Tracking Your Response to Lumizyme

Just as Pompe disease affects people differently, responses to Lumizyme® (alglucosidase alfa) treatment will also vary from person to person. Talk to your doctor about what you might expect from treatment with Lumizyme. Some people find it useful to keep notes of any changes they experience over the course of their treatment, so they can keep track of important information to share with their healthcare team.

Regular Health Assessments

Regular visits with your physician are important to check how you’re responding to Lumizyme and to assess your overall health. You can assist with the monitoring process by keeping a journal to record changes in your health and condition, any new symptoms that have developed between visits. Record improvements as well as any declines in function that you observe. Taking photos and videos over time can be a good way to document changes and share them with your medical team. Open communication is important so that your healthcare providers are aware of all changes and can provide you with appropriate care.

Annual Comprehensive Visits

In addition to regular check-ups with your doctor, it is recommended that most people with Pompe disease have comprehensive medical evaluations that allow a variety of specialists to monitor how Pompe disease and treatment are affecting different parts of the body.

Learn more about Comprehensive Assessments and Supportive Care

Monitoring for Antibodies

Antibodies are proteins produced naturally by the body to “attack” foreign substances. In some patients, the body may react to Lumizyme as a foreign substance and form antibodies. There are two types of antibodies that may develop:

  • IgG antibodies are the smallest, most common antibodies produced by the immune system and are very important in fighting bacterial and viral infections.
  • IgE antibodies are formed when the body has an allergic reaction against foreign substances. This includes sudden reactions that result in the effects seen in hay fever, asthma, hives, and anaphylactic shock.

It is important to follow up with your doctor for regular monitoring when you are receiving Lumizyme treatment to find out if antibodies have formed and to follow the level (titers) of these antibodies over time. As a general guideline:

  • You should be monitored by your treating physician for IgG antibody formation every 3 months for the first 2 years, and then yearly. Your doctor may also consider testing for IgG titers if you develop an allergic or other immune mediated reaction.
  • If you experience allergic or anaphylactic (severe, life-threatening allergic) reactions, you may also be tested for IgE antibodies.

For more information on antibodies and monitoring, see the Full Prescribing Information or talk to your doctor.

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.

Product Information

Download this document for more details on Lumizyme, its indication, safety information, and its usage: