Awiqli Calculator

Abbreviated Prescribing Information
For the use only of registered medical practitioner or a hospital or a laboratory

Abbreviated prescribing information (and not full package insert)

Generic Name: Insulin Icodec Awiqli® 700 units/mL Solution for injection in pre-filled pen (FlexTouch®) (r-DNA Origin). Brand Name: Awiqli® 700 units/mL Presentation: Awiqli® is available as 700 units of insulin icodec in 1 mL solution, 1050 units of insulin icodec in 1.5 mL solution and 2100 units of insulin icodec in 3 mL solution [with or without Disposable Hypodermic needles (NovoFine® Plus 32G 4 mm needles)]. Indication: Treatment of diabetes mellitus in adults. Description: Solution for injection in pre-filled pen (FlexTouch®). Clear and colourless isotonic solution with a pH of approximately 7.4 Dosing and administration: 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. Awiqli® is available in one strength, 700 units/mL. 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. Patients with type 2 diabetes mellitus (insulin-naïve): the recommended weekly starting dose is 70 units and followed by individual once-weekly dose adjustments. 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 a one-time additional 50% Awiqli® dose is always recommended (for the first injection only). 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. Method of administration: Subcutaneous use only. 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. 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. Special Population: Elderly: No dose adjustment is required for elderly patients. Renal impairment: No dose adjustment is required for patients with renal impairment. In patients with renal impairment, more frequent glucose monitoring is recommended. Hepatic impairment: No dose adjustment is required for patients with hepatic impairments. In patients with hepatic impairment, more frequent glucose monitoring is recommended. Paediatric population: The safety and efficacy of Awiqli® in children and adolescents below 18 years have not yet been established. No data are available. Contraindications: Hypersensitivity to the active substance or to any of the excipients Special warnings and precautions: Omission of a meal or unplanned, strenuous physical exercise may lead to hypoglycaemia. Upon onset of a hypoglycaemic episode, patient is recommended to closely measure blood glucose until recovery. Inadequate dosing and/or discontinuation of treatment in patients requiring insulin may lead to hyperglycaemia and potentially to diabetic ketoacidosis. Furthermore, concomitant illness, especially infections, may lead to hyperglycaemia and thereby cause an increased insulin requirement. Switching a patient between another insulin medicinal product and insulin icodec should be done under medical supervision and may result in the need for a change in dosage. Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis. Patients must be instructed to always check the label on the insulin pen before each injection to avoid accidental mix-ups between once-weekly insulin icodec and other insulin products. Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of congestive heart failure. Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs. Use in special populations (Pregnancy, lactation and fertility): Fertility: Animal reproduction studies with insulin icodec have not revealed any adverse reactions on fertility. Pregnancy: There is no clinical experience with use of insulin icodec in pregnant women. Breast-feeding: It is unknown whether insulin icodec is excreted in human milk. Drug Interaction: A number of medicinal products are known to interact with glucose metabolism. Refer to pack insert for complete information on drug interactions. Undesirable Effects: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10000 to < 1/1 000); very rare (< 1/10000) and not known (cannot be estimated from the available data). Very common: Hypoglycaemia. Common: Injection site reactions, Peripheral oedema. Uncommon: Hypersensitivity. Rare: Lipodystrophy. Refer to pack insert for complete information on side effects. Shelf life: 30 months. Storage: 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 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. Disclaimer: The abbreviated package insert is updated from the CDSCO approved package insert (File no. Permission no.: IMP/BIO/25/000010 (File No. BIO/IMP/23/000082 dated 19 Feb 2025). Awiqli® , Flextouch® , NovoFine® Plus & NovoFine® are trademarks owned by Novo Nordisk A/S and registered in Denmark. Imported by: Novo Nordisk India Private Limited, Bangalore. *For full prescribing information, please contact +91-8040303200 or write to us at [email protected] or reach us at Novo Nordisk India Pvt Ltd, NXT Tower-2, Floor 1 & 2, Embassy Manyata Business Park, Nagavara Village, Kasaba Hobli, Bangalore – 560 045, Karnataka, India. Note: For detailed information on this product, please refer to full package insert*. This material is developed by: Novo Nordisk India Private Limited, NXT Tower -2, Floor 1 & 2, Embassy Manyata Business Park, Nagavara Village, Kasaba Hobli, Bangalore-560 045, Karnataka, India. For the use of HCPs or medical practitioners only. The photographs are only for illustrative purposes