Generic Name: idursulfase (EYE dur SUL fase)Brand Names: 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.
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.
Before receiving idursulfase, 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 idursulfase if you have a breathing disorder. You may need to receive other medications to prevent an symptoms of a reaction to idursulfase. 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 idursulfase 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 idursulfase 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.
Idursulfase 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. Idursulfase 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.
Call your doctor if you miss an appointment for your idursulfase injection.
Symptoms of an idursulfase overdose are not known.
Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are receiving idursulfase.
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:
blue lips or fingernails;
vision problems; or
increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).
Less serious side effects may include:
pain in your arms or legs;
itching, mild skin rash; or
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.
Usual Adult Dose for Mucopolysaccharidosis Type II:
Recommended dose: 0.5 mg/kg of body weight every week administered as an intravenous infusion
Usual Pediatric Dose for Mucopolysaccharidosis Type II:
>= 5 years oldRecommended dose: 0.5 mg/kg of body weight every week administered as an intravenous infusion
There may be other drugs that can interact with idursulfase. 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.