Awiqli Insulin icodec-abae 700 U/mL Injection, Solution
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Insulins and analogues for injection, long-acting class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Patient education
Supplement & herbal interactions
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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15 mg / 1 mL
UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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1.08 mg / 1 mL
UNII GGO4Y809LO
Metacresol is a preservative derived from coal tar or petroleum. It prevents bacterial and fungal growth in liquid medicines, helping keep the product safe and stable during storage.
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5.65 mg / 1 mL
UNII 339NCG44TV
Phenol is a chemical compound derived from coal tar or petroleum. It serves as a preservative and antimicrobial agent in medicines, helping prevent bacterial and fungal growth to keep the product stable and safe during storage.
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1.17 mg / 1 mL
UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
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101 ug / 1 mL
UNII FM5526K07A
Zinc acetate is a salt compound containing zinc. It acts as a buffer and pH stabilizer in formulations, helping maintain the medicine's chemical stability and shelf life.
6 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J1815 | No ASP payment limit on file for J1815 this quarter. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Awiqli 700 U/mLthis 00169-3121-13 | Novo | 1 syringe | — | — | FDA listed | — |
| Awiqli 700 U/mL 00169-3105-11 | Novo | 1 syringe | — | — | FDA listed | — |
| Awiqli 700 U/mL 00169-3170-97 | Novo | 1 syringe | — | — | FDA listed | — |
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⏳ Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00169-3121-13 You're viewing this | 1 SYRINGE in 1 CARTON (0169-3121-13) / 3 mL in 1 SYRINGE (0169-3121-01) | 2026-03-26 | Active |
🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🎯 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 )
2.1General 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 )] .
2.2Important 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 )] .
2.3Recommended 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.
2.4Switching 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 fr…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Injection: 700 units per mL (U-700) available as a clear and colorless solution: • 3 mL single-patient-use FlexTouch prefilled pen (containing 2,100 units) • 1.5 mL single-patient-use FlexTouch prefilled pen (containing 1,050 units) • 1 mL single-patient-use FlexTouch prefilled pen (containing 700 units) Injection: 700 units/mL (U-700) available as a clear and colorless solution: • 3 mL single-patient-use FlexTouch prefilled pen (containing 2,100 units) ( 3 ) • 1.5 mL single-patient-use FlexTouch prefilled pen (containing 1,050 units) ( 3 ) • 1 mL single-patient-use FlexTouch prefilled pen (containing 700 units) ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Awiqli is contraindicated: • During episodes of hypoglycemia [see Warnings and Precautions ( 5.2 )] . • In patients with hypersensitivity to insulin icodec-abae or any of the excipients in Awiqli FlexTouch. Serious hypersensitivity reactions have included anaphylaxis [see Warnings and Precautions ( 5.4 )] . • During episodes of hypoglycemia ( 4 ) • Hypersensitivity to insulin icodec-abae or any of the excipients in Awiqli ( 4 )
⚠️ Warnings and Cautions ▾
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. Increase monitoring with changes to: insulin dosage, co-administered glucose lowering medications, meal pattern, physical activity, and in patients with renal impairment, hepatic impairment or hypoglycemia unawareness. ( 5.2 ) • Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen : Make changes to a patient’s insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) under close medical supervision with increased frequency of blood glucose monitoring.
( 5.3 ) • Hypersensitivity Reactions : Severe, life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue Awiqli FlexTouch, monitor and treat if indicated. ( 5.4 ) • Hypokalemia : May be life-threatening.
Monitor potassium levels in patients at risk for hypokalemia and treat if indicated. ( 5.5 ) • Never share an Awiqli FlexTouch pen between patients, even if the needle is changed. ( 5.6 ) • Fluid Retention and Heart Failure with Concomitant Use of Thiazolidinediones (TZDs) : Observe for signs and symptoms of heart failure; consider dosage reduction or discontinuation if heart failure occurs.
( 5.7 )
5.1Hypoglycemia Due to Medication Errors and Accidental Overdose Serious hypoglycemia requiring hospitalization has occurred due to accidental mix-ups between Awiqli and other insulin products or once-weekly injectable antidiabetic medicines, incorrect dose selection, and dosing frequency errors. To avoid dosing errors when switching from daily basal insulin to Awiqli, follow the dosage recommendations in the Dosage and Administration Section ( 2.2 ) . Administer Awiqli once weekly only.
