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?

Some people receiving a taliglucerase alfa injection have had a reaction when the medicine was injected, or up to 3 hours later. Tell your caregivers right away if you have a sudden headache, dizziness, warmth or tingling, chest pain, wheezing, nausea, or a red skin rash.

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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; swelling of your face, lips, tongue, or throat.

Some people receiving a taliglucerase alfa injection have had a reaction when the medicine was injected, or up to 3 hours later. Tell your caregivers right away if you have:

  • dizziness, anxiety, weakness, tired feeling;

  • sudden headache, or light-headed feeling (like you might pass out);

  • flushing (warmth, redness, or tingly feeling);

  • fast or uneven heartbeats, chest pain or tightness, wheezing;

  • nausea, vomiting; or

  • red skin rash.

Common side effects may include:

  • headache;

  • rash, itching, warmth or tingly feeling;

  • dizziness or tired feeling;

  • nausea, stomach pain, vomiting; or

  • joint pain, back pain, pain in your arms or legs.

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:

Therapy-naive patients: 60 units/kg via IV infusion (administered over 60 to 120 minutes) every other week

Patients switching from imiglucerase:
-Patients currently being treated with imiglucerase for type 1 Gaucher disease can be switched to this drug.
-Patients previously receiving a stable dose of imiglucerase should begin this drug at that same dose when they switch from imiglucerase to taliglucerase alfa.
-Dose adjustments can be made based on achievement and maintenance of each patient's therapeutic goals.
-A clinical study evaluated doses ranging from 9.5 to 60 units/kg IV every other week.

Use: For long-term enzyme replacement therapy (ERT) for patients with confirmed diagnosis of type 1 Gaucher disease

Usual Pediatric Dose for Gaucher Disease:

4 years or older:
Therapy-naive patients: 60 units/kg via IV infusion (administered over 60 to 120 minutes) every other week

Patients switching from imiglucerase:
-Patients currently being treated with imiglucerase for type 1 Gaucher disease can be switched to this drug.
-Patients previously receiving a stable dose of imiglucerase should begin this drug at that same dose when they switch from imiglucerase to taliglucerase alfa.
-Dose adjustments can be made based on achievement and maintenance of each patient's therapeutic goals.
-A clinical study evaluated doses ranging from 9.5 to 60 units/kg IV every other week.

Use: For long-term enzyme ERT for patients with confirmed diagnosis of type 1 Gaucher disease

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: 2.01. Revision Date: 2014-09-20, 5:03:14 PM.

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