Diabetes mellitus

This medicinal product is a basal insulin for once-weekly subcutaneous administration. It is intended to be administered on the same day of the week.

The potency of insulin analogues, including insulin icodec, is expressed in units. One (1) unit of insulin icodec corresponds to 1 unit of insulin glargine (100 units/mL), 1 unit of insulin detemir, 1 unit of insulin degludec, or 1 international unit of human insulin.

Insulin icodec is available in one strength, 700 units/mL. The needed dose is dialled in units. A dose of 10-700 units per injection, in steps of 10 units, can be administered.

In patients with type 1 diabetes mellitus, this medicinal product must be combined with bolus insulin to cover mealtime insulin requirements.

In patients with type 2 diabetes mellitus, this medicinal product can be administered alone or in any combination with oral antidiabetic medicinal products, GLP-1 receptor agonists and bolus insulin. When insulin icodec is added to sulfonylurea therapy, discontinuation or a reduction in the dose of sulfonylurea should be considered.

Insulin icodec is to be dosed in accordance with the individual patient’s needs. It is recommended to optimise glycaemic control via dose adjustment based on fasting plasma glucose.

Due to the long half-life of insulin icodec, adjustment of dose is not advised during acute illness nor if patients make short-term changes in their physical activity level or usual diet. In these situations, patients should be instructed to consult their healthcare professional for further guidance on other applicable adjustments, e.g., glucose intake or changes to other glucose lowering medication.

Initiation of insulin icodec

Patients with type 2 diabetes mellitus (insulin-naïve)

The recommended weekly starting dose is 70 units and followed by individual once-weekly dose adjustments.

Patients newly diagnosed with type 1 diabetes mellitus

The safety and efficacy of insulin icodec in newly diagnosed insulin-naïve type 1 diabetes patients have not been established. No data are available.

Switch from once- or twice-daily basal insulin medicinal products to insulin icodec in type 2 and type 1 diabetes

The first once-weekly dose of insulin icodec should be administered on the day following the last dose of once- or twice-daily basal insulin.

When switching patients from once- or twice-daily basal insulin, the recommended once-weekly insulin icodec dose is the total daily basal dose multiplied by 7. For the first injection only (week 1 dose), a one-time additional 50% insulin icodec dose is recommended if seeking faster achievement of glycaemic control in patients with type 2 diabetes. For type 1 diabetes patients, this dose is always recommended (for the first injection only). If the one-time additional 50% insulin icodec dose is administered, the week 1 dose should be the total daily basal insulin dose multiplied by 7 and then multiplied by 1.5, rounded to the nearest 10 units (see Table 1).

The one-time additional dose must not be added for the second injection onwards. The second once-weekly dose of insulin icodec is the total daily basal dose multiplied by 7.

The third and subsequent once-weekly doses should be based on the patient’s metabolic needs, blood glucose monitoring results, and glycaemic control goal until the desired fasting plasma glucose is achieved. Adjustment of the dose should be made based on the self-monitored fasting glucose values on the day of titration and the two prior days.

Close glucose monitoring is recommended during the switch and in the following weeks. Doses and timing of concurrent bolus insulin products or other concomitant antidiabetic treatment may need to be adjusted.

Table 1. Insulin icodec dose when switching from once- or twice-daily basal insulin for type 2 diabetes and type 1 diabetes patients, in case initially (week 1) a one-time additional dose is administered:

^a all doses are rounded to the nearest 10 units
^b 1.5 x previous total daily basal insulin dose multiplied by 7. One-time additional dose given in week 1 is recommended if seeking faster achievement of glycaemic control in type 2 diabetes patients. For type 1 diabetes patients, this dose is always recommended.
^c previous total daily basal insulin dose multiplied by 7
^d when the required dose is larger than the maximum dose stop of the pre-filled pen (700 units), split dose with two injections may be needed.

Missed dose

If a dose is missed, it is recommended that it is administered as soon as possible.

Type 1 diabetes patients

Type 1 diabetes patients must be instructed to continue their dosing once weekly. The once weekly dosing schedule will then be changed to the day of the week where the missed dose was administered. Monitoring of fasting plasma glucose should be performed.

If the original day of once-weekly administration is to be maintained, the time between subsequent doses can be successively extended to finally obtain the same administration day.

Type 2 diabetes patients

If it is still within 3 days of the missed dose, the type 2 diabetes patient can then resume their original once weekly dosing schedule. Monitoring of fasting blood glucose should be performed.

If more than 3 days have passed, the missed dose should still be administered as soon as possible. The once weekly dosing schedule will then be changed to the day of the week where the missed dose was administered. If the original day of once-weekly administration is to be maintained, the time between subsequent doses can be successively extended to finally obtain the same administration day.

Insulin icodec is administered subcutaneously by injection in the thigh, the upper arm or the abdominal wall. Injection sites should always be rotated within the same region in order to reduce the risk of lipodystrophy and cutaneous amyloidosis.