taliglucerase alfa

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

What is taliglucerase alfa?

Taliglucerase is a man-made form of an enzyme that occurs naturally in the body. It is used as an enzyme replacement in people with Type I Gaucher disease.

Gaucher disease is a genetic condition in which the body lacks the enzyme needed to break down certain fatty materials (lipids). Lipids can build up in the body, causing symptoms such as easy bruising or bleeding, weakness, anemia, bone or joint pain, enlarged liver or spleen, or weakened bones that are easily fractured.

Taliglucerase may improve the condition of the liver, spleen, bones, and blood cells in people with Type I Gaucher disease. However, taliglucerase is not a cure for this condition.

Taliglucerase may also be used for purposes not listed in this medication guide.

What is the most important information I should know about taliglucerase alfa?

You should not use taliglucerase alfa if you are allergic to it.

Some people receiving a taliglucerase alfa injection have had a reaction to the infusion (when the medicine is injected into the vein). Most infusion reactions have been mild. However, tell your caregiver right away if you feel dizzy, nauseated, anxious, light-headed, weak or tired, or have a sudden headache, red skin rash, fast or uneven heartbeats, chest pain or tightness, or buzzing in your ears during the injection. These side effects could occur up to 24 hours after your injection.

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Taliglucerase is not a cure for Gaucher disease.

What should I discuss with my healthcare provider before receiving taliglucerase alfa?

You should not use taliglucerase alfa if you are allergic to it.

FDA pregnancy category B. Taliglucerase alfa is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether taliglucerase alfa passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is taliglucerase alfa given?

Taliglucerase alfa is injected into a vein through an IV. A healthcare provider will give you this injection.

You may be given other medications to prevent certain side effects of taliglucerase alfa.

Taliglucerase alfa is usually given every other week. Follow your doctor's dosing instructions very carefully.

Your doctor may occasionally change your dose to make sure you get the best results.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your taliglucerase alfa injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking taliglucerase alfa?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Taliglucerase alfa side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; blue lips or fingernails; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Some people receiving a taliglucerase alfa injection have had a reaction to the infusion (when the medicine is injected into the vein). Most infusion reactions have been mild. However, tell your caregiver right away if you feel dizzy, nauseated, anxious, light-headed, weak or tired, or have a sudden headache, red skin rash, fast or uneven heartbeats, chest pain or tightness, or buzzing in your ears during the injection. These side effects could occur up to 24 hours after your injection.

Call your doctor at once if you have:

  • pain or burning when you urinate; or

  • fever, chills, body aches, flu symptoms, sores in your mouth and throat.

Common side effects may include:

  • mild headache;

  • low fever;

  • mild dizziness or tired feeling;

  • nausea, stomach pain;

  • joint pain, back pain; or

  • cold symptoms such as stuffy nose, sinus pain, 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.

See also: Side effects (in more detail)

Taliglucerase alfa dosing information

Usual Adult Dose for Gaucher Disease:

For long-term treatment of type 1 Gaucher disease: 60 units/kg via IV infusion (administered over 60 to 120 minutes) every 2 weeks

Patients currently being treated with imiglucerase for type 1 Gaucher disease can be switched to taliglucerase alfa. Patients previously treated on a stable dose of imiglucerase are recommended to begin treatment with taliglucerase alfa at that same dose when they switch from imiglucerase to taliglucerase alfa.

What other drugs will affect taliglucerase alfa?

Other drugs may interact with taliglucerase alfa, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about taliglucerase alfa.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum'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. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum 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.

Copyright 1996-2012 Cerner Multum, Inc. Version: 1.02. Revision Date: 2013-01-22, 4:14:53 PM.

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