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Insulin Lispro 100 [iU]/mL Injection, Solution — NDC 00002-7737-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Insulin Lispro 100 [iU]/mL Injection, Solution — NDC 0002-7737-01 (Billing 00002-7737-01)

by Eli Lilly and Company · 1 VIAL in 1 CARTON / 10 mL in 1 VIAL

This is a package of Insulin Lispro 100 [iU]/mL Injection, Solution from Eli Lilly and Company, marketed since Feb 2020 and currently FDA-listed; retail pharmacies pay about $2.40 per mL (NADAC). It is this product's only package size.

NDC 00002-7737-01
🏷️ FDA NDC (as labeled) 0002-7737-01 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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 0002-7737-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0002 labeler · 7737 product · 01 package
Package marketed since
Feb 12, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0002773701 0
Medicaid fills, this package
557,841 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Insulin Lispro (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Apr 11, 2023 — Lack of Assurance of Sterility: Malformed crimped collar seal (Sanofi-Aventis U.S. LLC) · FDA recall D-0575-2023
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0002-7737-01
Product NDC 0002-7737
11-digit billing NDC 00002773701
NCPDP billing unit ML — per mL (volume)
RxCUI 242120, 1652639, 1926331
UNII GFX7QIS1II
Application # BLA020563
SPL Set ID 97d5e596-aae1-42c9-ae89-c3780959c467
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 2020-02-12
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

GPI-14 27104005002022
GPI class Insulin Lispro
GCN Seq No 027413
GCN 05679
HICL code 011528
Ingredient (HICL) Insulin Lispro
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 INSULIN LISPRO 100 UNIT/ML VL
FDB brand name Insulin Lispro
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 027413
  • GCN: 05679
  • GPI-14 (Medi-Span): 27104005002022
  • HICL (First Databank): 011528
  • AHFS class code: 68:20.08.00
  • RxCUI (RxNorm): 242120
Why two NDCs? The FDA registers this code as 0002-7737-01 — 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 → 00002-7737-01. 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 INSULIN LISPRO 100 UNIT/ML VL Ingredient Insulin Lispro
📗 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 may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Insulin Lispro 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 $2.403 $24.03 / 10 ml
Medicaid paysCMS SDUD · 12 mo $2.63 $26.28 / 10 ml
Medicare drug plans payPart D · Q2 2026 $2.41 $24.14 / 10 ml
Medicare Part B allowsASP · J1817 $3.062 / J1817 unit —
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Aug 2022 Jan 2026 Sep 2026 $13.175 $2.399
▼ Down 82% over the last 24 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)0002-7737-01
11-digit billing NDC00002-7737-01
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ1817
DescriptorINSULIN 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))$7,997,475 · 28,262 claims · $282.98 per claim (all NDCs under J1817)
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
00002-7737-01 You're viewing this Main listing 1 VIAL in 1 CARTON / 10 mL in 1 VIAL 2020-02-12 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Insulin Lispro 100 [iU]/mLthis 00002-7737-01 Eli 1 vial $2.403 — Availability likely —
Humalog 100 [iU]/mL 00002-7510-01 Eli 1 vial $6.357 — Availability likely +165%
Admelog 100 U/mL 00024-5924-10 Sanofi-Aventis 1 vial $9.394 — Availability likely +291%
Humalog 100 [iU]/mL 00002-7516-59 Eli 5 cartridges $9.786 — Availability likely +307%
Humalog KwikPen 100 [iU]/mL 00002-8799-59 Eli 5 syringes $10.168 — Availability likely +323%
Insulin Lispro KwikPen 100 [iU]/mL 00002-8222-59 Eli 5 syringes $10.193 — Availability likely +324%
Admelog 100 U/mL 00024-5926-05 Sanofi-Aventis 1 vial $12.561 — Availability likely +423%
Humalog 100 [iU]/mL 50090-1375-00 A-S 1 vial — — FDA listed —
Humalog 100 [iU]/mL 50090-4488-00 A-S 1 vial — — FDA listed —
Insulin Lispro 100 [iU]/mL 50090-5391-00 A-S 1 vial — — FDA listed —
Humalog KwikPen 100 [iU]/mL 50090-4073-00 A-S 5 syringes — — FDA listed —
Humalog KwikPen 100 [iU]/mL 50090-1663-00 A-S 5 syringes — — 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

🏛️
1996
First FDA approval
Jun 1996
📍
2026
Currently FDA-listed
30 years listed
🧬
·
Biosimilars
see Purple Book
🧬Biologic — competition comes from biosimilars

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

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.
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.

