Idursulfase Solution for injection

What is this medicine?

IDURSULFASE (EYE dur SUL fase) is used to replace an enzyme that is missing in patients with Hunter syndrome. It is not a cure.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• infection or fever

• heart disease

• lung disease

• an unusual or allergic reaction to idursulfase, other medicines, foods, dyes, or preservatives

• previous swelling of the tongue, face, or lips with difficulty breathing, difficulty swallowing, hoarseness, or tightening of the throat

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

The medicine is for injection into a vein. It is given as an infusion by a health care professional in a hospital or clinic setting.

Contact your pediatrician or health care professional regarding the use of this medicine in children. While this drug may be prescribed for children as young as 16 months of age for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

Interactions are not expected.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor for regular check ups. Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse.

You can be a part of a registry for patients with Hunter syndrome. This registry may ask for information over a long time. Ask your healthcare professional for more information.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• chest pain or tightness

• dizziness; feeling faint or lightheaded, falls; unusually weak of tired

• fast, irregular heartbeat

• fever or chills

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• cough

• diarrhea

• facial flushing

• headache

• muscle or joint pain

• nausea, vomiting

• tiredness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

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