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LYUMJEV Insulin lispro-aabc 100 [iU]/mL Injection, Solution — NDC 00002-7728-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

LYUMJEV Insulin lispro-aabc 100 [iU]/mL Injection, Solution — NDC 0002-7728-01 (Billing 00002-7728-01)

by Eli Lilly and Company · 1 VIAL, MULTI-DOSE in 1 CARTON / 10 mL in 1 VIAL, MULTI-DOSE

This is a package of LYUMJEV Insulin lispro-aabc 100 [iU]/mL Injection, Solution from Eli Lilly and Company, marketed since Jun 2020 and currently FDA-listed; retail pharmacies pay about $7.87 per mL (NADAC). It is the main listing for this product, which comes in 2 package sizes.

NDC 00002-7728-01
🏷️ FDA NDC (as labeled) 0002-7728-01 billing pads the labeler segment with a zero
This package
Contains10 mL in 1 vial, multi-dose Cost per mL$7.87 NADAC Per package$78.73 / 10 ml Pack sizes2 compare ↓
Also priced by: Medicaid pays $23.39/unit · Part D plans $8.47/unit — full pricing hub ↓
Main listing for product 0002-7728 · Also comes in: 10 mL 0002-7728-99
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 20, 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 0002-7728-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0002 labeler · 7728 product · 01 package
Package marketed since
Jun 15, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0002772801 8
Medicaid fills, this package
8,259 prescriptions in the last four reported quarters
FDA record last changed
Aug 20, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0002-7728-01
Product NDC 0002-7728
11-digit billing NDC 00002772801
NCPDP billing unit ML — per mL (volume)
RxCUI 2380231, 2380236, 2380248, 2380250, 2380254, 2380256, 2380259, 2380260,
UNII GFX7QIS1II
Application # BLA761109
SPL Set ID c5a056e2-b568-4ca6-9ed8-79c010942d00
Established class (EPC) Insulin Analog
Chemical class Insulin
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-06-15
Route INTRAVENOUS, SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance INSULIN LISPRO
Biologic (Purple Book) 351(a)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 081183
GCN 48226
HICL code 046616
Ingredient (HICL) Insulin Lispro-Aabc
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C4
Therapeutic class — intermediate (HIC2) Antihyperglycemics
HIC3 code C4G
Therapeutic class — specific (HIC3) Insulins
AHFS code 68:20.08.00
AHFS class Insulins
FDB label name LYUMJEV 100 UNIT/ML VIAL
FDB brand name Lyumjev
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 081183
  • GCN: 48226
  • HICL (First Databank): 046616
  • AHFS class code: 68:20.08.00
  • RxCUI (RxNorm): 2380231
Why two NDCs? The FDA registers this code as 0002-7728-01 — 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 → 00002-7728-01. 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 Insulin Analog class.

Pharmacologic class Insulin Analog
Drug family (ATC) Insulins and analogues for injection, fast-acting, Insulins and analogues for injection, intermediate-acting, Insulins and analogues for injection, intermediate- or long-acting combined with fast-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

Label name LYUMJEV 100 UNIT/ML VIAL Ingredient Insulin Lispro-Aabc
📗 Our plain-language guide HelloPharmacist
  • Insulin lispro is a fast-acting insulin that helps your body manage blood sugar around mealtimes. It works by helping your muscles and fat cells absorb glucose from your blood, whi...
  • What exactly does insulin lispro do, and why did my doctor prescribe it?
  • For subcutaneous injections, you should inject insulin lispro within 15 minutes before a meal or immediately after a meal. Because it acts quickly, timing really matters — injectin...
  • When exactly should I inject this insulin — before or after I eat?
📖 Read our full Insulin Lispro Injection guide →
1
Nutrient depletion considerations

Insulin Lispro-Aabc may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Insulin Lispro-Aabc nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 $7.873 $78.73 / 10 ml
Medicaid paysCMS SDUD · 12 mo $23.39 $233.91 / 10 ml
Medicare drug plans payPart D · Q2 2026 $8.47 $84.72 / 10 ml
Medicare Part B allowsASP · J1813 $4.802 / J1813 unit —
NADAC price history (per mL) — tap or hover for the price & month
Nov 2021 Dec 2025 Jun 2026 Sep 2026 $26.425 $7.873
▼ Down 70% over the last 10 months.
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)0002-7728-01
11-digit billing NDC00002-7728-01
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ1813
DescriptorINSULIN (LYUMJEV) FOR ADMINISTRATION THROUGH DME (I.E., INSULIN PUMP) PER 50 UNITS
Billing units / pkg2 units
How the units are derivedThis package is 10 ML; the HCPCS unit is 50 U, so one package = 2 billing units.
Medicare Part B spend (2026 (Q1))$402,908 · 526 claims · $765.98 per claim (all NDCs under J1813)
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 Per unit Per pack Marketing startMarketing endStatus
00002-7728-01 You're viewing this Main listing 1 VIAL, MULTI-DOSE in 1 CARTON / 10 mL in 1 VIAL, MULTI-DOSE $7.87 / mL $78.73 2020-06-15 — Active
00002-7728-99 0002-7728-99 1 VIAL, MULTI-DOSE in 1 CARTON / 10 mL in 1 VIAL, MULTI-DOSE — — 2020-06-15 — Discontinued by firm

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 vial, multi-dose in 1 carton / 10 ml in 1 vial, multi-dose.
What NDC number is used to bill for this package of LYUMJEV Insulin lispro-aabc 100 [iU]/mL Injection, Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Lyumjev 100 [iU]/mLthis 00002-7728-01 Eli 1 vial $7.873 — Availability likely —
Lyumjev 100 [iU]/mL 50090-7433-00 A-S 1 vial — — 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

🏛️
2020
First FDA approval
Jun 2020
📍
2026
Currently FDA-listed
6 years listed
🛡️
2032
Latest patent/protection listed
not a guaranteed launch date
🧬Biologic — competition comes from biosimilars

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

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jun 2032. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved Jun 15, 2020 ⏳ ~5.7 yr to latest listed protection

Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Admeloginsulin lispro Humaloginsulin lispro Lyumjevinsulin lispro-aabc
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2020 2022 2024 2026 2028 2030 2032
Today
LOE
Biologic patent Exclusivity
🏛️Reference-product exclusivity
A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.
🧪Listed biologic patents
Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.
🔁Interchangeability
An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.
🛈 What do these terms mean?
Biologic patent
A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
Reference-product exclusivity
A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
Interchangeable exclusivity
The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
Earliest biosimilar (LOE)
The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.

Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.

FDA exclusivity
CodeWhat it grantsExpires
RefProductReference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this dateJun 15, 2032
Common questions
Is there a biosimilar for LYUMJEV 100 UNIT/ML VIAL?
No FDA-licensed biosimilar is currently listed for this biologic in the FDA Purple Book.
Why do different websites show different biosimilar dates?
Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.
Can a biosimilar launch before the last patent expires?
Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.
What does “current Purple Book estimate” mean?
It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.
What does “FDA listed” mean?
It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.
Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange 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.

🧪 Avoiding an ingredient? See Insulin Lispro Injection inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 12.1 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.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • 1.02 mg / 1 mL UNII 02F3473H9O
    A mineral salt used in medications as a source of magnesium. It helps bind ingredients together, improve texture, and maintain the product's stability during storage.
  • 3.15 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.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 1.06 ug / 1 mL UNII 7JZ75N2NT6
    Treprostinil sodium is a prostacyclin analog, a medication that acts as a vasodilator. While primarily an active ingredient in products for pulmonary hypertension, it may serve as a therapeutic agent rather than a typical inactive filler or binder in formulations.
  • 4.41 mg / 1 mL UNII B22547B95K
    A salt derived from citric acid that helps maintain the proper acid-base balance in the medicine. It's used as a buffer to keep the product stable and at the right pH level.
  • 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.
  • UNII SOI2LOH54Z
    Zinc oxide is a white mineral powder used in medicines as a protective barrier agent and color additive. It helps shield skin in topical products and may also serve as a filler or opacifying ingredient.

9 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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

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

LabelerEli Lilly and Company
FDA applicationBLA761109 (BLA)
Labeler code00002
First marketedJun 2020
Product typeHuman Prescription Drug
Portfolio192 products on file

More NDCs from Eli Lilly and Company labeler code 00002

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 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 44 words ▾

1 INDICATIONS AND USAGE LYUMJEV ® is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. LYUMJEV ® is a rapid-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION See Full Prescribing Information for important administration instructions. ( 2.1 , 2.2 ) Subcutaneous Injection ( 2.2 ): Administer LYUMJEV U-100 or U-200 at the start of a meal or within 20 minutes after starting a meal subcutaneously into the abdomen, upper arm, thigh, or buttocks. Rotate injection sites within the same region to reduce risk of lipodystrophy and localized cutaneous amyloidosis.

