Uses

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.

How To Use

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

If you are using this medication at home, galsulfase will be shipped to your home. A nurse will come to your home to give you the treatment and to monitor you afterward. Do not shake the medication. Galsulfase should be colorless or pale yellow. Before using, check this product visually for particles or discoloration. If either is present, do not use it. Discard any unused prepared medication. Do not save for later use. Learn how to store and discard medical supplies safely.

Galsulfase may cause side effects (such as fever, chills, rash, shortness of breath, nausea/vomiting, increased blood pressure, headache, chest pain, dizziness, weakness/tiredness, joint pain, flushing, coughing) while it is being given and for a short time after the infusion has stopped. Your doctor may decide to stop or slow down the medication infusion for a while if this happens. Tell your healthcare professional right away if you have any of these symptoms. Your doctor may direct you to take other medications (such as antihistamines, drugs for fever, or corticosteroids such as prednisone) to treat your reaction and before your next treatment(s) to prevent these reactions from happening again.

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.

Side Effects

See also How to Use section.

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)

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

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.

Precautions

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 breast-feeding.

Drug Interactions

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.

Overdose

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 their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Missed Dose

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. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Before mixing, store the vial in the refrigerator. Protect from light and freezing.

Once it has been mixed, consult the product instructions and your pharmacist for storage details. Discard any unused portion. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.