Drug Information

Aldurazyme

What is ALDURAZYME?

(ALDURAZYME) Laronidase is used to treat a certain rare genetic problem (mucopolysaccharidosis-MPS I). It works by replacing a certain natural substance (lysosomal enzyme) that is missing in people with this genetic problem. This medication improves lung function and how far you can walk. Laronidase is not a cure and treatment must be continued for life.

How should I use ALDURAZYME?

Read the Patient Information Leaflet if available from your pharmacist before you start using laronidase and each time you get a refill. If you have any questions, ask your doctor or pharmacist. This medication is given by injection into a vein as directed by your doctor, usually every week. The injection is given by a health care professional, usually over 3 to 4 hours. The dosage is based on your medical condition, weight, and response to treatment. Infusion reactions may occur while you are receiving laronidase. Tell your doctor or nurse right away if any of these side effects occur: flushing, fever, headache, or abdominal pain. Your infusion may be slowed down or stopped depending on your symptoms. To prevent infusion reactions, your doctor may prescribe other medications 60 minutes before each infusion. Carefully follow your doctor's directions for all your medications. See also Warning section. Use this medication regularly to get the most benefit from it. To help you remember, it may help to mark your calendar with a reminder. Tell your doctor if your condition gets worse.

What should I tell my health care provider before I take ALDURAZYME?

See Warning section. Before using laronidase, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

What may interact with ALDURAZYME?

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

What should I watch for while using ALDURAZYME?

Laronidase can rarely cause a very serious (sometimes fatal) allergic reaction. This reaction may occur during or up to 3 hours after the infusion. Get medical help right away if you notice any symptoms of a serious allergic reaction, including: itching/swelling (especially of the face/tongue/throat), trouble breathing, severe dizziness, fainting, or rash/hives. Your health care professional will monitor you closely for any signs of allergic reactions during your infusion and for some time after. Before you start your infusion, tell your doctor if you have a fever or an infection (such as cold or flu) or if you have a history of heart problems (such as heart failure), breathing problems, interrupted breathing during sleep (such as sleep apnea), or swelling. Your health care professional will monitor you closely to prevent these problems from getting worse, and may delay your infusion if necessary.

What if I miss a dose of ALDURAZYME?

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

What side effects may I notice from receiving ALDURAZYME?

See also How to Use section and Warning section. Cold symptoms (such as stuffy/runny nose, cough) may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Where should I keep ALDURAZYME?

Not applicable. This medication is given in a hospital or clinic and will not be stored at home.

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