Elaprase

Generic Name: idursulfase (EYE dur SUL fase)
Brand Names: Elaprase

What is Elaprase?

Elaprase (idursulfase) is an IV infusion 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 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

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

Some side effects may occur during the infusion, or up to 24 hours afterward. Get emergency medical help if you have any of these signs of an allergic reaction: feeling like you might pass out; hives; trouble breathing; seizure (convulsions); swelling of your face, lips, tongue, or throat.

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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.

Before receiving Elaprase

You should not receive Elaprase if you are allergic to idursulfase.

To make sure Elaprase is safe for you, tell your doctor if you have asthma or any other lung problems. You may be more likely to have a reaction to Elaprase if you have a breathing disorder.

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. It is not known whether Elaprase will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

See also: Pregnancy and breastfeeding warnings (in more detail)

It is not known whether idursulfase passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How is Elaprase given?

Elaprase is injected into a vein through an IV. You will most likely receive this injection in a clinic or hospital setting.

Elaprase must be given slowly through an IV infusion, and can take up to 3 hours or longer to complete.

Your doctor may also prescribe other medications to help prevent an allergic reaction to galsulfase. Take all of your medications as directed.

Elaprase is usually given once per week. Follow your doctor's instructions.

Your doctor will need to check your progress while you are using galsulfase.

What happens if I miss a dose?

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

What happens if I overdose?

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Elaprase side effects

Some side effects may occur during the Elaprase infusion, or up to 24 hours afterward. Get emergency medical help if you have any of these signs of an allergic reaction to Elaprase: feeling like you might pass out; hives; trouble breathing, seizure (convulsions); 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 infusion to help prevent symptoms of a reaction.

Common Elaprase side effects may include:

  • vomiting, diarrhea;

  • headache;

  • fever, cough;

  • itching, mild skin rash; or

  • flushing (warmth, redness, or tingly feeling).

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.

See also: Side effects (in more detail)

Elaprase dosing information

Usual Adult Dose for Mucopolysaccharidosis Type II:

0.5 mg/kg via IV infusion once a week

Comments:
-Has been shown to improve walking capacity

Approved indication: For patients with Hunter syndrome (mucopolysaccharidosis II [MPS II])

Usual Pediatric Dose for Mucopolysaccharidosis Type II:

16 months or older: 0.5 mg/kg via IV infusion once a week

Comments:
-Has been shown to improve walking capacity in patients 5 years and older
-No data available to show improvement in disease-related symptoms or long-term clinical outcome in patients 16 months to 5 years; however, spleen volume reduced similarly to that of patients 5 years and older.

Approved indication: For patients with Hunter syndrome (MPS II)

What other drugs will affect Elaprase?

Other drugs may interact with Elaprase, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about Elaprase.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Elaprase only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2014 Cerner Multum, Inc. Version: 2.02. Revision Date: 2013-11-27, 5:38:07 PM.

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