  • 16 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.
  • 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 339NCG44TV
    Phenol is a chemical compound derived from coal tar or petroleum. It serves as a preservative and antimicrobial agent in medicines, helping prevent bacterial and fungal growth to keep the product stable and safe during storage.
  • 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.
  • 1.0 mg / 1 mL UNII GR686LBA74
    Sodium phosphate, dibasic is a salt derived from phosphoric acid. It acts as a buffer to help maintain the medicine's pH balance and may serve as a binder or filler in tablets and capsules.
  • 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.
  • .0197 mg / 1 mL UNII J41CSQ7QDS
    A mineral element that strengthens tablet structure and acts as a processing aid. Zinc helps bind ingredients together and may improve the medicine's stability during manufacturing and storage.

8 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 applicationBLA020563 (BLA)
Labeler code00002
First marketedFeb 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 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 45 words ▾

1 INDICATIONS AND USAGE Insulin Lispro is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Insulin Lispro 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 , 2.3 , 2.4 ) Subcutaneous Injection ( 2.2 ): Administer Insulin Lispro by subcutaneous injection into the abdominal wall, thigh, upper arm, or buttocks within 15 minutes before a meal or immediately after a meal. Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis.

Continuous subcutaneous infusion (Insulin Pump) ( 2.2 ): Refer to the insulin infusion pump user manual to see if Humalog can be used. Use in accordance with the insulin pump instructions for use. Administer Insulin Lispro by continuous subcutaneous infusion using an insulin pump in a region recommended in the instructions from the pump manufacturer.

Rotate infusion sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis. Intravenous Infusion ( 2.2 ): Administer Insulin Lispro by intravenous infusion ONLY after dilution and under medical supervision. The dosage of Insulin Lispro must be individualized based on the route of administration and the individual's metabolic needs, blood glucose monitoring results and glycemic control goal.

( 2.3 ) Do not perform dose conversion when using the Insulin Lispro prefilled pens. The dose window shows the number of insulin units to be delivered and no conversion is needed. ( 2.1 , 2.3 )

2.1Important Administration Instructions Always check insulin labels before administration. This product is HUMALOG (insulin lispro) [see Warnings and Precautions ( 5.4 )] . Inspect Insulin Lispro visually before use.

It should appear clear and colorless. Do not use Insulin Lispro if particulate matter or coloration is seen. Use Insulin Lispro prefilled pens with caution in patients with visual impairment that may rely on audible clicks to dial their dose.

Do NOT mix Insulin Lispro with other insulins when using a continuous subcutaneous infusion pump. Do NOT perform dose conversion when using any Insulin Lispro prefilled pens. The dose window shows the number of insulin units to be delivered and no conversion is needed.

2.2Administration Instructions for the Approved Routes of Administration Subcutaneous Injection Administer the dose of Insulin Lispro within fifteen minutes before a meal or immediately after a meal by injection into the subcutaneous tissue of the abdominal wall, thigh, upper arm, or buttocks. Rotate the injection site within the same region from one injection to the next (abdominal wall, thigh, upper arm, or buttocks) 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 ( 5.2 ) and Adverse Reactions ( 6 )] .

During changes to a patient's insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions ( 5.2 )] . Insulin Lispro administered by subcutaneous injection should generally be used in regimens with an intermediate- or long-acting insulin. The Insulin Lispro KwikPen dials in 1 unit increments and delivers a maximum dose of 60 units per injection.

The Insulin Lispro Junior KwikPen dials in 0.5 unit increments and delivers a maximum dose of 30 units per injection. Subcutaneous Injection: Diluted Insulin Lispro Insulin Lispro may be diluted with Sterile Diluent for Insulin Lispro for subcutaneous injection ONLY under medical supervision. Dilute one part Insulin Lispro to: Nine parts diluent to yield a concentration one-tenth that of Insulin Lispro (equivalent to U-10).

