Galsulfase injection

What is this medication?

GALSULFASE is an enzyme replacement. It is used to treat the symptoms of mucopolysaccharidosis VI (also known as MPS VI or Maroteaux-Lamy syndrome). This medicine is not a cure.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Naglazyme

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• fever or infection
• sleep apnea
• an unusual or allergic reaction to galsulfase, any human or hamster proteins, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 5 years of age for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medication?

• chloroquine
• gentamicin
• hydroxychloroquine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your doctor for regular check ups.

You may take part in a Clinical Surveillance Program to better understand the effects of this medicine. Ask your doctor or other health care professional for more information.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• changes in vision
• chest pain
• ear pain, infection
• feeling faint or lightheaded, falls
• fever or chills
• high blood pressure
• snoring that disrupts sleep

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• aches and pains
• diarrhea
• headache
• nausea, vomiting
• stomach upset
• tiredness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This drug is given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.