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Elosulfase alfa

Generic Name: elosulfase alfa (EL-oh-SUL-fase AL-fa)
Brand Name: Vimizim

Severe and sometimes fatal allergic reactions have happened during infusion of elosulfase alfa. You will be watched closely during and after the infusion. Tell your doctor right away if you have a cough, skin redness, tightness in the throat, itching, flushing, blue skin, severe or persistent dizziness, fainting, rash, shortness of breath, chest pain, nausea or vomiting, or stomach pain during the infusion.

If you have lung or breathing problems, you may be at risk for worsening of your condition. The risk may also be increased if you have a fever. This could be life-threatening. Discuss any questions or concerns with your doctor.


Elosulfase alfa is used for:

Treating mucopolysaccharidosis type IVA (MPS IVA or Morquio A syndrome).

Elosulfase alfa is an enzyme. It works by helping to decrease a substance in the body that can cause cell, tissue, and organ problems.

Do NOT use elosulfase alfa if:

  • you are allergic to any ingredient in elosulfase alfa

Contact your doctor or health care provider right away if any of these apply to you.

Before using elosulfase alfa:

Some medical conditions may interact with elosulfase alfa. 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 fever, or lung or breathing problems (eg, sleep apnea)

Some MEDICINES MAY INTERACT with elosulfase alfa. However, no specific interactions with elosulfase alfa are known at this time.

Ask your health care provider if elosulfase alfa 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 elosulfase alfa:

Use elosulfase alfa as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Elosulfase alfa is usually given as an injection at your doctor's office, hospital, or clinic.
  • Continue to use elosulfase alfa even if you feel well. Do not miss any doses.
  • Keep this product, as well as syringes and needles, out of the reach of children and away from 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 elosulfase alfa, contact your doctor right away.

Ask your health care provider any questions you may have about how to use elosulfase alfa.

Important safety information:

  • Your doctor will give you other medicines before elosulfase alfa to help avoid infusion side effects.
  • Elosulfase alfa 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 elosulfase alfa while you are pregnant. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you use elosulfase alfa, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of elosulfase alfa:

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:

Headache; tiredness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back pain; cough; fever or chills; loss of bladder or bowel control; not able to move; swelling of hands or legs.

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 elosulfase alfa:

Elosulfase alfa is handled and stored by a health care provider. Keep elosulfase alfa out of the reach of children and away from pets.

General information:

  • If you have any questions about elosulfase alfa, please talk with your doctor, pharmacist, or other health care provider.
  • Elosulfase alfa 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 elosulfase alfa 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 elosulfase alfa. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to elosulfase alfa. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using elosulfase alfa.

Review Date: November 3, 2016

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.

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