Drugs Information Online
Drugs and diseases reference index
 |
EN |
Generic Name: alglucosidase alfa (injection) (AL gloo KOE si dase AL fa)Brand Names: Myozyme
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.
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.
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.
Contact your doctor if you miss a dose of this medication.
There are no restrictions on food, beverages, or activity while receiving alglucosidase alfa unless your doctor has told you otherwise.
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.
Usual Adult Dose for Pompe disease:
Dose: 20 mg/kg body weight as an intravenous infusion administered every 2 weeksJanuary 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 weeksJanuary 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.
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.