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Awiqli is a brand name for Insulin Icodec. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of diabetes mellitus in adults.
Verbatim from this product's EMA label. Tap a section to expand.
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.
1. 3 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.
, 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
1). Tabulated list of adverse reactions The overall safety profile of insulin icodec is based on six phase 3 (ONWARDS 1-6) trials where a total of 2 170 patients were exposed to insulin icodec, 1 880 with type 2 diabetes and 290 with type 1 diabetes.
Adverse reactions listed below are based on clinical trial data and classified according to MedDRA System Organ Class.
Frequency categories are defined according to the following convention:
Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000) and not known (cannot be estimated from the available data). Table 2 Tabulated list of adverse reactions * Hypoglycaemia is defined below ** Grouped term covering adverse events related to peripheral oedema *** Grouped term covering adverse events related to hypersensitivity.
1). 0 mmol/L). Type 2 diabetes The proportion of patients reporting severe or clinically significant hypoglycaemic episodes for insulin icodec vs daily basal insulin was 9%-12% vs 6%-11% in insulin naïve type 2 diabetes patients (ONWARDS 1, 3 and 5), 14% vs 7% in type 2 diabetes patients previously treated with basal insulin (ONWARDS 2), and 51% vs 56% in type 2 diabetes patients previously on basal-bolus insulin regimen (ONWARDS 4).
62 (type 2 diabetes patients previously on basal-bolus insulin regimen). The main phase of ONWARDS 1 trial was followed by an extension part of 26 weeks treatment duration in order to investigate long-term safety. 16 episodes per PYE.
1. Type 1 diabetes The proportion of patients reporting severe or clinically significant hypoglycaemic episodes for insulin icodec vs insulin degludec was 85% vs 76% in previously basal insulin-treated patients with type 1 diabetes.
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). 5, rounded to the nearest 10 units (see Table 1). 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.
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.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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37. ONWARDS 6 trial was followed by an extension part of 26 weeks treatment duration in order to investigate long-term safety. 16 episodes per PYE. 1. Across the ONWARDS trials, most hypoglycaemic episodes were observed day 2-4 after the weekly administration.
Hypersensitivity As with other insulins, allergic reactions may occur with insulin icodec. Immediate-type allergic reactions to either insulin itself or the excipients may potentially be life-threatening. Hypersensitivity reactions (such as urticaria, lip swelling and swelling face) have been reported in the phase 3a program with insulin icodec.
6% of daily basal insulin-treated patients. Two out of the 10 events reported by insulin icodec-treated patients were severe (urticaria) and one of these was also reported as serious. 4% of daily basal insulin-treated patients. The majority of injection site reactions in the insulin icodec-treated patients (75%) were reported in the double-blinded, double-dummy, active- 11 controlled trial (ONWARDS 3).
In the daily basal insulin-treated patients, 21% of injection site reactions were reported in ONWARDS 3. Overall, in the phase 3 trials, the most common signs and symptoms of injection site reactions were erythema and pruritus. The maximum severity of injection site reactions for patients treated with insulin icodec was mild (94 %) or moderate (6 %).
No injection site reactions were serious. Skin and subcutaneous tissue disorders Lipodystrophy (including lipohypertrophy, lipoatrophy) and cutaneous amyloidosis may occur at the injection site and delay local insulin absorption. 4).
Other special populations Based on results from clinical trials with insulin icodec, the frequency, type and severity of adverse reactions observed in elderly patients and in patients with renal or hepatic impairment do not in general indicate any differences to the broader experience in the overall insulin […]
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 5 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.
8). Renal impairment No dose adjustment is required for patients with renal impairment. 2). Hepatic impairment No dose adjustment is required for patients with hepatic impairments. 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. 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. 4). 6. 3 Contraindications Hypersensitivity to the active substance or to any of the […]