One part diluent to yield a concentration one-half that of Insulin Lispro (equivalent to U-50). Diluted Insulin Lispro for subcutaneous injection may be stored for 28 days when refrigerated at 41°F (5°C) and for 14 days at room temperature up to 86°F (30°C). Continuous Subcutaneous Infusion (Insulin Pump) This Insulin Lispro product can be used with continuous subcutaneous insulin infusion pumps labeled for use with Humalog (insul… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 61 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 KwikPen prefilled pen 3 mL single-patient-use Junior KwikPen prefilled pen Injection: 100 units/mL (U-100) is available as: ( 3 ) 10 mL multiple-dose vial 3 mL single-patient-use KwikPen ® prefilled pen 3 mL single-patient-use Junior KwikPen ® prefilled pen

⛔ Contraindications 74 words ▾

4 CONTRAINDICATIONS Insulin Lispro is contraindicated: during episodes of hypoglycemia [see Warnings and Precautions ( 5.3 )] . in patients who are hypersensitive to Insulin Lispro or to any of the excipients in Insulin Lispro [see Warnings and Precautions ( 5.5 )] . Do not use during episodes of hypoglycemia. ( 4 ) Do not use in patients with hypersensitivity to Insulin Lispro or any of the excipients in Insulin Lispro. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Never share an Insulin Lispro prefilled pen or syringe 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 blood glucose monitoring. ( 5.2 ) Hypoglycemia: May be life-threatening.

Monitor blood glucose and increase monitoring frequency with changes to insulin dosage, use of glucose lowering medications, meal pattern, physical activity; in patients with renal or hepatic impairment; and in patients with hypoglycemia unawareness. ( 5.3 , 7 , 8.6 , 8.7 ) Hypoglycemia Due to Medication Errors: Accidental mix-ups between insulin products can occur. Instruct patients to check insulin labels before injection.

( 5.4 ) Hypersensitivity Reactions: May be life-threatening. Discontinue Insulin Lispro, monitor and treat if indicated. ( 5.5 ) Hypokalemia: May be life-threatening.

Monitor potassium levels in patients at risk of hypokalemia 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 if heart failure occurs. ( 5.7 ) Hyperglycemia and Ketoacidosis Due to Insulin Pump Device Malfunction: Monitor glucose and administer Insulin Lispro by subcutaneous injection if pump malfunction occurs.

( 5.8 )

5.1Never Share an Insulin Lispro Prefilled Pen or Syringe Between Patients Insulin Lispro prefilled pens must never be shared between patients, even if the needle is changed. Patients using Insulin Lispro 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 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 )] .

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 antidiabetic products may be needed.

5.3Hypoglycemia Hypoglycemia is the most common adverse reaction associated with insulins, including Insulin Lispro. 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).

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 ( 7 )] , or in patients who experience recurrent hypoglycemia. Risk Factors for Hypoglycemia The risk of hypoglycemia after an injection is related to the duration of action of the insulin and, in general, is highest when the glucose lowering effect of the insulin is maximal.

As with all insulins, the glucose low… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

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

Hypokalemia [see Warnings and Precautions ( 5.6 )] . Adverse reactions associated with Insulin Lispro include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, and rash. ( 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 designs, the adverse reaction rates reported in one clinical trial may not be easily compared with those rates reported in another clinical trial, and may not reflect the rates actually observed in clinical practice. Common adverse reactions, excluding hypoglycemia, were defined as events that occurred in ≥5% of patients treated with Insulin Lispro or regular human insulin. The frequencies of adverse reactions during Insulin Lispro clinical trials in patients with type 1 diabetes mellitus and type 2 diabetes mellitus are listed in the tables below.

Table 1: Adverse Reactions That Occurred in ≥5% in Patients with Type 1 Diabetes Mellitus Insulin Lispro (%) (n=81) Regular human insulin (%) (n=86) Flu syndrome 34.6

32.6Pharyngitis 33.3

33.7Rhinitis 24.7

29.1Headache 29.6

22.1Pain 19.8

16.3Cough increased 17.3

17.4Infection 13.6

20.9Nausea 6.2

15.1Accidental injury 8.6

11.6Surgical procedure 6.2

14.0Fever 6.2

11.6Abdominal pain 7.4

8.1Asthenia 7.4

8.1Bronchitis 7.4

7.0Diarrhea 8.6

5.8Dysmenorrhea 6.2

7.0Myalgia 7.4

5.8Urinary tract infection 6.2

4.7Table 2: Adverse Reactions That Occurred in ≥5% in Patients with Type 2 Diabetes Mellitus Insulin Lispro (%) (n=714) Regular human insulin (%) (n=709) Headache 11.6