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. Prior to initiation, train patients and their caregiver(s) on how to select their weekly Awiqli dosage. Advise patients using other injectable medications for glycemic control that the dosage selection of Awiqli differs [see Dosage and Administration ( 2.2 , 2.3 , 2.4 ), Instructions for Use] .
Instruct patients to visually verify the dialed units on the dose counter of the Awiqli FlexTouch prefilled pen before each injection to avoid dosing errors. Do not dial the maximum single dose (700 units) of Awiqli unless this is the prescribed dose [see Dosage and Administration ( 2.4 )] . Do not use a syringe to remove Awiqli from the Awiqli FlexTouch disposable insulin prefilled pen.
Monitor patients for signs and symptoms of hypoglycemia, particularly during the first several weeks after initiation or dose escalation of Awiqli. Ensure patients understand how to recognize and manage hypoglycemia [see Warnings and Precautions ( 5.2 )] .
5.2Hypoglycemia Hypoglycemia is the most common adverse reaction associated with insulin, including Awiqli [see Adverse Reactions ( 6.1 )] . Severe hypoglycemia can cause seizures, may be life-threatening or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important (e.g., driving or operating other machinery).
Awiqli, or any insulin, should not be used during episodes of hypoglycemia [see Contraindications ( 4 )] . Hypoglycemia can happen suddenly and symptoms may differ in each individual and change over time in the same individual. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions are also discussed elsewhere: • Hypoglycemia Due to Medication Errors and Accidental Overdose [see Warnings and Precautions ( 5.1 )] • Hypoglycemia [see Warnings and Precautions ( 5.2 )] • Hypersensitivity reactions [see Warnings and Precautions ( 5.4 )] • Hypokalemia [see Warnings and Precautions ( 5.5 )] Adverse reactions commonly associated with Awiqli are: • hypoglycemia, hypersensitivity reactions (e.g., urticaria, swelling face and lips), injection site reactions, lipodystrophy, pruritus, rash, edema, and weight gain.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk at 1-844-668-6463 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Awiqli in patients with type 2 diabetes was evaluated in five clinical trials involving 1,880 adults with type 2 diabetes exposed to Awiqli, with a mean exposure duration of 26 to 52 weeks across the five trials [see Clinical Studies ( 14 )] .
The type 2 diabetes population had the following characteristics: mean age was 59 years and 5% were older than 75 years, 59% were male, 71% were White, 3.6% were Black or African American, and 13% were Hispanic or Latino ethnicity. The mean BMI was 30.7 kg/m 2 . The mean duration of diabetes was 13 years and the mean HbA 1c at baseline was 8.6%.
At baseline, the mean eGFR was 86.1 mL/min/1.73 m 2 and 11% of patients had an eGFR less than 60 mL/min/1.73 m 2 . Common Adverse Reactions Hypoglycemia Hypoglycemia is the most commonly observed adverse reaction in patients treated with Awiqli [see Warnings and Precautions ( 5.2 )] . The rates of reported hypoglycemia depend on the definition of hypoglycemia used, diabetes type, insulin dose, intensity of glucose control, background therapies, and other intrinsic and extrinsic patient factors.
For these reasons, comparing rates of hypoglycemia in clinical trials for Awiqli with the incidence of hypoglycemia for other products may be misleading and also, may not be representative of hypoglycemia rates that will occur in clinical practice. In clinical trials [see Clinical Studies ( 14 )] , events of severe hypoglycemia (level 3) were defined as an episode associated with severe cognitive impairment requiring external assistance for recovery. Hypoglycemia episodes with a glucose level below 54 mg/dL with or without associated symptoms (level 2 hypoglycemia) were also assessed in patients with type 2 diabetes.
