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Elaprase
Idursulfase
$4920.00
2mg/1ml · 6
BrandBranded medicine· By Takeda
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FDA boxed warningRisk of anaphylaxis
Life-threatening anaphylactic reactions have occurred in some patients during and up to 24 hours after ELAPRASE infusions. Anaphylaxis, presenting as respiratory distress, hypoxia, hypotension, urticaria and/or angioedema of throat or tongue have been reported to occur during and after ELAPRASE infusions, regardless of duration of the course of treatment. Closely observe patients during and after ELAPRASE administration and be prepared to manage anaphylaxis. Inform patients of the signs and symptoms of anaphylaxis and have them seek immediate medical care should symptoms occur. Patients with compromised respiratory function or acute respiratory disease may be at risk of serious acute exacerbation of their respiratory compromise due to hypersensitivity reactions and require additional monitoring.
Life-threatening anaphylactic reactions, presenting as respiratory distress, hypoxia, hypotension, urticaria and/or angioedema of throat or tongue have occurred in some patients during and up to 24 hours after ELAPRASE infusions. Closely observe patients during and after ELAPRASE administration and be prepared to manage anaphylaxis. Inform patients of the signs and symptoms of anaphylaxis and have them seek immediate medical care should symptoms occur. Patients with compromised respiratory function or acute respiratory disease may be at risk of serious acute exacerbation of their respiratory compromise due to hypersensitivity reactions and require additional monitoring.
About Elaprase
Overview
Elaprase (idursulfase) is an enzyme replacement medicine used to treat Hunter syndrome, also called mucopolysaccharidosis II (MPS II). It has been shown to improve walking capacity in patients aged 5 years and older. It works by supplying an enzyme that is missing or defective in Hunter syndrome, helping cells break down substances called glycosaminoglycans (GAGs) that would otherwise build up.
What it treats
- Hunter syndrome (mucopolysaccharidosis II, MPS II).
Safety information
Side effects
Common side effects in patients aged 5 years and older include headache, itching, muscle and bone pain, hives, diarrhea and cough. In patients aged 7 years and younger, common side effects include fever, rash, vomiting and hives. Seek emergency medical help for a severe allergic reaction (anaphylaxis) or breathing difficulties. Allergic reactions may include rash, hives, itching, flushing, fever and headache, and may require medical treatment. Contact a doctor if these occur. Patients with impaired breathing, a respiratory illness or an illness with fever may be at higher risk of life-threatening complications from allergic reactions. Children aged 7 years and younger with certain severe genetic mutations causing Hunter syndrome have a higher risk of allergic reactions, serious side effects and developing antibodies against idursulfase.
FDA boxed warning
Risk of anaphylaxis
Life-threatening anaphylactic reactions have occurred in some patients during and up to 24 hours after ELAPRASE infusions. Anaphylaxis, presenting as respiratory distress, hypoxia, hypotension, urticaria and/or angioedema of throat or tongue have been reported to occur during and after ELAPRASE infusions, regardless of duration of the course of treatment. Closely observe patients during and after ELAPRASE administration and be prepared to manage anaphylaxis. Inform patients of the signs and symptoms of anaphylaxis and have them seek immediate medical care should symptoms occur. Patients with compromised respiratory function or acute respiratory disease may be at risk of serious acute exacerbation of their respiratory compromise due to hypersensitivity reactions and require additional monitoring.
Life-threatening anaphylactic reactions, presenting as respiratory distress, hypoxia, hypotension, urticaria and/or angioedema of throat or tongue have occurred in some patients during and up to 24 hours after ELAPRASE infusions. Closely observe patients during and after ELAPRASE administration and be prepared to manage anaphylaxis. Inform patients of the signs and symptoms of anaphylaxis and have them seek immediate medical care should symptoms occur. Patients with compromised respiratory function or acute respiratory disease may be at risk of serious acute exacerbation of their respiratory compromise due to hypersensitivity reactions and require additional monitoring.
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
The FDA label lists no contraindications for Elaprase. Serious allergic reactions, including anaphylaxis, can occur. Staff administering Elaprase must be trained in cardiopulmonary resuscitation and have ready access to emergency medical services. Extra caution is needed in people with impaired breathing, an acute illness with fever, or an acute respiratory illness. These conditions may increase the risk of life-threatening complications from allergic reactions. The care team should assess the person’s condition before treatment and consider delaying the infusion. Children aged 7 years and younger with Hunter syndrome and certain severe genetic mutations had higher rates of allergic reactions, serious adverse reactions, and antibodies against idursulfase. These mutations include complete gene deletions, large gene rearrangements, and nonsense, frameshift or splice-site mutations.
Using Elaprase
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store in the original carton below 25°C, protected from light, unless the pack states refrigeration. Do not freeze. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label ELAPRASE (IDURSULFASE) SOLUTION, CONCENTRATE [TAKEDA PHARMACEUTICALS AMERICA, INC.] (DailyMed, retrieved 19 September 2026).
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