The sponsor should provide a The sponsor provided There were a number tabular of the Risk Table 4: of the of discrepancies ‘Summary ‘Summary Management Plan in Australia’ in a Risk Minimisation Plan in observed between revised ASA, including reference to Australia’ in the revised Table 4 of the ASA and specific wording pertaining to the ASA. the source document: routine risk minimisation activities EU-RMP Version 10.1 for all the specified ongoing safety (dated October 2012) – concerns in the proposed see above. Australian PI and CMI. In regard to the proposed routine The sponsor states that the This is acceptable. risk minimisation activities, it is Precautions section of the recommended to the Delegate that Australian PI for Humira the draft product information has been updated to document be revised as follows: include text relating to Melanoma and Merkel cell For the important identified carcinoma under the risks: and ‘Melanoma’ ‘Merkel Malignancies. cell carcinoma (Neuroendocrine carcinoma of the skin)’, a statement such as “Melanoma and Merkel cell carcinoma have also been reported in patients treated with TNF-antagonists including adalimumab” should be included in the PRECAUTIONS section of the PI under the sub-heading: and crossed ‘Malignancies’ referenced to the ADVERSE EFFECTS section of the PI. This would align with the approved UK SPC and enhance safe use of these products In regard to the proposed routine The sponsor states that This is acceptable. risk minimisation activities, it is the Side effect section of recommended to the Delegate that the Humira CMIs have the draft consumer medicine been updated to reflect information document be revised changes to the PI relating to adequately reflect any changes to Melanoma and Merkel made to the Australian PI as a cell carcinoma. result of the above recommendations. VI. Overall conclusion and risk/benefit assessment The submission was summarised in the following Delegate’s overview and recommendations:
The sponsor should provide a tabular ‘Summary of the Risk Management Plan in Australia’ in a revised ASA, including reference to specific wording pertaining to the routine risk minimisation activities for all the specified ongoing safety concerns in the proposed Australian PI and CMI. The sponsor provided Table 4: ‘Summary of the Risk Minimisation Plan in Australia’ in the revised ASA. There were a number of discrepancies observed between Table 4 of the ASA and the source document: EU-RMP Version 10.1 (dated October 2012) – see above. In regard to the proposed routine risk minimisation activities, it is recommended to the Delegate that the draft product information document be revised as follows: For the important identified risks: ‘Melanoma’ and ‘Merkel cell carcinoma (Neuroendocrine carcinoma of the skin)’, a statement such as “Melanoma and Merkel cell carcinoma have also been reported in patients treated with TNF-antagonists including adalimumab” should be included in the PRECAUTIONS section of the PI under the sub-heading: ‘Malignancies’ and crossed referenced to the ADVERSE EFFECTS section of the PI. This would align with the approved UK SPC and enhance safe use of these products The sponsor states that the Precautions section of the Australian PI for Humira has been updated to include text relating to Melanoma and Merkel cell carcinoma under the Malignancies. This is acceptable. In regard to the proposed routine risk minimisation activities, it is recommended to the Delegate that the draft consumer medicine information document be revised to adequately reflect any changes made to the Australian PI as a result of the above recommendations. The sponsor states that the Side effect section of the Humira CMIs have been updated to reflect changes to the PI relating to Melanoma and Merkel cell carcinoma. This is acceptable. VI. Overall conclusion and risk/benefit assessment The submission was summarised in the following Delegate’s overview and recommendations:
auspar-adalimumab-140805.docx