Dosing and administration ULTOMIRIS® offers freedom from infusions for up to 8 weeks in most patients.*1
*Starting 2 weeks after the loading dose, maintenance doses are administered once every 8 weeks for patients weighing ≥ 20kg (every 4 weeks for pediatric patients with body weight ≥ 10 to <20kg).1
Before starting ULTOMIRIS® immunise your patients with appropriate vaccination.**1

ULTOMIRIS® is contraindicated in patients who are not currently vaccinated against Neisseria meningitidis.1

Please consult the Summary of Product Characteristics prior to prescribing.
**Vaccines against serogroups A, C, Y, W135 and B where available, are recommended in preventing the commonly pathogenic meningococcal serogroups. Patients must be vaccinated or revaccinated according to current national guidelines for vaccination use. If the patient is being switched from eculizumab treatment, physicians should verify that meningococcal vaccination is current according to national guidelines for vaccination use.1
  • Vaccination may not be sufficient to prevent meningococcal infection1
  • Consideration should be given to official guidance on the appropriate use of antibacterial agents1
  • Cases of serious meningococcal infections/sepsis have been reported in patients treated with ULTOMIRIS®1
  • Cases of serious or fatal meningococcal infections/sepsis have been reported in patients treated with other terminal complement inhibitors1
  • All patients should be monitored for early signs of meningococcal infection and sepsis, evaluated immediately if infection is suspected, and treated with appropriate antibiotics1
  • Patients should be informed of these signs and symptoms, and steps should be taken to seek medical care immediately1
  • Physicians should provide patients with important safety information to minimise the risk of serious side effects: ULTOMIRIS® Patient Information Brochure and Patient Alert Card.1

For patients switching from eculizumab to ravulizumab, the loading dose of ravulizumab should be administered 2 weeks after the last eculizumab infusion, and then maintenance doses should be administered per ravulizumab weight-based dosing regimen, starting 2 weeks after loading dose administration.1

  • Ultomiris is for intravenous infusion only. Must be administered through a 0.2 µm filter and should not be administered as an intravenous push or bolus injection1
  • Typical infusion lasts < 1 hour for many patients,‡ with monitoring for at least 1 hour after infusions for signs or symptoms of an infusion-related reaction1
  • The dosing schedule is allowed to occasionally vary by ±7 days of the scheduled infusion day, except for the first maintenance dose of ULTOMIRIS®1
  • Ultomiris 10 mg/ mL concentrate for solution for infusion must not be mixed with Ultomiris 100 mg/ mL concentrates for solution for infusion1

†ULTOMIRIS® must be administered by a healthcare professional and under the supervision of a physician experienced in the management of patients with haematological, renal, neuromuscular or neuroinflammatory disorders.1

‡Minimum infusion time for ULTOMIRIS® 100 mg/mL maintenance doses ranges from 30 minutes to 75 minutes, depending on body weight.1
ULTOMIRIS® SmPC
Adverse Event Reporting

Please report any adverse events via your national reporting system. Adverse events can also be reported to Alexion Pharmaceuticals by contacting: https://contactazmedical.astrazeneca.com/
ULTOMIRIS® EU Summary of Product Characteristics available at https://www.ema.europa.eu/en/documents/product-information/ultomiris-epar-product-information_en.pdf. Last accessed: December 2024. Singh NS, et al. Am J Kidney Dis. 2021;78(1):96–102.e1 Chopra V, et al. Lancet. 2013;382(9889):311–325 Walco GA. Pediatrics. 2008;122(Suppl 3):S125–S129 Van Loon FHJ, et al. J Vasc Access. 2018;19(3):258–265. Mauch TJ, et al. J Comp Eff Res. 2023;12(9):e230036 Rondeau E, et al. Kidney Int. 2020;97(6):1287–1296. Ariceta G, et al. Kidney Int. 2021;100(1):225–237. Barbour T, et al. Kidney Int Rep. 2021;6(6):1603–1613