In the clinical trials of patients with type 2 diabetes, percentages of adults randomized to Awiqli who experienced at least one episode of severe or clinically significant (level 2) hypoglycemia in clinical trials are shown in Table 2 . Table 2: Proportion (%) of Patients with Type 2 Diabetes Experiencing at Least One Episode of Severe (Level 3) or Clinically Significant (Level 2) Hypoglycemia in Clinical Trials Type 2 Diabetes Trial A Trial B Trial C Trial D Trial E c Awiqli + anti-diabetic drugs d insulin naïve 52 weeks (N=492) Awiqli + anti-diabetic drugs e insulin naïve 26 weeks (N=293) Awiqli + anti-diabetic drugs d 26 weeks (N=262) Awiqli ± anti-diabetic drugs d + insulin aspart 26 weeks (N=291) Awiqli + anti-diabetic drugs d insulin naïve 52 weeks (N=542) Level 3 Hypoglycemia a 0.2 0 0 1.4 0 Level 2 Hypoglycemia b 9.8 8.9 14.1 50.9 11.8 a Level 3 hypoglycemia is an episode associated with severe cognitive impairment requiring external assistance for recovery. b Level 2 hypoglycemia is hypoglycemia episode with a self-measured blood glucose level below 54 mg/dL with or without associated symptoms. c In Trial E, Awiqli arm titration was performed via a digital titration app. d Excludes sulfonylureas and glinides. e Sulfonulurea and…
🔄 Drug Interactions ▾
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.
Intervention: Dose increases and increased frequency of glucose monitoring may be required when Awiqli is co-administered with these drugs. Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of Awiqli Drugs: Alcohol, beta-blockers, clonidine, and lithium salts.Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia. Intervention: Dose adjustment and increased frequency of glucose monitoring may be required when Awiqli is co-administered with these drugs.
Drugs That May Blunt Signs and Symptoms of Hypoglycemia Drugs: Beta-blockers, clonidine, guanethidine, and reserpine Intervention: Increased frequency of glucose monitoring may be required when Awiqli is co-administered with these drugs. • Drugs that may increase the risk of hypoglycemia : antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analog (e.g., octreotide), sulfonamide antibiotics, GLP-1 receptor agonists, DPP-4 inhibitors, and SGLT-2 inhibitors.
( 7 ) • Drugs that may decrease the blood glucose lowering effect : atypical antipsychotics, 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. ( 7 ) • Drugs that may increase or decrease the blood glucose lowering effect : Alcohol, beta-blockers, clonidine, lithium salts, and pentamidine.
( 7 ) • Drugs that may blunt the signs and symptoms of hypoglycemia : beta-blockers, clonidine, guanethidine, and reserpine. ( 7 )
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no available data with Awiqli in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations] . Rats and rabbits were exposed to insulin icodec-abae in animal reproduction studies during organogenesis.
No adverse developmental effects were observed in rats or rabbits at exposures approximately equal to human exposure at a dose of 230 U/week [see Data] . The estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with an HbA 1c >7 and has been reported to be as high as 20-25% in women with an HbA 1c >10. The estimated background risk of miscarriage for the indicated population is unknown.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-associated Maternal and/or Embryo/fetal Risk Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, still birth, and macrosomia related morbidity.
Data Animal Data Insulin icodec-abae was investigated in studies covering the periods of embryo-fetal development and pre- and post-natal development in rats and the period of embryo-fetal development in rabbits. In these studies, insulin icodec-abae did not cause adverse effects on embryo-fetal development when given subcutaneously at up to 10 U/kg/day in rats and 3 U/kg/day in rabbits, resulting in exposures comparable to human exposure (AUC) at a human subcutaneous dose of 230 U/week. Maternal deaths and abortions were observed in rabbits at human exposures secondary to maternal hypoglycemia.
In a pre- and postnatal developmental study in rats where insulin icodec-abae was given by the subcutaneous route at doses up to
8.3U/kg/day (from Gestation Day 6 through Lactation Day 20), maternal and pup mortality occurred during the lactation period at exposures approximately equal to human exposures, which were secondary to maternal hypoglycemia.
8.2Lactation Risk Summary There are no data on the presence of insulin icodec-abae in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Awiqli and any potential adverse effects on the breastfed infant from Awiqli or from the underlying maternal condition.
8.4Pediatric Use The safety and effectiveness of Awiqli have not been established in pediatric patients.
8.5Geriatric Use In controlled clinical trials [see Clinical Studies ( 14 )] a total of 646 (34.4%) of the 1,880 Awiqli-treated patients with type 2 diabetes were 65 years of age or older and 97 (5.2%) were 75 years of age or older. No overall differences in safety or effectiveness of Awiqli have been observed between patients 65 years of age and older and younger adult patients. Greater caution should be exercised when Awiqli is administered to geriatric patients since greater sensitivity of some older individuals to the effects of Awiqli cannot be ruled out.
