Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Fabrazyme (Agalsidase-beta).
Allergic and infusion-related reactions: Fabrazyme (Agalsidase-beta) can cause allergic reactions, some of which can be severe. You will receive Fabrazyme (Agalsidase-beta) under close medical supervision, especially at the beginning of treatment.
Most people develop antibodies when treated with enzyme replacement therapy. If you develop antibodies to agalsidase beta, you might experience allergic side effects such as an infusion-related reaction. The antibodies are not likely to stop Fabrazyme (Agalsidase-beta) from working and will decrease with time.
Infusion-related reactions can include chills, fever, increased blood pressure, feeling hot or cold, burning sensations, nausea, vomiting, flushing, fatigue, pain, headache, chest pain, or itchy skin, and usually within the first 3 months of treatment. If you experience an infusion-related reaction, your doctor can decrease the infusion rate or treat the reaction with other medications (e.g., Acetaminophen, Ibuprofen, antihistamines, or corticosteroids).
Heart rhythm: Agalsidase beta can cause changes to the normal rhythm of the heart, including an irregular heartbeat called QT prolongation. QT prolongation is a serious life-threatening condition that can cause fainting, seizures, and sudden death.
If you are at risk for heart rhythm problems (e.g., people with heart failure, Angina, low potassium or magnesium levels), discuss with your doctor how Fabrazyme (Agalsidase-beta) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Fabrazyme (Agalsidase-beta), and whether any special monitoring is needed.
Pregnancy: Fabrazyme (Agalsidase-beta) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Fabrazyme (Agalsidase-beta), contact your doctor immediately.
Breast-feeding: It is not known if agalsidase beta passes into breast milk. If you are a breast-feeding mother and are taking Fabrazyme (Agalsidase-beta), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using Fabrazyme (Agalsidase-beta) have not been established for children under 8 years of age.
Seniors: The safety and effectiveness of using Fabrazyme (Agalsidase-beta) have not been established for seniors.
