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Fabrazyme

Generic Name: agalsidase beta (ay-GAL-si-dase)
Brand Name: Fabrazyme

Fabrazyme is used for:

Treating Fabry disease.

Fabrazyme is a glycoprotein. It works by providing the enzyme alpha-galactosidase A to the body.

Do NOT use Fabrazyme if:

  • you are allergic to any ingredient in Fabrazyme

Contact your doctor or health care provider right away if any of these apply to you.

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Before using Fabrazyme:

Some medical conditions may interact with Fabrazyme. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you are or have recently been ill
  • if you have heart or lung problems

Some MEDICINES MAY INTERACT with Fabrazyme. However, no specific interactions with Fabrazyme are known at this time.

Ask your health care provider if Fabrazyme may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Fabrazyme:

Use Fabrazyme as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Fabrazyme is usually given as an injection at your doctor's office, hospital, or clinic.
  • Do not use Fabrazyme if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • Continue to use Fabrazyme even if you feel well. Do not miss any doses.
  • If you miss a dose of Fabrazyme, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Fabrazyme.

Important safety information:

  • Fabrazyme may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Fabrazyme with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Many patients may experience a reaction while they are receiving their dose of Fabrazyme. Some reactions may be severe. Tell your doctor right away if you develop fever, chills, headache, rash, hives, itching, swelling, stomach pain, nausea, vomiting, muscle pain, dizziness, chest pain or tightness, fast heartbeat, throat tightness, or shortness of breath while you are receiving your dose. Discuss any questions or concerns with your doctor.
  • Lab tests, including allergy tests, may be performed while you use Fabrazyme. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Fabrazyme should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fabrazyme while you are pregnant. It is not known if Fabrazyme is found in breast milk. If you are or will be breast-feeding while you are using Fabrazyme, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Fabrazyme:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; headache; nausea; runny or stuffy nose; sore throat; stomach upset.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bone pain; chest pain or tightness; chills; confusion; decreased hearing or hearing loss; decreased or painful urination; fainting; fast, slow, or irregular heartbeat; fever; joint pain; loss of coordination; mental or mood changes (eg, anxiety, depression); muscle pain or weakness; numbness or pain of an arm or leg; one-sided weakness; severe headache, dizziness, or nausea; shortness of breath; slurred speech; stomach pain; sudden vision changes; swelling (eg, hands, legs, feet, lips, ears); throat tightness; unusual tiredness or weakness; unusually pale skin; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Fabrazyme:

Fabrazyme is usually handled and stored by a health care provider. If you are using Fabrazyme at home, store Fabrazyme as directed by your pharmacist or health care provider. Keep Fabrazyme out of the reach of children and away from pets.

General information:

  • If you have any questions about Fabrazyme, please talk with your doctor, pharmacist, or other health care provider.
  • Fabrazyme is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Fabrazyme or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Fabrazyme. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Fabrazyme. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Fabrazyme.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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