Ultomiris Adverse Reactions

Summary of the Safety Profile: The most common adverse drug reactions (≥ 10%) across all clinical trials are headache, upper respiratory tract infection, nasopharyngitis, and diarrhoea. The most serious adverse reactions in patients in clinical trials are meningococcal infections.
Tabulated List of Adverse Reactions: Table 20 lists the adverse reactions observed from clinical trials and post-marketing experience. Adverse reactions with ULTOMIRIS are listed by System Organ Class and preferred term using MedDRA frequency convention very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. (See Table 20.)

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Description of Selected Adverse Reactions: In clinical studies, the most serious adverse reactions from ULTOMIRIS were meningococcal infections, which were uncommon in frequency (0.5%) (see Precautions). Meningococcal infections in patients treated with ULTOMIRIS have presented as meningococcal sepsis. Patients should be informed of the signs and symptoms of meningococcal septicemia and advised to seek medical care immediately.
Infusion Reactions: In clinical trials, infusion reactions (infusion-related reactions) were common (1.6%). They were mild to moderate in severity and transient (e.g., lower back pain, abdominal pain, muscle spasms, drop in blood pressure, elevation in blood pressure, rigors, limb discomfort, drug hypersensitivity [allergic reaction], dysgeusia [bad taste], and drowsiness). These reactions did not require discontinuation of ULTOMIRIS.
Reporting of Suspected Adverse Reactions: Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via their national reporting system.
Pediatric Population: In children and adolescent PNH patients (aged 9 to 17 years old) included in the pediatric PNH Study (ALXN1210-PNH-304), the safety profile of ULTOMIRIS was consistent with that observed in adult PNH patients. The most common adverse reaction reported in pediatric PNH patient was abdominal pain and nasopharyngitis.
In pediatric aHUS patients (aged 10 months to 17 years old) included in Study ALXN1210-aHUS-312, the safety profile of ULTOMIRIS was consistent with that observed in adult patients with evidence of aHUS. The safety profile was also consistent for pediatric patients in the different age-group subsets. The safety data for patients below 2 years of age are limited to four patients. The most common adverse reaction reported in pediatric patients was pyrexia.
ULTOMIRIS has not been evaluated in pediatric patients with gMG.
Geriatric Population: No overall differences in safety were reported between elderly (≥ 65 years) and younger patients (< 65 years) with ULTOMIRIS.