Agalsidase beta Injection

Agalsidase beta has been associated with hypersensitivity (severe allergic) reactions, including anaphylaxis, and may cause infusion-related reactions during and within 24 hours after infusions. Your doctor or nurse will monitor you very closely during your infusion. If you experience any of the following symptoms, tell your doctor immediately or seek emergency medical care: headache; nausea; vomiting; diarrhea; stomach pain; swelling of your face, lips, tongue, or throat; rash; hives; itching; fever; chills; dizziness; weakness; difficulty breathing; fast or irregular heartbeat; or chest pain. Your doctor will give you your medicine at a hospital or clinic and monitor you closely. Your doctor may given you medicines prior to each infusion to reduce the chance of these events occurring.

Agalsidase beta injection is used to treat Fabry disease (an inherited condition in which a type of fatty substance builds up in the body, resulting in nerve and organ damage) in adults and children 2 years of age and older. Agalsidase beta injection is in a class of medications called enzymes. It works by replacing an enzyme normally produced by the body that helps prevent the build up of the fatty substance in the body.

Agalsidase beta comes as a powder to be mixed with a liquid and injected intravenously (into a vein) by a doctor or a nurse in a hospital or clinic. Agalsidase beta injection is usually infused (injected slowly) intravenously over a period of at least 90 minutes once every 2 weeks.

Agalsidase beta injection may cause serious adverse reactions, including allergic reactions during an infusion and for 24 hours afterwards.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving agalsidase beta injection,

• tell your doctor and pharmacist if you are allergic to agalsidase beta, any other medications, or any of the ingredients in agalsidase beta injection. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• tell your doctor if you have or have ever had heart or kidney problems.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving agalsidase beta injection, call your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

If you miss an appointment to receive a dose of agalsidase beta injection, call your doctor right away.

Agalsidase beta injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• cough, sore throat, runny nose, or other signs of infection
• fatigue
• back pain
• ringing in the ears
• hearing loss
• repeatedly picking or scratching skin
• anxiety
• depression
• hot flashes
• falling

Agalsidase beta injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Fabrazyme^®