The initial dosing, dose increments, and maintenance dosage should be conservative to avoid hypoglycemia. Hypoglycemia may be more difficult to recognize in the elderly. More frequent glucose monitoring is recommended and the insulin dose is to be adjusted on an individual basis.
8.6Renal Impairment No clinically relevant difference in the pharmacokinetics of Awiqli was identified in a study comparing healthy subjects and subjects with renal impairment including subjects with end stage renal disease. Additional dose adjustment should not be ne…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no available data with Awiqli in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations] . Rats and rabbits were exposed to insulin icodec-abae in animal reproduction studies during organogenesis.
No adverse developmental effects were observed in rats or rabbits at exposures approximately equal to human exposure at a dose of 230 U/week [see Data] . The estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with an HbA 1c >7 and has been reported to be as high as 20-25% in women with an HbA 1c >10. The estimated background risk of miscarriage for the indicated population is unknown.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-associated Maternal and/or Embryo/fetal Risk Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, still birth, and macrosomia related morbidity.
Data Animal Data Insulin icodec-abae was investigated in studies covering the periods of embryo-fetal development and pre- and post-natal development in rats and the period of embryo-fetal development in rabbits. In these studies, insulin icodec-abae did not cause adverse effects on embryo-fetal development when given subcutaneously at up to 10 U/kg/day in rats and 3 U/kg/day in rabbits, resulting in exposures comparable to human exposure (AUC) at a human subcutaneous dose of 230 U/week. Maternal deaths and abortions were observed in rabbits at human exposures secondary to maternal hypoglycemia.
In a pre- and postnatal developmental study in rats where insulin icodec-abae was given by the subcutaneous route at doses up to
8.3U/kg/day (from Gestation Day 6 through Lactation Day 20), maternal and pup mortality occurred during the lactation period at exposures approximately equal to human exposures, which were secondary to maternal hypoglycemia.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of Awiqli have not been established in pediatric patients.
🧓 Geriatric Use ▾
8.5Geriatric Use In controlled clinical trials [see Clinical Studies ( 14 )] a total of 646 (34.4%) of the 1,880 Awiqli-treated patients with type 2 diabetes were 65 years of age or older and 97 (5.2%) were 75 years of age or older. No overall differences in safety or effectiveness of Awiqli have been observed between patients 65 years of age and older and younger adult patients. Greater caution should be exercised when Awiqli is administered to geriatric patients since greater sensitivity of some older individuals to the effects of Awiqli cannot be ruled out.
The initial dosing, dose increments, and maintenance dosage should be conservative to avoid hypoglycemia. Hypoglycemia may be more difficult to recognize in the elderly. More frequent glucose monitoring is recommended and the insulin dose is to be adjusted on an individual basis.
🆘 Overdosage ▾
10 OVERDOSAGE An excess of insulin relative to food intake, energy expenditure, or both may lead to severe and sometimes prolonged and life-threatening hypoglycemia and hypokalemia [see Warnings and Precautions ( 5.2 , 5.5 )] . Mild episodes of hypoglycemia usually can be treated with oral glucose. Lowering the dosage of Awiqli, adjustments in meal patterns, or physical activity may be needed.
More severe episodes of hypoglycemia with coma, seizure, or neurologic impairment may be treated with a glucagon product for emergency use or concentrated intravenous glucose. After apparent clinical recovery from hypoglycemia, continued observation and additional carbohydrate intake may be necessary to avoid reoccurrence of hypoglycemia. Hypokalemia must be corrected appropriately.
Overdosing has been investigated in a clinical pharmacology trial [see Clinical Pharmacology ( 12.2 )] .
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The primary activity of insulin, including Awiqli, is regulation of glucose metabolism. Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin also inhibits lipolysis and proteolysis, and enhances protein synthesis.
Awiqli binds reversibly to albumin, resulting in a depot in the circulation from which insulin icodec-abae is slowly released. The insulin receptor is activated by insulin icodec-abae leading to a stable glucose-lowering effect over the entire dosing interval of one week. When insulin icodec-abae binds to the human insulin receptor it results in the same pharmacological effects as human insulin.
