What is the most important information I should know about idursulfase?
Some side effects may occur during the idursulfase infusion, or up to 24 hours afterward. Get emergency medical help if you have signs of an allergic reaction: feeling like you might pass out; hives; trouble breathing; seizure (convulsions); swelling of your face, lips, tongue, or throat.
What is idursulfase?
Idursulfase contains a natural enzyme that some people lack because of a genetic disorder. Idursulfase helps replace this missing enzyme.
Idursulfase is 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).
Hunter syndrome is a metabolic disorder in which the body lacks the enzyme needed to break down certain natural substances. 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 should I discuss with my health care provider before receiving idursulfase?
You should not receive this medication if you are allergic to idursulfase.
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 idursulfase has on long-term treatment.
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
It may not be safe to breast-feed a baby while you are using this medicine. Ask your doctor about any risks.
How is idursulfase given?
Idursulfase is given as an infusion into a vein. A healthcare provider will give you this injection, usually once per week.
This medicine must be given slowly, and the infusion can take up to 3 hours to complete.
Your doctor may also prescribe other medications to help prevent an allergic reaction to idursulfase. Take all of your medications as directed.
Your doctor will need to check your progress on a regular basis.
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your idursulfase injection.
What happens if I overdose?
Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.
What should I avoid while receiving idursulfase?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What are the possible side effects of idursulfase?
Some side effects may occur during the idursulfase infusion, or up to 24 hours afterward. Get emergency medical help if you have signs of an allergic reaction: 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 side effects may include:
- vomiting, diarrhea;
- 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.
What other drugs will affect idursulfase?
Other drugs may affect idursulfase, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Where can I get more information?
Your doctor or pharmacist can provide more information about idursulfase.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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