new information will be communicated appropriately. Recommendation 7: ACSOM The sponsor notes that The Delegate is advice will be sought regarding ACSOM advice will be sought advised that the the appropriateness of the regarding the proposed ACSOM advice currently proposed pharmacovigilance plan. has been pharmacovigilance plan. incorporated into the final RMP It is The sponsor will be The proposed Recommendation 8: recommended that the sponsor implementing additional risk Pharmacist’s produces a preparation/dosing minimisation measures for guide has been guide or chart which may aid to the safety concerns of reviewed for mitigate the risk of medication neurologic events, medication general content errors. errors and cytokine release (Note, the syndrome as outlined in evaluator has Response to not reviewed Recommendations 9 and 10 individual (and the revised ASA to the calculations for EU RMP Version 1.2). This accuracy). includes provision of The guide should individual educational also include the materials directed to instruction that pharmacists, physicians, ‘for nurses and patients. Each of comprehensive these materials includes preparation information aimed instructions, specifically at raising please refer to awareness and minimising the Blincyto PI’. the risk of medication errors. In particular, the preparation guide for pharmacists contains detailed information regarding the reconstitution and preparation procedures for blinatumomab. These brochures are in line with those prepared for the EU, with the exception that the Australian pharmacist brochure has instructions on preparing cassettes in addition to IV bags. In addition to educational materials, the sponsor has also planned an observational patient registry study (Protocol 20150136; Annex 6 of EU RMP v1.2) in Europe to further characterise the safety profile of blinatumomab in routine clinical practice.
new information will be communicated appropriately. Recommendation 7: ACSOM advice will be sought regarding the appropriateness of the currently proposed pharmacovigilance plan. The sponsor notes that ACSOM advice will be sought regarding the proposed pharmacovigilance plan. The Delegate is advised that the ACSOM advice has been incorporated into the final RMP Recommendation 8: It is recommended that the sponsor produces a preparation/dosing guide or chart which may aid to mitigate the risk of medication errors. The sponsor will be implementing additional risk minimisation measures for the safety concerns of neurologic events, medication errors and cytokine release syndrome as outlined in Response to Recommendations 9 and 10 (and the revised ASA to the EU RMP Version 1.2). This includes provision of individual educational materials directed to pharmacists, physicians, nurses and patients. Each of these materials includes information aimed specifically at raising awareness and minimising the risk of medication errors. In particular, the preparation guide for pharmacists contains detailed information regarding the reconstitution and preparation procedures for blinatumomab. These brochures are in line with those prepared for the EU, with the exception that the Australian pharmacist brochure has instructions on preparing cassettes in addition to IV bags. In addition to educational materials, the sponsor has also planned an observational patient registry study (Protocol 20150136; Annex 6 of EU RMP v1.2) in Europe to further characterise the safety profile of blinatumomab in routine clinical practice. The proposed Pharmacist’s guide has been reviewed for general content (Note, the evaluator has not reviewed individual calculations for accuracy). The guide should also include the instruction that ‘for comprehensive preparation instructions, please refer to the Blincyto PI’.
auspar-blinatumomab-180207.docx