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Awiqli Insulin icodec-abae 700 U/mL Injection, Solution — NDC 00169-3121-13 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Awiqli Insulin icodec-abae 700 U/mL Injection, Solution — NDC 0169-3121-13 (Billing 00169-3121-13)

by Novo Nordisk · 1 SYRINGE in 1 CARTON / 3 mL in 1 SYRINGE

This is a package of Awiqli Insulin icodec-abae 700 U/mL Injection, Solution from Novo Nordisk, marketed since Mar 2026 and currently FDA-listed. It is this product's only package size.

NDC 00169-3121-13
🏷️ FDA NDC (as labeled) 0169-3121-13 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 0169-3121-13 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0169 labeler · 3121 product · 13 package
Package marketed since
Mar 26, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0169312113 4
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0169-3121-13
Product NDC 0169-3121
11-digit billing NDC 00169312113
RxCUI 2740401, 2740408, 2740410, 2740411, 2740412, 2740413
UNII P7YU3ED05N
Application # BLA761326
SPL Set ID 5162b93e-5775-4581-a5e9-e8783ae0acd7
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-03-26
Route SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance INSULIN ICODEC
Quick answers
  • RxCUI (RxNorm): 2740401
Why two NDCs? The FDA registers this code as 0169-3121-13 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00169-3121-13. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Insulins and analogues for injection, long-acting class.

Drug family (ATC) Insulins and analogues for injection, long-acting
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer mLPer 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.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)0169-3121-13
11-digit billing NDC00169-3121-13
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ1815
DescriptorINJECTION, INSULIN, PER 5 UNITS
Billing units / pkg140 units
How the units are derivedThis package is 3 ML; the HCPCS unit is 5 U, so one package = 140 billing units.
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00169-3121-13 You're viewing this Main listing 1 SYRINGE in 1 CARTON / 3 mL in 1 SYRINGE 2026-03-26 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice 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 —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & biosimilar status

🏛️
2026
On the market since
Mar 2026
📍
2026
Currently FDA-listed
listed with the FDA
🧬
·
Biosimilars
see Purple Book
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerNovo Nordisk
FDA applicationBLA761326 (BLA)
Labeler code00169
First marketedMar 2026
Product typeHuman Prescription Drug
Portfolio74 products on file

More NDCs from Novo Nordisk labeler code 00169

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 54 words ▾

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 ~3 min read ▾

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… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 98 words ▾

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 71 words ▾

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 ~3 min read ▾

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… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

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… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

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 ~3 min read ▾

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… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

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 16 words ▾

8.4Pediatric Use The safety and effectiveness of Awiqli have not been established in pediatric patients.

🧓 Geriatric Use 138 words ▾

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 128 words ▾

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 ~3 min read ▾

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

1.5U/kg Awiqli was administered in an open-label, single-dose study of 25… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 110 words ▾

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 ~1 min read ▾

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 187 words ▾

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 ~2 min read ▾

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

🧬 Pharmacokinetics ~2 min read ▾

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

1.5U/kg Awiqli was administered in an open-label, single-dose study of 25 subjects with normal or different degree of hepatic impairment (mild, moderate and severe) classified based on Child-Pugh Scores ranging from 0 (healthy volunteers) to 12 (severe hepatic impairment). In this study, there was no apparent impact of the degree of hepatic impairment on the pharmacokinetic parameters of insulin icodec-abae.

🧬 Pharmacodynamics 114 words ▾

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

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Overview of Clinical Trials The efficacy of Awiqli administered once-weekly in adult patients with Type 2 diabetes, used in combination with a mealtime insulin or in combination with common oral anti-diabetic agents and/or GLP-1 receptor agonist, was evaluated in three randomized, open-label, treat-to-target, active-controlled trials and one randomized, double-blind, treat-to-target, active-controlled trial (Trials A, B, C, and D). Blinded continuous glucose monitoring (CGM) was utilized in Trials A, C, and D. Across all four trials, insulin icodec-abae was titrated in 20-unit increments, and the fasting plasma glucose (FPG) glycemic target (based on the mean of the 3 most recent FPG values) was 80-130 mg/dL for both treatment arms.

Type 2 insulin naïve patients and basal-only patients treated with Awiqli achieved statistically significant improvement in glycemic control compared to insulin glargine U-100 or insulin degludec U-100. Type 2 patients with basal-bolus regimen achieved similar glycemic control with Awiqli as those achieved with insulin glargine U-100 or insulin degludec U-100.

