Share on Facebook
Share on Twitter
Share on LinkedIn
Share by Email
Print
Naglazyme Generic Name & Formulations
Legal Class
Rx
General Description
Galsulfase 1mg/mL; conc. soln for IV infusion after dilution; preservative-free.
Pharmacological Class
Recombinant human N-acetylgalactosamine 4-sulfatase enzyme.
How Supplied
Single-dose vial (5mL)—1
Manufacturer
Generic Availability
NO
Naglazyme Indications
Indications
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 Contraindications
Not Applicable
Naglazyme Boxed Warnings
Not Applicable
Naglazyme Warnings/Precautions
Warnings/Precautions
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 Pharmacokinetics
See Literature
Naglazyme Interactions
Not Applicable
Naglazyme Adverse Reactions
Adverse Reactions
Rash, pain, urticaria, pyrexia, pruritus, chills, headache, nausea, vomiting, abdominal pain, dyspnea; infusion reactions.
Naglazyme Clinical Trials
See Literature
Naglazyme Note
Not Applicable
Naglazyme Patient Counseling
See Literature
