Idursulfase Injection

Idursulfase injection may cause serious or life-threatening allergic reactions. These reactions may occur during and up to 24 hours after your injection.Tell your doctor if you have or have ever had breathing problems or any lung conditions that affect your breathing. If you experience any of the following symptoms, tell your doctor immediately: difficulty breathing, dizziness, rash, hives, or swelling of the throat or tongue.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain tests to check your body's response to Idursulfase injection.

Idursulfase injection is used to improve walking ability in people with Hunter Syndrome ((mucopolysaccharidosis type II [MPS II)]; an inherited condition in which the body doesn't break down certain sugar substances in the body called glycosaminoglycans (GAG)). Idursulfase injection is in a class of medications called enzymes. It works by helping to reduce the levels of glycosaminoglycans in the body.

Idursulfase injection comes as a solution (liquid) to be mixed diluted and given intravenously (into a vein) by a healthcare professional. It is given once weekly.

Idursulfase injection controls Hunter's Syndrome but does not cure it. Continue to receive idursulfase injection even if you feel well. Do not stop recieving iursulfase injection without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking idursulfase injection,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• tell your doctor if you have or have ever had heart disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving idursulfase injection, call your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

Idursulfase injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• muscle pain
• vomiting, diarrhea
• cough
• fever

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• changes in heart beat, chest pain

Idursulfase injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to Idursulfase injection.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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