" 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 How Should I Take
In this Article
- 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 should I discuss with my health care provider before receiving alglucosidase alfa (Lumizyme)?
You should not receive alglucosidase alfa if you are allergic to it.
To make sure you can safely use alglucosidase alfa, tell your doctor if you have other medical conditions, especially:
- 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. Alglucosidase alfa is not expected to harm 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 receive this medication without telling your doctor if you are breast-feeding a 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 alglucosidase alfa.
How is alglucosidase alfa given (Lumizyme)?
Alglucosidase alfa is injected into a vein through an IV using an infusion pump. You will receive this injection in a clinic or hospital setting. Alglucosidase alfa must be given slowly, and the IV infusion can take up to 4 hours to complete.
This medication 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.
To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested every 3 months for 2 years and then once every year after that. Visit your doctor regularly.
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.
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.
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