Description
Ultomiris is a complement inhibitor used for:
the treatment of adult and pediatric patients aged one month and older with paroxysmal nocturnal hemoglobinuria (PNH).
The treatment of adult and pediatric patients aged one month and older with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA).
Recommended Dosage: The recommended dosing regimen in adult and pediatric patients, aged one month or older weighing 5 kg or greater, with PNH and aHUS consists of a loading dose followed by maintenance dosing, administered by intravenous infusion. The dosing is based on the patient’s body weight. Starting 2 weeks after the loading dose administration, begin maintenance doses once every 4 or 8 weeks, based on body weight.
The dosing schedule is allowed to occasionally vary within one week of the scheduled infusion day (except for the 1’st maintenance dose of ultomiris injection); but the subsequent doses should be used as per the original schedule.
Recommended dosage for Patients with Body Weight Range (kg):
5 to less than 10 kg: 600 mg (Loading Dose); 300 mg maintenance dose for every 4 weeks.
10 to less than 20 kg: 600 mg (Loading Dose); 600 mg maintenance dose for every 4 weeks.
20 to less than 30 mg: 900 mg (Loading Dose); 2,100 mg maintenance dose for every 8 weeks.
30 to less than 40 mg: 1,200 mg (Loading Dose); 2,700 mg maintenance dose for every 8 weeks.
40 to less than 60 mg: 2,400 mg (Loading Dose); 3,000 mg maintenance dose for every 8 weeks.
60 to less than 100 mg: 2,700 mg (Loading Dose); 3,300 mg maintenance dose for every 8 weeks.
100 kg or greater: 3,000 mg (Loading Dose); 3,600 mg maintenance dose for every 8 weeks.
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