14.2Insulin Naïve Adults with Type 2 Diabetes Mellitus The efficacy of Awiqli was evaluated in a 52-week randomized, open label, active-controlled, parallel-group, multicenter, multinational, treat-to-target trial that enrolled 984 insulin naïve adult patients with type 2 diabetes mellitus inadequately controlled on one or more oral antidiabetic agents (OADs) or GLP-1 receptor agonist [Trial A (NCT04460885)]. Patients were randomized to Awiqli once-weekly or insulin glargine U-100 once-daily according to the approved labeling.

Pre-trial non-insulin anti-diabetic medications were continued as background therapy in both treatment arms throughout the entire trial except for sulfonylureas and glinides, which were discontinued at randomization. The trial population had the following characteristics: mean age was 59 years; mean duration of diabetes was 12 years; 57% were male, 66% were White, 28% were Asian, 3% were Black or African American, and 11% were Hispanic or Latino ethnicity; and 11% of patients had eGFR <60 mL/min/1.73m 2 . The mean BMI was approximately 30.1 kg/m 2 .

Treatment with Awiqli once-weekly for 52 weeks resulted in a statistically significant reduction in HbA 1c compared to once daily insulin glargine U-100 with an estimated treatment difference of -0.18% [-0.29%; -0.08%] 95%CI (see Table 4 ). Treatment with Awiqli once-weekly for 52 weeks also resulted in a statistically significantly longer Time in Range (TIR) (4.27% [1.92; 6.62] 95CI , ~ 1 hour per day) compared to once daily insulin glargine U-100 treatment during the last 4 weeks of the trial (Weeks 48 to 52) (see Table 4 ).

Table 4: Results at Week 52 in Trial A Comparing Awiqli to Insulin Glargine U-100 in Insulin Naïve Adult Patients with Type 2 Diabetes Mellitus on OAD(s) or GLP-1 Receptor Agonist Awiqli + OAD(s)/GLP-1 Receptor Agonist Insulin glargine + OAD(s)/GLP-1 Receptor Agonist N 492 492 HbA 1c (%) Baseline 8.5

8.44End of trial (LSMean) a,b 6.96

7.15Change from baseline (LSMean) a,b -1.51 -1.33 Estimated treatment difference a,b [95%CI] Awiqli – insulin glargine U-100 -0.18 [-0.29; -0.08] c Proportion Achieving HbA 1c < 7% at Trial End (LSMean) d 56.52% 44.57% FPG (mg/dL) Baseline 185.31 185.71 End of trial (LSMean) a,b 125.19 125.43 Change from baseline (LSMean) a,b -60.32 -60.08 TIR (70-180 mg/dL) (%) Week 48 to 52 (LSMean) e 71.27

67.00Estimated treatment difference e [95%CI] Awiqli – insulin glargine U-100 4.27 [1.92; 6.62] f Weekly basal insulin dose (Units) End of trial (LSMean) e,g 214.23 222.39 a Estimated using an ANCOVA with treatment, and region as fixed factors and baseline response as covariate. b Missing values were imputed by the baseline value adding a random term, using multiple imputation. There were 2.6% of patients in the Awiqli arm and 2.6% in the glargine arm for whom HbA 1c data was missing at Week 52. c p=0.000… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 202 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Standard 2-year carcinogenicity studies in animals have not been performed to evaluate the carcinogenic potential of insulin icodec-abae. In a 52-week study including human insulin (NPH insulin) as comparator, Sprague-Dawley rats were dosed subcutaneously with insulin icodec-abae at 3.3, 5 (female only), 6.7 and 10 (male only) U/kg/day, resulting in 4 times (males) and 2 times (females) the human exposure (AUC) when compared to a human subcutaneous dose of 230 U/week.

Human insulin was dosed at

6.7U/kg/day. No treatment-related increases in benign or malignant tumors were recorded in female mammary glands from rats dosed with insulin icodec-abae. Further, no treatment related changes in the occurrence of hyperplastic or neoplastic lesions were seen in other tissues in animals dosed with insulin icodec-abae when compared to vehicle or human insulin.

Genotoxicity testing of insulin icodec-abae was not performed. In a combined fertility and embryo-fetal study in male and female rats, treatment with insulin icodec-abae up to 17 U/kg/day in males and 10 U/kg/day in females (4 times and comparable to human exposure (AUC) at 230 U/week, respectively) prior to mating and in female rats during gestation had no effect on mating performance and fertility.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 199 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Standard 2-year carcinogenicity studies in animals have not been performed to evaluate the carcinogenic potential of insulin icodec-abae. In a 52-week study including human insulin (NPH insulin) as comparator, Sprague-Dawley rats were dosed subcutaneously with insulin icodec-abae at 3.3, 5 (female only), 6.7 and 10 (male only) U/kg/day, resulting in 4 times (males) and 2 times (females) the human exposure (AUC) when compared to a human subcutaneous dose of 230 U/week.

