DrugindexOnline^{2nd edition}

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.

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, lung or breathing disease or illness (eg, infection), or sleep apnea, or if you use supplemental oxygen

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 administered as an injection at your doctor's office, hospital, or clinic.
• If this medicine 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. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
• If you miss a dose of Galsulfase , contact your doctor immediately.

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

Important safety information:

• Use Galsulfase with extreme caution in CHILDREN younger than 5 years of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Galsulfase , discuss with your doctor the benefits and risks of using Galsulfase during pregnancy. It is unknown if Galsulfase is excreted in breast milk. If you are or will be breast-feeding while you are using Galsulfase , check with your doctor or pharmacist to discuss the 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; diarrhea; 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); chest pain; chills; decreased reflexes; difficulty swallowing; eye redness or irritation; fever; hoarseness; joint pain; 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; vision problems; vomiting.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), 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.

This information is a summary only. It does not contain all information about Galsulfase . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.