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What is ELAPRASE® (Idursulfase)?

ELAPRASE is a prescription medicine for patients with Hunter syndrome.

ELAPRASE has been shown to improve walking ability in patients 5 yrs and older.

In patients 16 months to 5 yrs old, ELAPRASE did not show improvement in disease-related symptoms or long term clinical result; however, treatment with ELAPRASE has reduced spleen size similarly to patients 5 yrs and older.

It is not known if ELAPRASE is safe and effective in children under 16 months old.

Mother and son walking outside
Supporting your MPS II journey

OnePath SUPPORT

Joyce and Laura, OnePath patient support managers Joyce and Laura, OnePath patient support managers

Joyce and Laura,

OnePath Patient Support Managers

OnePath provides support for eligible Hunter syndrome patients and their caregivers. If you and your doctor decide that ELAPRASE is right for you or your child, OnePath can help you set up your ELAPRASE therapy and provide you with information to help you locate a treatment center. OnePath can also help you, if necessary, arrange delivery of ELAPRASE to the treatment center.

Download a OnePath
Start Form here:
English Español

If you wish to sign up for OnePath product support services, you and your doctor may sign a OnePath Start Form (English|Español). You don’t have to sign the Start Form to receive ELAPRASE therapy, but you will need to do so if you would like to receive OnePath product support services. After you and your doctor sign the form, your doctor will fax it to us and we’ll handle the rest.

The OnePath patient support team is committed to providing personalized, one-on-one product support services to help you access your prescribed Takeda treatment.

MEET THE OnePath SUPPORT TEAM:

OnePath Patient Support Manager (PSM)

When you enroll in OnePath, your dedicated Patient Support Manager (PSM) will be your primary support contact and will help you with many aspects of your treatment. This includes navigating insurance coverage and changes, providing information about financial assistance options, working with your specialty pharmacy, helping to coordinate infusion services, and connecting you with additional resources.

OnePath Patient Access Manager (PAM)

Your Patient Access Manager (PAM) is located in your area and may help assist you through any potential insurance challenges or coverage issues. Your PAM can serve as a resource for complex reimbursement, financial, or other access-related issues.

To learn more, simply call OnePath toll-free at 1-866-888-0660 or visit OnePath.com.

Read stories from other people with Hunter syndrome
Find out more, click here for FAQs
Important Safety Information
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RISK OF SERIOUS ALLERGIC REACTIONS

Some patients have experienced serious allergic reactions (including life-threatening anaphylactic reactions) during and up to 24 hours after treatment, regardless of how long they were taking ELAPRASE. Anaphylactic reactions are immediate and include breathing problems, low oxygen levels, low blood pressure, hives and/or swelling of the throat or tongue. If a patient (you or your child) has experienced an anaphylactic reaction, the patient may require an extended period of observation by the patient’s healthcare team. If you or your child has breathing problems, a fever, or a respiratory illness, you or your child may be at risk of life-threatening worsening of those conditions due to allergic reactions from ELAPRASE. Your healthcare team should be advised of those conditions before treatment with ELAPRASE because the information may affect the timing of ELAPRASE treatment.

You or your child should be closely watched during and after ELAPRASE treatment and you should confirm with your healthcare team in advance of treatment that it is prepared to manage serious allergic reactions, including anaphylactic reactions. Tell your healthcare team immediately if any signs of an allergic reaction happen. Those signs may include breathing problems, low blood pressure, rash, hives, itching, flushing, fever and/or headache.

When serious allergic reactions happened during clinical trials, later ELAPRASE treatments were managed with allergy-controlling drugs before or during treatment, a slower rate of ELAPRASE treatment, and/or early discontinuation of treatment.

Children with serious genetic mutations may be at risk for allergic reactions, serious side effects and antibody development. In a clinical study of children 7 years and younger, patients with certain types of genetic mutations experienced a higher number of allergic reactions, serious side effects, and development of an immune response to treatment. This immune response may interfere with the effectiveness of ELAPRASE. Talk to your healthcare team about whether you or your child may be at risk.

If you or your child has breathing problems, other respiratory illness, heart problems, or susceptibility to fluid overload, you or your child may be at higher risk of fluid overload during ELAPRASE treatment. Your healthcare team should be advised of those problems before treatment and you should confirm with your healthcare team in advance of treatment that it is appropriately trained to watch for signs of fluid overload and provide the necessary medical support. Patients at risk for fluid overload may require longer observation time.

