Ravulizumab

Therapeutic indications

Ravulizumab is indicated for:

Paroxysmal nocturnal haemoglobinuria

Population group: only children (1 year - 12 years old) , adolescents (12 years - 18 years old) , adults (18 years old or older)

Ravulizumab is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with paroxysmal nocturnal haemoglobinuria (PNH):

in patients with haemolysis with clinical symptom(s) indicative of high disease activity.
in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

2,400-3,000 mg at week 0, 3,000-3,600 mg at week 2 and once every 8 weeks thereafter, based on body weight

600-3,000 mg at week 0 and thereafter 600 mg every 4 weeks or 900-3,600 mg every 8 weeks, based on body weight

Atypical haemolytic uremic syndrome

Population group: only children (1 year - 12 years old) , adolescents (12 years - 18 years old) , adults (18 years old or older)

Ravulizumab is indicated in the treatment of patients with a body weight of 10 kg or above with atypical haemolytic uremic syndrome (aHUS) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

2,400-3,000 mg at week 0, 3,000-3,600 mg at week 2 and once every 8 weeks thereafter, based on body weight

600-1,200 mg at week 0 and thereafter 600 mg every 4 weeks or 900-2,700 mg every 8 weeks, based on body weight

Generalised myasthenia gravis

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

Ravulizumab is indicated as an add-on to standard therapy for the treatment of adult patients with gMG who are anti-acetylcholine receptor (AChR) antibody-positive.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

2,400-3,000 mg at week 0, 3,000-3,600 mg at week 2 and once every 8 weeks thereafter, based on body weight

Neuromyelitis optica spectrum disorder

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

Ravulizumab is indicated in the treatment of adult patients with NMOSD who are anti-aquaporin 4 (AQP4) antibody-positive.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

2,400-3,000 mg at week 0, 3,000-3,600 mg at week 2 and once every 8 weeks thereafter, based on body weight

Contraindications

Ravulizumab is contraindicated in the following cases:

Lactation

Patients with unresolved Neisseria meningitidis infection at treatment initiation

Meningococcal infectious disease

Patients who are not currently vaccinated against Neisseria meningitidis

Meningococcus vaccination

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Ravulizumab

Therapeutic indications

Paroxysmal nocturnal haemoglobinuria

2,400-3,000 mg at week 0, 3,000-3,600 mg at week 2 and once every 8 weeks thereafter, based on body weight

600-3,000 mg at week 0 and thereafter 600 mg every 4 weeks or 900-3,600 mg every 8 weeks, based on body weight

Atypical haemolytic uremic syndrome

2,400-3,000 mg at week 0, 3,000-3,600 mg at week 2 and once every 8 weeks thereafter, based on body weight

600-1,200 mg at week 0 and thereafter 600 mg every 4 weeks or 900-2,700 mg every 8 weeks, based on body weight

Generalised myasthenia gravis

2,400-3,000 mg at week 0, 3,000-3,600 mg at week 2 and once every 8 weeks thereafter, based on body weight

Neuromyelitis optica spectrum disorder

2,400-3,000 mg at week 0, 3,000-3,600 mg at week 2 and once every 8 weeks thereafter, based on body weight

Contraindications

Lactation

Patients with unresolved Neisseria meningitidis infection at treatment initiation

Patients who are not currently vaccinated against Neisseria meningitidis

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