daily is insufficiently acceptable. The sponsor proposed changes regarding durability of clinical response and updated safety data with TOF are acceptable for inclusion in the amended PI. The evaluator recommends the continued registration of TOF 5 mg twice daily treatment for the treatment of active RA is subject to regular periodic safety update reports and when available, the sponsor provides the TGA with the final clinical study report for the long term Study A3921024. VI. Pharmacovigilance findings Risk management plan Summary of RMP evaluation The sponsor submitted an Australian specific RMP (version 2.0; 28 January 2016; data lock point 15 June 2015) in support of this application and did not provide a revision with the Section 31 response. The proposed summary of safety concerns and their associated risk monitoring and mitigation strategies are summarised below. Table 9: Summary of safety concerns Summary of safety concerns Pharmacovigilance Risk Minimisation Routine Additional Routine Important Serious and other *,^ identified important risks infections Decrease in - neutrophil counts and neutropenia Decrease in ^ lymphocyte counts and lymphopenia Decrease in - haemoglobin levels and anaemia Lipid elevations - and hyperlipidaemia Nonmelanoma skin *,^ cancer Transaminase - elevation and
daily is insufficiently acceptable. The sponsor proposed changes regarding durability of clinical response and updated safety data with TOF are acceptable for inclusion in the amended PI. The evaluator recommends the continued registration of TOF 5 mg twice daily treatment for the treatment of active RA is subject to regular periodic safety update reports and when available, the sponsor provides the TGA with the final clinical study report for the long term Study A3921024. VI. Pharmacovigilance findings Risk management plan Summary of RMP evaluation The sponsor submitted an Australian specific RMP (version 2.0; 28 January 2016; data lock point 15 June 2015) in support of this application and did not provide a revision with the Section 31 response. The proposed summary of safety concerns and their associated risk monitoring and mitigation strategies are summarised below. Table 9: Summary of safety concerns Summary of safety concerns Pharmacovigilance Risk Minimisation Routine Additional Routine Important identified risks Serious and other important infections *,^ Decrease in neutrophil counts and neutropenia - Decrease in lymphocyte counts and lymphopenia ^ Decrease in haemoglobin levels and anaemia - Lipid elevations and hyperlipidaemia - Nonmelanoma skin cancer *,^ Transaminase elevation and -
auspar-tofacitinib-as-citrate-180525.docx