" Citing a lack of cardiovascular benefit, the FDA is taking the unusual step of withdrawing approvals it had previously given for use of niacin and fenofibric acid with statins to treat high cholesterol.
The decision affects niac"...
Lumizyme Patient Information Including Side Effects
Brand Names: Lumizyme, Myozyme
Generic Name: alglucosidase alfa (injection) (Pronunciation: AL gloo KOE si dase AL fa)
- What is alglucosidase alfa (Lumizyme)?
- What are the possible side effects of alglucosidase alfa (Lumizyme)?
- What is the most important information I should know about alglucosidase alfa (Lumizyme)?
- What should I discuss with my health care provider before receiving alglucosidase alfa (Lumizyme)?
- How is alglucosidase alfa given (Lumizyme)?
- What happens if I miss a dose (Lumizyme)?
- What happens if I overdose (Lumizyme)?
- What should I avoid while receiving alglucosidase alfa (Lumizyme)?
- What other drugs will affect alglucosidase alfa (Lumizyme)?
- Where can I get more information?
What is alglucosidase alfa (Lumizyme)?
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) in adults and children who are at least 8 years old.
Alglucosidase alfa may also be used for purposes not listed in this medication guide.
What are the possible side effects of alglucosidase alfa (Lumizyme)?
Some people receiving an injection of alglucosidase alfa 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. Tell your caregivers or get emergency medical help right away if you have any of these signs of a severe allergic reaction:
- feeling like you might pass out, even while lying down;
- feeling restless, nervous, dizzy, or nauseated;
- pale skin, redness under your skin, sweating, feeling hot or cold;
- fast or slow heart rate;
- pain or tightness in your chest or throat;
- wheezing, trouble breathing;
- cold hands, blue lips;
- back pain;
- numbness, warmth, redness, or tingly feeling;
- seizure (convulsions);
- hives, severe skin rash; or
- swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- pain or fullness in your ear, problems with hearing;
- skin ulcers;
- fast, slow, or uneven heartbeats;
- urinating less than usual or not at all;
- weak pulse, fainting, slow breathing (breathing may stop); or
- chest pain or heavy feeling, pain spreading to the arm or shoulder, sweating, general ill feeling.
Less serious side effects may include:
- mild skin rash or itching;
- diarrhea, constipation, stomach pain or upset, vomiting;
- sore throat, neck pain;
- pain or swelling in your arms or legs; or
- pain, swelling, burning, or irritation around the IV needle.
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.
Read the Lumizyme (alglucosidase alfa) Side Effects Center for a complete guide to possible side effects
What is the most important information I should know about alglucosidase alfa (Lumizyme)?
Alglucosidase alfa is available only under a special program called ACE. Under this program, only registered doctors and pharmacists can prescribe and dispense alglucosidase alfa. You must be registered in the program and sign documents stating that you understand the risks of using this medication and the possibility of severe allergic reaction. Ask your doctor or call the drug maker if you have questions about the program or the written requirements.
Before receiving this medication, 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 alglucosidase alfa 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.
Tell your caregivers or get emergency medical help right away if you have any signs of a severe allergic reaction, such as feeling restless, nervous, dizzy, numb, tingly, hot or cold, sweaty, nauseated, or lightheaded, or if you have trouble breathing, chest pain or tightness, fast or slow heart rate, hives, severe skin rash, seizure (convulsions), or swelling of your face, lips, tongue, or throat.
Additional Lumizyme Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.