Galsulfase injection

What is this medicine?

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.

How should I use this medicine?

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.

What side effects may I notice from receiving this medicine?

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

What may interact with this medicine?

• chloroquine

• gentamicin

• hydroxychloroquine

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.

Where should I keep my medicine?

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

What should I tell my health care provider before I take this medicine?

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

What should I watch for while using this medicine?

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.