A complication of SAA is for the treatment of the appearance of cytogenetic SAA patients and abnormalities in bone marrow should be included. cells. Cytogenetic This can be brief. abnormalities have been It is recommended reported in 15 to 20 % of the existing patients with SAA. The clinical additional risk consequences are variable, minimisation depending upon the specific activities be updated abnormality and the presence to include specific or absence of clinical sequelae risks associated with such as dysplasia or the SAA indication (in worsening cytopenias.6 particular cytogenetic Novartis does not propose to abnormalities and the include any specific need for long-term information about cytogenetic follow-up). The abnormalities in the sponsor should educational materials. provide the updated Information communicated to materials to the TGA. physicians through the Australian PI document is considered the primary tool to educate physicians about this risk. No other regulatory body including the US Food and Drug Administration (US FDA) and the European Medicines Agency (EMA) have requested the addition of such information in the currently implemented educational materials. 7. The sponsor should provide The educational materials for Given the new the TGA with the following cITP have been finalised by information details for agreement: Novartis and are provided in provided, this is considered the attachment of Australian -All draft education materials; Specific Annex v2.1 [Module acceptable in the -A clear distribution plan; and 1.8.2]. The educational context of this materials for HCV are application. -A clear plan to measure the currently being amended by effectiveness of the education The amended Novartis, and it is estimated programme as an additional materials are that these will be available by risk minimisation activity. herewith requested. 18 September 2015. For further details regarding the different educational materials and their availability please refer to [Table 7b]. Both sets of educational materials will be amended to align with the Australian PI and mailed out to the prescribers of Revolade for all indications, within 90 days following availability of the
A complication of SAA is the appearance of cytogenetic abnormalities in bone marrow cells. Cytogenetic abnormalities have been reported in 15 to 20 % of patients with SAA. The clinical consequences are variable, depending upon the specific abnormality and the presence or absence of clinical sequelae such as dysplasia or worsening cytopenias.6 Novartis does not propose to include any specific information about cytogenetic abnormalities in the educational materials. Information communicated to physicians through the Australian PI document is considered the primary tool to educate physicians about this risk. No other regulatory body including the US Food and Drug Administration (US FDA) and the European Medicines Agency (EMA) have requested the addition of such information in the currently implemented educational materials. for the treatment of SAA patients and should be included. This can be brief. It is recommended the existing additional risk minimisation activities be updated to include specific risks associated with the SAA indication (in particular cytogenetic abnormalities and the need for long-term follow-up). The sponsor should provide the updated materials to the TGA. 7. The sponsor should provide the TGA with the following details for agreement: -All draft education materials; -A clear distribution plan; and -A clear plan to measure the effectiveness of the education programme as an additional risk minimisation activity. The educational materials for cITP have been finalised by Novartis and are provided in the attachment of Australian Specific Annex v2.1 [Module 1.8.2]. The educational materials for HCV are currently being amended by Novartis, and it is estimated that these will be available by 18 September 2015. For further details regarding the different educational materials and their availability please refer to [Table 7b]. Both sets of educational materials will be amended to align with the Australian PI and mailed out to the prescribers of Revolade for all indications, within 90 days following availability of the Given the new information provided, this is considered acceptable in the context of this application. The amended materials are herewith requested.
auspar-eltrombopag-160330.docx