Should generally be used in regimens with an intermediate or long-acting insulin. Continuous subcutaneous infusion (Insulin Pump) ( 2.2 ): Refer to the insulin infusion pump user manual to see if LYUMJEV can be used. Use in accordance with the insulin pump instructions for use.

Administer LYUMJEV U-100 by continuous subcutaneous infusion using an insulin pump in a region recommended in the instructions from the pump manufacturer. Rotate infusion sites within the same region to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not administer LYUMJEV U-200 by continuous subcutaneous infusion.

Intravenous Infusion ( 2.2 ): Administer LYUMJEV U-100 intravenously only under medical supervision. DO NOT administer LYUMJEV U-200 by intravenous infusion. Dilute LYUMJEV U-100 to a concentration of 1 unit/mL.

Individualize and adjust the dosage of LYUMJEV based on the patient's metabolic needs, glucose monitoring results, and glycemic control goal. ( 2.3 ) Dose adjustments may be needed when switching from another insulin, with changes in physical activity, changes in concomitant medications, changes in meal patterns (i.e., amount and type of food, timing of food intake), changes in renal or hepatic function, or during acute illness. ( 2.3 )

2.1Important Administration Instructions Always check insulin labels before administration [see Warnings and Precautions ( 5.4 )] . Inspect LYUMJEV visually before use. It should appear clear and colorless.

Do not use LYUMJEV if particulate matter and discoloration is seen. Use LYUMJEV prefilled pens with caution in patients with visual impairment that may rely on audible clicks to dial their dose. Do not perform dose conversion when using any LYUMJEV U-100 or U-200 prefilled pens.

The dose window of LYUMJEV prefilled pens shows the number of units of LYUMJEV to be delivered and no conversion is needed . Do not transfer LYUMJEV U-200 from the prefilled pen to a syringe for administration [see Warnings and Precautions ( 5.4 )] . Do not mix LYUMJEV with any other insulin products.

Do not administer LYUMJEV U-200 using continuous subcutaneous infusion insulin pump. Do not administer LYUMJEV U-200 intravenously.

2.2Route of Administration Instructions Subcutaneous Injection for LYUMJEV U-100 or U-200 Administer LYUMJEV at the start of a meal or within 20 minutes after starting a meal subcutaneously into the abdomen, upper arm, thigh, or buttocks. 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 Adverse Reactions ( 6.1 , 6.2 )].

LYUMJEV given by subcutaneous injection should generally be used in regimens with intermediate or long-acting insulin. The LYUMJEV U-100 KwikPen, LYUMJEV U-100 Tempo Pen, and LYUMJEV U-200 KwikPen each dial in 1 unit increments and deliver a maximum dose of 60 units per injection. The LYUMJEV U-100 Junior KwikPen dials in 0.5 unit increments and delivers a maximum dose of 30 units per injection.

Continuous Subcutaneous Insulin Infusion (Insulin Pump) for LYUMJEV U-100 Only Do not administer LYUMJEV U-200 using an insulin pump. Refer to the continuous subcutaneous insulin infusion pump user manual to see if LYUMJEV can be used with the insulin pump. Use LYUMJEV in accordance with the insulin pump system's instructions for use.

Administer LYUMJEV U-100 by continuous subcutaneous infusion in a region recommended in the instructions from the pump manufacturer.… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 115 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 100 units/mL (U-100) clear and colorless solution available as: 10 mL multiple-dose vial 3 mL single-patient-use LYUMJEV KwikPen 3 mL single-patient-use LYUMJEV Junior KwikPen 3 mL single-patient-use LYUMJEV Tempo Pen 3 mL single-patient-use cartridges Injection: 200 units/mL (U-200) clear and colorless solution available as: 3 mL single-patient-use LYUMJEV KwikPen Injection: 100 units/mL (U-100) available as: 10 mL multiple-dose vial ( 3 ) 3 mL single-patient-use KwikPen ® ( 3 ) 3 mL single-patient-use Junior KwikPen ® ( 3 ) 3 mL single-patient-use Tempo Pen ® ( 3 ) 3 mL single-patient-use cartridges ( 3 ) Injection: 200 units/mL (U-200) available as: 3 mL single-patient-use KwikPen ® ( 3 )

⛔ Contraindications 44 words ▾

4 CONTRAINDICATIONS LYUMJEV is contraindicated: during episodes of hypoglycemia. in patients with hypersensitivity to insulin lispro-aabc or any of the excipients in LYUMJEV. During episodes of hypoglycemia. ( 4 ) Hypersensitivity to insulin lispro-aabc or any of the excipients in LYUMJEV. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Never share a LYUMJEV prefilled pen or cartridge between patients, even if the needle is changed. ( 5.1 ) 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 glucose monitoring. ( 5.2 ) Hypoglycemia: May be life-threatening.

Increase frequency of glucose monitoring with changes to: insulin dosage, co-administered glucose lowering medications, meal pattern, physical activity; and in patients with renal impairment or hepatic impairment or hypoglycemia unawareness. ( 5.3 ) Hypoglycemia due to medication errors: Accidental mix-ups between insulin products can occur. Instruct patients to check insulin labels before injection.

Do not transfer LYUMJEV U-200 from the LYUMJEV KwikPen to a syringe as overdosage and severe hypoglycemia can result. ( 5.4 ) Hypokalemia: May be life-threatening. Monitor potassium levels in patients at risk for hypokalemia and treat if indicated.

( 5.5 ) Hypersensitivity reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue LYUMJEV, monitor, and treat if indicated. ( 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 of TZD if heart failure occurs.

( 5.7 ) Hyperglycemia and ketoacidosis due to insulin pump device malfunction: Monitor glucose and administer LYUMJEV by subcutaneous injection if pump malfunction occurs. ( 5.8 )

5.1Never Share a LYUMJEV Prefilled Pen, Cartridge, or Syringe Between Patients LYUMJEV prefilled pens or cartridges should never be shared between patients, even if the needle is changed. Patients using LYUMJEV vials must never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.

5.2Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen Changes in an insulin regimen (e.g., insulin, insulin strength, manufacturer, type, injection site or method of administration) may affect glycemic control and predispose to hypoglycemia [see Warnings and Precautions ( 5.3 )] or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia [see Adverse Reactions ( 6.1 )] .

Make any changes to a patient's insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. For patients with type 2 diabetes, dosage adjustments of concomitant anti-diabetic products may be needed.

5.3Hypoglycemia Hypoglycemia is the most common adverse reaction associated with insulins, including LYUMJEV [see Adverse Reactions ( 6.1 )] . Severe hypoglycemia can cause seizures, may lead to unconsciousness, 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).

LYUMJEV, 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 diabetes, in patients with diabetic nerve disease, in patients using medications that block the sympathetic nervous system (e.g., beta-blockers) [see Drug Interactions (… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are also discussed elsewhere: Hypoglycemia [see Warnings and Precautions ( 5.3 )] . Hypoglycemia Due to Medication Errors [see Warnings and Precautions ( 5.4 )] Hypokalemia [see Warnings and Precautions ( 5.5 )] . Hypersensitivity Reactions [see Warnings and Precautions ( 5.6 )] .

Adverse reactions observed with LYUMJEV include hypoglycemia, injection/infusion site reactions, allergic reactions, rash, pruritus, lipodystrophy, and weight gain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials 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 actually observed in clinical practice. Adverse Reaction Database – Adult Patients with Type 1 and Type 2 Diabetes The data in Table 1 reflect the exposure of 780 adult patients with type 1 diabetes to LYUMJEV with a mean exposure duration of 26 weeks [see Clinical Studies ( 14.2 )] .

The mean age was 44 years, the mean duration of diabetes was 19 years, 55% were male, 77% were White, 2% were Black or African American, and 9% were Hispanic. The mean BMI was 26.6 kg/m 2 and the mean HbA 1c at baseline was 7.3%. The data in Table 2 reflect the exposure of 336 adult patients with type 2 diabetes to LYUMJEV with a mean exposure duration of 26 weeks [see Clinical Studies ( 14.3 )] .

