Soliris Adverse Reactions

Summary of the safety profile: Supportive safety data were obtained from 32 clinical studies that included 1544 patients exposed to eculizumab in complement-mediated disease populations, including PNH, aHUS, refractory gMG, and NMOSD. The most common adverse reaction was headache (occurred mostly in the initial phase), and the most serious adverse reaction was meningococcal infection.
Tabulated list of adverse reactions: Table 21 presents the adverse reactions observed from spontaneous reporting and in SOLIRIS completed clinical studies. Adverse reactions reported at a very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100) or rare (≥1/10000 to <1/1000) frequency with SOLIRIS, are listed by system organ class and preferred term. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. (See Table 21.)

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Description of selected adverse reactions: In all clinical studies, the most serious adverse reaction was meningococcal infection. Meningococcal infections in patients treated with SOLIRIS have presented as meningococcal sepsis (see Precautions). Patients should be informed of the signs and symptoms of meningococcal infection and sepsis and advised to seek medical care immediately.
Other cases of Neisseria species have been reported including sepsis with Neisseria gonorrhoeae, Neisseria sicca/subflava, Neisseria spp unspecified.
Antibodies to SOLIRIS were detected in 2% patients with PNH using an ELISA assay, 3% of patients with aHUS and 2% of patients with NMOSD using the ECL bridging format assay. In refractory gMG placebo-controlled studies, no antidrug antibodies were observed. As with all proteins there is a potential for immunogenicity.
Cases of haemolysis have been reported in the setting of missed or delayed SOLIRIS dose in PNH clinical studies (see also Precautions).
Cases of TMA complication have been reported in the setting of missed or delayed SOLIRIS dose in aHUS clinical studies (see also Precautions).
Paediatric population: In children and adolescent patient with PNH (aged 11 years to less than 18 years) included in the paediatric PNH Study M07-005, the safety profile appeared similar to that observed in adult patients with PNH. The most common adverse reaction reported in paediatric patients was headache.
In patients with aHUS, the safety profile in adolescents (patients aged 12 years to less than 18 years) is consistent with that observed in adults. In paediatric patients with aHUS (aged 2 months to less than 18 years) included in the aHUS studies C08-002, C08-003, C09-001r and C10-003, the safety profile appeared similar to that observed in adult patients with aHUS. The safety profiles in the different paediatric subsets of age appear similar.
Patients with other diseases: Safety Data from Other Clinical Studies: Supportive safety data were obtained in 13 clinical studies that included 856 patients exposed to eculizumab in other disease populations other than PNH and aHUS. There was an unvaccinated patient diagnosed with idiopathic membranous glomerulonephropathy who experienced meningococcal meningitis. Adverse reactions reported in patients with disease other than PNH or aHUS were similar to those reported in patients with PNH or aHUS (see Table 21 previously). No specific adverse reactions have emerged from these clinical studies.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation 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 the national reporting system.