For Healthcare Professionals

flag This site is intended for U.S. Patients & Families

Parents and children in the waiting room of a doctor’s surgery
Supporting your MPS II journey

ELAPRASE RISK & SAFETY
PROFILE

ELAPRASE risk profile

Risk of serious allergic reactions: Some patients have experienced serious allergic reactions, including anaphylactic reactions, during and up to 24 hours after an ELAPRASE infusion, regardless of how long they have been taking ELAPRASE.

Anaphylactic reactions are immediate and life-threatening allergic reactions. Anaphylactic reactions include breathing problems, low oxygen levels, low blood pressure, hives and/or swelling of the throat or tongue. Inform your healthcare provider immediately if you notice the beginning of any of these symptoms.

Children with serious genetic mutations may be at higher risk for allergic reactions, serious side effects and antibody development, compared with those with other types of mutation. Talk to your healthcare team about whether you/your child may be at risk.

Download the patient eBrochure here:

Children with serious genetic mutations may be at higher risk for allergic reactions, serious side effects and antibody development, compared with those with other types of mutation. Talk to your healthcare team about whether you/your child may be at risk.

Let your healthcare team know if a patient has breathing problems, a fever, or a respiratory illness, prior to an ELAPRASE infusion, because they may be at risk of life-threatening worsening of respiratory conditions due to allergic reactions to ELAPRASE. Your healthcare team may decide to delay the ELAPRASE infusion.

Prior to an ELAPRASE infusion, let your healthcare team know if a patient has breathing problems, other respiratory illnesses, heart problems, or susceptibility to fluid overload, because they may be at higher risk of fluid overload during ELAPRASE treatment. Confirm that your healthcare team 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.

Adverse reactions

In all ELAPRASE clinical trials, the most common adverse reactions (side effects) requiring medical intervention were allergic (hypersensitivity) reactions and included rash, hives, itching, flushing, fever, and headache. The most frequent serious adverse reactions were episodes of insufficient oxygen supply, called hypoxia.

Read more about the warnings, precautions and possible adverse reactions for ELAPRASE in the Important Safety Information below and the full Prescribing Information.

ELAPRASE safety profile

Adverse reactions reported since the approval of ELAPRASE

Late-emergent symptoms and signs of anaphylactic reactions have occurred up to 24 hours after initial treatment and recovery from an initial anaphylactic reaction. In addition, patients experienced repeated anaphylaxis over a two-to four-month period, up to several years after initiating ELAPRASE treatment.

Serious adverse reactions that resulted in death included cardiorespiratory arrest, respiratory failure, respiratory distress, cardiac failure, and pneumonia.

Managing allergic reactions

The treatment center should have procedures and emergency preparations in place to prepare for possible allergic reactions to the ELAPRASE infusion, including serious allergic reactions, such as life-threatening anaphylactic reactions. Your healthcare team should be on hand to observe the patient during and after the infusion. If anaphylactic or other acute reactions occur, immediately discontinue the infusion of ELAPRASE and initiate appropriate medical treatment.

One way in which allergic reactions are often managed is slowing the speed at which ELAPRASE is infused or temporarily stopping the infusion. Therefore, the infusion may take longer if allergic reactions occur; however, infusion times should not exceed 8 hours.

Other possible treatments for allergic reactions include antihistamines or corticosteroids, given either before or during the ELAPRASE infusion. Treatments for anaphylactic reactions may also include inhaled beta-adrenergic agonists, oxygen, and vasopressors.

Read more about the warnings and precautions for ELAPRASE in the Important Safety Information below and the full Prescribing Information.

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 years old, ELAPRASE did not show improvement in disease-related symptoms or long-term clinical results; 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.