Atypical haemolytic uremic syndrome (aHUS)

Active Ingredient: Eculizumab

Indication for Eculizumab

Population group: only adults (18 years old or older)

Eculizumab is indicated in adults and children for the treatment of atypical haemolytic uremic syndrome (aHUS).

For this indication, competent medicine agencies globally authorize below treatments:

900-1,200 mg once a week

Route of admnistration

Intravenous

Defined daily dose

900 - 1,200 mg

Dosage regimen

From 900 To 1,200 mg once every 7 day(s)

Loading dose

900 mg

Maintenance dose

1,200 mg

Detailed description

The aHUS, refractory gMG and NMOSD dosing regimen for adult patients (≥18 years of age) consists of a 4 week initial phase followed by a maintenance phase:

  • Initial phase: 900 mg of eculizumab administered via a 25–45 minute (35 minutes ± 10 minutes) intravenous infusion every week for the first 4 weeks.
  • Maintenance phase: 1,200 mg of eculizumab administered via a 25–45 minute (35 minutes ± 10 minutes) intravenous infusion for the fifth week, followed by 1,200 mg of eculizumab administered via a 25–45 minute (35 minutes ± 10 minutes) intravenous infusion every 14 ± 2 days.

Dosage considerations

The diluted solution of eculizumab should be administered by intravenous infusion over 25–45 minutes (35 minutes ± 10 minutes) in adults.

Active ingredient

Eculizumab is a monoclonal antibody, a terminal complement inhibitor that specifically binds to the complement protein C5 with high affinity, thereby inhibiting its cleavage to C5a and C5b and preventing the generation of the terminal complement complex C5b-9. Eculizumab preserves the early components of complement activation that are essential for opsonization of microorganisms and clearance of immune complexes.

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