The mean age was 60 years, the mean duration of diabetes was 16 years, 55% were male, 69% were White, 4% were Black or African American, and 24% were Hispanic. The mean BMI was 32.1 kg/m 2 and the mean HbA 1c at baseline was 7.3%. The data in Table 3 reflect the exposure of 215 adult patients with type 1 diabetes to LYUMJEV via CSII administration with a mean exposure duration of 16 weeks [see Clinical Studies ( 14.4 )] .

The mean age was 48 years, the mean duration of diabetes was 26 years, 44% were male, 94% were White, 3% were Black or African American, and 8% were Hispanic. The mean BMI was 27.0 kg/m 2 and the mean HbA 1c at baseline was 7.6%. Common adverse reactions, excluding hypoglycemia, were defined as events that occurred in ≥5% and at the same rate or greater for LYUMJEV-treated patients than HUMALOG-treated patients.

Table 1. Adverse Reactions That Occurred in ≥5% of LYUMJEV-Treated Adult Patients with Type 1 Diabetes Mealtime LYUMJEV + basal insulin (N=451) % Postmeal LYUMJEV + basal insulin (N=329) % Nasopharyngitis 14.2

14.6Table 2. Adverse Reactions That Occurred in ≥5% of LYUMJEV-Treated Adult Patients with Type 2 Diabetes Mealtime LYUMJEV + basal insulin (N=336) % Nasopharyngitis

12.5 Upper Respiratory Tract Infection

7.4Table 3. Adverse Reactions That Occurred in ≥5% of LYUMJEV-Treated Adult Patients with Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion CSII LYUMJEV administration (N=215) % Infusion site reaction

19.1 Infusion site pain

15.8 Nasopharyngitis

6.0Adverse Reaction Database – Pediatric Patients with Type 1 Diabetes The data in Table 4 reflect the exposure of 418 pediatric patients with type 1 diabetes to LYUMJEV with a mean exposure duration of 26 weeks [see Clinical Studies ( 14.5 )] . The mean age was 12 years; 50% were male, 91% were White, 1% were Black or African American; and 24% of the US subpopulation in this trial were Hispanic. The mean BMI was 20.5 kg/m 2 , the mean duration of diabetes was 5 years, and the mean HbA 1c at baseline was 7.8%.

Common adverse reactions, excluding hypoglycemia, were defined as events that occurred in ≥5% and at the same rate or greater for LYUMJEV-treated patients than HUMALOG-treated patients. Table 4. Adverse Reactions That Occurred in ≥5% of LYUMJEV-Treated Pediatric Patients with Type 1 Diabetes Mealtime LYUMJEV + basal insulin (N=280) % Postmeal… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Table 6 includes clinically significant drug interactions with LYUMJEV. Table 6. Clinically Significant Drug Interactions with LYUMJEV Drugs That May Increase the Risk of Hypoglycemia Drugs: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics.

Intervention: Dose reductions and increased frequency of glucose monitoring may be required when LYUMJEV is co-administered with these drugs. Drugs That May Decrease the Blood Glucose Lowering Effect of LYUMJEV 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 LYUMJEV is co-administered with these drugs. Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of LYUMJEV 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 LYUMJEV 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 LYUMJEV is co-administered with these drugs.

Drugs that Increase Hypoglycemia Risk or Increase or Decrease Blood Glucose Lowering Effect: Adjustment of dosage may be needed; closely monitor blood glucose. ( 7 ) Drugs that Blunt Hypoglycemia Signs and Symptoms (e.g., beta-blockers, clonidine, guanethidine, and reserpine): Increased frequency of glucose monitoring may be required. ( 7 )

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Published studies with insulin lispro used during pregnancy have not reported an association between insulin lispro and the induction of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data) . There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations). Pregnant rats and rabbits were exposed to insulin lispro in animal reproduction studies during organogenesis.

No adverse effects on embryo/fetal viability or morphology were observed in offspring of rats exposed to insulin lispro at a dose approximately 3 times the human subcutaneous dose of 1 unit insulin lispro/kg/day. No adverse effects on embryo/fetal development were observed in offspring of rabbits exposed to insulin lispro at doses up to approximately 0.2 times the human subcutaneous dose of 1 unit/kg/day (see Data) . The estimated background risk of major birth defects is 6% to 10% in women with pre-gestational diabetes with a HbA 1c >7 and has been reported to be as high as 20% to 25% in women with a 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% to 4% and 15% to 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, stillbirth, and macrosomia related morbidity. Data Human Data Published data from retrospective studies and meta-analyses do not report an association with insulin lispro and major birth defects, or adverse maternal or fetal outcomes when insulin lispro is used during pregnancy. However, these studies cannot definitely establish or exclude the absence of any risk because of methodological limitations including small sample size, selection bias, confounding by unmeasured factors, and some lacking comparator groups.

Animal Data Animal reproduction studies have not been performed with LYUMJEV. However, subcutaneous reproduction and teratology studies have been conducted with insulin lispro. In a combined fertility and embryo-fetal development study, female rats were given subcutaneous insulin lispro injections of 1, 5, and 20 units/kg/day (0.2, 0.8, and 3 times the human subcutaneous dose of 1 unit insulin lispro/kg/day, based on units/body surface area, respectively) from 2 weeks prior to cohabitation through Gestation Day 19.

There were no adverse effects on female fertility, implantation, or fetal viability and morphology. However, fetal growth retardation was produced at the 20 units/kg/day-dose as indicated by decreased fetal weight and an increased incidence of fetal runts/litter. In an embryo-fetal development study in pregnant rabbits, insulin lispro doses of 0.1, 0.25, and 0.75 unit/kg/day (0.03, 0.08, and 0.2 times the human subcutaneous dose of 1 unit insulin lispro/kg/day, based on units/body surface area, respectively) were injected subcutaneously on Gestation Days 7 through 19.

There were no adverse effects on fetal viability, weight, and morphology at any dose.

8.2Lactation Risk Summary Available data from published literature suggests that exogenous human insulin products, including insulin lispro, are transferred into human milk. There are no adverse reactions reported in breastfed infants in the literature. There are no data on the effects of exogenous human insulin products, including insulin lispro, on milk production.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for insulin, any potential adverse effects on the breastfed child from LYUMJE… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Published studies with insulin lispro used during pregnancy have not reported an association between insulin lispro and the induction of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data) . There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations). Pregnant rats and rabbits were exposed to insulin lispro in animal reproduction studies during organogenesis.

No adverse effects on embryo/fetal viability or morphology were observed in offspring of rats exposed to insulin lispro at a dose approximately 3 times the human subcutaneous dose of 1 unit insulin lispro/kg/day. No adverse effects on embryo/fetal development were observed in offspring of rabbits exposed to insulin lispro at doses up to approximately 0.2 times the human subcutaneous dose of 1 unit/kg/day (see Data) . The estimated background risk of major birth defects is 6% to 10% in women with pre-gestational diabetes with a HbA 1c >7 and has been reported to be as high as 20% to 25% in women with a 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% to 4% and 15% to 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, stillbirth, and macrosomia related morbidity. Data Human Data Published data from retrospective studies and meta-analyses do not report an association with insulin lispro and major birth defects, or adverse maternal or fetal outcomes when insulin lispro is used during pregnancy. However, these studies cannot definitely establish or exclude the absence of any risk because of methodological limitations including small sample size, selection bias, confounding by unmeasured factors, and some lacking comparator groups.

Animal Data Animal reproduction studies have not been performed with LYUMJEV. However, subcutaneous reproduction and teratology studies have been conducted with insulin lispro. In a combined fertility and embryo-fetal development study, female rats were given subcutaneous insulin lispro injections of 1, 5, and 20 units/kg/day (0.2, 0.8, and 3 times the human subcutaneous dose of 1 unit insulin lispro/kg/day, based on units/body surface area, respectively) from 2 weeks prior to cohabitation through Gestation Day 19.

There were no adverse effects on female fertility, implantation, or fetal viability and morphology. However, fetal growth retardation was produced at the 20 units/kg/day-dose as indicated by decreased fetal weight and an increased incidence of fetal runts/litter. In an embryo-fetal development study in pregnant rabbits, insulin lispro doses of 0.1, 0.25, and 0.75 unit/kg/day (0.03, 0.08, and 0.2 times the human subcutaneous dose of 1 unit insulin lispro/kg/day, based on units/body surface area, respectively) were injected subcutaneously on Gestation Days 7 through 19.

