Paroxysmal nocturnal haemoglobinuria (PNH)

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 paroxysmal nocturnal haemoglobinuria (PNH). Evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history.

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

600-900 mg once a week

Route of admnistration

Intravenous

Defined daily dose

600 - 900 mg

Dosage regimen

From 600 To 900 mg once every 7 day(s)

Loading dose

600 mg

Maintenance dose

900 mg

Detailed description

The PNH dosing regimen for adult patients (≥18 years of age) consists of a 4-week initial phase followed by a maintenance phase:

  • Initial phase: 600 mg of eculizumab administered via a 25–45 minute (35 minutes ± 10 minutes) intravenous infusion every week for the first 4 weeks.
  • Maintenance phase: 900 mg of eculizumab administered via a 25–45 minute (35 minutes ± 10 minutes) intravenous infusion for the fifth week, followed by 900 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

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.

Read more about Eculizumab

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