What are possible side effects of ELAPRASE?
The most common side effects of ELAPRASE include:

  • In patients aged 5 and older:
    • - Headache
    • - Itching
    • - Muscle and bone pain
    • - Hives
    • - Diarrhea
    • - Cough
  • In patients aged 7 years or younger:
    • - Fever
    • - Rash
    • - Vomiting
    • - Hives

The most common side effects needing medical attention were allergic reactions, and included rash, hives, itching, flushing, fever, and headache. Tell your healthcare team immediately if any signs of an allergic reaction happen. These are not all the possible side effects of ELAPRASE.

What is ELAPRASE® (Idursulfase)?

ELAPRASE is a prescription medicine for patients with Hunter syndrome. ELAPRASE has been shown to improve walking ability in patients 5 yrs and older. In patients 16 months to 5 yrs old, ELAPRASE did not show improvement in disease-related symptoms or long term clinical result; however, treatment with ELAPRASE has reduced spleen size similarly to patients 5 yrs and older. It is not known if ELAPRASE is safe and effective in children under 16 months old.

Important Safety Information
v

RISK OF SERIOUS ALLERGIC REACTIONS

Some patients have experienced serious allergic reactions (including life-threatening anaphylactic reactions) during and up to 24 hours after treatment, regardless of how long they were taking ELAPRASE. Anaphylactic reactions are immediate and include breathing problems, low oxygen levels, low blood pressure, hives and/or swelling of the throat or tongue. If a patient (you or your child) has experienced an anaphylactic reaction, the patient may require an extended period of observation by the patient’s healthcare team. If you or your child has breathing problems, a fever, or a respiratory illness, you or your child may be at risk of life-threatening worsening of those conditions due to allergic reactions from ELAPRASE. Your healthcare team should be advised of those conditions before treatment with ELAPRASE because the information may affect the timing of ELAPRASE treatment.

You or your child should be closely watched during and after ELAPRASE treatment and you should confirm with your healthcare team in advance of treatment that it is prepared to manage serious allergic reactions, including anaphylactic reactions. Tell your healthcare team immediately if any signs of an allergic reaction happen. Those signs may include breathing problems, low blood pressure, rash, hives, itching, flushing, fever and/or headache.

When serious allergic reactions happened during clinical trials, later ELAPRASE treatments were managed with allergy-controlling drugs before or during treatment, a slower rate of ELAPRASE treatment, and/or early discontinuation of treatment.

Children with serious genetic mutations may be at risk for allergic reactions, serious side effects and antibody development. In a clinical study of children 7 years and younger, patients with certain types of genetic mutations experienced a higher number of allergic reactions, serious side effects, and development of an immune response to treatment. This immune response may interfere with the effectiveness of ELAPRASE. Talk to your healthcare team about whether you or your child may be at risk.

If you or your child has breathing problems, other respiratory illness, heart problems, or susceptibility to fluid overload, you or your child may be at higher risk of fluid overload during ELAPRASE treatment. Your healthcare team should be advised of those problems before treatment and you should confirm with your healthcare team in advance of treatment that it is appropriately trained to watch for signs of fluid overload and provide the necessary medical support. Patients at risk for fluid overload may require longer observation time.

What are possible side effects of ELAPRASE?
The most common side effects of ELAPRASE include:

  • In patients aged 5 and older:
    • - Headache
    • - Itching
    • - Muscle and bone pain
    • - Hives
    • - Diarrhea
    • - Cough
  • In patients aged 7 years or younger:
    • - Fever
    • - Rash
    • - Vomiting
    • - Hives

The most common side effects needing medical attention were allergic reactions, and included rash, hives, itching, flushing, fever, and headache. Tell your healthcare team immediately if any signs of an allergic reaction happen. These are not all the possible side effects of ELAPRASE.

What is ELAPRASE® (Idursulfase)?

ELAPRASE is a prescription medicine for patients with Hunter syndrome. ELAPRASE has been shown to improve walking ability in patients 5 yrs and older. In patients 16 months to 5 yrs old, ELAPRASE did not show improvement in disease-related symptoms or long term clinical result; however, treatment with ELAPRASE has reduced spleen size similarly to patients 5 yrs and older. It is not known if ELAPRASE is safe and effective in children under 16 months old.

For additional safety information, please click here for Full Prescribing Information,
including Boxed Warning for Risk of Anaphylaxis, and discuss with your doctor