9.3Pain 10.8

10.0Infection 10.1

7.6Pharyngitis 6.6

8.2Rhinitis 8.1

6.6Flu syndrome 6.2

8.2Surgical procedure 7.4

6.8Insulin initiation and intensification of glucose control Intensification or rapid improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy, and acute painful peripheral neuropathy. However, long-term glycemic control decreases the risk of diabetic retinopathy and neuropathy. Hypoglycemia Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including Insulin Lispro.

Lipodystrophy Long-term use of insulin, including Insulin Lispro, can cause lipodystrophy at the site of repeated insulin injections or infusion. Lipodystrophy includes lipohypertrophy (thickening of adipose tissue) and lipoatrophy (thinning of adipose tissue), and may affect insulin absorption [see Dosage and Administration ( 2.2 )] . Weight gain Weight gain can occur with insulins, including Insulin Lispro, and has been attributed to the anabolic effects of insulin and the decrease in glucosuria.

Peripheral Edema Insulins, including Insulin Lispro, may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy. Adverse Reactions with Continuous Subcutaneous Insulin Infusion (CSII) In a 12-week, randomized, crossover study in adult patients with type 1 diabetes (n=39), the rates of catheter occlusions and infusion site reactions were similar for Insulin Lispro and regular human insulin treated patients ( see Table 3 ). Table 3: Catheter Occlusions and Infusion Site Reactions Insulin Lispro (n=38) Regular human insulin (n=39) Catheter occlusions/month 0.09

0.10Infusion site reactions 2.6% (1/38) 2.6% (1/39) In a randomized, 16-week, open-label, parallel design study of pediatric patients with type 1 diabetes, adverse reactions related to infusion-site reactions were similar for Insulin Lispro and insulin aspart (2… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS The table below includes clinically significant drug interactions with Insulin Lispro. 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 analog (e.g., octreotide), and sulfonamide antibiotics. Intervention: Dose adjustment and increased frequency of glucose monitoring may be required when Insulin Lispro is co-administered with these drugs.

Drugs That May Decrease the Blood Glucose Lowering Effect of Insulin Lispro 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 adjustment and increased frequency of glucose monitoring may be required when Insulin Lispro is co-administered with these drugs.

Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of Insulin Lispro 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 Insulin Lispro 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 Insulin Lispro 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), and sulfonamide antibiotics ( 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 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 6-10% in women with pre-gestational diabetes with a HbA1c >7 and has been reported to be as high as 20-25% in women with a HbA1c >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, 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, miscarriage, 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 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 Insulin Lispro or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of Insulin Lispro to improve glycemic control have been established in… [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 6-10% in women with pre-gestational diabetes with a HbA1c >7 and has been reported to be as high as 20-25% in women with a HbA1c >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, 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, miscarriage, 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 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 79 words ▾

8.4Pediatric Use The safety and effectiveness of Insulin Lispro to improve glycemic control have been established in pediatric patients with diabetes mellitus. Use of Insulin Lispro for this indication is supported by evidence from adequate and well-controlled studies in 831 pediatric patients with type 1 diabetes mellitus aged 3 years and older and from studies in adults with diabetes mellitus [see Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 ), and Clinical Studies ( 14 )] .

🧓 Geriatric Use 66 words ▾

8.5Geriatric Use Of the total number of patients (n=2,834) in eight clinical studies of Insulin Lispro, twelve percent (n=338) were 65 years of age or over. The majority of these patients had type 2 diabetes. HbA 1c values and hypoglycemia rates did not differ by age. Pharmacokinetic/pharmacodynamic studies to assess the effect of age on the onset of Insulin Lispro action have not been performed.