There were no adverse effects on fetal viability, weight, and morphology at any dose.

🧒 Pediatric Use 166 words ▾

8.4Pediatric Use The safety and effectiveness of LYUMJEV to improve glycemic control in pediatric patients with diabetes mellitus have been established. Use of LYUMJEV for this indication is supported by evidence from an adequate and well-controlled study in 716 pediatric patients with type 1 diabetes mellitus aged 1 year and older, and from studies in adult and pediatric patients with diabetes mellitus [see Clinical Pharmacology ( 12.3 ) and Clinical Studies ( 14.5 )] . LYUMJEV-treated pediatric patients reported a higher incidence of subcutaneous injection site-related reactions compared to LYUMJEV-treated adults [see Adverse Reactions ( 6.1 )] .

It is expected that LYUMJEV-treated pediatric patients who receive continuous subcutaneous insulin infusion (CSII) are more likely to have infusion site-related adverse reactions than those who receive subcutaneous injections [see Adverse Reactions ( 6.1 )] . Monitor injection and infusion sites closely when initiating therapy with LYUMJEV in pediatric patients. If persistent injection or infusion site reactions occur, discontinue LYUMJEV and initiate therapy with an alternative insulin.

🧓 Geriatric Use 76 words ▾

8.5Geriatric Use Of the total number of LYUMJEV-treated patients in clinical studies for type 1 or type 2 diabetes (PRONTO-T1D and PRONTO-T2D, respectively), 17% (187/1,116) were 65 years of age and older, while 2% (18/1,116) were 75 years of age and older [see Clinical Studies ( 14.2 , 14.3 )] . No overall differences in safety or effectiveness of LYUMJEV have been observed between patients 65 years of age and older and younger adult patients.

🆘 Overdosage 81 words ▾

10 OVERDOSAGE Excess insulin administration may cause hypoglycemia and hypokalemia [see Warnings and Precautions ( 5.3 , 5.5 )] . Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise, may be needed.

More severe episodes with coma, seizure, or neurologic impairment may be treated with glucagon or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery. Hypokalemia must be corrected appropriately.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The primary activity of LYUMJEV is the regulation of glucose metabolism. Insulins, including insulin lispro-aabc, exert their specific action through binding to insulin receptors. Receptor-bound insulin lowers glucose by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulins inhibit lipolysis and proteolysis, and enhance protein synthesis.

12.2Pharmacodynamics The time course of insulin action (i.e., glucose lowering) may vary considerably in different individuals or within the same individual. The average pharmacodynamic profile [i.e., glucose lowering effect measured as glucose infusion rate (GIR) in a euglycemic clamp study] for subcutaneous administration of 7, 15, and 30 units of LYUMJEV in 42 healthy subjects is shown in Figure 1 and key characteristics of the timing of the effect are described in Table 7 below. Figure 1.

Mean Insulin Effect Over Time After Subcutaneous Administration of 7, 15, and 30 units of LYUMJEV in Healthy Subjects. Table 7. Timing of Insulin Effect (i.e., Mean Pharmacodynamic Effect) After Subcutaneous Administration of 7, 15, and 30 Units of LYUMJEV in Healthy Subjects (N=42) and Corresponding to the Data Shown in Figure 1 Parameter for Insulin Effect LYUMJEV 7 units LYUMJEV 15 units LYUMJEV 30 units Time to first measurable effect ~17 minutes ~17 minutes ~15 minutes Time to peak effect ~120 minutes ~138 minutes ~174 minutes Time for effect to return to baseline ~4.6 hours ~6.2 hours ~7.3 hours On average, the pharmacodynamic effects of LYUMJEV, measured as area under the glucose infusion rate-time curve (AUC GIR ), was 1080 mg/kg, 1860 mg/kg, and 3030 mg/kg following administration of 7, 15, and 30 units of LYUMJEV in healthy subjects.

Similar pharmacodynamic profiles were observed in separate studies conducted in 40 patients with type 1 diabetes and 38 patients with type 2 diabetes given LYUMJEV subcutaneously as a single 15 unit dose. The onset and total glucose lowering were similar when LYUMJEV was administered in the abdomen, deltoid, or thigh. The day-to-day variability [percent coefficient of variation (CV%)] within subjects in the glucose-lowering-effect of LYUMJEV was 24% for the early glucose lowering (AUC GIR , 0-1h), 27% for the total glucose lowering (AUC GIR , 0-10h), and 19% for maximum glucose lowering effect (GIR max ).

Figure 1 Postprandial Glucose Lowering When given at the start of a meal or 20 minutes after the start of the meal, LYUMJEV reduced postprandial glucose during a standardized test meal over the complete 5-hour period [change from premeal AUC(0-5h)] in patients with type 1 or type 2 diabetes. The maximum and total glucose lowering were comparable for a single 15 unit dose of LYUMJEV 200 units/mL or LYUMJEV 100 units/mL when administered subcutaneously to healthy subjects. The insulin time action profile with LYUMJEV 200 units/mL was the same as observed with LYUMJEV 100 units/mL.

12.3Pharmacokinetics Absorption Absorption of insulin lispro-aabc was evaluated in healthy subjects (see Figure 2 ) and patients with diabetes following subcutaneous injection of LYUMJEV. Insulin lispro-aabc appeared in circulation approximately 1 minute after injection of LYUMJEV. Time to 50% maximum insulin lispro-aabc concentration was 13 minutes.

Time to maximum insulin lispro-aabc concentration was achieved at 57 minutes. In healthy subjects, the day-to-day variability [CV%] within subjects of LYUMJEV was 10% for total exposure (AUC, 0-10h) and 16% for maximum insulin lispro-aabc concentration (C max ). Figure 2.

Mean Serum Insulin Lispro-aabc After Subcutaneous Injection of LYUMJEV (15 unit dose) in Healthy Subjects The absolute bioavailability of insulin lispro-aabc after subcutaneous administration of LYUMJEV in the abdomen, deltoid, and thigh was approximately 65%. The rate of absorption of insulin lispro-aabc is maintained regardless of injection site. Maximum co… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 57 words ▾

12.1Mechanism of Action The primary activity of LYUMJEV is the regulation of glucose metabolism. Insulins, including insulin lispro-aabc, exert their specific action through binding to insulin receptors. Receptor-bound insulin lowers glucose by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulins inhibit lipolysis and proteolysis, and enhance protein synthesis.

📦 How Supplied / Storage and Handling ~3 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied LYUMJEV (insulin lispro-aabc) injection is a clear and colorless solution available as shown in Table 12 . Table 12. How Supplied a 3 mL cartridge is for use in Eli Lilly and Company's HumaPen ® Luxura ® HD insulin delivery device.

Patients need to check their device manual to determine if the LYUMJEV cartridge is compatible for use in other devices. b Tempo Pen contains a component that allows for data connectivity when used with a compatible transmitter. LYUMJEV NDC Number Concentration Total Units in Presentation Dose Increment Package Size U-100 multiple-dose 10 mL vial 0002-7728-01 100 units/mL 1,000 units n/a 1 vial U-100 single-patient-use 3 mL cartridge a 0002-7726-05 100 units/mL 300 units n/a 5 cartridges U-100 single-patient-use 3 mL KwikPen 0002-8207-05 100 units/mL 300 units 1 unit 5 pens U-100 single-patient-use 3 mL Junior KwikPen 0002-8351-05 100 units/mL 300 units 0.5 unit 5 pens U-100 single-patient-use 3 mL Tempo Pen b 0002-8235-05 100 units/mL 300 units 1 unit 5 pens U-200 single-patient-use 3 mL KwikPen 0002-8228-27 200 units/mL 600 units 1 unit 2 pens

16.2Storage and Handling Dispense in the original sealed carton with the enclosed Instructions for Use. Refrigerate unopened LYUMJEV vials, pens, and cartridges between 36°F to 46°F (2°C to 8°C) until time of use and keep in the original carton to protect from light. Do not freeze or use LYUMJEV if it has been frozen.

Do not expose to direct heat. Discard opened or unopened LYUMJEV vials, pens, and cartridges stored at room temperature below 86°F (30°C) after 28 days. The storage conditions for vials, pens, and cartridges are summarized in Table 13 .