12.2Pharmacodynamics Euglycemic clamps were performed at steady state in a single-center, open-label, one-period, multiple-dose study in 46 patients with Type 2 diabetes from 0 to 36 hours, 40 to 64 hours, and 144 to 168 hours post dose. Individualized insulin icodec-abae doses were used to obtain pre-breakfast self-monitored plasma glucose within 80-126 mg/dL, the mean dose at steady state was
2.9U/kg/week (range: 1.5-5.6 U/kg/week). Glucose infusion rate profiles for all three clamps are shown together with the model-derived data suggesting the duration of the glucose-lowering effect to cover a full week ( Figure 2 ). Figure 2: Full-week Glucose Infusion Rate Profile of Insulin icodec-abae at Steady-state in Type 2 Diabetes figure_2
12.3Pharmacokinetics Absorption Dose proportionality in total exposure is observed after subcutaneous administration of Awiqli within the therapeutic dose range. Insulin icodec-abae concentration reached steady state levels after 2 to 3 weeks of Awiqli administration with a one-time 50% additional dose for the first dose [see Dosage and Administration ( 2.4 )] and after 3 to 4 weeks when initiating Awiqli without a one-time additional dose [see Dosage and Administration ( 2.4 )] . In patients with type 2 diabetes, after 8 weekly doses with
2.9U/kg of Awiqli maximum insulin icodec-abae concentrations of 283 nmol/L were attained at a median of 15 hours (t max ) post-dose. Distribution The affinity of Awiqli to serum albumin corresponds to a plasma protein binding of >99% in human plasma. The results of the in vitro protein binding studies demonstrate that there is no clinically relevant interaction between Awiqli and fatty acids or other protein-bound drugs.
Elimination The half-life after subcutaneous administration is approximately one week independent of dose. Degradation of insulin icodec-abae is similar to that of human insulin; all metabolites formed are inactive. Specific Populations Age, Sex, Race, Ethnicity, and Body Weight The effect of covariates on the pharmacokinetics of Awiqli was examined in a population PK analysis of several exploratory and confirmatory trials.
Age (18 to 86 years), sex, race (68% white, 4% Black, and 25% Asian) and ethnicity (86% not of Hispanic or Latino origin, 13% Hispanic or Latino) did not meaningfully affect the pharmacokinetics and pharmacodynamics of Awiqli. Body weight had a clear effect on Awiqli exposure which decreased with increasing body weight (40 to 160 kg). Renal Impairment The pharmacokinetics of insulin icodec-abae were studied in 58 subjects with normal or impaired renal function/end-stage renal disease following administration of single subcutaneous dose (1.5 U/kg) of Awiqli .
Renal function was defined using measured iohexol clearance as follows: ≥90 mL/min (normal), 60-89 mL/min (mild), 30-59 mL/min (moderate) and <30 mL/min (severe). Subjects requiring hemodialysis were classified as having end-stage renal disease (ESRD). In this study, there was no apparent effect of renal function or dialysis on the pharmacokinetics of insulin icodec-abae.
Hepatic Impairment A single subcutaneous dose of
1.5 U/kg Awiqli was administered in an open-label, single-dose study of 25…
🧬 Mechanism of Action ▾
12.1Mechanism of Action The primary activity of insulin, including Awiqli, is regulation of glucose metabolism. Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin also inhibits lipolysis and proteolysis, and enhances protein synthesis.
Awiqli binds reversibly to albumin, resulting in a depot in the circulation from which insulin icodec-abae is slowly released. The insulin receptor is activated by insulin icodec-abae leading to a stable glucose-lowering effect over the entire dosing interval of one week. When insulin icodec-abae binds to the human insulin receptor it results in the same pharmacological effects as human insulin.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Awiqli (insulin icodec-abae) injection is a 700 units/mL (U-700) clear and colorless solution available as follows: Table 8: Presentations of Awiqli FlexTouch Awiqli Presentation NDC number Total units Max dose per Injection (units) Dose Increment (units) Package Size 3 mL single-patient-use FlexTouch Pen 0169-3121-13 2,100 700 10 1 pen/pack with 13 disposable needles Trade only 1.5 mL single-patient-use FlexTouch Pen 0169-3105-11 1,050 700 10 1 pen/pack with 13 disposable needles Trade only 1 mL single-patient-use FlexTouch Pen 0169-3170-97 700 700 10 1 pen/pack with 9 disposable needles Sample only Awiqli U-700 FlexTouch pen dials in 10 unit increments.