🆘 Overdosage 76 words ▾

10 OVERDOSAGE Excess insulin administration may cause hypoglycemia and hypokalemia. 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 a glucagon product for emergency use 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 Regulation of glucose metabolism is the primary activity of insulins and insulin analogs, including insulin lispro. Insulins lower blood 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 Insulin Lispro has been shown to be equipotent to human insulin on a molar basis. One unit of Insulin Lispro has the same glucose-lowering effect as one unit of regular human insulin. Studies in normal volunteers and patients with diabetes demonstrated that Insulin Lispro has a more rapid onset of action and a shorter duration of activity than regular human insulin when given subcutaneously.

The time course of action of insulin and insulin analogs, such as Insulin Lispro, may vary considerably in different individuals or within the same individual. The parameters of Insulin Lispro activity (time of onset, peak time, and duration) as designated in Figure 1 should be considered only as general guidelines. The rate of insulin absorption, and consequently the onset of activity are known to be affected by the site of injection, exercise, and other variables [see Warnings and Precautions ( 5.2 )] .

Figure 1: Blood Glucose Levels After Subcutaneous Injection of Regular Human Insulin or Insulin Lispro (0.2 unit/kg) Immediately Before a High Carbohydrate Meal in 10 Patients with Type 1 Diabetes a . a Baseline insulin concentration was maintained by infusion of 0.2 mU/min/kg human insulin. Figure 1 Intravenous Administration — The glucose lowering effect of intravenously administered Insulin Lispro was tested in 21 patients with type 1 diabetes. For the study, the patients' usual doses of insulin were held and blood glucose concentrations were allowed to reach a stable range of 200 to 260 mg/dL during a one to three hours run-in phase.

The run-in phase was followed by a 6-hour assessment phase. During the assessment phase, patients received intravenous Insulin Lispro at an initial infusion rate of 0.5 units/hour. The infusion rate of Insulin Lispro could be adjusted at regular timed intervals to achieve and maintain blood glucose concentrations between 100 to 160 mg/dL.

The mean blood glucose levels during the assessment phase for patients on Insulin Lispro therapy are summarized below in Table 4 . All patients achieved the targeted glucose range at some point during the 6-hour assessment phase. At the endpoint, blood glucose was within the target range (100 to 160 mg/dL) for 17 of 20 patients treated with Insulin Lispro.

The average time (±SE) required to attain near normoglycemia was 129 ± 14 minutes for Insulin Lispro. Table 4: Mean Blood Glucose Concentrations (mg/dL) During Intravenous Infusions of Insulin Lispro a Results shown as mean ± SD Time from Start of Infusion (minutes) Mean Blood Glucose (mg/dL) Intravenous 0 224 ± 16 30 205 ± 21 60 195 ± 20 120 165 ± 26 180 140 ± 26 240 123 ± 20 300 120 ± 27 360 122 ± 25

12.3Pharmacokinetics Absorption and Bioavailability — Studies in healthy volunteers and patients with diabetes demonstrated that Insulin Lispro is absorbed more quickly than regular human insulin. In healthy volunteers given subcutaneous doses of Insulin Lispro ranging from 0.1 to 0.4 unit/kg, peak serum levels were seen 30 to 90 minutes after dosing. When healthy volunteers received equivalent doses of regular human insulin, peak insulin levels occurred between 50 to 120 minutes after dosing.

Similar results were seen in patients with type 1 diabetes ( see Figure 2 ). Figure 2: Serum Insulin Lispro and Insulin Levels After Subcutaneous Injection of Regular Human Insulin or Insulin Lispro (0.2 unit/kg) Immediately Before a High Carbohydrate Meal in 10 Patients with Type 1 Diabetes a . a Baseline insulin concentration was maintained by infusion of 0.2 mU/min/kg human insulin. Insulin Lispro was absorbed at a consistently… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 49 words ▾

12.1Mechanism of Action Regulation of glucose metabolism is the primary activity of insulins and insulin analogs, including insulin lispro. Insulins lower blood 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 ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Insulin Lispro injection is a clear and colorless solution available as: Insulin Lispro Total Volume Concentration NDC Number Package Size U-100 multiple-dose vial 10 mL 100 units/mL 0002-7737-01 1 vial U-100 single-patient-use KwikPen 3 mL 100 units/mL 0002-8222-59 5 pens U-100 single-patient-use Junior KwikPen 3 mL 100 units/mL 0002-7752-05 5 pens The KwikPen dials in 1-unit increments. The Junior KwikPen dials in 0.5-unit increments. Each Insulin Lispro prefilled pen is for single-patient-use only.