Table 13. Storage Conditions for Vials, Pens, and Cartridges a In-use (opened) vials, whether or not refrigerated, must be used within 28 days. b When stored at room temperature, LYUMJEV can only be used for a total of 28 days including both not in-use (unopened) and in-use (opened) storage time. LYUMJEV Presentation Not In-use (Unopened) In-use (Opened) Room Temperature (below 86°F [30°C]) Refrigerated (36°F to 46°F [2°C to 8°C]) Room Temperature (below 86°F [30°C]) Refrigerated (36°F to 46°F [2°C to 8°C]) 10 mL vial a,b 28 days Until expiration date 28 days 28 days 3 mL cartridge b 28 days Until expiration date 28 days Do not refrigerate 3 mL LYUMJEV KwikPen (U-100 and U-200) b 28 days Until expiration date 28 days Do not refrigerate 3 mL LYUMJEV Junior KwikPen b 28 days Until expiration date 28 days Do not refrigerate 3 mL LYUMJEV Tempo Pen b 28 days Until expiration date 28 days Do not refrigerate Storage of LYUMJEV in Insulin Pump Change the LYUMJEV U-100 in the pump reservoir at least every 9 days, or according to the pump user manual, whichever is shorter, or after exposure to temperatures that exceed 98.6°F (37°C).

Storage of LYUMJEV in Intravenous Infusion Fluids Diluted LYUMJEV may be stored for up to 4 days when refrigerated at 36°F to 46°F (2°C to 8°C) until time of use. The same solution may be stored up to 12 hours at room temperature at 68°F to 77°F (20°C to 25°C) [see Dosage and Administration ( 2.2 )].

16.1How Supplied LYUMJEV (insulin lispro-aabc) injection is a clear and colorless solution available as shown in Table 12 . Table 12. How Supplied a 3 mL cartridge is for use in Eli Lilly and Company's HumaPen ® Luxura ® HD insulin delivery device.

Patients need to check their device manual to determine if the LYUMJEV cartridge is compatible for use in other devices. b Tempo Pen contains a component that allows for data connectivity when used with a compatible transmitter. LYUMJEV NDC Number Concentration Total Units in Presentation Dose Increment Package Size U-100 multiple-dose 10 mL vial 0002-7728-01 100 units/mL 1,000 units n/a 1 vial U-100 single-patient-use 3 mL cartridge a 0002-7726-05 100 units/mL 300 units n/a 5 cartridges U-100 single-patient-use 3 mL KwikPen 0002-8207-05 100 units/mL 300 units 1 unit 5 pens U-100 single-patient-u… [Excerpted — this section continues on DailyMed.]

📦 Storage and Handling ~2 min read ▾

16.2Storage and Handling Dispense in the original sealed carton with the enclosed Instructions for Use. Refrigerate unopened LYUMJEV vials, pens, and cartridges between 36°F to 46°F (2°C to 8°C) until time of use and keep in the original carton to protect from light. Do not freeze or use LYUMJEV if it has been frozen.

Do not expose to direct heat. Discard opened or unopened LYUMJEV vials, pens, and cartridges stored at room temperature below 86°F (30°C) after 28 days. The storage conditions for vials, pens, and cartridges are summarized in Table 13 .

Table 13. Storage Conditions for Vials, Pens, and Cartridges a In-use (opened) vials, whether or not refrigerated, must be used within 28 days. b When stored at room temperature, LYUMJEV can only be used for a total of 28 days including both not in-use (unopened) and in-use (opened) storage time. LYUMJEV Presentation Not In-use (Unopened) In-use (Opened) Room Temperature (below 86°F [30°C]) Refrigerated (36°F to 46°F [2°C to 8°C]) Room Temperature (below 86°F [30°C]) Refrigerated (36°F to 46°F [2°C to 8°C]) 10 mL vial a,b 28 days Until expiration date 28 days 28 days 3 mL cartridge b 28 days Until expiration date 28 days Do not refrigerate 3 mL LYUMJEV KwikPen (U-100 and U-200) b 28 days Until expiration date 28 days Do not refrigerate 3 mL LYUMJEV Junior KwikPen b 28 days Until expiration date 28 days Do not refrigerate 3 mL LYUMJEV Tempo Pen b 28 days Until expiration date 28 days Do not refrigerate Storage of LYUMJEV in Insulin Pump Change the LYUMJEV U-100 in the pump reservoir at least every 9 days, or according to the pump user manual, whichever is shorter, or after exposure to temperatures that exceed 98.6°F (37°C).

Storage of LYUMJEV in Intravenous Infusion Fluids Diluted LYUMJEV may be stored for up to 4 days when refrigerated at 36°F to 46°F (2°C to 8°C) until time of use. The same solution may be stored up to 12 hours at room temperature at 68°F to 77°F (20°C to 25°C) [see Dosage and Administration ( 2.2 )].

📋 Description ~1 min read ▾

11 DESCRIPTION Insulin lispro-aabc is a rapid-acting human insulin analog used to lower blood glucose. Insulin lispro-aabc is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli . Insulin lispro-aabc differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline.

Chemically, it is Lys(B28), Pro(B29) human insulin analog and has the empirical formula C 257 H 383 N 65 O 77 S 6 and a molecular weight of 5808 daltons, both identical to that of human insulin. Insulin lispro-aabc has the following primary structure: LYUMJEV (insulin lispro-aabc) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous administration. Each mL of LYUMJEV U-100 contains 100 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 39 mcg zinc ion), and Water for Injection, USP.

Each mL of LYUMJEV U-200 contains 200 units of insulin lispro-aabc and the inactive ingredients: glycerol (12.1 mg), magnesium chloride hexahydrate (1.02 mg), metacresol (3.15 mg), sodium citrate dihydrate (4.41 mg), treprostinil sodium (1.06 mcg), zinc oxide (content adjusted to provide 52 mcg zinc ion), and Water for Injection, USP. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH. LYUMJEV has a pH of 7.0 to 7.8.

Primary Structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-Approved Patient Labeling (Patient Information and Instructions for Use). Never Share a LYUMJEV Prefilled Pen, Cartridge, or Syringe Between Patients Advise patients that they must never share a LYUMJEV prefilled pen or cartridge with another person, even if the needle is changed. Advise patients using LYUMJEV vials not to share needles or syringes with another person.

Sharing poses a risk for transmission of blood-borne pathogens [see Warnings and Precautions ( 5.1 )] . Hyperglycemia or Hypoglycemia Inform patients that hypoglycemia is the most common adverse reaction with insulin. Instruct patients on self-management procedures including glucose monitoring, proper injection technique, and management of hypoglycemia and hyperglycemia, especially at initiation of LYUMJEV therapy.

Instruct patients on handling of special situations such as intercurrent conditions (illness, stress, or emotional disturbances), an inadequate or skipped insulin dose, inadvertent administration of an increased insulin dose, inadequate food intake, and skipped meals. Instruct patients on the management of hypoglycemia. Inform patients that their ability to concentrate and react may be impaired as a result of hypoglycemia.

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 ( 5.3 )] . 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 ( 5.2 )] . Hypoglycemia due to Medication Errors Instruct patients to always check the insulin label before each injection to avoid mix-ups between insulin products.

Inform patients that LYUMJEV U-200 contains 2 times as much insulin per mL as LYUMJEV U-100. The LYUMJEV U-200 KwikPen dose window shows the number of units of LYUMJEV U-200 to be injected so no dose conversion is required [see Dosage and Administration ( 2.1 )] . Instruct patients to not transfer LYUMJEV U-200 from the LYUMJEV U-200 KwikPen to a syringe [see Warnings and Precautions ( 5.4 )] .

Hypersensitivity Reactions Advise patients that hypersensitivity reactions have occurred with LYUMJEV. Inform patients on the symptoms of hypersensitivity reactions [see Warnings and Precautions ( 5.6 )] . Instructions for Patients Using Continuous Subcutaneous Infusion (Insulin Pump) Do not use LYUMJEV U-200 in an insulin pump.

Train patients in intensive insulin therapy with multiple injections and in the function of their pump and pump accessories. Instruct patients to follow healthcare provider recommendations when setting pump basal rates and bolus settings. Refer to the continuous subcutaneous infusion pump user manual to see if LYUMJEV can be used with the pump.

See recommended reservoir and infusion sets in the insulin pump user manual. Instruct patients to replace insulin in the reservoir at least every 9 days, or according to the pump user manual whichever is shorter. By following this schedule, patients avoid insulin degradation, infusion set occlusion, and loss of the insulin preservative.

