Charitable Access Program

In addition to our other patient support programs the Charitable Access Program (CAP) has been established in the United States through the Genzyme Charitable Foundation, Inc. The program is committed to providing Lumizyme® to individuals who:

  • Medically need Cerezyme and
  • Are uninsured or have inadequate insurance coverage for Cerezyme

Qualified individuals with Pompe disease whose physicians have recommended treatment with Lumizyme may be eligible for the Charitable Access Program. To be considered for the program, your patient will be asked to provide the following:

  • A Letter of Intent to Treat with Lumizyme. The letter must be on MD letterhead and you must request charitable Lumizyme in the letter and reason why you are requesting charitable medication
  • A Statement of Medical Necessity
  • A completed program application

Your Sanofi Genzyme Case Manager will coordinate with you and your patient to obtain the necessary documentation, including a signed waiver, and keep you updated on the status of your patients application. Applications are reviewed on a monthly basis and are kept confidential by the Charitable Access Program Committee. If your patient is ineligible for our program, your Sanofi Genzyme Case Manager will work with your patient to explore alternative coverage options.

Please note that the Charitable Access Program is considered a temporary program. Patients and their families are expected to continue exploring alternative resources with the assistance of a Sanofi Genzyme Case Manager. These may include:

  • Private insurance
  • Government programs

To Learn More

To learn more about the Sanofi Genzyme's Charitable Access Program or to request an application form call 1-800-745-4447, option 3

Disclaimer: Genzyme's Charitable Access Program may be discontinued at anytime at the discretion of the Charitable Access Program Committee

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

The Pompe Registry

To learn more about the Pompe Registry, visit www.registrynxt.com.

Contact Us

Sanofi Genzyme
50 Binney Street
Cambridge, MA 02142

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