Human insulin was dosed at

6.7U/kg/day. No treatment-related increases in benign or malignant tumors were recorded in female mammary glands from rats dosed with insulin icodec-abae. Further, no treatment related changes in the occurrence of hyperplastic or neoplastic lesions were seen in other tissues in animals dosed with insulin icodec-abae when compared to vehicle or human insulin.

Genotoxicity testing of insulin icodec-abae was not performed. In a combined fertility and embryo-fetal study in male and female rats, treatment with insulin icodec-abae up to 17 U/kg/day in males and 10 U/kg/day in females (4 times and comparable to human exposure (AUC) at 230 U/week, respectively) prior to mating and in female rats during gestation had no effect on mating performance and fertility.

📄 Patient Package Insert ~3 min read ▾

Patient Package Insert PATIENT INFORMATION Awiqli ® FlexTouch ® [Ah–wik-lee] (insulin icodec-abae) injection, for subcutaneous use Do not share your Awiqli FlexTouch pen or needles with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them. Make sure you use the right type and dose of insulin.

Always check the label on your insulin pen before each injection to avoid mix-ups with Awiqli and other insulin products or injectable medicines used to treat diabetes. If you use another injectable medicine to treat your diabetes, pay close attention to how you select your Awiqli dosage. The dosage of Awiqli is different from other injectable medicines used to treat diabetes.

Always make sure that you select the correct dosage of your Awiqli FlexTouch pen as prescribed by your healthcare provider, to avoid dosing errors and accidental overdose. People who are blind or have vision problems should not use this pen without help from a person trained to use the pen. Do not dial the maximum single dosage (700 units) of your Awiqli FlexTouch Pen, unless prescribed by your healthcare provider.

Do not use a syringe to withdraw Awiqli from your pen. Talk to your healthcare provider if you have any questions about how to correctly dose Awiqli FlexTouch. What is Awiqli? • Awiqli is a long-acting man-made insulin (U-700) that is used to control high blood sugar in adults with type 2 diabetes mellitus. • It is not known if Awiqli is safe and effective in children and adolescents. • Awiqli FlexTouch is only available in one concentration (U-700): o The Awiqli FlexTouch pen can be injected from 10 units to 700 units in a single injection, in 10 unit increments.

Who should not take Awiqli? Do not take Awiqli if you: • are having an episode of low blood sugar (hypoglycemia). • have an allergy to Awiqli or any of the ingredients in Awiqli. See the end of this Patient Information leaflet for a complete list of ingredients in Awiqli.

Before taking Awiqli, tell your healthcare provider about all your medical conditions including, if you are: • have liver or kidney problems. • take other medicines, especially ones called TZDs (thiazolidinediones). • have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with Awiqli. • pregnant, planning to become pregnant, or are breastfeeding. • taking new prescription or over-the-counter medicines, vitamins, or herbal supplements. Before you start taking Awiqli, talk to your healthcare provider about low blood sugar and how to manage it.

How should I take Awiqli FlexTouch? • Read the Instructions for Use that come with your Awiqli FlexTouch Pen. • Your healthcare provider should show you how to use Awiqli FlexTouch Pen before you use it for the first time. • Take Awiqli exactly as your healthcare provider tells you to. Do not do any conversion of your dose. The dose counter always shows the selected dose in units.

Awiqli FlexTouch pens are made to deliver your insulin dose in units. • Know the type and strength of insulin you take. Do not change the type of insulin you take unless your healthcare provider tells you to. The amount of insulin and the best time for you to take your insulin may need to change if you take different types of insulin. • Inject Awiqli FlexTouch 1 time each week on any day of the week on the same day each week. • If you need to change the day of the week, you may do so if your last dose has been at least 4 days . • If you missed your dose, take your missed dose as soon as possible as long as it has been 4 days or less.

Then continue the 1 time each week schedule 1 week from the day your missed dose was taken. • If more than 4 days has passed, skip the missed dose and take your next Awiqli dose on your regularly scheduled day. • Check your blood sugar levels. Ask your healthcare provider what your blood sugar should be and when you should check your blood sugar levels… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

Instructions for Use INSTRUCTIONS FOR USE Awiqli ® [Ah–wik-lee] FlexTouch ® (insulin icodec-abae) injection, for subcutaneous use 700 units/mL (U-700) Read these instructions carefully, and talk to your healthcare provider about how to use the needle and inject Awiqli before you begin using your Awiqli FlexTouch Pen. Make sure that you know how to give yourself an injection with the pen before you start your treatment. Important information before you start using your pen: • Do not share your Awiqli FlexTouch Pen or needles with other people, even if the needle has been changed.

