Taking NAGLAZYME® (galsulfase)

Once you’ve been prescribed NAGLAZYME® (galsulfase), it is important to start the treatment as soon as you can. And once you start, it is important to keep getting your treatments.

In a study of patients taking NAGLAZYME for 96 weeks, patients received 98% of scheduled infusions and saw sustained improvements in endurance.

BioMarin RareConnections™ is focused on helping people with MPS VI get access to NAGLAZYME therapy.

This program is available at no cost and provides confidential and personalized support to assist with your healthcare needs. The goal of BioMarin RareConnections™ is to help you navigate the healthcare system and get access to NAGLAZYME therapy as well as other resources to help you manage MPS VI. Just call 1‐866‐906‐6100 or email support@biomarin-rareconnections.com to find out how BioMarin RareConnections can help you.

What does this really mean?

An Account Manager, Case Manager, and Clinical Nurse Educator all make up your experienced BioMarin RareConnections team, dedicated to helping you start and stay on NAGLAZYME therapy.

Your BioMarin RareConnections Case Manager will help you coordinate all of the details of your treatment, including confirming that your insurance will pay for NAGLAZYME. Most insurance plans will provide coverage for NAGLAZYME, but if you need help getting insurance, your Case Manager will look for options to get you sufficient coverage. Your Case Manager will also put you in touch with other people at BioMarin who can help you work with your healthcare team and who can provide NAGLAZYME and MPS VI education to you and your family.

Are you ready? Let’s talk.

Important information to help your treatment

In this part of Naglazyme.com, there are tools and information to help you with your NAGLAZYME therapy.

taking-naglazyme_video
play-btn
play-btn_hov
View video: NAGLAZYME therapy.
Next Page

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.