Taliglucerase alfa

Generic Name: taliglucerase alfa (TAL-i-GLOO-ser-ase AL-fa)
Brand Name: Elelyso

Taliglucerase alfa is used for:

Treating type I Gaucher disease.

Taliglucerase alfa is an enzyme. It breaks down a substance (glucocerebroside) that builds up in the body in patients with Gaucher disease. This helps to decrease the harmful effects of the disease.

Do NOT use taliglucerase alfa if:

  • you are allergic to any ingredient in taliglucerase alfa, unless your doctor tells you otherwise

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

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Before using taliglucerase alfa:

Some medical conditions may interact with taliglucerase alfa. 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

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

Ask your health care provider if taliglucerase alfa 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 taliglucerase alfa:

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

  • Taliglucerase alfa is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using taliglucerase alfa at home, a health care provider will teach you how to use it. Be sure you understand how to use taliglucerase alfa. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Gently swirl taliglucerase alfa when mixing. Do not shake.
  • If taliglucerase alfa contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
  • 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.
  • If you miss a dose of taliglucerase alfa, contact your doctor for advice on when to schedule the next dose.

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

Important safety information:

  • Taliglucerase alfa may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use taliglucerase alfa with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Infusion reactions and allergic reactions have occurred in patients while receiving taliglucerase alfa or within 24 hours of receiving it. Most infusion reactions were mild; however, severe allergic reactions have also been reported. Tell your doctor right away if you experience bluish skin or nails; chest pain or discomfort; flushing or redness; rash; hives; itching; difficulty breathing or shortness of breath; fainting; severe or persistent cough; severe or persisting dizziness, light-headedness, or headache; swelling of the mouth, face, lips, throat, or tongue; tightness in the chest; unusual hoarseness; or wheezing.
  • Taliglucerase alfa 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 taliglucerase alfa during pregnancy. It is not known if taliglucerase alfa is found in breast milk. If you are or will be breast-feeding while you are using taliglucerase alfa, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of taliglucerase alfa:

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:

Arm, back, joint, or leg pain; flu-like symptoms; headache; symptoms of upper respiratory tract infection (eg, cough, runny or stuffy nose, sneezing, sore throat); tiredness; weakness.

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, throat, or tongue; unusual hoarseness); bluish skin or nails; burning, numbness, or tingling; chest pain or discomfort; difficult, frequent, or painful urination; fainting; flushing or redness; pain at the injection site; severe or persistent cough; severe or persistent dizziness, light-headedness, or headache; shortness of breath; swelling of the hands, ankles, or feet; wheezing.

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 taliglucerase alfa:

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

General information:

  • If you have any questions about taliglucerase alfa, please talk with your doctor, pharmacist, or other health care provider.
  • Taliglucerase alfa 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 taliglucerase alfa 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 taliglucerase alfa. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to taliglucerase alfa. 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 taliglucerase alfa.

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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