Medication Guide App

Galsulfase

Generic Name: galsulfase (gal-SUL-fase)
Brand Name: Naglazyme

Galsulfase is used for:

Treating patients with mucopolysaccharidosis type VI, a mucopolysaccharide enzyme deficiency.

Galsulfase 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 galsulfase if:

  • you are allergic to any ingredient in galsulfase

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

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Before using galsulfase:

Some medical conditions may interact with galsulfase. 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, heart problems (eg, heart failure), lung or breathing problems (eg, infection), or sleep apnea, or if you use supplemental oxygen or continuous positive airway pressure (CPAP) during sleep

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

This may not be a complete list of all interactions that may occur. Ask your health care provider if galsulfase 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 galsulfase:

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

  • Galsulfase is usually given as an injection at your doctor's office, hospital, or clinic.
  • If galsulfase contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
  • Because galsulfase may cause serious reactions when you receive it, you will need to take other medicines (eg, antihistamines, fever reducers) before using galsulfase.
  • Continue to use galsulfase 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 galsulfase, contact your doctor right away.

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

Important safety information:

  • Galsulfase 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 galsulfase while you are pregnant. It is not known if galsulfase is excreted in breast milk. If you are or will be breast-feeding while you use galsulfase, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of galsulfase:

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:

Cough; ear pain; headache.

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; chest pain; chills; decreased reflexes; difficulty swallowing; eye redness or irritation; fever; hoarseness; joint pain; loss of bladder or bowel control; nausea; pain, swelling, or redness at the injection site; shortness of breath; sore throat; stomach pain; sudden, severe headache or dizziness; swelling of hands or legs; tremor; trouble moving arms or legs; vision problems; vomiting.

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 galsulfase:

Galsulfase is usually handled and stored by a health care provider. If you are using galsulfase at home, store galsulfase as directed by your pharmacist or health care provider. Keep galsulfase out of the reach of children and away from pets.

General information:

  • If you have any questions about galsulfase, please talk with your doctor, pharmacist, or other health care provider.
  • Galsulfase 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 galsulfase 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 galsulfase. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to galsulfase. 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 galsulfase.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

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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