• Inborn errors of metabolism

Naglazyme Generic Name & Formulations

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

Generic Availability


Naglazyme 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


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

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