Neutropenia Neutropenia Rash Rash Important potential risks Drug-drug interaction with Drug-drug interaction with CYP3A inducers CYP3A inducers Reproductive toxicity Reproductive toxicity including teratogenicity including teratogenicity - Progressive multifocal leukoencephalopathy Drug-drug interaction with (PML) CYP3A substrates Intestinal perforation Photosensitivity Drug-drug interaction with Skin cancer CYP3A substrates Missing information Safety in children Safety in children Safety of breastfeeding Safety of breastfeeding Safety in patients with Safety in patients with severe hepatic impairment severe hepatic impairment Development of drug Carcinogenicity resistance Drug-drug interaction with Carcinogenicity oral contraceptive Long-term safety Safety in patients with severe renal impairment Drug-drug interaction with oral contraceptive Safety in patients with chronic active hepatitis Safety in patients with severe renal impairment Safety of patients with concomitant immunisation Safety in patients with chronic active hepatitis Safety of patients with concomitant immunisation Immunological effects and auto-immunity For the important potential & cancer’; and the missing ‘Photosensitivity’ ‘Skin information: of drug resistance’, safety’ & effects ‘Development ‘Long-term ‘Immunological and auto-immunity’, the ASA states: proposed for inclusion into ASA. Please refer to “Not Table 7”. Table 7: Table of Risk Minimization Measures’ of the ASA provides the ‘Summary following justification for such omission, respectively, although it would appear no further links to the specified data or relevant correspondence between the sponsor and TGA have been provided to substantiate such justification: Information concerning photosensitivity was provided to TGA in the pre ACPM Response, and subsequently approved by TGA. Information concerning the risk of secondary malignancy was provided to TGA in the Response to the Section 31 Request (Clinical Evaluation), and subsequently approved by TGA. Clinical studies to date have not shown any increase in incidence of skin cancers. Not included in EU labelling, but provided as Missing Information in EU RMP following EMA evaluation. PAM to provide data on resistance mechanisms is planned for submission in EU in December 2015. Therefore, not included in ASA.
Neutropenia Rash Neutropenia Rash Important potential risks Drug-drug interaction with CYP3A inducers Reproductive toxicity including teratogenicity - Drug-drug interaction with CYP3A substrates Photosensitivity Skin cancer Drug-drug interaction with CYP3A inducers Reproductive toxicity including teratogenicity Progressive multifocal leukoencephalopathy (PML) Intestinal perforation Drug-drug interaction with CYP3A substrates Missing information Safety in children Safety of breastfeeding Safety in patients with severe hepatic impairment Development of drug resistance Carcinogenicity Long-term safety Drug-drug interaction with oral contraceptive Safety in patients with severe renal impairment Safety in patients with chronic active hepatitis Safety of patients with concomitant immunisation Immunological effects and auto-immunity Safety in children Safety of breastfeeding Safety in patients with severe hepatic impairment Carcinogenicity Drug-drug interaction with oral contraceptive Safety in patients with severe renal impairment Safety in patients with chronic active hepatitis Safety of patients with concomitant immunisation For the important potential ‘Photosensitivity’ & ‘Skin cancer’; and the missing information: ‘Development of drug resistance’, ‘Long-term safety’ & ‘Immunological effects and auto-immunity’, the ASA states: “Not proposed for inclusion into ASA. Please refer to Table 7”. Table 7: ‘Summary Table of Risk Minimization Measures’ of the ASA provides the following justification for such omission, respectively, although it would appear no further links to the specified data or relevant correspondence between the sponsor and TGA have been provided to substantiate such justification: Information concerning photosensitivity was provided to TGA in the pre ACPM Response, and subsequently approved by TGA. Information concerning the risk of secondary malignancy was provided to TGA in the Response to the Section 31 Request (Clinical Evaluation), and subsequently approved by TGA. Clinical studies to date have not shown any increase in incidence of skin cancers. Not included in EU labelling, but provided as Missing Information in EU RMP following EMA evaluation. PAM to provide data on resistance mechanisms is planned for submission in EU in December 2015. Therefore, not included in ASA.
auspar-idelalisib-171019.docx