AWIQLI Solution for injection Ref.[110293] Active ingredients: Insulin icodec

Posology

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.

Awiqli 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. See sections 4.5 and 5.1.

Awiqli 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 Awiqli

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 Awiqli in newly diagnosed insulin-naïve type 1 diabetes patients have not been established. No data are available. See section 4.4.

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

The first once-weekly dose of Awiqli 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 Awiqli dose is the total daily basal dose multiplied by 7. For the first injection only (week 1 dose), a one-time additional 50% Awiqli 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% Awiqli 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 (see section 4.4). The second once-weekly dose of Awiqli 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. Awiqli 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.

Special populations

Elderly

No dose adjustment is required for elderly patients (see section 4.8).

Renal impairment

No dose adjustment is required for patients with renal impairment. In patients with renal impairment, more frequent glucose monitoring is recommended (see section 5.2).

Hepatic impairment

No dose adjustment is required for patients with hepatic impairments. In patients with hepatic impairment, more frequent glucose monitoring is recommended (see section 5.2).

Paediatric population

The safety and efficacy of Awiqli in children and adolescents below 18 years have not yet been established. No data are available.

Method of administration

Subcutaneous use only.

Awiqli must not be administered intravenously as it may result in severe hypoglycaemia. This medicinal product must not be administered intramuscularly as it may change the absorption. This medicinal product must not be used in insulin infusion pumps.

Awiqli 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 (see section 4.4).

Patients should be instructed to always use a new needle. The reuse of pre-filled pen needles increases the risk of blocked needles, which may cause under- or overdosing. In the event of blocked needles, patients must follow the instructions described in the instructions for use accompanying the package leaflet.

Awiqli is available in a pre-filled pen. The dose window shows the number of units of insulin icodec to be injected. No dose recalculation is required. The pre-filled pen delivers 10-700 units in steps of 10 units.

Awiqli must not be drawn from the cartridge of the pre-filled pen into a syringe (see section 4.4).

For further information before administration see section 6.6.

A specific overdose for insulin cannot be defined; however, hypoglycaemia may develop over sequential stages if a patient is dosed with more insulin than required:

• Mild hypoglycaemic episodes can be treated by oral administration of glucose or other products containing sugar. It is therefore recommended that the patient always carries sugar-containing products.
• Severe hypoglycaemic episodes, where the patient is not able to treat themselves, can be treated with glucagon given intramuscularly, subcutaneously or intranasally by a trained person, or with glucose given intravenously by a healthcare professional. Glucose must be given intravenously if the patient does not respond to glucagon within 10 to 15 minutes. Upon regaining consciousness, administration of oral carbohydrates is recommended for the patient in order to prevent a relapse.

Overdose events may occur during switch from once- or twice-daily basal insulin to insulin icodec, especially if the one-time additional dose, against recommendation, continues to be administered after the first injection (see section 4.4).

30 months.

Shelf life after first opening of the pen: After first opening or carried as a spare, the medicinal product may be stored for a maximum of 12 weeks. Store below 30°C. Can be stored in a refrigerator (2°C-8°C). Keep the cap on the pen in order to protect from light.

Before first use:

Store in a refrigerator (2°C-8°C).

Do not freeze. Keep away from the freezing element.

Keep the cap on the pen in order to protect from light.

After first opening or if carried as a spare:

For storage conditions after first opening of the medicinal product, see section 6.3.

1, 1.5 or 3 mL solution in a cartridge (type I glass) with a plunger (halobutyl) and a laminated rubber sheet (halobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene, polyoxymethylene, polycarbonate and acrylonitrile butadiene styrene. The cap holder for the longer cartridge containing 3 mL (2 100 units solution has a design feature as a clip on the pen injector cap.

The pre-filled pen is designed to be used with disposable needles up to a length of 8 mm.

The pen body is in green while the pen label is in darker green with a yellow box highlighting the strength. The outer packaging is in green with the formulation strength indicated in a yellow-coloured box.

Pack sizes:

Awiqli pre-filled pen containing 700 units of insulin icodec in 1 mL solution.

• 1 pre-filled pen (without needles).
• 1 pre-filled pen with 9 disposable NovoFine Plus needles.
• 1 pre-filled pen with 14 disposable NovoFine Plus needles.

Awiqli pre-filled pen containing 1 050 units of insulin icodec in 1.5 mL solution.

• 1 pre-filled pen (without needles).
• 1 pre-filled pen with 13 disposable NovoFine Plus needles.
• 1 pre-filled pen with 14 disposable NovoFine Plus needles.
• Multipack containing 2 (2 packs of 1) pre-filled pens with 26 (2 packs of 13) disposable NovoFine Plus needles.
• Multipack containing 2 (2 packs of 1) pre-filled pens with 28 (2 packs of 14) disposable NovoFine Plus needles.

Awiqli pre-filled pen containing 2 100 units of insulin icodec in 3 mL solution.

• 1 pre-filled pen (without needles).
• 2 pre-filled pens (without needles).
• 1 pre-filled pen with 13 disposable NovoFine Plus needles.
• 1 pre-filled pen with 14 disposable NovoFine Plus needles.
• Multipack containing 2 (2 packs of 1) pre-filled pens with 26 (2 packs of 13) disposable NovoFine Plus needles.
• Multipack containing 2 (2 packs of 1) pre-filled pens with 28 (2 packs of 14) disposable NovoFine Plus needles.

Not all pack sizes may be marketed.

This medicinal product is for use by one person only.

Awiqli must not be used if the solution does not appear clear and colourless.

Awiqli which has been frozen must not be used.

A new needle must always be attached before each injection. Needles must not be reused. Needles must be discarded immediately after use.

In the event of blocked needles, patients must follow the instructions described in the instructions for use accompanying the package leaflet.

For detailed instructions for use, see the package leaflet.

Any waste material should be disposed of in accordance with local requirements.