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Alglucerase

 
  Generic Name: Alglucerase (al GLOO ser ase)
 
  Brand Names: Ceredase  
     
   
 

What is alglucerase?

Alglucerase 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.

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

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

What is the most important information I should know about alglucerase?

Alglucerase may improve the condition of the liver, spleen, bones, and blood cells in people with Type I Gaucher disease. However, alglucerase is not a cure for this condition. Some people receiving an alglucerase injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel itchy, dizzy, light-headed, or have hives, stomach cramps, pain or tightness in your chest, trouble breathing, or swelling of your face, lips, tongue, or throat.

It may still be possible for you to receive alglucerase even after you have had a reaction to it. There are other medications that can be given to you before your alglucerase infusion to help prevent any reaction symptoms.

What should I discuss with my health care provider before taking alglucerase?

Before using alglucerase, tell your doctor if you are allergic to any drugs, or if you have a hormone-related cancer such as prostate cancer. You may need a dose adjustment or special tests to safely take alglucerase.

Alglucerase is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Alglucerase may pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is alglucerase given?

Alglucerase is given as an injection through a needle placed into a vein. You will most likely receive this injection in a clinic or hospital setting.

The medicine must be given slowly through an IV infusion, and can take up to 2 hours to complete.

Alglucerase is sometimes given 3 times per week at first. Your dosage may be changed to once per week, once every 2 weeks, or once every 4 weks. Follow your doctor's instructions.

Your doctor may also prescribe other medications to help prevent an allergic reaction to alglucerase. Take all of your medications as directed.

You may be shown how to use this medicine at home. Do not inject alglucerase yourself if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine.

Do not shake the medication vial (bottle). Vigorous shaking can ruin the medicine. Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

To be sure this medication is helping your condition and not causing harmful effects, your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

If you store this medication at home, keep it in the refrigerator and do not allow it to freeze.

What happens if I miss a dose?

Call your doctor if you miss an appointment for your alglucerase injection or forget to use it at home.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of an alglucerase overdose are not known.

What should I avoid while taking alglucerase?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using alglucerase.

Alglucerase side effects

Some people receiving an alglucerase injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel itchy, dizzy, light-headed, or have hives, stomach cramps, pain or tightness in your chest, trouble breathing, or swelling of your face, lips, tongue, or throat.

It may still be possible for you to receive alglucerase after you have had a reaction to it. There are other medications that can be given to you before your alglucerase infusion to help prevent any reaction symptoms.

Call your doctor at once if you have any of these serious side effects:
  • mouth sores;

  • warmth, redness, or tingly feeling under your skin;

  • easy bruising or bleeding;

  • extreme weakness or tired feeling;

  • swollen belly, stomach discomfort; or

  • pale skin.

Some of these may be symptoms of your condition and not actual side effects of alglucerase.

Less serious side effects may include:

  • hot flashes;

  • changes in your menstrual periods;

  • headache;

  • back pain;

  • swelling in your hands or feet;

  • changes in your sense of smell;

  • nausea, diarrhea, upset stomach;

  • fever or chills; or

  • any burning, itching, or swelling around the IV needle when the medicine is injected.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect alglucerase?

There may be other drugs that can interact with alglucerase. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about alglucerase.
  • 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 1996-2006 Cerner Multum, Inc. Version: 1.02. Revision Date: 4/12/2009 4:37:47 PM.;
 
 
 
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