Facebook icon

Diabetes Qualified

Changes to available insulins in Australia from December 2024

Changes to available insulins in Australia from December 2024

By Carolien Koreneff CDE-RN

In Australia, three companies supply the insulins available for managing diabetes: Lilly Diabetes, Novo Nordisk, and Sanofi. Insulin was first made available in 1922 and has undergone significant advancements over time.

Types of insulin available in 2024

The range of insulin types available to people with diabetes includes:

  • Rapid-acting insulin, such as Apidra, Fiasp, Humalog and Novorapid
  • Regular or short-acting insulin, such as Actrapid and Humulin-R
  • Intermediate-acting insulin, such as Humulin NPH and Protaphane
  • Long-acting insulin, such as Levemir, Optisulin (formerly Lantus) and Toujeo
  • Pre-mixed insulin, such as Humalog Mix25, Humalog Mix50, Humulin 30/70, Mixtard 30/70, and Ryzodeg 70/30

Insulin delivery options

Insulin is available in various formats to suit individual preferences and needs:

  • Prefilled disposable pen devices
  • Penfill cartridges for use with compatible reusable pen devices
  • Vials for use with insulin syringes

Changes ahead

The Therapeutic Goods Administration of Australia (TGA) announced recently that Novo Nordisk has advised them that they will gradually discontinue some of their products between late 2024 and late 2026.

The TGA states that the sponsor (Novo Nordisk) has announced that:

  • In some cases, although one presentation of a product is discontinued, the product will remain available in a different presentation (for example, the FlexTouch prefilled pen may be replaced by a Penfill cartridge)
  • People living with diabetes will have ample time to move to alternative options before products are discontinued
  • this is part of a global strategy and is not the result of any safety, efficacy or quality related concerns.

Novo Nordisk commented in a letter to health professionals that they:

“understand this change can bring uncertainty. To minimise the disruption to impacted patients [they] are announcing these changes now, to help patients transition safely to alternative options for continuity of care.”

This table lists the products and presentations that will be impacted in Australia

*Based on current forecast and patient demand.
**Novo Nordisk informed the TGA, PBAC and healthcare professionals in January 2024 about the discontinuation of Mixtard<® 30/70 Penfill® and Innolet®. The discontinuation timing for Mixtard® 30/70 Penfill® has been updated to October 2024 to align with the availability of our remaining supply in the market.

What does this mean for you and your clients?

Any patient that changes from a pre-filled, disposable pen device (Flexpen or Flextouch) to a Penfill cartridge will need a Novopen reusable pen device. Current reusable Novopen devices include the Novopen-4, Novopen Echo and Novopen-6.

People can obtain a reusable Novopen-4 or Novopen Echo devices, along with information on the differences between the devices and how to administer them, through their endocrinologist or credentialled diabetes educator.

Alternatively, patients 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. Pharmacies wanting to join the NovoPen 6 program, or those wanting to find out more about it, can contact PharmaPrograms via email novopen@pharmaprograms.com.au or phone on 1300 377 781.

Novopen reusable pen devices use the same pen needles as the Flexpen and Flextouch devices.

Novo Nordisk will provide support materials to healthcare professionals to assist patients transitioning to alternative treatments closer to the timings of each product phase out.

Ryzodeg Flextouch shortages

There has been a shortage of Ryzodeg Flextouch prefilled pens since June 2023, due to unprecedented global demand for other medicines using the FlexTouch delivery device. 

The TGA advised on 27 September 2024 that “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.

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. It is expected that all patients using Ryzodeg insulin will have a prescription for the Penfill cartridges by February 2025.

Actrapid

Actrapid is Insulin Neutral Human 100 units/ml, it is essentially the same as Humulin-R. Any patients who are currently using Actrapid Penfill cartridges, could be changed over to the vials using a U-100 insulin syringe, or they could be swapped over to Humulin R cartridges, dose for dose. The Humulin R cartridges fit into the HumaPen, patients can obtain a reusable HumaPen device, along with information on how to use it, through their endocrinologist or credentialled diabetes educator. Please advise your clients to use the correct administration device for each insulin.

Actrapid is a short-acting insulin. As it has a longer duration of action than rapid-acting insulin, around 8 hours instead of 4-5 hours, it tends to mainly be used in patients who are on steroid treatment.

Protaphane

Protaphane is Insulin Isophane Human 100 units/ml, an intermediate-acting insulin, and is the same as Humulin NPH.