You may give other people a serious infection, or get a serious infection from them. • People who are blind or have vision problems should not use this pen without help from a person trained to use the pen. • Make sure you use the right type and dose of insulin. Always check the label on your insulin pen before each injection to avoid mix-ups with Awiqli and other insulin products or injectable medicines used to treat diabetes. • If you use another injectable medicine to treat your diabetes, pay close attention to how you select your Awiqli dosage.

The dosage of Awiqli is different from other injectable medicines used to treat diabetes. • Always make sure that you select the correct dosage of your Awiqli FlexTouch Pen as prescribed by your healthcare provider, to avoid taking the wrong dose or taking too much Awiqli. • Do not dial the maximum single dose (700 units) of your Awiqli FlexTouch Pen, unless prescribed by your healthcare provider. • Do not use a syringe to withdraw Awiqli from your pen. • Do not try to refill your pen. After it is empty, it must be thrown away (disposed of). • Needles are for single use only.

Do not re-use your needles as it may lead to contamination, infection, and blocked needles, which may lead to you injecting the wrong dose. • Caregivers must be careful when handling used needles to prevent accidental needle stick injuries and infection. Information about your pen Awiqli FlexTouch Pen (pen) is a prefilled disposable single-patient-use pen containing 700 units of insulin icodec-abae. You can inject from 10 to 700 units in a single injection.

The units can be increased by 10 units at a time. Supplies you will need to give your Awiqli injection: • Awiqli FlexTouch Pen (included) • 1 new NovoFine Plus, or NovoFine needle (included) • 1 alcohol swab (not included) • 1 cotton ball or gauze pad (not included) • 1 sharps disposal container for throwing away (disposing of) used Awiqli FlexTouch Pens and needles. See “ Disposing of used Awiqli FlexTouch pens and needles ” at the end of this Instructions for Use.

Look at the pictures to get to know the different parts of your pen and needle. Awiqli FlexTouch Pen Note : Your pen may differ in size from the pen shown in the pictures. These instructions apply to all Awiqli FlexTouch Pens.

Needle About your needles: Your pen is designed to be used with NovoFine ® Plus, or NovoFine ® disposable needles up to a length of 8 mm. Disposable needles are included in the pack. Always check the flow as described in Step 2 and use a new needle for each injection.

Always throw away the needle after each use in a sharps disposal container. Step 1: Prepare your pen with a new needle Wash your hands with soap and water. Check the name and concentration on the pen label to make sure that your pen contains Awiqli 700 units/mL.

Pull off the pen cap. See Figure A . Always check that Awiqli in your pen is clear and colorless.

Look through the pen window. If Awiqli looks cloudy or contains particles, do not use the pen. See Figure B .

Always use a new needle for each injection. Check the paper tab and the outer needle cap for damage. If you see any damage, this could mean the needle is not clean.

Throw away the needle in a sharps disposal container and use a new one. Take a needle and tear off the paper tab. Do not attach a new needle to your pen until you are ready to give your injection.

See Figure C .… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 182 words ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 1 mL Sample Carton Awiqli ® FlexTouch ® NDC 0169- 3170 -97 (insulin icodec-abae) injection List: 317097 700 units/mL (U-700) Use Once Weekly For Single-Patient-Use Only For subcutaneous use Pen delivers doses in 10 unit increments only Rx only Dispense in this sealed carton. Sample not for resale Contains: 1 x 1 mL Prefilled Pen, 9 disposable needles carton_sample_1mL

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 1.5 mL Carton Awiqli ® FlexTouch ® NDC 0169- 3105 -11 (insulin icodec-abae) injection List: 310511 700 units/mL (U-700) Use Once Weekly For Single-Patient-Use Only For subcutaneous use Pen delivers doses in 10 unit increments only Rx only Dispense in this sealed carton. Contains: 1 x 1.5 mL Prefilled Pen, 13 disposable needles Carton_1-5mL

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 3 mL Carton Awiqli ® FlexTouch ® NDC 0169- 3121 -13 (insulin icodec-abae) injection List: 312113 700 units/mL (U-700) Use Once Weekly For Single-Patient-Use Only For subcutaneous use Pen delivers doses in 10 unit increments only Rx only Dispense in this sealed carton. Contains: 1 x 3 mL Prefilled Pen, 13 disposable needles Carton_3mL

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Novo Nordisk. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Novo Nordisk is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J1815 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 00169-3105-11 · Novo 00169-3170-97 · Novo →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.