Translation of a-t 2026; 57: 63-4

Insulin icodec (AWIQLI): caution when switching to daily basal insulin

Insulin icodec (AWIQLI) is a long-acting insulin analogue that is injected subcutaneously once a week (a-t 2024; 55: 84-6). The process for switching from preparations to be used daily such as insulin glargin (LANTUS and others) to icodec is described in detail in the summary of product characteristics, and reference is made to the risk of an overdose in this situation. No information, by contrast, is provided about switching in the opposite direction.¹

However, switching from icodec to a daily basal insulin or an analogue also brings with it an increased risk of overdose, as shown in a suspected case report² that was sent to the Drug Commission of the German Medical Association (Arzneimittelkommission der deutschen Ärzteschaft, AkdÄ). The report described an 88-year-old man with type 2 diabetes who was taking metformin (GLUCOPHAGE, generics) and empagliflozin (JARDIANCE) and recently startet treatment with 220 units (U) insulin icodec weekly. Since the insulin preparation was not available in the pharmacy, his wife injected him 30 U insulin glargin in the evening seven days after he last used icodec. The following night he experienced severe hypoglycaemia with a generalised seizure, from which he fully recovered over the course.²

Due to the long half-life of insulin icodec of around a week,¹ there is still a relatively high level of the active substance even seven days after the last injection. However, the patient's wife did not know this, as the summary of product characteristics (and thus also the package leaflet) did not mention either the risk of hypoglycaemia when switching to daily basal insulin. The AkdÄ is therefore urgently requesting appropriate additions.² According to the US product information for insulin icodec, any change to the insulin regime should only be made under careful medical monitoring and with more frequent blood sugar checks.³ On request, the provider also referred to approval studies in which patients with type 2 diabetes generally started daily basal insulin (initially at the last icodec dose divided by seven) two weeks after the last icodec injection.⁴ However, evidently no changes to the summary of product characteristics are currently planned.

In our opinion, this suspected case report also highlights the possible serious consequences of supply bottlenecks, which could jeopardise patients not just as a result of a lack of alternatives but also, among other things, as a result of forced changes to treatment (see a-t 2015; 46: 81-2, 2022; 53: 44-5, 2024; 55: 22 and others), –Ed.

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