The Therapeutic Goods Administration (TGA) has been notified of a current shortage of Ryzodeg 70/30 FlexTouch insulin prefilled pen, until 5 June 2024. The shortage due to manufacturing issues resulting from unprecedented global demand for other medicines using the FlexTouch delivery device.
To help manage the shortage, we have made a Serious Scarcity Substitution Instrument (SSSI): Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Insulin Degludec and Insulin Aspart) Instrument 2023. This SSSI:
- declares Ryzodeg 70/30 FlexTouch as a scarce medicine
- specifies Ryzodeg 70/30 Penfill as the substitute medicine as per the substitution protocol included in the SSSI.
This means that pharmacists can give patients Ryzodeg 70/30 Penfill cartridges instead of Ryzodeg 70/30 FlexTouch prefilled pen under certain conditions. Both products contain the same medicine, at the same strength, have the same storage requirements, and are administered by subcutaneous injection, however the device to administer the medicine is different.
Ryzodeg FlexTouch insulin prefilled pen is an all-in-one insulin and administration device, but the Ryzodeg Penfill insulin is a cartridge of insulin that must be administered using a separate delivery device (NovoPen).
The SSSI is in force from 6 July 2023 until 5 June 2024. It may be extended if the shortage continues, or the TGA may revoke the SSSI before its end date if the serious scarcity is resolved, or safety concerns are identified. This SSSI is in effect in all states and territories.
For detailed information and to find out what you should do, visit About the shortage of Ryzodeg 70/30 FlexTouch insulin.