Joint swelling Musculoskeletal and Arthralgia connective tissue disorders Bone pain Myalgia Musculoskeletal pain Muscular weakness Muscle spasms Pain in extremity Sensation of heaviness Renal failure Renal and urinary disorders Proteinuria Cystitis noninfective Micturition disorder Haematuria Leukocyturia Menstrual disorder Reproductive system and breast disorders General physical health General disorders and Pyrexia deterioration Oedema administration site Pain Mucosal conditions Feeling of body temperature change inflammation Xerosis Malaise creatinine increased Investigations Hepatic enzyme Electrocardiogram QT prolonged increased International normalised ratio Blood alkaline increased phosphatase Activated partial thromboplastin increased time prolonged Weight decreased urea increased Blood lactate dehydrogenase increased Protein total decreased C-reactive protein increased Haematocrit decreased a. Different MedDRA preferred terms that were considered clinically similar have been grouped into a single term. b. Fatal cases have been reported. c. Hand-foot skin reaction. Rare and very rare events reported in the Phase III (RECOURSE) clinical could not be estimated from the available data due to the limited number of patients exposed to LONSURF. Elderly Patients aged 65 years who received LONSURF had a higher incidence of the following events ≥ compared to patients aged < 65 years: Grade 3 or 4 neutropenia (48% v 30%), Grade 3 anaemia (26% v 12%), Grade 3 or 4 leucopenia (26% v 18%) and Grade 3 or 4 thrombocytopenia (9% v 2%). Infections
Musculoskeletal and connective tissue disorders Joint swelling Arthralgia Bone pain Myalgia Musculoskeletal pain Muscular weakness Muscle spasms Pain in extremity Sensation of heaviness Renal and urinary disorders Proteinuria Renal failure Cystitis noninfective Micturition disorder Haematuria Leukocyturia Reproductive system and breast disorders Menstrual disorder General disorders and administration site conditions Pyrexia Oedema Mucosal inflammation Malaise General physical health deterioration Pain Feeling of body temperature change Xerosis Investigations Hepatic enzyme increased Blood alkaline phosphatase increased Weight decreased creatinine increased Electrocardiogram QT prolonged International normalised ratio increased Activated partial thromboplastin time prolonged urea increased Blood lactate dehydrogenase increased Protein total decreased C-reactive protein increased Haematocrit decreased a. Different MedDRA preferred terms that were considered clinically similar have been grouped into a single term. b. Fatal cases have been reported. c. Hand-foot skin reaction. Rare and very rare events reported in the Phase III (RECOURSE) clinical could not be estimated from the available data due to the limited number of patients exposed to LONSURF. Elderly Patients aged ≥ 65 years who received LONSURF had a higher incidence of the following events compared to patients aged < 65 years: Grade 3 or 4 neutropenia (48% v 30%), Grade 3 anaemia (26% v 12%), Grade 3 or 4 leucopenia (26% v 18%) and Grade 3 or 4 thrombocytopenia (9% v 2%). Infections
auspar-lonsurf-180612-pi.docx