For now, people using Protaphane Innolet, a pre-filled, disposable device, can change to Protaphane Penfill cartridges, which can be used with the Novopen 4, Novopen Echo or Novopen 6, as described above.

However, from December 2026 the Protaphane Penfill cartridges will no longer be available. Anybody using Protaphane Penfill cartridges could be changed over to the vials using a U-100 insulin syringe, or they could be swapped over to Humulin R cartridges, dose for dose. Humulin R cartridges fit into the HumaPen. Patients can obtain a reusable HumaPen device, along with information on how to use it, through their endocrinologist or credentialled diabetes educator.

Protaphane is mainly used in women with gestational diabetes who do not meet glucose targets, and in people who are on steroid treatment.

Mixtard 30/70

Mixtard 30/70 is essentially the same as Humulin 30/70; both these insulins are insulin neutral human 30 units/ml combined with insulin isophane human 70 units/ml. Hence clients could  be swapped over to Humulin 30/70 cartridges, dose for dose. Humulin 30/70 cartridges fit into the HumaPen. Patients can obtain a reusable HumaPen device, along with information on how to use it, through their endocrinologist or credentialled diabetes educator.

Patients currently on Mixtard 30/70 could also be changed over to Novomix-30. Novomix-30 is 30% soluble insulin aspart (rys) and 70% insulin aspart (rys) crystallised with protamine, making it another U-100 (100 U/mL) insulin preparation. Both Humulin 30/70 and Novomix-30 are biphasic, white suspensions which need to be reconstituted prior to administration.

Novomix-30 is said to produce insulin plasma profiles similar to premixed biphasic human insulin (Mixtard 30/70 or Humulin 30/70), apart from the initial faster absorption of the soluble component. Novomix-30 is available in Penfill cartridges for use with a reusable Novopen 4, 6 or Echo (as described above) or in a prefilled, disposable pen device called a Flexpen.

Levemir

Levemir is a long-acting insulin analogue, known as insulin detemir (rys). As no other preparations of this insulin will be available from December 2026, clients will need to be changed to another long-acting insulin. There is the option to replace with Optisulin or Toujeo, but dose adjustments may be required.

Optisulin contains the active ingredient insulin glargine U-100 (100 units/ml). Optisulin is an insulin analogue, equipotent to human insulin, with a peakless glucose lowering profile and a prolonged duration of action that permits once daily dosing.

It is available in a 3ml cartridge for use with the JuniorSTAR (which delivers Optisulin in 0.5-unit dose increments from 1 unit), or with the AllStar, AllStar Pro, or ClikSTAR (which deliver Optisulin in 1-unit dose increments). The other option is to use a prefilled, disposable pen device called the Solostar.

According to the Australian Product Information, when changing from a treatment regimen with an intermediate or long-acting insulin to a regimen with Optisulin, the amount and timing of a short-acting insulin or fast-acting insulin analogue or the dose of any oral glucose lowering medications may need to be adjusted.

It should also be noted that Optisulin must not be mixed with any other insulin nor be diluted. Mixing or diluting can change its time/action profile and mixing can cause precipitation.

Toujeo contains the active ingredient insulin glargine U-300 (300 units/ml). Similar to Optisulin it is an insulin analogue, equipotent to human insulin, with a peakless glucose lowering profile and a prolonged duration of action that permits once daily dosing. When changing from Levemir to Toujeo dose adjustments will be needed.

Toujeo is available in a pre-filled disposable pen injector that contains 1.5 mL solution for injection, called the Toujeo SoloStar. A dose of 1 to 80 units per single injection, in steps of 1 unit, can be injected.

The Toujeo Max SoloStar pre-filled disposable pen injector contains 3 mL solution for injection, each mL containing 300 units of insulin glargine, it is adjustable in 2-unit increments. If the patient’s previous dose was an odd number, when changing from Toujeo SoloStar and Toujeo Max SoloStar, the dose should be increased or decreased by 1 unit.

The Toujeo SoloStar pre-filled pens have been specifically designed for Toujeo, therefore no dose re-calculation is required. Toujeo must NOT be drawn from the cartridge of the pre-filled pen into a syringe due to an increased risk of hypoglycaemia. Syringes are for U-100 insulins only. Toujeo must not be mixed with any other insulin products. Mixing changes the time/action profile of insulin glargine 300 units/mL and causes precipitation.

