Semin and Selim
Naglazyme® (galsulfase) Patients
Brothers Semih and Selim, from Tekirdağ, Turkey, receive weekly Naglazyme® treatments for MPS VI.
They are among hundreds of people with MPS VI in the European Union, North Africa, the Middle East and Latin America who are benefitting from progressive new orphan disease drug policies and reimbursement programs instituted by their native countries to better meet patients’ unmet medical needs.
Full Indication and Important Safety Information
Naglazyme® (galsulfase) is indicated for patients with mucopolysaccharidosis VI (MPS VI). Naglazyme has been shown to improve walking and stair-climbing capacity.
Important Safety Information
The most common adverse events in patients treated with Naglazyme were headache, fever, joint pain, vomiting, upper respiratory infections, abdominal pain, diarrhea, ear pain, cough, and ear infections. Severe reactions included swollen blood vessels, low blood pressure, difficulty breathing, respiratory distress, stopping breathing, and hives.
The most common symptoms of infusion reactions included fever, chills/shakes, headache, rash, and mild to moderate hives. Nausea, vomiting, elevated blood pressure, chest pain, abdominal pain, malaise, and joint pain were also reported.
No patients discontinued Naglazyme treatment because of reactions. Nearly all patients developed antibodies as a result of the treatment, but the level of immune response did not correlate with the severity of the adverse reaction.
Because antihistamine use may increase the risk of stopping breathing, airways should be checked to ensure they are not blocked or obstructed. Treatment may be delayed if you have a fever or respiratory illness.
To report SUSPECTED ADVERSE REACTIONS, contact BioMarin Pharmaceutical Inc. at 1-866-906-6100, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Naglazyme is available by prescription only. To learn more, please visit www.naglazyme.com for full prescribing information. If you have any questions about this information, please talk with your doctor.