• Inborn errors of metabolism

Elaprase Generic Name & Formulations

General Description

Idursulfase 2mg/mL; soln for IV infusion after dilution; preservative-free.

Pharmacological Class

Hydrolytic lysosomal glycosaminoglycan (GAG)-specific enzyme.

How Supplied

Single-use vial (3mL)—1


Generic Availability


Elaprase Indications


Mucopolysaccharidosis II (MPS II; Hunter syndrome).

Elaprase Dosage and Administration

Adults and Children

<16mos: not established. Give by IV infusion over 3hrs; may gradually reduce to 1hr if no hypersensitivity reactions occur; max 8hrs. ≥16mos: 0.5mg/kg once weekly. Initial infusion rate: 8mL/hr for first 15mins; if tolerated, may increase by 8mL/hr increments every 15mins; max rate 100mL/hr.

Elaprase Contraindications

Not Applicable

Elaprase Boxed Warnings

Boxed Warning

Risk of anaphylaxis.

Elaprase Warnings/Precautions


Monitor for anaphylactic or other acute reactions; discontinue immediately if occur. Have resuscitative measures available. Risk of hypersensitivity, serious adverse reactions, antibody development in those with severe genetic mutations. Acute febrile or respiratory illness; evaluate clinical status and consider delaying infusion. Risk of acute cardiorespiratory failure if susceptible to fluid overload, acute underlying respiratory illness, compromised cardiac and/or respiratory function; may require prolonged observation. Pregnancy. Nursing mothers.

Elaprase Pharmacokinetics

See Literature

Elaprase Interactions

Elaprase Adverse Reactions

Adverse Reactions

Headache, pruritus, musculoskeletal pain, urticaria, diarrhea, cough, pyrexia, rash, vomiting; hypersensitivity reactions, flushing, hypoxic episodes.

Elaprase Clinical Trials

See Literature

Elaprase Note

Not Applicable

Elaprase Patient Counseling

See Literature