Getting started

Once you have a prescription, your physician and BioMarin RareConnections™ can help you find an infusion center and help make sure that your NAGLAZYME® (galsulfase) arrives at the center for you. If you don’t have a prescription for NAGLAZYME but think that NAGLAZYME may be right for you, talk to your doctor. Once you have a prescription, BioMarin RareConnections can help with billing and insurance.

How the infusion works

Here are the basic steps for a NAGLAZYME infusion:

  • You’ll go to the infusion center for your appointment
  • Before treatment, the nurse will make sure you don’t have a fever or infection
  • You may get an antihistamine or fever reducer to help you during the infusion
  • The nurse will start an IV, prepare the NAGLAZYME, and start the infusion
  • The infusion will take about 4 hours
  • The nurse will check with you regularly to make sure you continue to feel OK. The rate of infusion may be adjusted, if needed

If you don’t feel well or have questions, talk to your nurse. The nurse can answer your questions, and may be able to help you be more comfortable.

  • After the infusion, you’ll wait a short while to make sure everything is still OK. Then you’ll go home until next week.
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Important Safety Information

Indication

NAGLAZYME® (galsulfase) is indicated for patients with Mucopolysaccharidosis VI (MPS VI; Maroteaux-Lamy Syndrome). NAGLAZYME has been shown to improve walking and stair-climbing capacity.

Important Safety Information

Severe and life-threatening allergic reactions can occur during NAGLAZYME (galsulfase) infusions and up to 24 hours after infusion. Typical signs of an allergic reaction include shock, difficulty breathing, wheezing, swelling of the throat, and low blood pressure. If a severe allergic reaction occurs during infusion, the infusion should be stopped immediately and you should receive medical attention. Contact your doctor or get medical help right away if you develop any severe symptoms after infusion.

In clinical trials, most patients developed antibodies to NAGLAZYME treatment. There was no clear relationship between antibody formation and the safety or effectiveness of NAGLAZYME.

Serious and severe infusion reactions are associated with NAGLAZYME, including hives, chest pain, rash, abdominal pain, difficulty breathing, swelling, fever, and eye irritation. You should receive medication such as antihistamines before NAGLAZYME infusions to reduce the risk of infusion reactions. If an infusion reaction occurs, the infusion should be slowed or stopped and you may be given additional medication.

The most common side effects of NAGLAZYME seen in clinical trials were rash, pain, hives, fever, itching, chills, headache, nausea, vomiting, abdominal pain and difficulty breathing. The most common side effects requiring medical attention are infusion-related effects.

These are not all of the possible side effects with NAGLAZYME. Talk to your doctor if you have any symptoms that bother you or that do not go away.

NAGLAZYME is a prescription medicine. Before treatment with NAGLAZYME, it is important to discuss your medical history with your doctor. Tell your doctor if you are taking any medication and if you are allergic to any medicines. Your doctor will decide if NAGLAZYME is right for you. If you have questions or would like more information about NAGLAZYME, contact your doctor.

Spinal cord damage may occur due to the natural MPS VI disease process. Signs of spinal cord injury include back pain, loss of bladder and bowel control, numbness, and paralysis. Contact your doctor immediately if you develop any of these symptoms.

To report SUSPECTED ADVERSE REACTIONS contact BioMarin Pharmaceutical Inc. at 1-866-906-6100, or FDA at 1-800-FDA-1088 or go to www.fda.gov/medwatch.

Please see full Prescribing Information.