Fabrazyme

Generic name: Agalsidase Beta
Drug class: Lysosomal enzymes

Usage of Fabrazyme

Fabrazyme is a man-made form of the naturally-occurring alpha-galactosidase A enzyme. A deficiency of this enzyme is called Fabry disease. Agalsidase beta reduces deposits of globotriaosylceramide (GL-3) in the kidneys and certain other cells in the body.

Fabrazyme is used in the treatment of Fabry disease (a deficiency of alpha-galactosidase A enzyme) in adults and children at least 2 years old.

Fabrazyme may also be used for purposes other than those listed here.

Fabrazyme side effects

Get emergency medical help if you have signs of an allergic Reaction to Fabrazyme:

wheezing, chest tightness, trouble breathing, feeling light-headed;

skin rash, hives, flushing (warmth, redness, or tingly feeling);

trouble swallowing; or

swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver right away if you have any of these signs of an infusion reaction:

chest pain, tightness in your throat, fast or slow heartbeats, pounding in your neck or ears;

shortness of breath, stuffy nose, feeling hot or cold;

tiredness, drowsiness, dizziness, feeling like you might pass out;

rash, itching, numbness or tingling ;

nausea, vomiting, stomach pain, diarrhea; or

headache, muscle pain, swelling in your hands or feet.

Common Fabrazyme side effects may include:

fever, chills, cough;

dizziness;

swelling in your hands or feet;

numbness or tingling;

feeling tired;

rash; or

cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Fabrazyme

To make sure Fabrazyme is safe for you, tell your doctor if you have ever HAD:

heart problems; or

an allergic reaction to agalsidase beta or have antibodies to the medication.

Tell your doctor if you are pregnant or breastfeeding.

Your name may be listed on a Fabry disease patient registry. This is to track the progress of your disease and to evaluate the treatment effects of Fabrazyme. Taking part in this registry is especially important if you are pregnant or breastfeeding.

Relate drugs

How to use Fabrazyme

Usual Adult Dose for Fabry Disease:

1 mg/kg IV every 2 weeks Comments: -Initial infusion rate should not exceed 0.25 mg/min (15 mg/hr). -Clinical studies did not include a sufficient number of patients aged 65 years or older to determine if they respond differently than younger patients. Use: For treatment of patients with Fabry disease

Usual Pediatric Dose for Fabry Disease:

8 years or older: 1 mg/kg IV every 2 weeks Comments: -Initial infusion rate should not exceed 0.25 mg/min (15 mg/hr). Use: For treatment of patients with Fabry disease

Warnings

Many people have a severe reaction to Fabrazyme. Tell your caregiver if you have a skin rash or hives, fever, chills, headache, muscle pain, dizziness, numbness, swelling, vomiting, diarrhea, chest pain, trouble swallowing or breathing, fast or slow heart rate, or severe dizziness.

Most patients treated with Fabrazyme develop antibodies to agalsidase beta and many will develop symptoms of an infusion reaction. A slow rate of injection of the medication and pretreatment with other medications may decrease the severity of these symptoms. Emergency medical attention may be required if a severe allergic reaction is experienced.

What other drugs will affect Fabrazyme

Other drugs may interact with agalsidase beta, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.