Instruct patients to discard insulin exposed to temperatures higher than 98.6°F (37°C). Instruct patients to inform healthcare provider and select a new site for infusion if infusion site becomes erythematous, pruritic, or thickened. Instruct patients on the risk of rapid hyperglycemia and ketosis due to pump malfunction, infusion set occlusion, leakage, disconnection or kinking, and degraded insulin.

Instruct patients on the risk of hypoglycemia from pump malfunction. If these problems cannot be promptly corrected, instruct patients to resume therapy with subcutaneous insulin injection and contact their healthcare provider [see Warnings and Precautions ( 5 ) and How Supplied/Storage and Handling ( 16.2 )] . Eli Lilly and C… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Absorption Absorption of insulin lispro-aabc was evaluated in healthy subjects (see Figure 2 ) and patients with diabetes following subcutaneous injection of LYUMJEV. Insulin lispro-aabc appeared in circulation approximately 1 minute after injection of LYUMJEV. Time to 50% maximum insulin lispro-aabc concentration was 13 minutes.

Time to maximum insulin lispro-aabc concentration was achieved at 57 minutes. In healthy subjects, the day-to-day variability [CV%] within subjects of LYUMJEV was 10% for total exposure (AUC, 0-10h) and 16% for maximum insulin lispro-aabc concentration (C max ). Figure 2.

Mean Serum Insulin Lispro-aabc After Subcutaneous Injection of LYUMJEV (15 unit dose) in Healthy Subjects The absolute bioavailability of insulin lispro-aabc after subcutaneous administration of LYUMJEV in the abdomen, deltoid, and thigh was approximately 65%. The rate of absorption of insulin lispro-aabc is maintained regardless of injection site. Maximum concentration and time to maximum concentration were comparable for the abdomen and upper arm regions; time to maximum concentration was longer and maximum concentration was lower for the thigh.

Total insulin lispro-aabc exposure and maximum insulin lispro-aabc concentration increased proportionally with increasing subcutaneous doses of LYUMJEV within the therapeutic dose range. The results of a study in healthy subjects demonstrated that LYUMJEV 200 units/mL is bioequivalent to LYUMJEV 100 units/mL following administration of a single 15 unit dose for the area under the serum insulin lispro-aabc concentration-time curve from time zero to infinity and maximum insulin lispro-aabc concentration. The rate of insulin lispro-aabc absorption after administration of LYUMJEV 200 units/mL was similar as observed with LYUMJEV 100 units/mL.

Figure 2 Distribution Following a 15 unit intravenous bolus injection of LYUMJEV in healthy subjects, the geometric mean (CV%) volume of distribution of insulin lispro-aabc (Vd) was 34 L (30%). Elimination Following a 15 unit intravenous bolus injection of LYUMJEV in healthy subjects, the geometric mean (CV%) clearance of insulin lispro-aabc was 32 L/hour (22%) and the median half-life of insulin lispro-aabc was 44 minutes. Specific Populations Age, biological sex, and race did not affect the pharmacokinetics and pharmacodynamics of LYUMJEV.

Patients with Renal and Hepatic Impairment Renal and hepatic impairment is not known to impact the pharmacokinetics of insulin lispro-aabc. Insulin requirements may be reduced in the presence of renal or hepatic impairment.

🧬 Pharmacodynamics ~2 min read ▾

12.2Pharmacodynamics The time course of insulin action (i.e., glucose lowering) may vary considerably in different individuals or within the same individual. The average pharmacodynamic profile [i.e., glucose lowering effect measured as glucose infusion rate (GIR) in a euglycemic clamp study] for subcutaneous administration of 7, 15, and 30 units of LYUMJEV in 42 healthy subjects is shown in Figure 1 and key characteristics of the timing of the effect are described in Table 7 below. Figure 1.

Mean Insulin Effect Over Time After Subcutaneous Administration of 7, 15, and 30 units of LYUMJEV in Healthy Subjects. Table 7. Timing of Insulin Effect (i.e., Mean Pharmacodynamic Effect) After Subcutaneous Administration of 7, 15, and 30 Units of LYUMJEV in Healthy Subjects (N=42) and Corresponding to the Data Shown in Figure 1 Parameter for Insulin Effect LYUMJEV 7 units LYUMJEV 15 units LYUMJEV 30 units Time to first measurable effect ~17 minutes ~17 minutes ~15 minutes Time to peak effect ~120 minutes ~138 minutes ~174 minutes Time for effect to return to baseline ~4.6 hours ~6.2 hours ~7.3 hours On average, the pharmacodynamic effects of LYUMJEV, measured as area under the glucose infusion rate-time curve (AUC GIR ), was 1080 mg/kg, 1860 mg/kg, and 3030 mg/kg following administration of 7, 15, and 30 units of LYUMJEV in healthy subjects.

Similar pharmacodynamic profiles were observed in separate studies conducted in 40 patients with type 1 diabetes and 38 patients with type 2 diabetes given LYUMJEV subcutaneously as a single 15 unit dose. The onset and total glucose lowering were similar when LYUMJEV was administered in the abdomen, deltoid, or thigh. The day-to-day variability [percent coefficient of variation (CV%)] within subjects in the glucose-lowering-effect of LYUMJEV was 24% for the early glucose lowering (AUC GIR , 0-1h), 27% for the total glucose lowering (AUC GIR , 0-10h), and 19% for maximum glucose lowering effect (GIR max ).

Figure 1 Postprandial Glucose Lowering When given at the start of a meal or 20 minutes after the start of the meal, LYUMJEV reduced postprandial glucose during a standardized test meal over the complete 5-hour period [change from premeal AUC(0-5h)] in patients with type 1 or type 2 diabetes. The maximum and total glucose lowering were comparable for a single 15 unit dose of LYUMJEV 200 units/mL or LYUMJEV 100 units/mL when administered subcutaneously to healthy subjects. The insulin time action profile with LYUMJEV 200 units/mL was the same as observed with LYUMJEV 100 units/mL.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Overview of Clinical Studies The effectiveness of LYUMJEV was evaluated in: Two randomized, active controlled trials of 26 weeks in adults with type 1 diabetes (N=780) or type 2 diabetes (N=336) (PRONTO-T1D and PRONTO-T2D, respectively) [see Clinical Studies ( 14.2 , 14.3 )]. A randomized, active controlled 16-week trial in adults with type 1 diabetes using continuous subcutaneous insulin infusion (N=432) (PRONTO-Pump-2) [see Clinical Studies ( 14.4 )]. A randomized, active controlled 26-week trial in pediatric patients with type 1 diabetes (N=716) (PRONTO-Peds) [see Clinical Studies ( 14.5 )].

14.2Adults with Type 1 Diabetes PRONTO-T1D (NCT03214367) was a 26 week, randomized (4:4:3), active controlled, treat-to-target, multinational trial that evaluated the efficacy of LYUMJEV in 1222 adult patients with type 1 diabetes. Patients were randomized to either blinded mealtime LYUMJEV (N=451), blinded mealtime HUMALOG (N=442), or open-label postmeal LYUMJEV (N=329), all in combination with either insulin glargine or insulin degludec. Mealtime LYUMJEV or HUMALOG was injected 0 to 2 minutes before the meal and postmeal LYUMJEV was injected 20 minutes after the start of the meal.

Patients had a mean age of 44 years; mean duration of diabetes of 19 years; 56% were male; race: 77% White, 19% Asian, and 2% Black or African American. Eight percent of the randomized patients were Hispanic. The mean BMI was 26.6 kg/m 2 .

At week 26, treatment with mealtime LYUMJEV provided a mean reduction in HbA 1c that met the pre-specified non-inferiority margin (0.4%) (see Table 8 ). In addition, postmeal LYUMJEV met the prespecified non-inferiority margin (0.4%) compared to mealtime HUMALOG. Insulin doses were similar in all treatment groups at baseline and at 26 weeks.

Table 8. Results from Study PRONTO-T1D: 26 Week Trial of Mealtime LYUMJEV and Postmeal LYUMJEV compared with Mealtime HUMALOG, all in Combination with Basal Insulin in Adults with Type 1 Diabetes a Analysis population: all randomized subjects regardless of adherence to treatment or availability of post-baseline assessment. Missing data at Week 26 were imputed by return to baseline approach.

