Table 7: Summary of the proposed summary of safety concerns and their associated risk monitoring and mitigation strategies Summary of safety concerns (ASA v3.0) Pharmacovigilance Risk Minimisation Routine Additional Routine Additional Important Serious infections § identified risks Hypersensitivity * § * * reactions* Important Increased risk of § potential infection secondary to risks neutropaenia Thrombocytopaenia and § potential risk of bleeding Clinically evident hepatic § injury Impact on cardiovascular § (CV) outcome (major adverse cardiac event (MACE)) secondary to low density lipoprotein (LDL) elevation Gastrointestinal (GI) § perforations Malignancy - Clinical consequences of - - immunogenicity Demyelinating disorders* * -* x* -* Missing Use in pregnant and - information lactating women Use in paediatric patients - - Use in patients with - - hepatic impairment* Use in patients with renal -* * -* impairment* Long term use* * * x* -* Use in patients switching * -* x* -* to/from other drugs in the anti-IL-6R class*
Table 7: Summary of the proposed summary of safety concerns and their associated risk monitoring and mitigation strategies Summary of safety concerns (ASA v3.0) Pharmacovigilance Risk Minimisation Routine Additional Routine Additional Important identified risks Serious infections § Hypersensitivity reactions* * § * * Important potential risks Increased risk of infection secondary to neutropaenia § Thrombocytopaenia and potential risk of bleeding § Clinically evident hepatic injury § Impact on cardiovascular (CV) outcome (major adverse cardiac event (MACE)) secondary to low density lipoprotein (LDL) elevation § Gastrointestinal (GI) perforations § Malignancy - Clinical consequences of immunogenicity - - Demyelinating disorders* * -* x* -* Missing information Use in pregnant and lactating women - Use in paediatric patients - - Use in patients with hepatic impairment* - - Use in patients with renal impairment* -* * -* Long term use* * * x* -* Use in patients switching to/from other drugs in the anti-IL-6R class* * -* x* -*
auspar-sarilumab-rch-180530.docx