Novo Nordisk, the sponsor of Ryzodeg in Australia, has notified us of its 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 of Ryzodeg Flextouch, we have made a Serious Scarcity Substitution Instrument (SSSI). This means that pharmacists can give patients Ryzodeg 70/30 Penfill cartridges instead of Ryzodeg 70/30 FlexTouch prefilled pens under certain conditions. Both products contain the same medicine, at the same strength, have the same storage requirements and are administered by injection under the skin (subcutaneous injection). However, the devices used to administer the medicine are different.
Ryzodeg FlexTouch insulin prefilled pen is an all-in-one insulin and administration device, while the Ryzodeg Penfill insulin is a cartridge that must be administered using a separate administration device (NovoPen).
This SSSI will be in force until 31 March 2025 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. The instrument:
- 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
For more information about SSSIs see Substituting scarce medicines and Serious Scarcity Substitution Instruments (SSSIs).
Information for patients and their carers
We understand the news of this shortage and discontinuation may cause concern if you, or someone you care for, is prescribed Ryzodeg 70/30 FlexTouch insulin prefilled pens.
If you have been prescribed Ryzodeg 70/30 FlexTouch insulin prefilled pens, your pharmacist might offer you Ryzodeg 70/30 Penfill cartridges instead. This substitution is permitted on a temporary basis to help ease the impact of the unavailability of the prefilled pens.
Your pharmacist, doctor, credentialled diabetes educator or nurse can explain to you the differences between FlexTouch prefilled pens and Penfill cartridges, how to administer them, and provide you a new delivery device (a NovoPen) for free.
NovoPens (NovoPen 4, NovoPen Echo or NovoPen 6) are reusable insulin delivery devices used to administer Ryzodeg Penfill cartridges. NovoPens use the same needles as Ryzodeg 70/30 FlexTouch prefilled pens. Keep this reusable pen, as you will need to use it for your future injections.
You can get a reusable NovoPen 6 for free through the NovoPen 6 Pharmacy Program. Any retail pharmacy can be a part of this program and those already participating are listed via the Online Pharmacy Locator.
If you are unsure how to use the reusable NovoPen 6, ask your pharmacist, doctor, diabetes educator or nurse to explain how to use it. You can also watch a NovoPen 6 How to Use Video.
Your pharmacist can also provide you the Consumer Medicine Information (CMI) leaflet and additional information from the sponsor of these medicines.
Talk to your pharmacist, doctor, diabetes educator or nurse if you have any questions or concerns about this issue, including potential substitution.
This webpage is updated as information changes. The TGA also updates supply information about Ryzodeg 70/30 FlexTouch insulin prefilled pens on the Medicine Shortage Reports Database.
Information for pharmacists
The SSSI allows you to substitute Ryzodeg FlexTouch prefilled pens with Ryzodeg Penfill without prior approval from the prescriber, so long as the permitted circumstances provided within the SSSI are met. See both the Specific permitted circumstances (in Schedule 1) and General permitted circumstances (in Schedule 2).
Use your professional and clinical judgement to determine if substitution is right for the patient. It might not be appropriate for all patients currently prescribed Ryzodeg FlexTouch to be given Ryzodeg Penfill.
Please assess the following when considering the substitution:
- the patient’s health literacy
- the patient’s dexterity and ability to use the substituted medication and device
- the patient’s capacity to understand the substitution
- the patient’s consent to the change.
You must ensure that the patient has a suitable insulin delivery device to administer the Ryzodeg Penfill cartridges. Any NovoPen device is suitable – NovoPen 4, NovoPen Echo or NovoPen 6.
You may also consider referral to a credentialed diabetes educator for further guidance and advice on using the substitutable medicine and NovoPen.
Patients do not have to pay for the reusable NovoPen administration device obtained through the NovoPen 6 Pharmacy Program, available to all retail pharmacies via PharmaPrograms. If your pharmacy is not signed up to the program, you can locate participating retail pharmacies on the Online Pharmacy Locator. To join the NovoPen 6 program or to find out more about it, contact PharmaPrograms via email novopen@pharmaprograms.com.au or phone on 1300 377 781.
Ensure you provide the patient or their carer with the necessary information and instructions for the substitution and administration of their medicine. This includes ensuring they understand the NovoPen device is reusable. You may provide resources such as:
- the Consumer Medicine Information (CMI) leaflet
- the printed NovoPen user guide
- educational resources, such as the instructional NovoPen 6 - How to Use Video.
You may need to use educational resources, translation services, or engage a support from a carer or organisation, such as the local Aboriginal Community Controlled Health Organisation (ACCHO). You can also refer patients to their prescriber or another suitably qualified health practitioner, such as their diabetes educator.
Resources for health professionals and patients affected by this substitution, as well how to access a credentialled diabetes educator can be found on the Australian Diabetes Educators Association.
For further information for pharmacists on dispensing substitutable medicines, see our Serious Scarcity Substitution Instruments (SSSI) web page.
Information on Pharmaceutical Benefits Scheme (PBS) subsidy arrangements for medicines substituted using an SSSI can be found on the PBS website.
Information for prescribers, credentialled diabetes educators and nurses
When prescribing for your patients, particularly when initiating new patients, consider the unavailability of Ryzodeg 70/30 FlexTouch prefilled pens, and prescribe the available presentation: Ryzodeg 70/30 Penfill cartridges.
Patients presenting to the pharmacy with a Ryzodeg FlexTouch prescription may be given Ryzodeg 70/30 Penfill cartridges instead by their pharmacist, or they may be referred to you for review of their prescribed treatment.
Consider instructing patients on how to use the substitute medicine and devices at their next appointment. Patients presenting at the pharmacy may be given information and guidance on how to administer the substitute product by their pharmacist, or they may be asked to contact you for this information.
NovoPen, the administration device needed to administer Ryzodeg Penfill cartridges, is a reusable insulin delivery device. Patients need to keep this reusable pen, as they need to use it for their future Ryzodeg Penfill injections.
The reusable NovoPen 6 administration device is free through the NovoPen 6 Pharmacy Program, with participating retail pharmacies listed via the Online Pharmacy Locator.
To assist health professionals and patients to safely use the NovoPen, Novo Nordisk have created an instructional video called: NovoPen 6 How to Use Video. This resource provides step-by-step guidance on using the NovoPen safely and effectively.