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Laronidase

Warning

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.

Precautions

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.

Side Effects

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.