Generic Name: idursulfase (EYE-dur-SUL-fase)
Brand Name: Elaprase
Serious and sometimes life-threatening allergic reactions have occurred during or after infusion of idursulfase. Tell your doctor right away if you develop rash; hives; itching; difficulty breathing or swallowing; chest tightness; fainting; severe dizziness or light-headedness; seizures; loss of consciousness; swelling of the mouth, face, lips, throat, or tongue; or unusual hoarseness.
Tell your doctor if you have lung or breathing problems. You may be at risk for severe worsening of your breathing problems if you experience an allergic reaction to idursulfase.
Idursulfase is used for:
Treating patients with Hunter syndrome (mucopolysaccharidosis type II/MPS II).
Idursulfase is a glycoprotein. It works by providing a certain enzyme (iduronate-2-sulfatase) to the body.
Do NOT use idursulfase if:
- you are allergic to any ingredient in idursulfase, unless your doctor tells you otherwise
Contact your doctor or health care provider right away if this applies to you.
Before using idursulfase:
Some medical conditions may interact with idursulfase. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have lung or breathing problems or a fever
Some MEDICINES MAY INTERACT with idursulfase. However, no specific interactions with idursulfase are known at this time.
Ask your health care provider if idursulfase may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use idursulfase:
Use idursulfase as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Idursulfase is given as an injection at your doctor's office, hospital, or clinic.
- Do not use idursulfase if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- If you miss a dose of idursulfase, contact your doctor right away.
Ask your health care provider any questions you may have about how to use idursulfase.
Important safety information:
- Serious and sometimes life-threatening allergic reactions have occurred with use of idursulfase. Your doctor may have you take certain other medicines before you receive idursulfase in order to decrease the risk of allergic reaction. Discuss any questions or concerns with your doctor.
- Idursulfase should be used with extreme caution in CHILDREN younger than 5 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using idursulfase while you are pregnant. It is not known if idursulfase is found in breast milk. If you are or will be breast-feeding while you use idursulfase, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of idursulfase:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Headache; indigestion; mild joint pain; mild swelling at the injection site.
Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; fainting; severe dizziness or light-headedness; seizures; loss of consciousness; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); anxiety; bluish skin or nails; chest pain; coughing up blood; fever, chills, or sore throat; irregular heartbeat; muscle or joint pain; rapid breathing; severe headache; shortness of breath; vision changes; wheezing.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of idursulfase:
Idursulfase is handled and stored by a health care provider. Keep idursulfase out of the reach of children and away from pets.
- If you have any questions about idursulfase, please talk with your doctor, pharmacist, or other health care provider.
- Idursulfase is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take idursulfase or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about idursulfase. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to idursulfase. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using idursulfase.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.