At week 26, primary efficacy assessment was missing for 3.8%, 4.8%, and 5.2% of subjects, for mealtime LYUMJEV, mealtime HUMALOG, and postmeal LYUMJEV, respectively. b Least-squares (LS) mean from ANCOVA adjusted for baseline value and other stratification factors. c Tested for non-inferiority. Mealtime LYUMJEV + basal insulin Mealtime HUMALOG + basal insulin Postmeal LYUMJEV + basal insulin Number of randomized subjects (N) 451 442 329 HbA 1c (%) (mean) a Baseline 7.3 7.3

7.4Adjusted mean change from baseline b -0.12 -0.04

0.1Estimated treatment difference versus HUMALOG [95% CI] -0.08 [-0.16, 0.00] c 0.14 [0.05, 0.22]

14.3Adults with Type 2 Diabetes PRONTO-T2D (NCT03214380) was a 26-week, randomized (1:1), active controlled, treat-to-target, multinational trial that evaluated the efficacy of LYUMJEV in 673 adult patients with type 2 diabetes who at study entry were on multiple daily injections with either basal insulin and at least one prandial insulin injection or premixed insulin with at least two injections daily. Patients may also have been treated with up to three oral anti-diabetic medications (OAMs) in addition to insulin.

Patients were allowed to continue on metformin and/or a SGLT2 inhibitor and were randomized to either mealtime LYUMJEV (N=336) or to mealtime HUMALOG (N=337), both in combination with insulin glargine or insulin degludec in a basal-bolus regimen. Mealtime LYUMJEV or mealtime HUMALOG was injected 0-2 minutes before the meal. Patients had a mean age of 61 years; mean duration of diabetes of 17 years; 53% were male; race: 69% White, 24% Asian, and 5% Black or African American.

Twenty-three percent of the randomized patients were Hispanic. The mean BMI was 32.3 kg/m 2 . At week 26, treatment with mealtime LYUMJEV provided a mean reduction of HbA 1… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 179 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In Fischer 344 rats, a 12-month repeat-dose toxicity study was conducted with insulin lispro at subcutaneous doses of 20 and 200 units/kg/day (approximately 3 and 32 times the human subcutaneous dose of 1 unit/kg/day, based on units/body surface area). Insulin lispro did not produce important target organ toxicity including mammary tumors at any dose. Insulin lispro was not mutagenic in the following genetic toxicity assays: bacterial mutation, unscheduled DNA synthesis, mouse lymphoma, chromosomal aberration, and micronucleus assays.

Male fertility was not compromised when male rats given subcutaneous insulin lispro injections of 5 and 20 units/kg/day (0.8 and 3 times the human subcutaneous dose of 1 unit/kg/day, based on units/body surface area) for 6 months were mated with untreated female rats. In a combined fertility, perinatal, and postnatal study in male and female rats given 1, 5, and 20 units/kg/day subcutaneously (0.2, 0.8, and 3 times the human subcutaneous dose of 1 unit/kg/day, based on units/body surface area), mating and fertility were not adversely affected in either gender at any dose.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 176 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In Fischer 344 rats, a 12-month repeat-dose toxicity study was conducted with insulin lispro at subcutaneous doses of 20 and 200 units/kg/day (approximately 3 and 32 times the human subcutaneous dose of 1 unit/kg/day, based on units/body surface area). Insulin lispro did not produce important target organ toxicity including mammary tumors at any dose. Insulin lispro was not mutagenic in the following genetic toxicity assays: bacterial mutation, unscheduled DNA synthesis, mouse lymphoma, chromosomal aberration, and micronucleus assays.

Male fertility was not compromised when male rats given subcutaneous insulin lispro injections of 5 and 20 units/kg/day (0.8 and 3 times the human subcutaneous dose of 1 unit/kg/day, based on units/body surface area) for 6 months were mated with untreated female rats. In a combined fertility, perinatal, and postnatal study in male and female rats given 1, 5, and 20 units/kg/day subcutaneously (0.2, 0.8, and 3 times the human subcutaneous dose of 1 unit/kg/day, based on units/body surface area), mating and fertility were not adversely affected in either gender at any dose.

📄 Patient Package Insert ~3 min read ▾

LYUMJEV PATIENT PACKAGE INSERT This Patient Information has been approved by the U.S. Food and Drug Administration Revised: October 2022 Patient Information LYUMJEV ® (LOOM-jehv) (insulin lispro-aabc) injection, for subcutaneous or intravenous use Do not share your LYUMJEV 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.

What is LYUMJEV? LYUMJEV is a man-made fast-acting insulin used to control high blood sugar in adults and children with diabetes mellitus. Do not take LYUMJEV if you: are having an episode of low blood sugar (hypoglycemia). have an allergy to insulin lispro-aabc or any of the ingredients in LYUMJEV.

See the end of this Patient Information leaflet for a complete list of ingredients in LYUMJEV. Before taking LYUMJEV, tell your healthcare provider about all of your medical conditions, including if you: have kidney or liver problems. take any other medicines, especially ones called thiazolidinediones (TZDs). have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with LYUMJEV. are pregnant or plan to become pregnant.

Talk with your healthcare provider about the best way to control your blood sugar if you plan to become pregnant or while you are pregnant. are breastfeeding or plan to breastfeed. It is not known if LYUMJEV passes into your breast milk. You and your healthcare provider should decide if you will take LYUMJEV while you breastfeed.

Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Before you start taking LYUMJEV, talk to your healthcare provider about low blood sugar and how to manage it. How should I take LYUMJEV?

Read the Instructions for Use that come with your LYUMJEV. Take LYUMJEV exactly as your healthcare provider tells you to. Your healthcare provider will tell you how much LYUMJEV to take and when to take it.

LYUMJEV starts acting fast. Inject LYUMJEV at the beginning of a meal or within 20 minutes after you start eating a meal. Know the type and strength of insulin you take.

Do not change the type or amount 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. Check your insulin label each time you give your injection to make sure you are using the correct insulin.

Check your blood sugar levels. Ask your healthcare provider what your blood sugars should be and when you should check your blood sugar level. LYUMJEV comes in U-100 (100 units/mL) and U-200 (200 units/mL) insulin strengths.

LYUMJEV U-200 contains 2 times as much insulin (200 units/mL) in 1 mL as LYUMJEV U-100 (100 units/mL). LYUMJEV U-100 and LYUMJEV U-200 can be injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs, or upper arms. LYUMJEV U-100 can be given by continuous infusion under the skin (subcutaneously) through an insulin pump into an area of your body recommended in the instructions that come with your insulin pump.

LYUMJEV U-200 cannot be given through an insulin pump. LYUMJEV U-100 can also be given in your vein (intravenously) by your healthcare provider. LYUMJEV U-200 cannot be given in your vein.

Change (rotate) your injection sites within the area you choose with each dose to reduce your risk of getting pits in skin or thickened skin (lipodystrophy) and skin with lumps (localized cutaneous amyloidosis) at the injection sites. Do not use the exact same spot for each injection. Do not inject where the skin has pits, is thickened, or has lumps.

Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin. If you miss a dose of LYUMJEV, monitor your blood sugar levels to decide if an insulin dose is needed. Continue with your regular dosing schedule at the next meal.

LYUMJEV co… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

LYUMJEV VIAL U-100 INSTRUCTIONS FOR USE Instructions for Use LYUMJEV™ (LOOM-jehv) (insulin lispro-aabc) injection for subcutaneous use (100 units/mL, 10 mL multiple-dose vial) Read the Instructions for Use before you start taking LYUMJEV and each time you get a new vial. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Do not share your syringes or needles with other people. You may give other people a serious infection or get a serious infection from them. Supplies needed to give your injection a multiple-dose LYUMJEV vial a U-100 insulin syringe and needle (Becton, Dickinson and Company syringes and needles recommended) 2 alcohol swabs gauze (optional) 1 sharps container for throwing away used syringes and needles.

See “ Disposing of used syringes and needles ” at the end of these instructions. Preparing your LYUMJEV dose Wash your hands with soap and water. Check the LYUMJEV label to make sure you are taking the right type of insulin.

This is especially important if you use more than 1 type of insulin. LYUMJEV should look clear and colorless. Do not use LYUMJEV if it is thick, cloudy, or colored, or if you see lumps or particles in it.

Do not use LYUMJEV past the expiration date printed on the label or 28 days after you first use it. Always use a new syringe and needle for each injection to prevent infections and blocked needles. Do not mix LYUMJEV U-100 with other insulins.

Step 1: If you are using a new vial, pull off the plastic protective cap, but do not remove the rubber stopper. Step 2: Wipe the rubber stopper with an alcohol swab. Step 3: Remove the needle shield from the syringe by pulling the needle shield straight off.

