sulfonylurea;...” (see FDA Product Label infection’ was not considered as listed event. As the USPI displayed the algorithm for page 2). The proposed Australian PI the side effect identification, the term was subsequently added. The term ‘urinary does not include this information. tract infection’ is not considered to be listed, therefore no updated was carried out for the EU SmPC or other labels (including the Australian PI). 8. The important potential risk Boehringer Ingelheim, supports the RMP evaluator's recommendation that the This was considered acceptable. of renal function’ is not important potential risk 'Worsening of renal function' is not assigned any risk ‘Worsening assigned any risk minimisation minimisation activities. activities. The FDA Product Label and As supported by Study 1218.43 [U11-3170-01], the use of linagliptin as add-on to EU SmPC also do not include any anti-diabetic therapy, the reported safety and laboratory results were information on this potential risk. comparable between linagliptin and placebo with no distinct safety concerns observed. A statistically significant and clinically relevant reduction in the change from baseline in HbA1c of -0.72% after 52 weeks of treatment was observed for linagliptin compared to placebo. The reduction in HbA1c observed for the linagliptin treatment group was sustained throughout the 52 weeks of the study. This study supports the assumption that renal impairment would not significantly alter the exposure of linagliptin and that no dose adjustment would be required in patients with any degree of renal impairment. SmPC=Summary of Product Characteristics
sulfonylurea;...” (see FDA Product Label page 2). The proposed Australian PI does not include this information. infection’ was not considered as listed event. As the USPI displayed the algorithm for the side effect identification, the term was subsequently added. The term ‘urinary tract infection’ is not considered to be listed, therefore no updated was carried out for the EU SmPC or other labels (including the Australian PI). 8. The important potential risk ‘Worsening of renal function’ is not assigned any risk minimisation activities. The FDA Product Label and EU SmPC also do not include any information on this potential risk. Boehringer Ingelheim, supports the RMP evaluator's recommendation that the important potential risk 'Worsening of renal function' is not assigned any risk minimisation activities. As supported by Study 1218.43 [U11-3170-01], the use of linagliptin as add-on to anti-diabetic therapy, the reported safety and laboratory results were comparable between linagliptin and placebo with no distinct safety concerns observed. A statistically significant and clinically relevant reduction in the change from baseline in HbA1c of -0.72% after 52 weeks of treatment was observed for linagliptin compared to placebo. The reduction in HbA1c observed for the linagliptin treatment group was sustained throughout the 52 weeks of the study. This study supports the assumption that renal impairment would not significantly alter the exposure of linagliptin and that no dose adjustment would be required in patients with any degree of renal impairment. This was considered acceptable. SmPC=Summary of Product Characteristics
auspar-linagliptin-130926.docx