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All about: Idursulfase

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

Trade Names:
Elaprase
- Solution for injection 2 mg/mL

Mechanism of Action

Pharmacology

Provides exogenous enzyme for uptake into cellular lysosomes.

Pharmacokinetics

Absorption

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.

Elimination

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).

Contraindications

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.

Storage/Stability

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

Cardiovascular

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

CNS

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

Dermatologic

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

EENT

Visual disturbances (22%).

GI

Dyspepsia (13%).

Local

Infusion site edema (13%).

Musculoskeletal

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

Respiratory

Wheezing (19%).

Miscellaneous

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

Precautions

Warnings

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.


Pregnancy

Category C .

Lactation

Undetermined.

Children

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.

Overdosage

Symptoms

No experience with overdosage in humans is available.

Patient Information

  • Encourage patient to participate in the Hunter Outcome Survey.

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