Genzyme Care Coordination

Living with a chronic illness like Pompe disease can be challenging, as can coordinating access to treatment, and Genzyme is here to help. Whether you've just been diagnosed or have been managing your condition for awhile, our Care Coordination services can support you through all aspects of coordinating your coverage for Lumizyme® (alglucosidase alfa) treatment. Our services are offered at no cost to you, and are completely voluntary. A consent form is required for a Genzyme Case Manager to work with you, your health care providers, and your insurance company, and all information you provide to us will be remain entirely confidential.

Personalized Support

If you decide to take advantage of Genzyme’s Care Coordination services, you will have access to your own personal Case Manager, someone who will get to know you, assess your unique situation, and tailor his or her services to meet your specific needs. Genzyme Case Managers are aligned regionally, so you will work with someone who is familiar with local resources and who understands your state’s insurance regulations.

lumizyme patient

Your Genzyme Case Manager will partner with you along the journey from diagnosis to treatment plan, helping you navigate any bumps along the way. Working closely with you and your family, your health care providers, and insurance company, your Genzyme Case Manager will help coordinate access to treatment with Lumizyme by providing one-on-one, personalized support, including:

  • Information about diagnostic testing options
  • Assistance finding treatment centers and medical experts in your area
  • Assistance understanding your current insurance coverage and benefits with regards to treatment with Lumizyme
  • Information about programs that may provide financial assistance for eligible applicants who are uninsured or underinsured
  • Support for your healthcare providers with insurance authorizations, claims, and billing for Lumizyme treatment

Your Call, Our Commitment

A Genzyme Case Manager is only a phone call away, ready to answer questions or provide assistance for your and your family. Contact Genzyme Care Coordination at 800-745-4447, option 3, Monday through Friday, 8AM to 6PM EST.

Spanish-speaking Case Managers are available, as well as interpreters for other languages.

Information that you provide will always be kept confidential. Genzyme offers all Care Coordination services in compliance with patient privacy regulations (HIPAA).

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.

To report suspected adverse reactions, contact Sanofi Genzyme at 1-800-745-4447 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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