Insulin Lispro prefilled pens must never be shared between patients, even if the needle is changed. Patients using Insulin Lispro vials must never share needles or syringes with another person.

16.2Storage and Handling Dispense in the original sealed carton with the enclosed Instructions for Use. Protect from direct heat and light. Do not freeze and do not use if it has been frozen.

See table below for storage information: * When stored at room temperature, Insulin Lispro can only be used for a total of 28 days, including both not in-use (unopened) and in-use (opened) storage time. Not In-Use (Unopened) Room Temperature (Up to 86°F [30°C]) Not In-Use (Unopened) Refrigerated (36° to 46°F [2° to 8°C]) In-Use (Opened) (see temperature below*) 10 mL multiple-dose vial 28 days Until expiration date 28 days Refrigerated or room temperature. 3 mL single-patient-use Insulin Lispro KwikPen 28 days Until expiration date 28 days Room temperature only (Do not refrigerate) 3 mL single-patient-use Insulin Lispro Junior KwikPen 28 days Until expiration date 28 days Room temperature only (Do not refrigerate) Use in an External Insulin Pump — Change the Insulin Lispro in the reservoir at least every 7 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 Diluted Insulin Lispro for Subcutaneous Injection — Diluted Insulin Lispro for subcutaneous injection may be stored for 28 days when refrigerated at 41°F (5°C) and 14 days at room temperature up to 86°F (30°C) [see Dosage and Administration ( 2.2 )] . Do not dilute Insulin Lispro used in an external insulin pump. Storage of Intravenous Infusion Preparations with Insulin Lispro Intravenous infusion bags prepared with Insulin Lispro maybe stored for 48 hours when refrigerated at 36° to 46°F (2° to 8°C).

The prepared intravenous bags may then be used at room temperature for up to an additional 48 hours [see Dosage and Administration ( 2.2 )] .

16.1How Supplied Insulin Lispro injection is a clear and colorless solution available as: Insulin Lispro Total Volume Concentration NDC Number Package Size U-100 multiple-dose vial 10 mL 100 units/mL 0002-7737-01 1 vial U-100 single-patient-use KwikPen 3 mL 100 units/mL 0002-8222-59 5 pens U-100 single-patient-use Junior KwikPen 3 mL 100 units/mL 0002-7752-05 5 pens The KwikPen dials in 1-unit increments. The Junior KwikPen dials in 0.5-unit increments. Each Insulin Lispro prefilled pen is for single-patient-use only.

Insulin Lispro prefilled pens must never be shared between patients, even if the needle is changed. Patients using Insulin Lispro vials must never share needles or syringes with another person.

📦 Storage and Handling ~1 min read ▾

16.2Storage and Handling Dispense in the original sealed carton with the enclosed Instructions for Use. Protect from direct heat and light. Do not freeze and do not use if it has been frozen.

See table below for storage information: * When stored at room temperature, Insulin Lispro can only be used for a total of 28 days, including both not in-use (unopened) and in-use (opened) storage time. Not In-Use (Unopened) Room Temperature (Up to 86°F [30°C]) Not In-Use (Unopened) Refrigerated (36° to 46°F [2° to 8°C]) In-Use (Opened) (see temperature below*) 10 mL multiple-dose vial 28 days Until expiration date 28 days Refrigerated or room temperature. 3 mL single-patient-use Insulin Lispro KwikPen 28 days Until expiration date 28 days Room temperature only (Do not refrigerate) 3 mL single-patient-use Insulin Lispro Junior KwikPen 28 days Until expiration date 28 days Room temperature only (Do not refrigerate) Use in an External Insulin Pump — Change the Insulin Lispro in the reservoir at least every 7 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 Diluted Insulin Lispro for Subcutaneous Injection — Diluted Insulin Lispro for subcutaneous injection may be stored for 28 days when refrigerated at 41°F (5°C) and 14 days at room temperature up to 86°F (30°C) [see Dosage and Administration ( 2.2 )] . Do not dilute Insulin Lispro used in an external insulin pump. Storage of Intravenous Infusion Preparations with Insulin Lispro Intravenous infusion bags prepared with Insulin Lispro maybe stored for 48 hours when refrigerated at 36° to 46°F (2° to 8°C).

