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Alglucosidase alfa

 
  Generic Name: Alglucosidase alfa (injection) (AL gloo KOE si dase AL fa)
 
  Brand Names: Myozyme  
     
   
 

What is alglucosidase alfa?

Alglucosidase alfa contains an enzyme that naturally occurs in the body in healthy people. Some people lack this enzyme because of a genetic disorder. Alglucosidase alfa helps replace this missing enzyme in such people.

Alglucosidase alfa is used to treat a glycogen storage disorder called Pompe disease, (also called GAA deficiency).

Alglucosidase alfa may also be used for purposes other than those listed in this medication guide.

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

Before receiving this medication, tell your doctor if you are allergic to mice, hamsters, or drug products made with "murine" proteins.

Alglucosidase alfa is given as an injection through a needle placed into a vein. You will receive this injection with an infusion pump in a clinic or hospital setting. The medicine must be given slowly through an IV infusion, and can take up to 4 hours to complete.

This medication is usually given every 2 weeks.

Some people receiving an injection of alglucosidase alfa have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, itchy, or have a fast heartbeat, cold hands, blue lips, tightness in your chest or throat, wheezing, or trouble breathing during the injection.

What should I discuss with my health care provider before receiving alglucosidase alfa?

You should not use this medication if you are allergic to alglucosidase alfa.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

  • heart disease;

  • lung disease or breathing disorder;

  • if you are allergic to mice, hamsters, or drug products made with "murine" proteins.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether alglucosidase 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 alglucosidase alfa given?

Alglucosidase alfa is given as an injection through a needle placed into a vein. You will receive this injection with an infusion pump in a clinic or hospital setting. The medicine must be given slowly through an IV infusion, and can take up to 4 hours to complete.

This medication is usually given every 2 weeks.

Before each injection, tell your doctor if you have recently been sick with a cold, flu, or other illness.

Your name may need to be listed on a patient registry for people with Pompe disease when you start using this medication.

What happens if I miss a dose?

Contact your doctor if you miss a dose of this medication.

What happens if I overdose?

Seek emergency medical attention if you think you have received too much of this medicine. An overdose of alglucosidase alfa is not expected to produce life-threatening symptoms.

What should I avoid while receiving alglucosidase alfa?

There are no restrictions on food, beverages, or activity while receiving alglucosidase alfa unless your doctor has told you otherwise.

Alglucosidase alfa side effects

Some people receiving an injection of alglucosidase alfa have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, itchy, or have a fast heartbeat, cold hands, blue lips, tightness in your chest or throat, wheezing, or trouble breathing during the injection.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:
  • fast, slow, or uneven heartbeats;

  • weak pulse, fainting, slow breathing (breathing may stop);

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, sweating, general ill feeling;

  • ongoing cough with heaviness in your chest;

  • tremors or shaking;

  • feeling light-headed, fainting;

  • muscle weakness; or

  • skin ulcers.

Other less serious side effects are more likely to occur, such as:

  • headache;

  • fever;

  • diarrhea, nausea, vomiting, stomach pain;

  • pain or fullness in your ear;

  • runny or stuffy nose, sore throat, cough; or

  • feeling irritable or agitated.

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.

Alglucosidase alfa Dosing Information

Usual Adult Dose for Pompe disease:

Dose: 20 mg/kg body weight as an intravenous infusion administered every 2 weeks

January 2009: Inventory levels of alglucosidase alfa (Myozyme) are low because of increased global demand. Increased production is planned once regulatory agencies throughout the world approve a larger scale manufacturing process. The Food and Drug Administration is expected to respond by the end of February, 2009. In the meantime, recommended guidelines have been developed to help with clinical decisions during this temporary period of supply constraint. To continue providing therapy to adult patients, adult regimens will be adjusted by increasing the dosing interval. No new adults will be enrolled in the Myozyme Temporary Access Program (MTAP). Any physician who feels their patient is in urgent need of therapy may contact Genzyme medical information at (800) 745-4447, option 2.

Usual Pediatric Dose for Pompe disease:

Dose: 20 mg/kg body weight as an intravenous infusion administered every 2 weeks

January 2009: Inventory levels of alglucosidase alfa (Myozyme) are low because of increased global demand. Increased production is planned once regulatory agencies throughout the world approve a larger scale manufacturing process. The Food and Drug Administration is expected to respond by the end of February, 2009. In the meantime, recommended guidelines have been developed to help with clinical decisions during this temporary period of supply constraint. Pediatric dosing regimens will be maintained. However, to continue providing therapy to adult patients, adult regimens will be adjusted by increasing the dosing interval. Children with newly-diagnosed disease may begin therapy, but no new adults will be enrolled in the Myozyme Temporary Access Program (MTAP). Any physician who feels their patient is in urgent need of therapy may contact Genzyme medical information at (800) 745-4447, option 2.

What other drugs will affect alglucosidase alfa?

There may be other drugs that can affect alglucosidase alfa. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist has more information about alglucosidase alfa written for health professionals that you may read.
  • 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.
  • 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 receiving, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 2.01. Revision Date: 06/04/2009 9:56:31 AM.;
 
 
 
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