About the discontinuation of Protaphane InnoLet insulin cartridges

Pharmaceutical company Novo Nordisk (the sponsor) has advised us that the Protaphane InnoLet human insulin (rys) 100 IU/mL injection multidose cartridge was discontinued on 1 February 2025. This is part of a global strategy and is not related to product safety, quality or effectiveness.

We recognise the vital role of this insulin product for people who use it, so we have made a Serious Scarcity Substitution Instrument (SSSI) that allows a pharmacist to dispense Protaphane Penfill human insulin (rys) 100 IU/mL injection multidose cartridge in the place of a Protaphane InnoLet cartridge without a new prescription from the prescriber.

For more information about SSSIs see Substituting scarce medicines and Serious Scarcity Substitution Instruments (SSSIs).

Please note:

• Protaphane Penfills must be administered using a NovoPen insulin delivery device. Novo Nordisk, the sponsor or Protaphane, recommends the NovoPen 4 device.
• Pharmacists should use their clinical judgement when substituting a product for a patient. If a substitution is unsuitable, for example when a patient cannot use a reusable pen device, you should refer them to their prescriber or diabetes health care team for review. 

Information for patients and their carers

We understand the news of this discontinuation may cause concern if you or someone you care for uses the Protaphane InnoLet human insulin multidose cartridge. The substitution arrangement (SSSI) will be in effect until 28 February 2026 so that people with a prescription for Protaphane InnoLet have time to access an alternative. Please note the following information:

• You can take your prescription for Protaphane InnoLet to your pharmacist, who can give you Protaphane Penfills and a NovoPen device to administer it.
• Your pharmacist will show you how to insert a Protaphane Penfill into the NovoPen device and how to replace the Penfill when it is empty or when the insulin expires. They will also show you how to administer your insulin with the NovoPen device. Please note that replacing the Penfill when it is empty is different to the Protaphane InnoLet device, which is discarded when empty or when the insulin expires.
• Your pharmacist may recommend you monitor your blood glucose more often after changing to Protaphane Penfill.
• Your pharmacist will inform the health professional who prescribed the insulin that they have substituted it with an appropriate alternative product. Next time you visit the health professional for a new prescription, you can talk about a long-term approach to replace Protaphane InnoLet.
• If you have any questions about the substitute product, including how to use it, talk to your pharmacist or the health professional who helps you manage your diabetes. 

In some cases, a health professional may change your treatment to a different insulin product that is better suited to your needs.

The Australian Commission on Safety and Quality in Health Care has published a fact sheet for all patients affected by the discontinuation of Novo Nordisk insulin products, including Protaphane InnoLet insulin cartridges.

Information for pharmacists

The SSSI allows you to substitute Protaphane InnoLet human insulin (rys) 100 IU/mL injection multidose cartridge with an equivalent quantity of Protaphane Penfill human insulin (rys) 100 IU/mL injection multidose cartridge without prior approval from the prescriber, as 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) for details.

Use your professional and clinical judgement to determine if substitution is right for the patient. Please assess the following when considering the substitution:

• the patient’s health and medicine 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.

According to the substitution protocol, one 3 mL (300 unit) cartridge of the substitutable medicine is equivalent to one 3 mL (300 unit) pre‑filled Protaphane InnoLet cartridge. You should advise the patient, or the person acting on their behalf, that the number of dose units of the substitute medicine that must be administered is the same as the prescribed insulin dose of the Protaphane InnoLet cartridge. 

You must ensure that the patient has a suitable NovoPen insulin delivery device to administer the substitute medicine. Novo Nordisk recommends that patients use a NovoPen 4 device to administer Protaphane Penfill. 

Hospital and community pharmacies can order NovoPen 4 devices at no cost for their patients who are starting on or transitioning to Protaphane Penfill. They can call Novo Nordisk Medical Information on 1800 668 626 or email aunrccc@novonordisk.com for details.

Other versions of NovoPen are also compatible with Protaphane Penfill.

When providing the patient or their carer with the necessary information and instructions for the substitution and administration of their medicine, you may need to use educational resources or translation services. You may also ask for support from a carer or organisation such as the local Aboriginal Community Controlled Health Organisation (ACCHO). 

You may also need to recommend additional blood glucose monitoring for patients transitioning to a substitutable insulin. You can also refer patients to their prescriber or another suitably qualified health practitioner, such as their credentialled diabetes educator. 

Resources for health professionals and patients affected by this substitution, as well as information about accessing a credentialled diabetes educator, can be found on the Australian Diabetes Educators Association.- external site

The Australian Commission on Safety and Quality in Health Care has published a fact sheet discussing strategies and safety considerations in managing the Protaphane InnoLet discontinuation.

You should also notify the prescriber of the substitution.

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- external site.

Information for prescribers, credentialled diabetes educators and nurses

Resources and fact sheets have been developed by the Australian Commission on Safety and Quality in Health Care (ACSQHC) and diabetes expert groups. These groups included: Australasian Diabetes in Pregnancy Society, Australian Diabetes Educators Association, Australian Diabetes Society, Diabetes Australia, Society of Obstetrics Medicine Australia and New Zealand and Royal Australian College of General Practitioners.

• The ACSQHC fact sheet for clinicians advising them on how to respond to the discontinuation of Protaphane InnoLet.
• The ACSQHC guidance for clinicians regarding strategies and safety considerations in responding to discontinuation of various Novo Nordisk insulin products, including Protaphane InnoLet.
• The Consensus advice for health services and clinicians following the discontinuation of the Protaphane InnoLet device.

When prescribing for your patients, particularly when initiating new patients, consider that prefilled Protaphane InnoLet cartridges will not be available after 1 February 2025.

The SSSI will be in effect until 1 February 2026. This will give you plenty of time to change your patients’ prescriptions to available presentations of insulin medicines. You can see the other products Novo Nordisk intends to discontinue over 2025 and 2026 at: About the changes to supply of Novo Nordisk insulin products.

Patients who take a Protaphane InnoLet prescription to their pharmacy may be given a substitute using the SSSI, or they may be referred to you to review their treatment.

The pharmacist may give the patient information and guidance on how to administer the substitute product or the patient may contact you for this information. 

If a patient has been given Protaphane Penfills as a substitute for Protaphane InnoLet, consider discussing this change with them at their next appointment, and checking their administration technique if needed.