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Idursulfase is used for:

Treating Hunter syndrome (mucopolysaccharidosis type II; MPS II).

Idursulfase is a lysosomal enzyme. It works in by increasing the amount of iduronate-2-sulfatase in patients with Hunter syndrome who do not make this enzyme on their own.

Do NOT use Idursulfase if:

• you have had a severe allergic reaction to Idursulfase unless your doctor tells you otherwise. If you must continue Idursulfase , your doctor may prescribe other medicines or treatments to reduce your risk of an allergic reaction

Contact your doctor or health care provider right away if any of these apply to you.

Before using Idursulfase :

Some medical conditions may interact with Idursulfase . 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 fever, lung or breathing problems, or a respiratory tract infection

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

Ask your health care provider if Idursulfase 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 Idursulfase :

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

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

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

Important safety information:

• Idursulfase 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: It is not known if Idursulfase can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Idursulfase while you are pregnant. It is not known if Idursulfase is found in breast milk. If you are or will be breast-feeding while you use Idursulfase , check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Idursulfase :

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:

Anxiety; general unwell feeling; headache; irritability; pain, swelling, or redness at the injection site; stomach upset.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blue/purple discoloration of lips, nails, or skin; chest pain; fever; hoarseness; irregular heartbeat; joint pain; seizures; severe headache or dizziness; shortness of breath; vision changes; wheezing.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or 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/findyour.htm), or emergency room immediately.

Idursulfase is usually handled and stored by a health care provider. If you are using Idursulfase at home, store Idursulfase as directed by your pharmacist or health care provider. Keep Idursulfase out of the reach of children and away from pets.

General information:

• If you have any questions about Idursulfase , please talk with your doctor, pharmacist, or other health care provider.
• Idursulfase 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 Idursulfase . 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.