relevance for the RMP, and gastrointestinal any specific information tract’ as an ongoing needed to address this issue safety concern and in the RMP. For any safety give consideration considerations so raised, the to appropriate sponsor should provide pharmacovigilance information that is relevant and risk and necessary to address minimisation the issue in the RMP. activities. Such revision should be reflected in an amended ASA before this application is approved. 2. It is recommended that The sponsor has This is acceptable. the following be added to replaced the important the list of potential safety missing information: concerns: Off-label patients’ ‘Potential ‘Paediatric use’. with off-label ‘Potential use, including paediatric patients’ to be monitored by routine pharmacovigilance activities with routine risk minimisation applied. 3. The safety and efficacy of The sponsor does not This this product has not been appear to make any recommendation to established in patients direct response to this the Delegate below the age of 18 years recommendation to the regarding revision and this is mentioned in the Delegate. to the PI is open PI. However, there has been for consideration. significant off-label use of sevelamer in paediatric patients in USA. The Delegate may wish to update the Australian PI to strengthen the wording (that is, is not ‘Sevelamer recommended in children below the age of 18 years’) in order to discourage the use of sevelamer in paediatric patients. 4. The Delegate may wish to The sponsor does not This update the Australian PI to appear to make any recommendation to strengthen the wording in direct response to this the Delegate order to discourage the use recommendation to the regarding revision of sevelamer in pre-dialysis Delegate. to the PI is still open patients. for consideration.
relevance for the RMP, and any specific information needed to address this issue in the RMP. For any safety considerations so raised, the sponsor should provide information that is relevant and necessary to address the issue in the RMP. gastrointestinal tract’ as an ongoing safety concern and give consideration to appropriate pharmacovigilance and risk minimisation activities. Such revision should be reflected in an amended ASA before this application is approved. 2. It is recommended that the following be added to the list of potential safety concerns: ‘Potential Off-label use’. The sponsor has replaced the important missing information: ‘Paediatric patients’ with ‘Potential off-label use, including paediatric patients’ to be monitored by routine pharmacovigilance activities with routine risk minimisation applied. This is acceptable. 3. The safety and efficacy of this product has not been established in patients below the age of 18 years and this is mentioned in the PI. However, there has been significant off-label use of sevelamer in paediatric patients in USA. The Delegate may wish to update the Australian PI to strengthen the wording (that is, ‘Sevelamer is not recommended in children below the age of 18 years’) in order to discourage the use of sevelamer in paediatric patients. The sponsor does not appear to make any direct response to this recommendation to the Delegate. This recommendation to the Delegate regarding revision to the PI is open for consideration. 4. The Delegate may wish to update the Australian PI to strengthen the wording in order to discourage the use of sevelamer in pre-dialysis patients. The sponsor does not appear to make any direct response to this recommendation to the Delegate. This recommendation to the Delegate regarding revision to the PI is still open for consideration.
auspar-sevelamer-hydrochloride-151105_0.docx