LUMIZYME® (Alglucosidase Alfa)

LUMIZYME® (alglucosidase alfa)

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Important Safety Information

LUMIZYME® (alglucosidase alfa) is an enzyme replacement therapy (ERT) for pediatric and adult patients with Pompe disease — a disorder that causes glycogen buildup in the cells. When not broken down, these high levels of glycogen become toxic, affecting vital organ function.

While LUMIZYME® alleviates symptoms of Pompe disease — such as headaches, muscle weakness, and infections of the respiratory system — individuals treated with this medication should be monitored throughout the duration of each infusion treatment to ensure there are no hypersensitivity reactions. Anaphylaxis has been observed in some patients after treatment. Tell your doctor immediately if you experience shortness of breath, abnormal heart rate, dizziness, abdominal pain, swelling of the lips, tongue, or throat, skin rashes, or hives. In such cases, infusions should be discontinued.

Pediatric patients with compromised heart or lungs may have a higher risk of fluid retention — and worsening the condition affecting these vital organs. Therefore, observation of these individuals should extend to several hours after treatment.

What is the most important information I should know about LUMIZYME®?

Some patients develop a high level of  IgG antibodies during treatment. This could increase the risk of developing an autoimmune disorder. Therefore, patients undergoing LUMIZYME® ERT should be monitored for IgG antibodies every 90 days during the first two years of treatment and once a year thereafter.

Patients undergoing treatment have a higher risk of anaphylaxis and cardiorespiratory failure. In addition, cardiac arrest has been observed on patients receiving LUMIZYME® while under general anesthesia. This has resulted in the death of infant patients. Talk with your doctor about your medical history, as you may require additional monitoring.

There is no information regarding adverse effects of LUMIZYME® in pregnancy or breast milk. Talk with your doctor if you’re pregnant, planning on becoming pregnant, are breastfeeding or planning to breastfeed. If you are pregnant or lactating, you may be encouraged to enroll in the Pompe disease registry. For more information, visit https://www.registrynxt.com/.

Side Effects of LUMIZYME®

As with any prescription medication, LUMIZYME® carries a risk of side effects. The most frequently reported ones include:

  • Fever
  • Headaches
  • Rapid heart rate
  • Nausea
  • Coughing
  • Excessive sweating
  • Muscle twitches
  • Chills
  • Fatigue
  • Vomiting
  • Muscle pain
  • Paleness of the face
  • Bluish tint to the skin
  • Hives
  • Throat tightness
  • Red, itchy welts on the skin (urticaria)

There’s also the possibility of delayed-onset reactions. These may include fatigue, nausea, and muscle pain (myalgia).

Tell your doctor if you experience any negative side effects. You are also encouraged to report such side effects to the Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088.

Indications

LUMIZYME® is used to treat pediatric and adult patients with Pompe disease. Infusions should be administered every two weeks — and each treatment lasts approximately four hours. The dosage will vary depending on the patient’s weight.

Please refer to the full prescribing information.