Enzyme Replacement Therapy
Enzyme Replacement Therapies (ERT) are a class of drugs that provide people with sufficient quantities of an important enzyme that their own body cannot make.
In MPS VI, the body is lacking in the ASB enzyme needed to break down GAG, a substance that builds up inside the body and leads to MPS VI. NAGLAZYME (galsulfase) provides sufficient quantities of ASB to break down the GAG buildup that leads to MPS VI symptoms.
To learn more about NAGLAZYME, please talk to your doctor, visit
www.naglazyme.com, or contact BioMarin Patient and Physician Support at 1-866-906-6100.
The information provided on this site is not intended to suggest the appropriate therapy or course of action for any individual with MPS VI. It is important to discuss treatment options for MPS VI with your Physician.
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 observed in clinical trials in patients treated with NAGLAZYME were headache, fever, arthralgia, vomiting, upper respiratory infections, abdominal pain, diarrhea, ear pain, cough, and otitis media. Severe reactions included angioneurotic edema, hypotension, dyspnea, bronchospasm, respiratory distress, apnea, and urticaria. The most common symptoms of infusion reactions included fever, chills/rigors, headache, rash, and mild to moderate urticaria. Nausea, vomiting, elevated blood pressure, retrosternal pain, abdominal pain, malaise, and joint pain were also reported. No patients discontinued infusions of NAGLAZYME for adverse events and all patients who completed the double-blind portion of the trial continued to receive weekly infusions of NAGLAZYME. Nearly all patients developed antibodies as a result of treatment, but the level of the immune response did not correlate with the severity of adverse events. Because antihistamine use may increase the risk of apneic episodes, evaluation of airway patency should be considered prior to the initiation of treatment. Consideration to delay infusion of NAGLAZYME should be given when treating patients who present with an acute febrile or respiratory illness.
Please see full Prescribing Information
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