(a gal' si dase be' ta)

Brand Name(s): Fabrazyme^®

WHY is this medicine prescribed?

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.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Agalsidase beta comes as a powder to be mixed with a liquid and injected intravenously (into a vein) by a healthcare provider. 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. A doctor or nurse will monitor you carefully while you are receiving the medication. You may be given other medications to treat or prevent reactions to agalsidase beta injection. Tell your doctor or nurse immediately or seek emergency care if you experience any of the following symptoms during or shortly after your infusion: nausea; vomiting; skin redness; rash; hives; itching; swelling of the face, eyes, mouth, throat, tongue, lips, hands, feet, ankles, or lower legs; difficulty breathing or swallowing; shortness of breath; fever; headache; chest pain; feeling hot or cold; diarrhea; stomach pain; dizziness; sleepiness; nasal congestion; fast or slow heartbeat; numbness, burning, or tingling in the arms, legs, hands, or feet; or muscle, arm, or leg pain.

What SPECIAL PRECAUTIONS should I follow?

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.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

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

What SIDE EFFECTS can this medicine cause?

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.

What should I do in case of OVERDOSE?

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.

What OTHER INFORMATION should I know?

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.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: July 15, 2023.