There is some evidence to suggest that some patients who develop high and sustained IgG antibody titers may experience reduced clinical efficacy. 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 (≥ 5%) in clinical trials were hypersensitivity reactions and included: anaphylaxis, rash, pyrexia, flushing/feeling hot, urticaria, headache, hyperhidrosis, nausea, cough, decreased oxygen saturation, tachycardia, tachypnea, chest discomfort, dizziness, muscle twitching, agitation, cyanosis, erythema, hypertension/increased blood pressure, pallor, rigors, tremor, vomiting, fatigue, and myalgia.

USE IN SPECIFIC POPULATIONS

Pregnancy: Based on animal data, alglucosidase alfa may cause fetal harm.

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

Contact Us

Sanofi Genzyme
50 Binney Street
Cambridge, MA 02142

Tel : 617-768-9000
Fax : 617 252 7600
Toll free : 800-745-4447