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All about: Idursulfase

Big Image Pronouncation: (EYE-dur-SUL-fase)
Class: Endocrine and metabolic agent

Trade Names:
- Solution for injection 2 mg/mL

Mechanism of Action


Provides exogenous enzyme for uptake into cellular lysosomes.



C max is about 1.5 mcg/mL after 1 wk and about 1.1 mcg/mL after 27 wk. The AUC after 1 wk and 27 wk is about 206 and 169 min•mcg/mL, respectively.


The t ½ after 1 wk and 27 wk is approximately 44 and 48 min, respectively. Total body Cl after 1 wk and 27 wk is about 3 and 3.4 mL/min/kg, respectively.

Indications and Usage

Treatment of patients with Hunter syndrome (mucopolysaccharidosis [MPS] ΙΙ).


None known.

Dosage and Administration

Adults and Children 5 yr of age and older

IV 0.5 mg/kg every week by IV infusion.

General Advice

  • Dilute in 100 mL of sodium chloride 0.9%.
  • Each vial is for single use only.
  • Use of an infusion with a 0.2 micrometer filter is recommended.
  • Administer total volume over a period of 1 to 3 h. If a longer infusion time is required because of infusion reactions, the infusion time should not exceed 8 h. However, the infusion rate may be slowed, temporarily stopped, or discontinued for that visit if infusion reactions occur.
  • The initial infusion rate should be 8 mL/h for the first 15 min. Then, if infusion is tolerated, the rate may be increased by 8 mL/h at 15-min intervals.
  • At no time should the infusion rate exceed 100 mL/h.
  • Do not infuse with other products in the infusion tubing.


Refrigerate at 36° to 46°F. Protect from light. Do not freeze or shake. If immediate use after reconstitution is not possible, the diluted solution can be refrigerated at 36° to 46°F for up to 48 h or must be administered within 8 h if held at room temperature.

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions


Hypertension (25%); atrial abnormality (13%).


Headache (59%); malaise (22%); anxiety, irritability (13%).


Pruritus (28%); urticaria (16%); pruritic rash, skin disorder (13%).


Visual disturbances (22%).


Dyspepsia (13%).


Infusion site edema (13%).


Arthralgia (31%); limb pain (28%); chest wall musculoskeletal pain, musculoskeletal dysfunction (16%).


Wheezing (19%).


Pyrexia (63%); anti-idursulfase immunoglobulin G antibodies (51%); abscess (16%); superficial injury (13%).



Anaphylactoid reactions, which may be life-threatening, have been observed during infusions. Patients with compromised respiratory function or acute respiratory disease may be at risk of serious, acute exacerbation of respiratory compromise caused by infusion reactions.


Category C .




Safety and efficacy not established in children younger than 5 yr of age.

Concomitant illness

Consider delaying infusion in patients with concomitant acute respiratory and/or febrile illness.



No experience with overdosage in humans is available.

Patient Information

  • Encourage patient to participate in the Hunter Outcome Survey.

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