The important potential The following MedDRA This is acceptable. risk: Disorders’ is a terms have been ‘Cardiac broad term, although the included to assess the EU-RMP states that only the potential risk of MedDRA term Cardiac cardio- and arrhythmia SMQ is used to cerebrovascular monitor this ongoing safety disorders in the concern. Consequently it is UMEC/VI EU RMP: suggested that it be arrhythmias’ ‘Cardiac replaced by the important (MedDRA term Cardiac potential risks: arrhythmias SMQ), ‘Cardiac arrhythmias’ (MedDRA failure’ ‘Cardiac term Cardiac arrhythmias (MedDRA term Cardiac SMQ); Failure SMQ), Cardiac ‘Myocardial infarction’ (MedDRA term Ischaemia (MedDRA Myocardial infarction SMQ terms Myocardial narrow); and Infarction SMQ, Other – ‘Cardiac failure’ (MedDRA term Ischaemic Heart Cardiac failure SMQ Disease SMQ), – ‘Stroke’ narrow). (MedDRA terms CNS haemorrhages and cerebrovascular conditions SMQ). The PI states: This is acceptable. ‘Narrow-angle glaucoma’ and with its “Consistent ‘Urinary antimuscarinic activity, retention/bladder Anoro Ellipta should be used outflow obstruction’ have been included as with caution in patients with narrow-angle glaucoma or important potential urinary retention.” In risks in the UMEC/VI addition the safety EU-RMP. specifications (SS) of the EU-RMP refers to effects’ as an important pharmacological class effect for LAMA. Consequently it is suggested that angle glaucoma’ and retention/bladder ‘Urinary obstruction’ should be included as important potential risks. The draft PI states: with This is acceptable. “As ‘Paradoxical other inhalation therapies, bronchospasm (which administration of Anoro may be life Ellipta may produce threatening)’ has been paradoxical bronchospasm included as an that may be life threatening. important potential Treatment with Anoro risk in the UMEC/VI Ellipta should be EU-RMP. discontinued if paradoxical
The important potential risk: ‘Cardiac Disorders’ is a broad term, although the EU-RMP states that only the MedDRA term Cardiac arrhythmia SMQ is used to monitor this ongoing safety concern. Consequently it is suggested that it be replaced by the important potential risks: ‘Cardiac arrhythmias’ (MedDRA term Cardiac arrhythmias SMQ); ‘Myocardial infarction’ (MedDRA term Myocardial infarction SMQ – narrow); and ‘Cardiac failure’ (MedDRA term Cardiac failure SMQ – narrow). The following MedDRA terms have been included to assess the potential risk of cardio- and cerebrovascular disorders in the UMEC/VI EU RMP: ‘Cardiac arrhythmias’ (MedDRA term Cardiac arrhythmias SMQ), ‘Cardiac failure’ (MedDRA term Cardiac Failure SMQ), Cardiac Ischaemia (MedDRA terms Myocardial Infarction SMQ, Other Ischaemic Heart Disease SMQ), ‘Stroke’ (MedDRA terms CNS haemorrhages and cerebrovascular conditions SMQ). This is acceptable. The PI states: “Consistent with its antimuscarinic activity, Anoro Ellipta should be used with caution in patients with narrow-angle glaucoma or urinary retention.” In addition the safety specifications (SS) of the EU-RMP refers to effects’ as an important pharmacological class effect for LAMA. Consequently it is suggested that glaucoma’ and ‘Urinary retention/bladder obstruction’ should be included as important potential risks. ‘Narrow-angle glaucoma’ and ‘Urinary retention/bladder outflow obstruction’ have been included as important potential risks in the UMEC/VI EU-RMP. This is acceptable. The draft PI states: “As with other inhalation therapies, administration of Anoro Ellipta may produce paradoxical bronchospasm that may be life threatening. Treatment with Anoro Ellipta should be discontinued if paradoxical ‘Paradoxical bronchospasm (which may be life threatening)’ has been included as an important potential risk in the UMEC/VI EU-RMP. This is acceptable. angle
auspar-umeclidinium-bromide-and-vilanterol_trifenatate-150408.docx