NAGLAZYME (Galsulfage) Logo

• Healthcare Professionals
• About MPS VI
  • Biochemical basis of MPS VI
  • Dangers of delayed diagnosis
  • Clinical manifestations
    • Identify suspicious clusters
    • Specialty Information: ENT
    • Specialty Information: Ophthalmology
    • Specialty Information: Radiology
  • Recognize the spectrum of severity
  • Refer
• Managing MPS VI with NAGLAZYME
  • Disease-focused therapy
  • Benefits
    • Improved endurance – walk test
    • Improved endurance – stair climb
    • Reduced urinary GAG
    • Open-label extension
  • Dosing and administration
    • Infusion training video
  • Safety
    • Managing infusion
      ARs
  • Cost concerns, billing, and reimbursement
  • General patient care – palliative Rx
• Improving compliance
  • Consequences of noncompliance
  • Become a patient advocate
  • Managing expectations
    • Infusion
      appointments
    • Exploring home infusions
  • BioMarin patient and physician support
• Clinical resources
  • Resource library
  • MPS VI Clinical Surveillance Program
  • Patient advocacy/
    support groups
• Full prescribing information
  • 
• References
  • 
• 

IMPORTANT SAFETY INFORMATION

NAGLAZYME is indicated for patients with Mucopolysaccharidosis VI (MPS VI). NAGLAZYME has been shown to improve walking and stair-climbing capacity.

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 agioneurotic 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 acute febrile or respiratory illness.

Please see full prescribing information (PDF 440KB)

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