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.
Myozyme is used to treat a glycogen storage disorder called Pompe disease, (also called GAA deficiency) in adults and children who are at least 8 years old.
Myozyme has been shown to improve ventilator-free survival in patients with infantile-onset Pompe disease.
Important information
Some people receiving Myozyme have had serious allergic reactions during or shortly after infusion of this medicine. Tell your caregivers or get emergency medical help right away if you have any signs of a severe allergic reaction, such as itching, rash. redness or tingling, severe headache, feeling like you might pass out, fast or slow heart rate, wheezing, trouble breathing, pale skin, and blue lips or fingernails.
Before receiving Myozyme, tell your doctor if you have heart disease, lung disease or a breathing disorder, or if you are allergic to mice, hamsters, or drug products made with "murine" proteins.
Before each injection, tell your doctor if you have recently been sick with a cold, flu, or other illness. Some people receiving an injection of Myozyme have had a reaction to the infusion. This type of reaction can occur when the medicine is injected into the vein, or as long as 3 hours after the injection.
Before receiving this medicine
You should not receive Myozyme if you are allergic to alglucosidase alfa.
To make sure this medicine is safe for you, tell your doctor if you have:
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heart disease;
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lung disease or breathing disorder;
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if you are allergic to mice, hamsters, or drug products made with "murine" proteins.
FDA pregnancy category C. It is not known whether alglucosidase alfa will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using Myozyme.
See also: Pregnancy and breastfeeding warnings (in more detail)
Alglucosidase alfa can pass into breast milk and may harm a nursing baby. Do not breast-feed within 24 hours after receiving Myozyme. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.
Your name may be listed on the Pompe Registry. This is to track the progress of your disease and the outcome of your treatment with Myozyme.
How is Myozyme given?
Myozyme is injected into a vein through an IV. A healthcare provider will give you this injection. Myozyme must be given slowly, and the IV infusion can take up to 4 hours to complete.
This medicine is usually given once every 2 weeks.
Before each injection, tell your doctor if you have recently been sick with a cold, flu, or other illness.
If you need surgery, tell the surgeon ahead of time that you are using Myozyme.
Myozyme can have long lasting effects on your body. Your blood will need to be tested every 3 months for 2 years and then once every year after that.
Myozyme dosing information
Usual Adult Dose of Myozyme for Pompe disease:
20 mg/kg via IV infusion every 2 weeks
Comments:
-Total volume of infusion is determined by patient"s body weight and should be infused over about 4 hours.
Usual Pediatric Dose for Pompe disease:
20 mg/kg via IV infusion every 2 weeks
Comments:
-Total volume of infusion is determined by body weight and should be infused over about 4 hours.
What other drugs will affect Myozyme?
Other drugs may interact with alglucosidase 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.
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your Myozyme 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 receiving Myozyme?
Follow your doctor"s instructions about any restrictions on food, beverages, or activity.
Myozyme side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Myozyme: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Some people receiving Myozyme have had serious allergic reactions when the medicine was injected into the vein, or as long as 3 hours afterward. Tell your caregivers or get emergency medical help right away if you have any of these signs of a severe allergic reaction:
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feeling like you might pass out, even while lying down;
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slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);
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bronchospasm (wheezing, tight feeling in your chest or throat, trouble breathing);
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pale skin, cold or clammy skin, blue lips or fingernails, cold hands or feet;
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warmth, redness, numbness, or tingly feeling under your skin;
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rash, itching, sweating, fever;
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severe headache, nausea, feeling restless or nervous;
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seizure (convulsions); or
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fast heart rate, pounding in your neck or ears, anxiety, confusion.
Also call your doctor at once if you have:
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skin changes (sores, lesions, ulcers, discoloring); or
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puffy eyes, swelling in your ankles or feet, weight gain, urine that looks foamy.
Common Myozyme side effects may include:
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pale skin, blue lips, feeling hot or feverish;
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skin rash, flushing (warmth, redness, or tingly feeling);
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headache, dizziness, agitation, muscle twitching;
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fast heart rate, rapid breathing, chest discomfort, cough;
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nausea, vomiting;
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tremor, shaking, increased sweating; or
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muscle pain, tiredness.
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)
What other drugs will affect Myozyme?
Other drugs may interact with alglucosidase 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.
