Ravulizumab

Paroxysmal Nocturnal Hemoglobinuria (PNH) ULTOMIRIS® (ravulizumab for injection) is indicated for the treatment of adult and pediatric patients one month of age and older with paroxysmal nocturnal hemoglobinuria (PNH). Atypical Hemolytic Uremic Syndrome (aHUS) ULTOMIRIS® (ravulizumab for injection) is indicated for the treatment of adult and pediatric patients one month of age and older with atypical hemolytic uremic syndrome (aHUS) to inhibit complement- mediated thrombotic microangiopathy (TMA).

Limitations of Use:

ULTOMIRIS is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). Generalized Myasthenia Gravis (gMG) ULTOMIRIS (ravulizumab for injection) is indicated for the treatment of adult patients with anti- acetylcholine receptor (AChR) antibody-positive generalized Myasthenia Gravis (gMG).

ULTOMIRIS was studied in adult gMG patients with a Myasthenia Gravis Foundation of America (MGFA) clinical classification Class II to IV and a Myasthenia Gravis Activities of Daily Living (MG-ADL) total score ≥ 6. Neuromyelitis Optica Spectrum Disorder (NMOSD) ULTOMIRIS® (ravulizumab for injection) is indicated for the treatment of adult patients with anti- aquaporin 4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD).

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

Generalised myasthenia gravis (gMG) Ultomiris 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. 1).

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

3 Generalised myasthenia gravis (gMG) Ultomiris 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. 1).