As with any elective injection procedure, As ‘Infections’ should be treatment with Belkyra is contraindicated added as an for patients with infection in the treatment Important area. Further, no post-treatment infections Potential Risk. were observed during the clinical trials in Belkyra or placebo patients. Given that standard medical practice acknowledges that any injection procedure has the potential for infection, the sponsor does not believe it is warranted to include this event as an Important Potential Risk. in in pregnancy’ has been added as As above. ‘Use ’Use pregnancy’ Missing Information. should be added as Missing Information. in in lactation’ has been added as Missing As above. ‘Use ’Use lactation’ Information. should be added as Missing Information. in in conjunction with other cosmetic As above. ‘Use ’Use conjunction injectables (such as botulinum toxin)’ has with been added as Missing Information. cosmetic Additionally, the planned post-approval injectables registry study (discussed in the response (such as below) will collect information on botulinum concomitant use of Belkyra with botulinum toxin) should be toxin (same or different treatment area). added as Missing Information. The safety The RMP has been updated to reflect the As above. concern in safety concern use’. ‘Use ’Off-label patients or for conditions or with not yet studied’ should be renamed label use’. The sponsor In pivotal Phase III Studies 22 and 23, local The sponsor’s should provide anaesthesia (topical or injectable lidocaine) response has a summary of could be utilised at the discretion of the been noted. the pre- and investigator (with or without ice) and was post-market used in 47% and 70% of the overall experience of treatment sessions, respectively, in each
‘Infections’ should be added as an Important Potential Risk. As with any elective injection procedure, treatment with Belkyra is contraindicated for patients with infection in the treatment area. Further, no post-treatment infections were observed during the clinical trials in Belkyra or placebo patients. Given that standard medical practice acknowledges that any injection procedure has the potential for infection, the sponsor does not believe it is warranted to include this event as an Important Potential Risk. As ‘Use in pregnancy’ should be added as Missing Information. ’Use in pregnancy’ has been added as Missing Information. As above. ‘Use in lactation’ should be added as Missing Information. ’Use in lactation’ has been added as Missing Information. As above. ‘Use in conjunction with cosmetic injectables (such as botulinum toxin) should be added as Missing Information. ’Use in conjunction with other cosmetic injectables (such as botulinum toxin)’ has been added as Missing Information. Additionally, the planned post-approval registry study (discussed in the response below) will collect information on concomitant use of Belkyra with botulinum toxin (same or different treatment area). As above. The safety concern ‘Use in patients or for conditions or with not yet studied’ should be renamed use’. The RMP has been updated to reflect the safety concern ’Off-label use’. As above. The sponsor should provide a summary of the pre- and post-market experience of In pivotal Phase III Studies 22 and 23, local anaesthesia (topical or injectable lidocaine) could be utilised at the discretion of the investigator (with or without ice) and was used in 47% and 70% of the overall treatment sessions, respectively, in each The sponsor’s response has been noted. label