Aldurazyme

Aldurazyme is used for:

Treating patients with Hurler and Hurler-Scheie forms of mucopolysaccharidosis I (MPS I), and patients with Scheie form who have moderate to severe symptoms.

Aldurazyme is a glycoprotein. It works by providing the enzyme alpha-L-iduronidase to the body.

Do NOT use Aldurazyme if:

• you are allergic to any ingredient in Aldurazyme

Contact your doctor or health care provider right away if this applies to you.

Before using Aldurazyme :

Some medical conditions may interact with Aldurazyme . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have lung or breathing problems (eg, bronchitis)

Some MEDICINES MAY INTERACT with Aldurazyme . However, no specific interactions with Aldurazyme are known at this time.

Ask your health care provider if Aldurazyme may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Aldurazyme :

Use Aldurazyme as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Aldurazyme is given as an injection at your doctor's office, hospital, or clinic.
• If you miss a dose of Aldurazyme , contact your doctor right away.

Ask your health care provider any questions you may have about how to use Aldurazyme .

Important safety information:

• Serious and sometimes fatal allergic reactions have occurred with use of Aldurazyme . You will need to take certain other medicines before you receive Aldurazyme in order to decrease the risk of allergic reaction. Discuss any questions or concerns with your doctor.
• Aldurazyme should be used with extreme caution in CHILDREN younger than 5 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Aldurazyme while you are pregnant. It is not known if Aldurazyme is found in breast milk. If you are or will be breast-feeding while you use Aldurazyme , check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Aldurazyme :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Aldurazyme is usually handled and stored by a health care provider. If you are using Aldurazyme at home, store Aldurazyme as directed by your pharmacist or health care provider.

General information:

• If you have any questions about Aldurazyme , please talk with your doctor, pharmacist, or other health care provider.
• Aldurazyme is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Aldurazyme . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.