evaluation, the TGA has and c., a recent Safety recommended changes received a PSUR Related Request (SRR) to the PI have been covering the period from was submitted by the approved, no further 25 September 2013 to sponsor which included action is required. 24 March 2014 these changes. This SRR (inclusive). This report was approved by TGA on provides updates and 12 May 2014. new information related to the safety profile of trastuzumab. It is recommended to the Delegate that relevant sections of the draft PI be revised as follows: The duration for an effective contraception to be used after trastuzumab treatment should be increased from six months to seven months; The frequency for the following adverse reactions should be increased from common to very common based on Joint Analysis and/or alignment’: white ‘SC blood cell count decrease/leukopaenia – 15.4%, infection – 24.0%, ejection fraction decreased 22.0%, nail – disorder 13.4%; – A frequency should be assigned to following adverse reactions based on a new clinical data review: dermatitis – 5% common, and urticarial 0.7% – uncommon. It was also recommended to the Delegate that the relevant content of the CMI be updated accordingly to provide adequate information to patients.
evaluation, the TGA has received a PSUR covering the period from 25 September 2013 to 24 March 2014 (inclusive). This report provides updates and new information related to the safety profile of trastuzumab. It is recommended to the Delegate that relevant sections of the draft PI be revised as follows: The duration for an effective contraception to be used after trastuzumab treatment should be increased from six months to seven months; The frequency for the following adverse reactions should be increased from common to very common based on Joint Analysis and/or ‘SC alignment’: white blood cell count decrease/leukopaenia – 15.4%, infection – 24.0%, ejection fraction decreased – 22.0%, nail disorder – 13.4%; A frequency should be assigned to following adverse reactions based on a new clinical data review: dermatitis – 5% common, and urticarial – 0.7% uncommon. and c., a recent Safety Related Request (SRR) was submitted by the sponsor which included these changes. This SRR was approved by TGA on 12 May 2014. recommended changes to the PI have been approved, no further action is required. It was also recommended to the Delegate that the relevant content of the CMI be updated accordingly to provide adequate information to patients.
auspar-trastuzumab-150803.docx