General MedicationsSUBCUTANEOUSHigh Alert

Awiqli

INSULIN ICODEC-ABAE

Standard Dose

2 DOSAGE AND ADMINISTRATION • Individualize dose based on type of diabetes, metabolic needs, blood glucose monitoring results and glycemic control goals. ( 2.1 ) • See Full Prescribing Information for important administration instructions ( 2.2 ) • Inject Awiqli subcutaneously into the thigh, upper arm, or abdomen. ( 2.2 ) • Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis. ( 2.2 ) • See Full Prescribing Information for the recommended starting dosage in insulin naïve patients ( 2.3 ) and recommendations for switching patients from daily basal insulin. ( 2.4 ) • Closely monitor glucose when switching to Awiqli. ( 2.4 ) 2.1 General Dosing Instructions Awiqli FlexTouch is available as a single-patient-use FlexTouch pen. • Inject Awiqli subcutaneously once-weekly on any day of the week on the same day each week. • The Awiqli FlexTouch pen delivers doses in 10 unit increments and can deliver up to 700 units in a single injection. • Individualize and titrate the dose of Awiqli based on the patient’s metabolic needs, blood glucose monitoring results, and glycemic control goal. • The potency of insulin analogues, including insulin icodec-abae is expressed in units. One (1) unit of insulin icodec-abae corresponds to 1 international unit of human insulin. • Dose adjustments may be needed with changes in renal or hepatic function or during illness to minimize the risk of hypoglycemia or hyperglycemia. Due to the long half-life of Awiqli, 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, consider other applicable adjustments, e.g. glucose intake or changes to other glucose lowering medication [see Warnings and Precautions ( 5.2 , 5.3 )] . 2.2 Important Administration Instructions • Always check the product label before administration [see Warnings and Precautions ( 5.1 )] . • Inspect visually for particulate matter and discoloration. Only use Awiqli if the solution appears clear and colorless. • Inject Awiqli subcutaneously into the thigh, upper arm, or abdomen. • Rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis [see Warnings and Precautions ( 5.3 ), Adverse Reactions ( 6.1 )] . • During changes to a patient’s insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions ( 5.2 , 5.3 )] . • Use Awiqli FlexTouch pen with caution in patients with visual impairment that may rely on audible clicks to dial their dose. • DO NOT administer Awiqli intramuscularly, intravenously or in an insulin infusion pump. • DO NOT dilute or mix Awiqli with any other insulin or solution. • DO NOT transfer Awiqli from the Awiqli FlexTouch pen into a syringe for administration [see Warnings and Precautions ( 5.1 )] . 2.3 Recommended Dosage in Insulin Naive Patients The recommended weekly starting dose of Awiqli in insulin naïve patients is 70 units administered subcutaneously once-weekly on the same day each week. 2.4 Switching to Awiqli from Daily Basal Insulin Therapy • Administer the first dose of Awiqli on the day after the last dose of daily basal insulin. • Week 1 dosage : The recommended one-time starting dosage of Awiqli FlexTouch is 1.5 times the total daily basal dosage multiplied by 7 rounded to the nearest 10 units. • Week 2 dosage : The recommended dosage is the previous total daily basal insulin dose multiplied by 7 and then rounded to the nearest 10 units. • See Table 1 for examples of Awiqli dosage for Week 1 and 2, when switching from daily basal insulin therapy. • Week 3 dosage and beyond : The recommended dosage of Awiqli can be titrated from the previous dosage based on the patient’s metabolic needs, blood glucose monitoring results, and glycemic control goal. • When switching from daily basal insulin to once-weekly Awiqli close glucose monitoring is recommended. Doses and timing of concurrent rapid-acting or short-acting insulin products or other concomitant antidiabetic treatment may need to be adjusted [see Warnings and Precautions ( 5.1 )] . Table 1. Example Awiqli Weekly Dosages When Switching from Daily Basal Insulin Therapy Previous total daily dosage of basal insulin (units) Week 1 Dosage of Awiqli (units) a Week 2 Dosage of Awiqli (units) b 10 110 70 11 120 80 12 130 80 13 140 90 14 150 100 15 160 110 16 170 110 17 180 120 18 190 130 19 200 130 20 210 140 21 220 150 22 230 150 23 240 160 24 250 170 25 260 180 26 270 180 27 280 190 28 290 200 29 300 200 30 320 210 31 330 220 32 340 220 33 350 230 34 360 240 35 370 250 36 380 250 37 390 260 38 400 270 39 410 270 40 420 280 41 430 290 42 440 290 43 450 300 44 460 310 45 470 320 46 480 320 47 490 330 48 500 340 49 510 340 50 530 350 100 1,050 c 700 a Week 1 dose only: Multiply the previous total daily basal insulin dosage by 7, then multiply by 1.5, and round to the nearest 10 units. b Week 2 dose: Previous total daily basal insulin dosage multiplied by 7, then rounded to the nearest 10 units. c When the required dose is larger than 700 units, split the dose into two injections (e.g., a 1,050 unit dose could be administered as a 700 unit injection followed by a 350 unit injection) 2.5 Recommendations Regarding Missed Doses • If a dose is missed, administer the missed dose as soon as possible within 4 days. Resume the once-weekly dosing schedule, one week from the day the missed dose was administered. • If more than 4 days have passed, skip the missed dose and administer the next dose on the regularly scheduled day. • Increase blood glucose monitoring with missed doses.

