Manufacturer
Alexion Pharma International Operations Limited(IRELAND)

Registraction Number
MAL24096028ACRZ


Content:
Ultomiris 100mg/mL Concentrate for Solution for Infusion contains 100 mg of ravulizumab in 1 ml. Ravulizumab is a monoclonal antibody that inhibits the complement system and is used to treat several rare and serious disorders.
Indications:

• Paroxysmal Nocturnal Haemoglobinuria (PNH): Treatment of adult and pediatric patients with PNH who have haemolysis with clinical symptoms indicative of high disease activity.
• Atypical Haemolytic Uremic Syndrome (aHUS): Treatment of adult and pediatric patients with aHUS who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.
• Generalized Myasthenia Gravis (gMG): Treatment of adult patients with gMG who are anti-acetylcholine receptor (AChR) antibody-positive.
• Neuromyelitis Optica Spectrum Disorder (NMOSD): Treatment of adult patients with NMOSD who are anti-aquaporin-4 (AQP4) antibody-positive.

Instructions:

1. Administration: Administered as an intravenous infusion under the supervision of a healthcare professional.
2. Dosage: The recommended dosing regimen consists of a loading dose followed by maintenance dosing. For adult patients, maintenance doses are typically administered once every 8 weeks3.
3. Timing: Take it at the same time each day to help you remember.
4. Monitoring: Regular monitoring of blood counts and other parameters is essential.