Dispense in this sealed carton with the enclosed Instructions for Use. Storage and Handling Dispense in the original sealed carton with the enclosed Instructions for Use. Do not store in the freezer or directly adjacent to the refrigerator cooling element.
Do not freeze. Do not use Awiqli if it has been frozen. The storage conditions are summarized in Table 9 : Table 9: Storage Conditions for 3 mL, 1.5 mL, and 1 mL Single-patient-use Awiqli FlexTouch Pen Not in-use (unopened) In-use (opened) Refrigerated 36ºF to 46ºF (2ºC to 8ºC) Room Temperature below 86°F (30°C) * Room Temperature below 86°F (30°C) * Refrigerated 36ºF to 46ºF (2ºC to 8ºC) Awiqli FlexTouch Until expiration date 12 Weeks 12 Weeks 12 Weeks * The total time at room temperature cannot exceed more than 12 Weeks including in-use time.
📋 Description ▾
11 DESCRIPTION Insulin icodec-abae is a once-weekly basal human insulin analog for subcutaneous injection produced by a process that includes expression of recombinant DNA in Saccharomyces cerevisiae followed by chemical modification. Insulin icodec-abae differs from human insulin in that the amino acid threonine in position B30 has been omitted, Tyr(A14) has been substituted with Glu and Tyr(B16) and Phe(B25) have been substituted with His. The side chain is connected to the peptide backbone via the amino group in the side chain at Lys(B29).
Insulin icodec-abae has a molecular formula of C 280 H 435 N 71 O 87 S 6 and a molecular weight of 6380.26 Da. It has the following structure: Figure 1: Structural Formula of Insulin icodec-abae Awiqli (insulin icodec-abae) injection is a sterile, clear and colorless solution available as 700 units/mL (U-700) for subcutaneous use. Each mL contains 700 units of insulin icodec-abae and glycerin (15 mg), metacresol (1.08 mg), phenol (5.65 mg), sodium chloride (1.17 mg), zinc acetate (101 mcg), and Water for Injection.
Awiqli has a pH of approximately 7.4. Hydrochloric acid or sodium hydroxide may be added to adjust pH. figure_1
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient and/or caregiver to read the FDA-approved patient labeling ( Patient Information and Instructions for Use ). Hypoglycemia Due to Medication Errors and Accidental Overdose 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. Advise patients using other injectable medications for glycemic control that the dosage selection of Awiqli differs.
Instruct patients to visually verify the dialed units on the dose counter of the Awiqli FlexTouch prefilled pen before each injection to avoid dosing errors [see Warnings and Precautions ( 5.1 )] . Hypoglycemia Inform patients that hypoglycemia is the most common adverse reaction with insulin. Inform patients of the symptoms of hypoglycemia (e.g., impaired ability to concentrate and react).
This may present a risk in situations where these abilities are especially important, such as driving or operating other machinery. Advise patients who have frequent hypoglycemia or reduced or absent warning signs of hypoglycemia to use caution when driving or operating machinery [see Warnings and Precautions ( 5.2 )] . Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen Advise patients that changes in insulin regimen can predispose to hyperglycemia or hypoglycemia and that changes in insulin regimen should be made under close medical supervision [see Warnings and Precautions ( 5.3 )] .
Hypersensitivity Reactions Advise patients that hypersensitivity reactions have occurred with Awiqli. Inform patients on the symptoms of hypersensitivity reactions [see Warnings and Precautions ( 5.4 )] . Never Share an Awiqli FlexTouch Pen or Needle Between Patients Awiqli FlexTouch disposable prefilled pens should never be shared between patients, even if the needle is changed.
Sharing poses a risk for transmission of blood-borne pathogens [see Warnings and Precautions ( 5.6 )] . Manufactured by: Novo Nordisk Inc. 800 Scudders Mill Rd.
Plainsboro, NJ 08536 U.S. License Number 1261 At: Novo Nordisk A/S Novo Allé 2880 Bagsvaerd Denmark www.awiqli.com For information about Awiqli contact: Novo Nordisk Inc. 800 Scudders Mill Road Plainsboro, NJ 08536 1-844-668-6463 Novo Nordisk ® , Awiqli ® , FlexTouch ® are registered trademarks of Novo Nordisk A/S. © 2026 Novo Nordisk Patent Information: http://novonordisk-us.com/products/product-patents.html