Fabrazyme

Fabrazyme is a prescription medication used to treat Fabry disease. Fabrazyme belongs to a group of drugs called enzymes which work by replacing an enzyme that people with Fabry disease are missing known as alpha-galactosidase A.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects include chills, fever, changes in blood pressure, and nausea.

Fabrazyme can also cause dizziness. Do not drive or operate heavy machinery until you know how Fabrazyme affects you.

Fabrazyme is a prescription medication used to treat Fabry disease. Fabry disease is an inherited condition that can cause kidney failure, heart problems, and stroke.

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

• Genzyme Corporation

Serious side effects have been reported with Fabrazyme. See the "Drug Precautions" section.

Common side effects of Fabrazyme include:

• fever
• chills
• shortness of breath
• feeling hot or cold
• flushing
• vomiting
• chest pain
• stomach pain
• dizziness
• diarrhea
• throat tightness
• tiredness
• changes in heart rate
• swelling in the face and limbs
• back and muscle pain
• nasal congestion
• changes in blood pressure
• nausea
• headache
• itching
• anxiety

This is not a complete list of Fabrazyme side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been studied by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Fabrazyme including the following:

Anaphylaxis and allergic reactions. Severe allergic reactions can occur while receiving Fabrazyme. Tell your healthcare provider about any signs or symptoms of an allergy, which include the following:

• chest pain
• swelling of the face, eyes, lips, tongue, arms, or legs
• difficulty breathing or swallowing
• rash
• itching

Infusion reactions. Infusion reactions can occur with this medication. Your doctor may give you medications before receiving Fabrazyme to help prevent a reaction. Tell your doctor or get medical help right away if you get any of these symptoms during or after an infusion of this medication:

• chills
• nausea or vomiting
• headache
• tiredness
• pain in your arms or legs
• ithcing
• swlling of your lips, tongue, throat, or face
• shortness of breath, difficulty breathing, or wheezing
• dizziness or feel faint
• palpitations (feel like your heart is racing)
• chest pain

Compromised cardiac function. Patients with Fabry disease may have heart problems that can increase the risk of having severe reactions to an infusion of Fabrazyme. Tell your doctor about any current or previous heart problems you have. If your doctor decides you can receive Fabrazyme, you will be closely monitored for reactions.

Immunogenicity and re-challenge. In clinical studies, some patients who received Fabrazyme developed IgE antibodies (proteins that are usually produced by the body's immune system during an allergic reaction). Your doctor may test you for these antibodies if you experience an allergic reaction to Fabrazyme.

Fabrazyme can cause dizziness. Do not drive or operate heavy machinery until you know how Fabrazyme affects you.

Do not take Fabrazyme if you are allergic to Fabrazyme or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Fabrazyme, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Fabrazyme, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Fabrazyme or to any of its ingredients
• have heart problems
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Fabrazyme falls into category B. There are no well-done studies that have been done in humans with Fabrazyme. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

A patient registry has been created to monitor the effect of Fabrazyme on pregnant women and their children. Women who are able to become pregnant should enroll in this registry by visitng www.fabryregistry.com or calling (800)-745-4447.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Fabrazyme crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Fabrazyme.

Fabrazyme comes in an injectable form to be given directly into a vein (IV) by a healthcare professional. Fabrazyme is usually given once every 2 weeks. Your doctor may give you certain medications before receiving Fabrazyme to help prevent any infusion reactions.

If you miss an appointment to receive a dose of Fabrazyme, contact your healthcare provider immediately to make plans to receive your next dose.

The dose of Fabrazyme your doctor recommends will be based on your weight and may change depending on how you respond to this medication.

The recommended dose of Fabrazyme is 1 mg/kg body weight infused once every 2 weeks. The time it takes to infuse this medication may change depending on how you tolerate the infusion. It is important to keep all of your appointments to receive your Fabrazyme dose.

If Fabrazyme is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Keep all appointments for receiving doses of Fabrazyme.

A registry has been created to better understand the progression of Fabry disease and to evaluate long-term effects of treatment with Fabrazyme. For more information, visit www.fabryregistry.com or call (800) 745-4447.