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Fabrazyme is used to treat Fabry disease, a rare inherited condition. Fabrazyme replaces an enzyme that either does not work correctly or is missing in people with Fabry disease. Common side effects of Fabrazyme include headache, tiredness, infection in the nose or throat, sore throat, or common cold symptoms. Get help right away if you have any symptoms of a serious allergic reaction, such as trouble breathing, a rash, or swelling of the face, mouth, or throat.

Uses

What is Fabrazyme used for?

Fabrazyme (agalsidase beta) is commonly used for a rare inherited condition called Fabry disease.

Fabrazyme may also be used for other conditions as determined by your health care provider.

How does Fabrazyme work (mechanism of action)?

A specific enzyme, called alpha-galactosidase A, does not work correctly or is missing in people with Fabry disease. This enzyme is needed to break down fatty substances. Over time, a certain type of fatty substance builds up in the body in people with Fabry disease, which can cause serious health issues. 

Fabrazyme is an enzyme replacement therapy (ERT). It replaces alpha-galactosidase A, which allows your body to break down the fatty substance the way it should and prevents it from building up in the body.

How is Fabrazyme supplied (dosage forms)?

Brands and other names

  • Fabrazyme

Dosage forms and strengths

Fabrazyme is available in an injectable form, which is given by a health care provider.

How should I store Fabrazyme?

Fabrazyme is usually given by a health care provider in a hospital or clinic. You will not store it at home.

Side Effects

What are the most common side effects of Fabrazyme?

The most common side effects of Fabrazyme are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Infection in the nose or throat, sore throat, or common cold symptoms
  • Chills or fever
  • Headache
  • Cough
  • Numbness, tingling, or burning in your arms, feet, or face
  • Tiredness
  • Swelling of the ankles, feet, or legs
  • Dizziness
  • Rash

There may be other side effects of Fabrazyme that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Fabrazyme?

While less common, the most serious side effects of Fabrazyme are described below, along with what to do if they happen.

Severe Allergic Reactions. Fabrazyme may cause allergic reactions, which can be serious. Allergic reactions can happen at any time during treatment with Fabrazyme, including when you first start treatment and after you have been on Fabrazyme for a while. Get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Wheezing or trouble breathing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Infusion Reactions. Fabrazyme can cause reactions that can be serious when it is given to you. Your infusion may need to be slowed or stopped if you have these reactions. Tell your health care provider right away if you have any of the following symptoms on the same day as your infusion.

  • Chills or fever
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Numbness, tingling, or burning in your arms, feet, or face
  • Trouble breathing
  • Redness of your face and neck
  • Headache
  • Tiredness
  • Hives or itching
  • Chest, joint, or muscle pain

Warnings & Precautions

Who should not use Fabrazyme?

Allergies to Ingredients. People who are allergic to any of the following should talk to their health care provider before using Fabrazyme.

  • Agalsidase beta
  • Fabrazyme
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Fabrazyme.

What should I know about Fabrazyme before using it?

Fabrazyme is usually given into a vein (IV) by a health care provider in a hospital or clinic. 

Your health care provider may prescribe other medicines for you to take before each dose of Fabrazyme. Make sure to take these medicines as directed. They are meant to reduce your risk of side effects from Fabrazyme.

What should I tell my health care provider before using Fabrazyme?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Fabrazyme is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

  • Heart problems
  • A previous allergic reaction or infusion reaction to Fabrazyme

Pregnancy. It is not known if or how Fabrazyme could affect pregnancy or harm a fetus. Tell your health care provider if you are pregnant or plan to become pregnant. Your health care provider will let you know if you should use Fabrazyme while you are pregnant or trying to get pregnant.

If you become pregnant while using Fabrazyme, you can sign up for a registry by calling 800-745-4447, extension 15500, or at www.registrynxt.com. This registry collects safety information about the use of Fabrazyme during pregnancy. If you have received Fabrazyme while pregnant, you can report this by calling 800-633-1610, option 1.

Breastfeeding. Fabrazyme passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should use Fabrazyme while breastfeeding. If you have received Fabrazyme while breastfeeding, you can report this by calling 800-633-1610, option 1.

How can I get more information about Fabrazyme?

For more information about Fabrazyme, you can visit the drugmaker’s website at www.fabrazyme.com or call them at 800-981-2491.

Interactions

Does Fabrazyme interact with foods or drinks?

There are no known interactions between Fabrazyme and foods or drinks.

It is unknown if drinking alcohol will affect Fabrazyme.

Does Fabrazyme interact with other medicines (drug interactions)?

Fabrazyme may interact with certain medicines. Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

This may not be a complete list of medicines that can interact with Fabrazyme. Always check with your health care provider.

 

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Fabrazyme?

If you or someone else has used too much Fabrazyme, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Fabrazyme?

Fabrazyme will be given by a health care provider in a hospital or clinic. If you miss an appointment to get your Fabrazyme dose, call to make another appointment as soon as possible.