An update for the Australian Cystinosis community regarding Cystagon® (mercaptamine / cysteamine bitartrate) 150 mg capsules, following a shortage notification issued by the Therapeutic Goods Administration (Therapeutic Goods Administration).
The TGA has advised that a temporary supply shortage of Cystagon® has occurred due to an unexpected manufacturing delay. This shortage is not related to any quality, safety, or efficacy concerns with the medicine.
Importantly, an alternative overseas-registered supply of Cystagon® has been secured and approved to ensure continued access for patients during the shortage period.
The Cystinosis Foundation Australia is working closely with the TGA and Viatris (Viatris), the Australian supplier of Cystagon®, to support clear communication and help ensure uninterrupted access for patients.
Hospital pharmacies have been formally notified of the shortage and the approved alternative supply pathway. Pharmacy teams are aware of the arrangements and can support patients in accessing their medication as required.
Patients are encouraged to continue collecting their prescriptions of Cystagon® as usual and are asked not to stockpile medication, to help maintain stable supply.
This issue is specific to Australia and does not affect Cystinosis patients in New Zealand.
The Cystinosis Foundation Australia will continue to work alongside the TGA and Viatris and will provide further updates to the community as additional information becomes available.
For official information regarding the shortage, please refer to the TGA Medicine Shortage Notification:
https://apps.tga.gov.au/Prod/msi/Search/Details/mercaptamine-cysteamine-bitartrate
