Naglazyme Generic Name & Formulations
Galsulfase 1mg/mL; conc. soln for IV infusion after dilution; preservative-free.
Recombinant human N-acetylgalactosamine 4-sulfatase enzyme.
Single-dose vial (5mL)—1
Mucopolysaccharidosis VI (MPS VI).
Naglazyme Dosage and Administration
Adults and Children
<5yrs: not recommended. ≥5yrs: Give by IV infusion over 4 hours. Initial infusion rate: 6mL/hr for the first hour, then, if tolerated, may increase to 80mL/hr for the remaining 3 hours. May extend infusion time up to 20 hours if infusion reactions occur. Pretreat with antihistamines w/wo antipyretics 30–60mins prior to starting infusion. 1mg/kg once weekly.
Naglazyme Boxed Warnings
Discontinue if severe infusion reactions occur. Antihistamine pretreatment may increase risk of apneic episodes. Risk of acute cardiorespiratory failure in patients susceptible to fluid volume overload (eg, weighing ≤20kg, underlying respiratory illness, compromised cardiac and/or respiratory function). Consider evaluation of airway patency prior to treatment. Acute febrile or respiratory illness: delay infusion. Monitor for spinal/cervical cord compression (including back pain, limb paralysis, urinary and fecal incontinence). Pregnancy. Nursing mothers.
Naglazyme Adverse Reactions
Rash, pain, urticaria, pyrexia, pruritus, chills, headache, nausea, vomiting, abdominal pain, dyspnea; infusion reactions.
Naglazyme Clinical Trials
Naglazyme Patient Counseling