Max Dose

See official label

Primary Use

1 INDICATIONS AND USAGE Awiqli is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Summary

Indications and usage 1 INDICATIONS AND USAGE Awiqli is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Awiqli is a long-acting human insulin analog indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus ( 1 ) Dosage and administration 2 DOSAGE AND ADMINISTRATION • Individualize dose based on type of diabetes, metabolic needs, blood glucose monitoring results and glycemic control goals. ( 2.1 ) • See Full Prescribing Information for important administration instructions ( 2.2 ) • Inject Awiqli subcutaneously into the thigh, upper arm, or abdomen. ( 2.2 ) • Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis. ( 2.2 ) • See Full Prescribing Information for the recommended starting dosage in insulin naïve patients ( 2.3 ) and recommendations for switching patients from daily basal insulin. ( 2.4 ) • Closely monitor glucose when switching to Awiqli. ( 2.4 ) 2.1 General Dosing Instructions Awiqli FlexTouch is available as a single-patient-use FlexTouch pen. • Inject Awiqli subcutaneously once-weekly on any day of the week on the same day each week. • The Awiqli FlexTouch pen delivers doses in 10 unit increments and can deliver up to 700 units in a single injection. • Individualize and titrate the dose of Awiqli based on the patient’s metabolic needs, blood glucose monitoring results, and glycemic control goal. • The potency of insulin analogues, including insulin icodec-abae is expressed in units.

