Elaprase

Generic Name: idursulfase (EYE dur SUL fase)

What is Elaprase?

Elaprase 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.

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

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

Important information about Elaprase

Elaprase may improve walking ability in people with Hunter syndrome. However, Elaprase is not a cure for this condition. Some people receiving an Elaprase 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 Elaprase even after you have had a reaction to it. There are other medications that can be given to you before your Elaprase infusion to help prevent any reaction symptoms.

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.

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 Elaprase has on long-term treatment of Hunter syndrome.

Before receiving Elaprase

You should not receive this medication if you are allergic to idursulfase.

Before receiving Elaprase, tell your doctor if you are allergic to any drugs, or if you have asthma or other breathing disorder.

You may be more likely to have a reaction to Elaprase if you have a breathing disorder. You may need to receive other medications to prevent an symptoms of a reaction to Elaprase. Follow your doctor’s instructions.

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 Elaprase has on long-term treatment of Hunter syndrome.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether Elaprase passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is Elaprase given?

Elaprase is given as an injection through a needle placed into a vein. You will most likely receive this injection in a clinic or hospital setting. Elaprase is usually given once per week.

The medicine must be given slowly through an IV infusion, and can take up to 3 hours to complete.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention if you think you have received too much of this medicine.

Symptoms of an Elaprase overdose are not known.

What should I avoid while receiving Elaprase?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity while you are receiving Elaprase.

Elaprase side effects

Some people receiving a Elaprase 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 Elaprase even after you have had a reaction to it. There are other medications that can be given to you before your Elaprase 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.

What other drugs will affect Elaprase?

There may be other drugs that can interact with Elaprase. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.