Hold the syringe with the needle pointing up. Pull down on the plunger until the plunger tip reaches the line for the number of units for your prescribed dose. (Example Dose: 20 units shown) Step 4: Push the needle through the rubber stopper of the vial.

Step 5: Push the plunger all the way in. This puts air into the vial. Step 6: Turn the vial and syringe upside down and slowly pull the plunger down until the plunger tip is a few units past the line for your prescribed dose.

(Example Dose: 20 units, plunger is shown at 24 units) If there are air bubbles, tap the syringe gently a few times to let any air bubbles rise to the top. Step 7: Slowly push the plunger up until the plunger tip reaches the line for your prescribed dose. Check the syringe to make sure that you have the right dose.

(Example Dose: 20 units shown) Step 8: Pull the syringe out of the rubber stopper of the vial. Giving your LYUMJEV injection with a syringe Inject your insulin exactly as your healthcare provider has shown you. Your healthcare provider should tell you if you should pinch the skin before injecting.

LYUMJEV starts acting fast, so give your injection at the start of a meal or within 20 minutes after you start a meal. Change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites. Do not use the exact same spot for each injection.

Do not inject where the skin has pits, is thickened, or has lumps. Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin. Step 9: Choose your injection site.

LYUMJEV is injected under the skin (subcutaneously) of your stomach area (abdomen), buttocks, upper legs, or upper arms. Wipe your skin with an alcohol swab, and let your skin dry before you inject your dose. Step 10: Insert the needle into your skin.

Step 11: Push down on the plunger to inject your dose. The needle should stay in your skin for at least 5 seconds after pushing down on the plunger to make sure you have injected all of your insulin dose. Step 12: Pull the needle out of your skin.

If you see blood after you take… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 7 words ▾

Indications and Usage ( 1 ) 10/2022

📄 Package Label / Principal Display Panel ~2 min read ▾

PACKAGE LABEL – LYUMJEV U100 Vial Carton NDC 0002-7728-01 LYUMJEV TM (insulin lispro-aabc) injection 100 units per mL (U-100) for subcutaneous or intravenous use 10 mL multiple-dose vial Rx only www.lyumjev.com Lilly PACKAGE LABEL – LYUMJEV U100 Vial Carton

PACKAGE LABEL – LYUMJEV U100 Cartridges 5 Count Carton NDC 0002-7726-05 5 x 3 mL Cartridges LYUMJEV TM (insulin lispro-aabc) injection For Single Patient Use Only 100 units per mL (U-100) For subcutaneous use Rx only For use in Eli Lilly and Company's HumaPen ® LUXURA ® HD and other compatible insulin delivery devices. www.lyumjev.com Lilly PACKAGE LABEL – LYUMJEV U100 Cartridges 5 Count Carton

PACKAGE LABEL – LYUMJEV U100 KwikPen 5 Count Carton Dispense in this sealed carton. NDC 0002-8207-05 LYUMJEV TM KwikPen ® (insulin lispro-aabc) injection For Single Patient Use Only 100 units per mL (U-100) For subcutaneous use 5 x 3 mL prefilled pens Rx only Needles not included This device is recommended for use with Becton, Dickinson and Company's insulin pen needles. Lilly PACKAGE LABEL – LYUMJEV U100 KwikPen 5 Count Carton

PACKAGE LABEL – LYUMJEV U100 Junior KwikPen 5 Count Carton Dispense in this sealed carton. NDC 0002-8351-05 LYUMJEV TM Junior KwikPen ® (insulin lispro-aabc) injection For Single Patient Use Only 100 units per mL (U-100) This pen can deliver 0.5 (1/2) to 30 units in one injection. 5 x 3 mL prefilled pens For subcutaneous use Rx only Needles not included This device is recommended for use with Becton, Dickinson and Company's insulin pen needles.

Lilly PACKAGE LABEL – LYUMJEV U100 Junior KwikPen 5 Count Carton

PACKAGE LABEL – LYUMJEV U100 Tempo Pen 5 Count Carton Dispense in this sealed carton. NDC 0002-8235-05 LYUMJEV TM Tempo Pen TM (insulin lispro-aabc) injection For Single Patient Use Only 100 units per mL (U-100) For subcutaneous use 5 x 3 mL prefilled pens Rx only Needles not included This device is recommended for use with Becton, Dickinson and Company's insulin pen needles. Lilly PACKAGE LABEL – LYUMJEV U100 Tempo Pen 5 Count Carton

PACKAGE LABEL – LYUMJEV U200 KwikPen 5 Count Carton Dispense in this sealed carton. NDC 0002-8228-27 LYUMJEV TM KwikPen ® (insulin lispro-aabc) injection For Single Patient Use Only 200 units per mL (U-200) For subcutaneous use 2 x 3 mL prefilled pens Rx only Needles not included This device is recommended for use with Becton, Dickinson and Company's insulin pen needles. Lilly DO NOT TRANSFER TO A SYRINGE SEVERE OVERDOSE CAN RESULT PACKAGE LABEL – LYUMJEV U200 KwikPen 5 Count Carton

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
8.3K
Units reimbursed last 4 qtrs
277.3K
Gross reimbursed last 4 qtrs
$6.49M
Avg / prescription
$785.32
Avg / unit
$23.3906
Latest quarter Q1 2026
2.1KRx
Medicaid pays / mL
$23.3906
gross reimbursed
vs
NADAC / mL
$7.8733
acquisition cost
=
Spread
+$15.5173
+197% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
38% FFS 62% MCO
Fee-for-service · 3,166 Rx Managed care · 5,093 Rx
State Medicaid map
Alaska: 2,390 units · 326 per 100k residents AK Maine: 3,000 units · 215 per 100k residents ME Washington: 13,390 units · 171 per 100k residents WA Idaho: 4,330 units · 220 per 100k residents ID Montana: 980 units · 86.6 per 100k residents MT North Dakota: no data reported ND Minnesota: 2,470 units · 43.1 per 100k residents MN Wisconsin: 2,920 units · 49.4 per 100k residents WI Michigan: 26,660 units · 266 per 100k residents MI New York: 25,853 units · 132 per 100k residents NY Vermont: no data reported VT New Hampshire: 1,005 units · 71.7 per 100k residents NH Oregon: no data reported OR Nevada: 4,330 units · 136 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 2,850 units · 88.9 per 100k residents IA Illinois: 4,990 units · 39.8 per 100k residents IL Indiana: 6,650 units · 96.9 per 100k residents IN Ohio: 12,520 units · 106 per 100k residents OH Pennsylvania: 8,430 units · 65.0 per 100k residents PA New Jersey: 4,580 units · 49.3 per 100k residents NJ Massachusetts: 10,010 units · 143 per 100k residents MA California: 37,160 units · 95.4 per 100k residents CA Utah: no data reported UT Colorado: 9,650 units · 164 per 100k residents CO Nebraska: 2,510 units · 127 per 100k residents NE Missouri: 400 units · 6.5 per 100k residents MO Kentucky: 6,180 units · 137 per 100k residents KY West Virginia: 560 units · 31.6 per 100k residents WV Virginia: 5,690 units · 65.3 per 100k residents VA Maryland: 2,700 units · 43.7 per 100k residents MD Connecticut: 17,780 units · 492 per 100k residents CT Rhode Island: no data reported RI Arizona: 2,640 units · 35.5 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 7,830 units · 72.3 per 100k residents NC South Carolina: 1,740 units · 32.4 per 100k residents SC Delaware: no data reported DE Oklahoma: 4,850 units · 120 per 100k residents OK Louisiana: 6,630 units · 145 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 2,500 units · 22.7 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 9,220 units · 30.2 per 100k residents TX Florida: 21,890 units · 96.8 per 100k residents FL
Units reimbursed · per 100k residents
6.5492
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Connecticut 492 /100k
2 Alaska 326 /100k
3 Michigan 266 /100k
4 Idaho 220 /100k
5 Maine 215 /100k
6 Washington 171 /100k
7 Colorado 164 /100k
8 Louisiana 145 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 vial this page00002-7728-01 8,259 Rx · $6,485,932
1 vial00002-7728-99 No Medicaid data
Drug total (last 4 qtrs): 8,259 Rx · 277,288 units · $6,485,932 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Lyumjev — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Lyumjev. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$2.72M
Claims incl. refills
4.2K
Beneficiaries
3.1K
Spend / beneficiary
$886.07
Spend / claim
$653.11
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
← 00002-7726-05 · Eli 00002-7737-01 · Eli →
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.