Soliris Adverse Reactions

Summary of the safety profile: Supportive safety data were obtained from 29 completed and one ongoing clinical studies that included 1,407 patients exposed to eculizumab in ten disease populations, including PNH and aHUS. The most common adverse reaction was headache, (occurred mostly in the initial phase), and the most serious adverse reaction was meningococcal sepsis.
Tabulated list of adverse reactions: Table 15 gives the adverse reactions observed from spontaneous reporting and in eculizumab completed clinical trials, including PNH and aHUS studies. Adverse reactions reported at a very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) or rare (≥1/10,000 to <1/1,000) frequency with eculizumab, are listed by system organ class and preferred term. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. (See Table 15.)

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Description of selected adverse reactions: In all clinical studies, including PNH and aHUS clinical trials, the most serious adverse reaction was meningococcal sepsis which is a common presentation of meningococcal infections in patients treated with SOLIRIS (see Precautions).
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 and 3% of patients with aHUS using the ECL bridging format assay. 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 trials (see also Precautions).
Cases of thrombotic microangiopathy complication have been reported in the setting of missed or delayed SOLIRIS dose in aHUS clinical trials (see also Precautions).
Paediatric population: In children and adolescent PNH patients (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 PNH patients. The most common adverse reaction reported in paediatric patients was headache.
In aHUS patients, the safety profile in adolescents (patients aged 12 years to less than 18 years) is consistent with that observed in adults. In paediatric aHUS patients (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 aHUS patients. 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 un-vaccinated 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 15 as previously mentioned). 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.