It is also important to note that Insulin glargine 100 units/mL (Optisulin) and insulin glargine 300 units/mL (Toujeo) are NOT bioequivalent and are not directly interchangeable. As they contain the same active ingredient, insulin glargine, they should NOT be used together.

Another option is to change from Levemir to Ryzodeg 70/30, but in this case, there are a few things to consider.

  1. Ryzodeg is a bi-phasic insulin, it contains 70% soluble insulin degludec (ultralong-acting basal insulin) and 30% soluble insulin aspart (rapid-acting mealtime insulin) a ready-to-use, clear, colourless, neutral solution. This means that no extra rapid-acting insulin will be needed at meals when Ryzodeg is given. However, other meals may require rapid-acting insulin.
  2. As with all insulin products, close glucose monitoring is recommended during transfer and in the following weeks. Doses and timing of concurrent rapid-acting or short-acting insulin products or other concomitant glucose lowering medications may need to be adjusted.
  3. Ryzodeg can be administered once or twice-daily with the main meal(s).
  4. Ryzodeg will only be available in a Penfill cartridge, as described above.

For information on how to change from Levemir to Ryzodeg is available in the Australian Ryzodeg Product Information leaflet, or you may contact the patient’s endocrinologist or credentialled diabetes educator for recommendations and advice.

Changing insulins

When changing a treatment regimen, the amount and timing of insulin products, or of the dose of any oral diabetes medications, may need to be adjusted.

It is crucial that you closely monitor any patients during any changeover and in the initial weeks thereafter.

With improved glycaemic management there will be an increase in insulin sensitivity (which will lead to reduced insulin requirements) and hence further adjustment of insulin doses or oral glucose lowering medications may become necessary.

Clients and, if appropriate, their relatives, must be alert to the possibility of hypo- or hyperglycaemia, and know what actions to take.

When you are discussing the changes with your client it would be a good opportunity to check their injection sites for any lipodystrophy. There is a risk of delayed insulin absorption and worsening of glucose levels when injecting into lipodystrophy. Regular monitoring of glucose levels is recommended when changing the injection site, due to the risk of hypoglycaemia associated with the improved uptake of the insulin.

Further information

More information on these changes is available through the TGA website.

Or, if you have any questions in relation to the above, you can contact the Novo Medical Information Team on aunrccc@novonordisk.com or 1800 668 626, or contact your local Novo Nordisk® representative.

Want to develop your diabetes knowledge?

A good way to develop your knowledge of diabetes is by doing the Diabetes Qualified Diabetes Essentials course.

Diabetes Qualified

Diabetes Essentials is a comprehensive learning program which covers all aspects of diabetes; from diagnosis to management. This online interactive course will provide you with the latest best practice information on diabetes. Including the pathophysiology of diabetes, diabetes management principles, and prevention of complications.

Enrol today and gain valuable knowledge, CPD points, and practical skills.

References

https://www.tga.gov.au/safety/shortages/information-about-major-medicine-shortages/about-discontinuation-ryzodeg-7030-flextouch-insulin-prefilled-pens

https://www.novonordisk.com.au/content/dam/nncorp/au/en/pdfs/Insulin-Product-Information.pdf

https://www.novonordisk.com.au/content/dam/nncorp/au/en/pdfs/2021-pi-and-cmi-pdfs/novorapid-novomix-pi-v8-2021.pdf

https://www.novonordisk.com.au/content/dam/nncorp/au/en/pdfs/NovoMix%2030%20FlexPen%20CM%20v15.pdf

https://www.novonordisk.com.au/content/dam/nncorp/au/en/pdfs/2021-pi-and-cmi-pdfs/levemir-pi-11.pdf

https://www.novonordisk.com.au/content/dam/nncorp/au/en/pdfs/levemir-flexpen-cmi-v15.pdf

https://www.nps.org.au/assets/medicines/544c8c87-6ad2-4a67-afd3-a8a100a875ee-reduced.pdf

https://www.nps.org.au/assets/medicines/0d0ed929-24c3-41d9-ad67-a6b100bf8128.pdf

https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2011-PI-01768-3&d=20241219172310101

https://www.nps.org.au/assets/medicines/0d0ed929-24c3-41d9-ad67-a6b100bf8128.pdf

https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2015-PI-02038-1

https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2021-PI-01226-1

X