galsulfase 5 mg/5 mL intravenous solution

Generic name:
Galsulfase - injection

Pronunciation
(gal-SUL-fase)

Brand name(s)
Naglazyme

Galsulfase may cause serious (sometimes fatal) allergic reactions during the infusion of this drug and for 24 hours afterward. Get medical help right away if you have any symptoms of a serious allergic reaction such as rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, or trouble breathing.

Galsulfase is used to treat a certain rare genetic problem (Maroteaux-Lamy syndrome - MLS). Galsulfase replaces a certain natural substance that is missing in people with MLS.

This medication improves how far you can walk and the number of stairs you can climb up. Galsulfase does not correct the genetic problem, and treatment must be continued for life.

This medication is given by injection into a vein by a health care professional. It is given as directed by your doctor, usually once a week. It is injected slowly into a vein over 4 hours. The dosage is based on your weight, medical condition, and response to treatment.

Infusion reactions may happen during the infusion of this drug. Your doctor may prescribe other medications (such as antihistamines, drugs for fever) before each treatment to help prevent these side effects. Tell your doctor right away if you have any symptoms of infusion reactions such as fever, chills, shortness of breath, nausea/vomiting, increased blood pressure, headache, chest pain, dizziness, weakness/tiredness, joint pain, flushing, or coughing. Your doctor may give you other medications to help with these side effects or may slow down or stop your treatment for some time.

Use this medication regularly to get the most benefit from it. To help you remember, use it on the same day each week.

Tell your doctor if your condition gets worse.

See also Warning and How to Use sections.

Ear pain, eye redness/itching/discharge, or stomach/abdominal pain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• vision/hearing changes
• back pain
• inability to move arms/legs
• inability to control urine/stool
• signs of kidney problems (such as change in the amount of urine)

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using galsulfase, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• heart problems (such as heart failure)
• lung problems

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Keep all medical and lab appointments.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a hospital or clinic or doctor's office and will not be stored at home.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.