Fabrazyme® (Agalsidase Beta)
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Fabrazyme®

Important Safety Information

Fabrazyme (agalsidase beta) is a medication that alleviates symptoms of Fabry disease — including joint and lower back pain, ringing in the ears, and a burning sensation in hands and feet. However, patients with advanced Fabry disease may be at a higher risk of severe infusion-related reactions. These can include breathing difficulties, swelling of the face, mouth, and throat, chest discomfort, itching, and flushing.

In a worst-case scenario, these complications could result in anaphylaxis and be life-threatening. To prevent such complications, it is crucial for the medical provider to monitor each infusion and stop it immediately and administer emergency care if the patient experiences complications.

What is the most important information I should know about Fabrazyme?

Fabry disease is a medical condition that occurs when there’s a mutation in the GLA gene. As a result, the body fails to metabolize globotriaosylceramide (GL-3) — causing a buildup of GL-3 and cell damage. Fabrazyme has been used effectively for more than 15 years to treat patients.

It is possible to develop antibodies while undergoing infusion treatment with Fabrazyme. If you experience an allergic reaction, your doctor will run tests to detect IgE antibodies. Tell your doctor immediately if you experience itchiness, hives, a rash, breathing difficulties, and/or chest tightness.

Side Effects of Fabrazyme

As with any prescription medication, Fabrazyme carries the risk of side effects. The most common ones were reported in approximately 20% of participants of the clinical studies. These include:

  • Headaches
  • Upper respiratory tract infection
  • Coughing
  • Burning or tingling sensation
  • Dizziness
  • Fatigue
  • Rash
  • Swelling in the legs

More serious side effects have been reported in approximately 5% of patients. These include:

  • Fever
  • Chest pain
  • Breathing difficulties
  • Nausea
  • Vomiting
  • Pain in the hands and feet
  • High blood pressure
  • Diarrhea
  • Muscle pain
  • Back pain
  • Slowing heart rate
  • Face swelling
  • Hives
  • Sleepiness

Anaphylactic shock has been observed in approximately 1% of patients who have undergone treatment with Fabrazyme. Such reactions have required hospitalization, resuscitation, administering oxygen, and treating the patient with corticosteroids to decrease allergy-induced inflammation.

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

Fabrazyme should be administered bi-weekly. Dosage varies depending on the patient’s body weight. The minimum infusion duration should be of one and a half hours — two hours.

Please refer to the full prescribing information.