Discontinuation of Protaphane® InnoLet® and other insulin products
Multiple insulin products are being discontinued by Novo Nordisk from the global market with stock of the affected products to be depleted over the next 2 years. For most of the insulin products being discontinued, alternative presentations will continue to be available in Australia.
Background
The decision by pharmaceutical company Novo Nordisk to discontinue multiple products remains, despite significant national advocacy from several peak diabetes organisations in Australia between September to November 2024. The discontinuations and changes to administration devices are staggered and outlined in Attachment 1. In some cases, although one presentation of a product is discontinued, the product will remain available in a different presentation. For example, the Protaphane®InnoLet® will be replaced by Protaphane® PenFill® and Protaphane® vial. This is part of a global strategy and is not related to product safety, quality or effectiveness.
Protaphane® contains isophane insulin which is an intermediate acting insulin commonly used to treat steroid induced hyperglycaemia and increased fasting blood glucose levels in women with gestational diabetes mellitus. The Protaphane® InnoLet® device will become unavailable in Australia from February 2025 with Protaphane® Penfill® cartridges being an alternative replacement. To minimise the impact on women, it is recommended all services review their workflows and education material.
Assessment
- Patients currently prescribed Protaphane® using an InnoLet® (pre-filled) device will need to be switched to Protaphane® Penfill® cartridges for administration (cartridge loaded
into a reusable pen) if they are to continue beyond February 2025. - The Therapeutic Goods Administration (TGA) has released a web statement and has made a Serious Scarcity Substitution Instrument (SSSI) to assist in managing the discontinuation of Protaphane® InnoLet® from 1 February 2025. The Therapeutic Goods (Serious Scarcity and Substitutable Medicine) (Insulin Isophane Human) Instrument 2024 has been registered and is now in force until 28 February 2026.
- Refer to Attachment 1 for a list of the insulin products being discontinued and the available alternatives. Some product alternatives will only be available temporarily. This includes Protaphane® Penfill® cartridge, the recommended alternative to Protaphane® InnoLet®, which will be discontinued in December 2026.
Please refer to the Queensland Health fact sheet for recommendations and available alternatives.
