Elaprase

Elaprase is a prescription medication used to improve walking ability in patients with Hunter syndrome who are 5 years and older.

Elaprase belongs to a group of drugs called enzymes. It works by replacing iduronate-2-sulfatase (I2S), an enzyme that people with Hunter syndrome do not have enough of.

This medication comes in injectable form to be given directly into a vein (IV) by a healthcare professional. It is given once a week as an infusion.

Common side effects of Elaprase include diarrhea, muscle pain, itching, and headache.

Elaprase is a prescription medication used to improve walking ability in patients 5 years and older with Hunter syndrome.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Shire US Manufacturing Inc.

Serious side effects have been reported with Elaprase. See the “Elaprase Precautions” section.

Common side effects of Elaprase include the following:

• diarrhea
• muscle pain
• headache
• cough
• itching
• hives
• rash
• flushing
• tiredness
• chills
• fast heart rate

This is not a complete list of Elaprase side effects. Ask your doctor or pharmacist for more information.

No drug interactions have been reported by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Elaprase including the following:

Hypersensitivity Reactions Including Anaphylaxis. Serious allergic reactions have occurred during and for up to 24 hours after receiving an Elaprase infusion. Your doctor may give you certain medications before receiving Elaprase to help prevent allergic reactions. Tell your healthcare provider if you experience any of the following:

• swelling of the face, eyes, lips, tongue, arms, or legs
• difficulty breathing or swallowing
• rash

Risk of Antibody Development. Certain patients with genetic mutations may develop antibodies (proteins made by your immune system in response to something it does not recognize as a normal part of the body) that can cause Elaprase to not work as well. Your doctor will monitor you for development of these antibodies.

Risk of Acute Respiratory Complications. Patients with breathing problems may be at a higher risk for serious allergic reactions when receiving Elaprase. Tell your doctor if you have any diseases that affect your lungs or breathing or if you are sick.

Risk of Acute Cardiorespiratory Failure. Patients with heart or lung problems may have an acute worsening of their condition when receiving Elaprase. Tell your doctor if you have any conditions that affect your heart or lungs. 

Do not take Elaprase if you are allergic to Elaprase or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Elaprase, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Elaprase, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Elaprase or to any of its ingredients
• have heart problems
• have lung problems
• are currently sick
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Elaprase falls into category C. There are no well-controlled studies that have been done in pregnant women. Elaprase should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional. It is given once a week as an infusion.

Typically, the infusion can take up to 3 hours, but may be longer if you have had an allergic reaction to Elaprase. The infusion should not be given over longer than 8 hours.

If you miss an appointment to receive a dose of Elaprase, contact your healthcare provider to make plans to receive your next infusion.

The dose your doctor recommends will be based on your weight.

The recommended dose of Elaprase is 0.5 mg per kg body weight given once a week as an intravenous (IV) infusion.

Since Elaprase is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Keep all appointments with your doctor and infusion center while receiving Elaprase.
• A program has been created to better understand Hunter Syndrome and the long-term effects of Elaprase. For more information on this program, talk to your doctor or call 1-866-888-0660.

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.