Charitable Access Program

The Sanofi Genzyme 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 Lumizyme and
  • Are uninsured or have inadequate insurance coverage for Lumizyme

Qualified individuals with Pompe disease whose physicians have recommended treatment with Lumizyme may be eligible for the Charitable Access Program. If you are ineligible for our program, your Sanofi Genzyme Case Manager will work with you and your health care providers to explore alternative coverage options.

 

To be considered for the program, you will be asked to provide the following:

 

  • A Letter of Intent to Treat with Lumizyme. The letter must be on MD letterhead and your physician must request charitable Lumizyme in the letter and reason why he/she is requesting charitable medication
  • A Statement of Medical Necessity from your physician
  • 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.

 

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

 

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

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.

WARNING 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 the 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.

You may report side effects to the FDA at 1-800-FDA-1088.

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

Pompe Registry

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