Myozyme

DRUG DESCRIPTION

MYOZYME® (alglucosidase alfa) consists of the human enzyme acid ?-glucosidase (GAA), encoded by the most predominant of nine observed haplotypes of this gene. MYOZYME (alglucosidase alfa) is produced by recombinant DNA technology in a Chinese hamster ovary cell line. Alglucosidase alfa degrades glycogen by catalyzing the hydrolysis of ?-1,4- and ?-1,6-glycosidic linkages of lysosomal glycogen.

Alglucosidase alfa is a glycoprotein with a calculated mass of 99,377 daltons for the polypeptide chain, and a total mass of approximately 109,000 daltons, including carbohydrates. Alglucosidase alfa has a specific activity of 3 to 5 U/mg (one unit is defined as that amount of activity that results in the hydrolysis of 1 ?µmole of synthetic substrate per minute under the specified assay conditions). MYOZYME (alglucosidase alfa) is intended for intravenous infusion. It is supplied as a sterile, nonpyrogenic, white to off-white, lyophilized cake or powder for reconstitution with 10.3 mL Sterile Water for Injection, USP. Each 50 mg vial contains 52.5 mg alglucosidase alfa, 210 mg mannitol, 0.5 mg polysorbate 80, 9.9 mg sodium phosphate dibasic heptahydrate, 31.2 mg sodium phosphate monobasic monohydrate. Following reconstitution as directed, each vial contains 10.5 mL reconstituted solution and a total extractable volume of 10 mL at 5.0 mg/mL alglucosidase alfa. MYOZYME (alglucosidase alfa) does not contain preservatives; each vial is for single use only.

What are the possible side effects of alglucosidase alfa (Myozyme)?

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.

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Myozyme Patient Information Including Side Effects

Brand Names: Myozyme

Generic Name: alglucosidase alfa (injection) (Pronunciation: AL gloo KOE si dase AL fa)

  • What is alglucosidase alfa (Myozyme)?
  • What are the possible side effects of alglucosidase alfa (Myozyme)?
  • What is the most important information I should know about alglucosidase alfa (Myozyme)?
  • What should I discuss with my health care provider before receiving alglucosidase alfa (Myozyme)?
  • How is alglucosidase alfa given (Myozyme)?
  • What happens if I miss a dose (Myozyme)?
  • What happens if I overdose (Myozyme)?
  • What should I avoid while receiving alglucosidase alfa (Myozyme)?
  • What other drugs will affect alglucosidase alfa (Myozyme)?
  • Where can I get more information?

What is alglucosidase alfa (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.

What are the possible side effects of alglucosidase alfa (Myozyme)?

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.

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

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.

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