Substitution allowed to address shortage of Ryzodeg 70/30 FlexTouch insulin

The Therapeutic Goods Administration (TGA) has made a Serious Scarcity Substitution Instrument (SSSI) to address the unavailability of Ryzodeg 70/30 FlexTouch insulin prefilled pens.

The TGA has been notified of Novo Nordisk’s decision to discontinue marketing Ryzodeg 70/30 FlexTouch insulin prefilled pens from 1 February 2025, due to commercial changes. Ryzodeg FlexTouch has been in short supply since 30 June 2023, due to unprecedented global demand for other medicines using the FlexTouch delivery device.

To help manage the unavailability, we have made a SSSI, which:

• 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.

The SSSI allows pharmacists to offer patients or their carers Ryzodeg 70/30 penfill cartridge 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.

The SSSI is in force until 31 March 2025 (unless revoked earlier) to enable patients with existing prescriptions for Ryzodeg 70/30 FlexTouch to continue accessing their medicine, without having to return to their doctor for a new prescription.

Ryzodeg 70/30 Penfill supplied in accordance with the SSSI will continue to be subsidised by the PBS.

For detailed information visit:  About the shortage of Ryzodeg 70/30 FlexTouch insulin.

More information about SSSIs can be found on the TGA website: Serious Scarcity Substitution Instruments (SSSIs)

The TGA will publish updates about the supply of Ryzodeg 70/30 FlexTouch insulin  Medicine Shortage Reports Database.

Visit the TGA medicine shortages page for more information about shortages.