Elaprase is an IV infusion used to treat some of the symptoms of a genetic condition called Hunter's syndrome, also called mucopolysaccharidosis (MYOO-koe-pol-ee-SAK-a-rye-DOE-sis). Idursulfase contains a natural enzyme that some people lack because of a genetic disorder. Elaprase helps replace this missing enzyme.

Hunter syndrome is a metabolic disorder in which the body lacks the enzyme needed to break down certain sugars and proteins. These substances can build up in the body, causing enlarged organs, abnormal bone structure, changes in facial features, breathing problems, heart problems, vision loss, and changes in mental or physical abilities.

Elaprase may improve walking ability in people with this condition. However, this medication is not a cure for Hunter syndrome.

Elaprase may improve walking ability in people with Hunter syndrome. However, Elaprase is not a cure for this condition.

Some side effects may occur during the infusion, or up to 24 hours afterward. Get emergency medical help if you have any signs of an allergic reaction: feeling like you might pass out; hives; trouble breathing; seizure (convulsions); swelling of your face, lips, tongue, or throat.

You may be more likely to have a reaction to Elaprase if you have a breathing disorder. Tell your doctor if you have asthma or other lung disease.

Elaprase is given as an infusion into a vein. A healthcare provider will give you this injection, usually once per week.

Elaprase must be given slowly through an IV infusion, and the infusion can take up to 3 hours or longer to complete.

Your doctor may also prescribe other medications to help prevent an allergic reaction to idursulfase. Take all of your medications as directed.

Elaprase is usually given once per week. Follow your doctor's instructions.

Your doctor will need to check your progress on a regular basis while you are using this medicine.

Usual Adult Dose for Mucopolysaccharidosis Type II:

0.5 mg/kg via IV infusion once a week

Comments:
-Has been shown to improve walking capacity

Approved indication: For patients with Hunter syndrome (mucopolysaccharidosis II [MPS II])

Usual Pediatric Dose for Mucopolysaccharidosis Type II:

16 months or older: 0.5 mg/kg via IV infusion once a week

Comments:
-Has been shown to improve walking capacity in patients 5 years and older
-No data available to show improvement in disease-related symptoms or long-term clinical outcome in patients 16 months to 5 years; however, spleen volume reduced similarly to that of patients 5 years and older.

Approved indication: For patients with Hunter syndrome (MPS II)

You should not receive Elaprase if you are allergic to idursulfase.

To make sure Elaprase is safe for you, tell your doctor if you have asthma or any other lung problems. An allergic reaction could trigger sudden breathing problems.

Your name may be listed on a Hunter Outcome Survey while you are using this medication. The purpose of this registry is to track the progression of this disorder and the effects that Elaprase has on long-term treatment of Hunter syndrome.

It is not known whether Elaprase will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether idursulfase passes into breast milk. It may not be safe to breast-feed a baby while you are using this medicine. Ask your doctor about any risks.

Call your doctor for instructions if you miss an appointment for your Elaprase injection.

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Some side effects may occur during the Elaprase infusion, or up to 24 hours afterward. Get emergency medical help if you have any signs of an allergic reaction to Elaprase: feeling like you might pass out; hives; trouble breathing, seizure (convulsions); swelling of your face, lips, tongue, or throat.

If you ever have an allergic reaction to idursulfase, you will be watched closely after receiving this medicine again.

Common Elaprase side effects may include:

• vomiting, diarrhea;

• headache;

• muscle or joint pain;

• fever, cough;

• itching, rash; or

• flushing (warmth, redness, or tingly feeling).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.