Eculizumab

Therapeutic indications

Eculizumab is indicated for:

Paroxysmal nocturnal haemoglobinuria (PNH)

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 (click for details):

Atypical haemolytic uremic syndrome (aHUS)

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 (click for details):

Generalized myasthenia gravis (gMG)

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

Eculizumab is indicated in adults for the treatment of refractory generalized myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor (AChR) antibody-positive.

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

Neuromyelitis optica spectrum disorder (NMOSD)

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

Eculizumab is indicated in adults and children for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in patients who are anti-aquaporin-4 (AQP4) antibody-positive with a relapsing course of the disease.

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

Paroxysmal nocturnal haemoglobinuria (PNH)

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

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 (click for details):

Atypical haemolytic uremic syndrome (aHUS)

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

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 (click for details):

Contraindications

Eculizumab is contraindicated in the following cases:

Neisseria meningitidis infection

Meningococcal infectious disease

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