Structured Monograph

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE Awiqli is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Awiqli is a long-acting human insulin analog indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus ( 1 ) Dosage and administration 2 DOSAGE AND ADMINISTRATION • Individualize dose based on type of diabetes, metabolic needs, blood glucose monitoring results and glycemic control goals. ( 2.1 ) • See Full Prescribing Information for important administration instructions ( 2.2 ) • Inject Awiqli subcutaneously into the thigh, upper arm, or abdomen. ( 2.2 ) • Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis. ( 2.2 ) • See Full Prescribing Information for the recommended starting dosage in insulin naïve patients ( 2.3 ) and recommendations for switching patients from daily basal insulin. ( 2.4 ) • Closely monitor glucose when switching to Awiqli. ( 2.4 ) 2.1 General Dosing Instructions Awiqli FlexTouch is available as a single-patient-use FlexTouch pen. • Inject Awiqli subcutaneously once-weekly on any day of the week on the same day each week. • The Awiqli FlexTouch pen delivers doses in 10 unit increments and can deliver up to 700 units in a single injection. • Individualize and titrate the dose of Awiqli based on the patient’s metabolic needs, blood glucose monitoring results, and glycemic control goal. • The potency of insulin analogues, including insulin icodec-abae is expressed in units. One (1) unit of insulin icodec-abae corresponds to 1 international unit of human insulin. • Dose adjustments may be needed with changes in renal or hepatic function or during illness to minimize the risk of hypoglycemia or hyperglycemia. Due to the long half-life of Awiqli, 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, consider other applicable adjustments, e.g. glucose intake or changes to other glucose lowering medication [see Warnings and Precautions ( 5.2 , 5.3 )] . 2.2 Important Administration Instructions • Always check the product label before administration [see Warnings and Precautions ( 5.1 )] . • Inspect visually for particulate matter and discoloration. Only use Awiqli if the solution appears clear and colorless. • Inject Awiqli subcutaneously into the thigh, upper arm, or abdomen. • Rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis [see Warnings and Precautions ( 5.3 ), Adverse Reactions ( 6.1 )] . • During changes to a patient’s insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions ( 5.2 , 5.3 )] . • Use Awiqli FlexTouch pen with caution in patients with visual impairment that may rely on audible clicks to dial their dose. • DO NOT administer Awiqli intramuscularly, intravenously or in an insulin infusion pump. • DO NOT dilute or mix Awiqli with any other insulin or solution. • DO NOT transfer Awiqli from the Awiqli FlexTouch pen into a syringe for administration [see Warnings and Precautions ( 5.1 )] . 2.3 Recommended Dosage in Insulin Naive Patients The recommended weekly starting dose of Awiqli in insulin naïve patients is 70 units administered subcutaneously once-weekly on the same day each week. 2.4 Switching to Awiqli from Daily Basal Insulin Therapy • Administer the first dose of Awiqli on the day after the last dose of daily basal insulin. • Week 1 dosage : The recommended one-time starting dosage of Awiqli FlexTouch is 1.5 times the total daily basal dosage multiplied by 7 rounded to the nearest 10 units. • Week 2 dosage : The recommended dosage is the previous total daily basal insulin dose multiplied by 7 and then rounded to the nearest 10 units. • See Table 1 for examples of Awiqli dosage for Week 1 and 2, when switching from daily basal insulin therapy. • Week 3 dosage and beyond : The recommended dosage of Awiqli can be titrated from the previous dosage based on the patient’s metabolic needs, blood glucose monitoring results, and glycemic control goal. • When switching from daily basal insulin to once-weekly Awiqli close glucose monitoring is recommended. Doses and timing of concurrent rapid-acting or short-acting insulin products or other concomitant antidiabetic treatment may need to be adjusted [see Warnings and Precautions ( 5.1 )] . Table 1. Example Awiqli Weekly Dosages When Switching from Daily Basal Insulin Therapy Previous total daily dosage of basal insulin (units) Week 1 Dosage of Awiqli (units) a Week 2 Dosage of Awiqli (units) b 10 110 70 11 120 80 12 130 80 13 140 90 14 150 100 15 160 110 16 170 110 17 180 120 18 190 130 19 200 130 20 210 140 21 220 150 22 230 150 23 240 160 24 250 17

Monitoring

• 5 WARNINGS AND PRECAUTIONS • Hypoglycemia Due to Medication Errors and Accidental Overdose : Accidental mix-ups between insulin products can occur.
• Advise patients to always check the product label before each injection to confirm they are using Awiqli and not another insulin or injectable antidiabetic medicine.
• DO NOT transfer Awiqli from the Awiqli FlexTouch pen into a syringe for administration as overdosage and severe hypoglycemia can result.
• ( 5.1 ) • Hypoglycemia : May be life-threatening.

Interaction Notes

• 7 DRUG INTERACTIONS Table 3 includes clinically significant drug interactions with Awiqli.
• Table 3: Clinically Significant Drug Interactions with Awiqli Drugs That May Increase the Risk of Hypoglycemia Drugs: Antidiabetic agents, angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics, glucagon-like peptide-1 (GLP-1) receptor agonists, dipeptidyl peptidase-4 (DPP-4) inhibitors, sodium-glucose co-transporter 2 (SGLT-2) inhibitors.
• Intervention: Dose reductions and increased frequency of glucose monitoring may be required when Awiqli is co-administered with these drugs.
• Drugs That May Decrease the Blood Glucose Lowering Effect of Awiqli Drugs: Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones.