When This Medicine Should Not Be Used:
You should not receive this medicine if you have had an allergic reaction to galsulfase.

How to Use This Medicine:
Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein.
• A nurse or other health provider will give you this medicine.
• The usual dose schedule for this medicine is 1 time each week. The medicine must be given slowly, so the needle will remain in place for at least 4 hours. An IV pump is sometimes used if the medicine needs to be given over several hours or throughout an entire day.
• You may also receive medicines to help prevent possible allergic reactions to the injection.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have heart disease or lung disease. Tell your doctor if you snore or have sleep apnea.
• This medicine may cause headaches and skin reactions, such as a rash or itching while you are receiving the injection or within 24 hours after you receive it. Check with your health caregiver right away if you have any of these symptoms.
• This medicine can cause fever and allergic-type reactions. You will receive medicines to prevent these side effects, and that medicine may make you drowsy. Avoid driving, using machines, or doing anything else that could be dangerous until you know how this medicine affects you.
• Spinal cord compression (SCC) has happened or gotten worse after people were treated with this medicine. Call your doctor right away if you have back pain, trouble moving your arms or legs, or trouble controlling your bladder or bowels.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Back pain, trouble moving arms or legs, loss of bladder or bowel control
• Eye pain, redness, watering
• Feeling very drowsy or sleepy
• Fever or chills, headache
• Lightheadedness, dizziness, or fainting
• Nausea, stomach pain
• Rapid weight gain, swelling in your hands, ankles, or feet
• Trouble breathing, chest pain

If you notice these less serious side effects, talk with your doctor:

• Cough, sore throat, ear pain, runny or stuffy nose
• Diarrhea, nausea, vomiting
• Joint or muscle pain
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088