When This Medicine Should Not Be Used:
This medicine is not right for everyone. You should not receive this medicine if you had an allergic reaction to elosulfase alfa.

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.
• 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:

• Tell your doctor if you are pregnant or breastfeeding, or if you have breathing or lung problems (such as sleep apnea) or a fever.
• This medicine may cause the following problems:
  
  • Allergic reactions, even after the infusion is finished
  • Lung or breathing problems
  • Spinal or cervical cord compression (may be part of the disease and not caused by this medicine)
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.

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, numbness in your legs
• Dizziness or lightheadedness
• Fever or chills
• Loss of bladder or bowel control
• Severe nausea, vomiting, or stomach pain
• Unusual tiredness or weakness

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

• Headache
• Mild nausea, vomiting, or stomach pain

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