Thursday, October 6, 2016

Idursulfase


Generic Name: idursulfase (EYE dur SUL fase)

Brand Names: Elaprase


What is idursulfase?

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 is the most important information I should know about idursulfase?


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.


What should I discuss with my health care provider before receiving idursulfase?


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

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.

How is idursulfase given?


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.

What happens if I miss a dose?


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


What happens if I overdose?


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

Symptoms of an idursulfase overdose are not known.


What should I avoid while receiving idursulfase?


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


Idursulfase side effects


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.


Idursulfase Dosing Information


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 old
Recommended dose: 0.5 mg/kg of body weight every week administered as an intravenous infusion


What other drugs will affect idursulfase?


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.



More idursulfase resources


  • Idursulfase Side Effects (in more detail)
  • Idursulfase Dosage
  • Idursulfase Use in Pregnancy & Breastfeeding
  • Idursulfase Support Group
  • 0 Reviews for Idursulfase - Add your own review/rating


  • idursulfase Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information

  • Idursulfase Professional Patient Advice (Wolters Kluwer)

  • Idursulfase MedFacts Consumer Leaflet (Wolters Kluwer)

  • Idursulfase Monograph (AHFS DI)

  • Elaprase Prescribing Information (FDA)

  • Elaprase Consumer Overview



Compare idursulfase with other medications


  • Mucopolysaccharidosis Type II


Where can I get more information?


  • Your doctor or pharmacist can provide more information about idursulfase.

See also: idursulfase side effects (in more detail)



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