Galsulfase Solution for 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.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
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
an unusual or allergic reaction to galsulfase, any human or hamster proteins, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
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.
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 medicine?
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 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.
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
changes in vision
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
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 medicine?
This drug is given in a hospital or clinic and will not be stored at home.
March 21, 2017
U.S. FDA-approved Package Insert