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Brand Names: Elaprase

Generic Name: idursulfase (Pronunciation: EYE dur SUL fase)

• What is idursulfase (Elaprase)?
• What are the possible side effects of idursulfase (Elaprase)?
• What is the most important information I should know about idursulfase (Elaprase)?
• What should I discuss with my health care provider before receiving idursulfase (Elaprase)?
• How is idursulfase given (Elaprase)?
• What happens if I miss a dose (Elaprase)?
• What happens if I overdose (Elaprase)?
• What should I avoid while receiving idursulfase (Elaprase)?
• What other drugs will affect idursulfase (Elaprase)?
• Where can I get more information?

What is idursulfase (Elaprase)?

Idursulfase is used to treat some of the symptoms of a genetic condition called Hunter's syndrome. Hunter syndrome is also called mucopolysaccharidosis (MYOO-koe-pol-ee-SAK-a-rye-DOE-sis).

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.

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

Idursulfase may also be used for purposes not listed in this medication guide.

What are the possible side effects of idursulfase (Elaprase)?

Some people receiving a idursulfase injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, light-headed, or have hives, seizure (convulsions), trouble breathing, or swelling of your face, lips, tongue, or throat.

It may still be possible for you to receive idursulfase even after you have had a reaction to it. There are other medications that can be given to you before your idursulfase infusion to help prevent any reaction symptoms.

Call your doctor at once if you have any of these serious side effects:

• worsened asthma;
• uneven heartbeats;
• blue lips or fingernails;
• fever;
• vision problems; or
• increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).

Less serious side effects may include:

• joint pain;
• pain in your arms or legs;
• headache;
• itching, mild skin rash; or
• weakness.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about idursulfase (Elaprase)?

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

Some people receiving an idursulfase injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, light-headed, or have hives, seizure (convulsions), trouble breathing, or swelling of your face, lips, tongue, or throat.

It may still be possible for you to receive idursulfase even after you have had a reaction to it. There are other medications that can be given to you before your idursulfase infusion to help prevent any reaction symptoms.

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

Your name may need to 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 idursulfase has on long-term treatment of Hunter syndrome.