(including Patient alert required to card) revisit these educational Preparation guide for materials. Pharmacists Regarding the Based on the proposed educational European RMP materials, the material for sponsor will no longer be Doctors and distributing a DHCP letter as Nurses, the an additional risk sponsor should minimisation tool as include advice to originally planned; targeted ensure that the educational materials will be patient/ disseminated instead (see caregiver Response to receives the Recommendation 8). To align patient with the US REMS which also educational included include cytokine material and release syndrome, the CMI. Australian educational materials will also discuss this additional risk (not included in the European materials). All educational materials proposed for Australia are provided in the revised ASA. Recommendation 10: The ASA A revised table detailing all The revisions should be revised to include a risk planned risk minimisation made by the minimisation activities table measures in the Australian sponsor are detailing all planned risk context and the EU-RMP acceptable in the minimisation measures in the context can be found in 2 context of this Australian context and the tables of the ASA. Differences evaluation. context. This table should in the two documents have include a comparison of the been justified accordingly. It actual content and wording of the should be noted that both the EU SmPC and the proposed EU RMP and SmPC are still Australian PI and CMI for all of under evaluation and may be the specified ongoing safety subject to further changes. concerns and missing information to identify and provide reasons for any observed differences; particularly where it appears the EU Summary of Product Characteristics (SmPC) is more restrictive. Summary of recommendations Outstanding issues Issues in relation to the RMP Pharmacovigilance plan: Once the protocol for Study 20150136 is finalised, relevant details should be included in an update to the RMP (see Recommendation 5 of Table 4, above).
(including Patient alert card) Preparation guide for Pharmacists Based on the proposed European RMP materials, the sponsor will no longer be distributing a DHCP letter as an additional risk minimisation tool as originally planned; targeted educational materials will be disseminated instead (see Response to Recommendation 8). To align with the US REMS which also included include cytokine release syndrome, the Australian educational materials will also discuss this additional risk (not included in the European materials). All educational materials proposed for Australia are provided in the revised ASA. required to revisit these educational materials. Regarding the educational material for Doctors and Nurses, the sponsor should include advice to ensure that the patient/ caregiver receives the patient educational material and CMI. Recommendation 10: The ASA should be revised to include a risk minimisation activities table detailing all planned risk minimisation measures in the Australian context and the context. This table should include a comparison of the actual content and wording of the EU SmPC and the proposed Australian PI and CMI for all of the specified ongoing safety concerns and missing information to identify and provide reasons for any observed differences; particularly where it appears the EU Summary of Product Characteristics (SmPC) is more restrictive. A revised table detailing all planned risk minimisation measures in the Australian context and the EU-RMP context can be found in 2 tables of the ASA. Differences in the two documents have been justified accordingly. It should be noted that both the EU RMP and SmPC are still under evaluation and may be subject to further changes. The revisions made by the sponsor are acceptable in the context of this evaluation. Summary of recommendations Outstanding issues Issues in relation to the RMP Pharmacovigilance plan: Once the protocol for Study 20150136 is finalised, relevant details should be included in an update to the RMP (see Recommendation 5 of Table 4, above).
auspar-blinatumomab-180207.docx