The prepared intravenous bags may then be used at room temperature for up to an additional 48 hours [see Dosage and Administration ( 2.2 )] .

📋 Description 181 words ▾

11 DESCRIPTION Insulin lispro is a rapid-acting human insulin analog produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli . Insulin lispro 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 5.808 kDa, both identical to that of human insulin.

Insulin lispro has the following primary structure: Insulin Lispro injection is a sterile, clear, and colorless solution for subcutaneous or intravenous use. Each mL of Insulin Lispro contains 100 units of insulin lispro, and the inactive ingredients: dibasic sodium phosphate (1.0 mg), glycerin (16 mg), metacresol (3.15 mg), trace amounts of phenol, zinc oxide (content adjusted to provide 0.0197 mg zinc ion), and Water for Injection, USP. Insulin Lispro has a pH of 7.0 to 7.8.

Hydrochloric acid 10% and/or sodium hydroxide 10% is added to adjust the pH. 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 an Insulin Lispro Prefilled Pen or Syringe Between Patients Advise patients that they must never share an Insulin Lispro prefilled pen with another person, even if the needle is changed. Advise patients using Insulin Lispro 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 Instruct patients on self-management procedures including glucose monitoring, proper injection technique, and management of hypoglycemia and hyperglycemia, especially at initiation of Insulin Lispro 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 container label before each injection to avoid mix-ups between insulin products [see Warnings and Precautions ( 5.4 )] . Hypersensitivity Reactions Advise patients that hypersensitivity reactions have occurred with Insulin Lispro.

Inform patients on the symptoms of hypersensitivity reactions [see Warnings and Precautions ( 5.5 )] . Instructions For Patients Using Continuous Subcutaneous Insulin Pumps 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.

This Insulin Lispro product can be used with continuous subcutaneous insulin infusion pumps labeled for use with Humalog (insulin lispro) – refer to the insulin pump user manual to see if Humalog can be used. See recommended reservoir and infusion sets in the insulin pump user manual. Instruct patients to replace insulin in the reservoir at least every 7 days, or according to the pump user manual, whichever is shorter; infusion sets and infusion set insertion sites should be changed in accordance with the manufacturers' user manual.

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). The temperature of the insulin may exceed ambient temperature when the pump housing, cover, tubing or sport case is exposed to sunlight or radiant heat.

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 )] . Manufactured by: Eli Lilly and Company Indianapolis, IN 46285, USA US License Number 1891 Humalog ® and KwikPen ® are r… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Absorption and Bioavailability — Studies in healthy volunteers and patients with diabetes demonstrated that Insulin Lispro is absorbed more quickly than regular human insulin. In healthy volunteers given subcutaneous doses of Insulin Lispro ranging from 0.1 to 0.4 unit/kg, peak serum levels were seen 30 to 90 minutes after dosing. When healthy volunteers received equivalent doses of regular human insulin, peak insulin levels occurred between 50 to 120 minutes after dosing.

Similar results were seen in patients with type 1 diabetes ( see Figure 2 ). Figure 2: Serum Insulin Lispro and Insulin Levels After Subcutaneous Injection of Regular Human Insulin or Insulin Lispro (0.2 unit/kg) Immediately Before a High Carbohydrate Meal in 10 Patients with Type 1 Diabetes a . a Baseline insulin concentration was maintained by infusion of 0.2 mU/min/kg human insulin. Insulin Lispro was absorbed at a consistently faster rate than regular human insulin in healthy male volunteers given 0.2 unit/kg at abdominal, deltoid, or femoral subcutaneous sites.

After Insulin Lispro was administered in the abdomen, serum drug levels were higher and the duration of action was slightly shorter than after deltoid or thigh administration. Bioavailability of Insulin Lispro is similar to that of regular human insulin. The absolute bioavailability after subcutaneous injection ranges from 55% to 77% with doses between 0.1 to 0.2 unit/kg, inclusive.

Figure 2 Distribution — When administered intravenously as bolus injections of 0.1 and

0.2U/kg dose in two separate groups of healthy subjects, the mean volume of distribution of Insulin Lispro appeared to decrease with increase in dose (1.55 and

0.72L/kg, respectively) in contrast to that of regular human insulin for which, the volume of distribution was comparable across the two dose groups (1.37 and

1.12L/kg for 0.1 and

0.2U/kg dose, respectively). Metabolism — Human metabolism studies have not been conducted. However, animal studies indicate that the metabolism of Insulin Lispro is identical to that of regular human insulin.

