ULTOMIRIS® is contraindicated in patients who are not currently vaccinated against Neisseria meningitidis and in patients with unresolved Neisseria meningitidis infection at treatment initiation.1
ULTOMIRIS® is also contraindicated in patients with hypersensitivity to the active substance or any excipients within the formulation.1
*Weight based dosing for every 4 weeks for <20 kg and every 8 weeks for ≥ 20 kg patients.1
†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
†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 or fatal 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 Safety Card1,3
aBody weight at time of treatment.
This dosing regimen is specific to ULTOMIRIS® 100mg/mL, please refer to the SmPC for the dosing regimens of the other formulations.1
This dosing regimen is specific to ULTOMIRIS® 100mg/mL, please refer to the SmPC for the dosing regimens of the other formulations.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 injection.1
- 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 reaction.1,2
- 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 infusion.1
*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 approximately 75 minutes, depending on body weight.1,2
†Minimum infusion time for ULTOMIRIS® 100 mg/mL maintenance doses ranges from 30 minutes to approximately 75 minutes, depending on body weight.1,2
For patients switching from SOLIRIS® to ULTOMIRIS® the loading dose of ULTOMIRIS® should be administered 2 weeks after the last SOLIRIS® infusion, and then maintenance doses should be administered per weight-based dosing regimen shown in table above, starting 2 weeks after loading dose administration.1
Please report any adverse events via your national reporting system. Adverse events can also be reported to Alexion,
AstraZeneca Rare Disease by contacting: https://contactazmedical.astrazeneca.com/
SmPC, Summary of Product Characteristics.1