Elimination — After subcutaneous administration of Insulin Lispro, the t 1/2 is shorter than that of regular human insulin (1 versus 1.5 hours, respectively). When administered intravenously, Insulin Lispro and regular human insulin demonstrated similar dose-dependent clearance, with a mean clearance of 21.0 mL/min/kg and 21.4 mL/min/kg, respectively (0.1 unit/kg dose), and 9.6 mL/min/kg and 9.4 mL/min/kg, respectively (0.2 unit/kg dose). Accordingly, Insulin Lispro demonstrated a mean t 1/2 of 0.85 hours (51 minutes) and 0.92 hours (55 minutes), respectively for 0.1 unit/kg and 0.2 unit/kg doses, and regular human insulin mean t 1/2 was 0.79 hours (47 minutes) and 1.28 hours (77 minutes), respectively for 0.1 unit/kg and 0.2 unit/kg doses.

Specific Populations The effects of age, gender, race, obesity, pregnancy, or smoking on the pharmacokinetics of Insulin Lispro have not been studied. Renal Impairment — Type 2 diabetic patients with varying degree of renal impairment showed no difference in pharmacokinetics of regular insulin and Insulin Lispro. However, the sensitivity of the patients to insulin did change, with an increased response to insulin as the renal function declined.

Some studies with human insulin have shown increased circulating levels of insulin in patients with renal impairment [see Use in Specific Populations ( 8.6 )]. Hepatic Impairment — Type 2 diabetic patients with impaired hepatic function showed no effect on the pharmacokinetics of Insulin Lispro as compared to patients with no hepatic dysfunction. However, some studies with human insulin have shown increased circulating levels of insulin in patients with liver failure [see Use in Specific Populations ( 8.7 )].

🧬 Pharmacodynamics ~2 min read ▾

12.2Pharmacodynamics Insulin Lispro has been shown to be equipotent to human insulin on a molar basis. One unit of Insulin Lispro has the same glucose-lowering effect as one unit of regular human insulin. Studies in normal volunteers and patients with diabetes demonstrated that Insulin Lispro has a more rapid onset of action and a shorter duration of activity than regular human insulin when given subcutaneously.

The time course of action of insulin and insulin analogs, such as Insulin Lispro, may vary considerably in different individuals or within the same individual. The parameters of Insulin Lispro activity (time of onset, peak time, and duration) as designated in Figure 1 should be considered only as general guidelines. The rate of insulin absorption, and consequently the onset of activity are known to be affected by the site of injection, exercise, and other variables [see Warnings and Precautions ( 5.2 )] .

Figure 1: Blood Glucose Levels After Subcutaneous Injection of Regular Human Insulin or Insulin Lispro (0.2 unit/kg) Immediately Before a High Carbohydrate Meal in 10 Patients with Type 1 Diabetes a . a Baseline insulin concentration was maintained by infusion of 0.2 mU/min/kg human insulin. Figure 1 Intravenous Administration — The glucose lowering effect of intravenously administered Insulin Lispro was tested in 21 patients with type 1 diabetes. For the study, the patients' usual doses of insulin were held and blood glucose concentrations were allowed to reach a stable range of 200 to 260 mg/dL during a one to three hours run-in phase.

The run-in phase was followed by a 6-hour assessment phase. During the assessment phase, patients received intravenous Insulin Lispro at an initial infusion rate of 0.5 units/hour. The infusion rate of Insulin Lispro could be adjusted at regular timed intervals to achieve and maintain blood glucose concentrations between 100 to 160 mg/dL.

The mean blood glucose levels during the assessment phase for patients on Insulin Lispro therapy are summarized below in Table 4 . All patients achieved the targeted glucose range at some point during the 6-hour assessment phase. At the endpoint, blood glucose was within the target range (100 to 160 mg/dL) for 17 of 20 patients treated with Insulin Lispro.

The average time (±SE) required to attain near normoglycemia was 129 ± 14 minutes for Insulin Lispro. Table 4: Mean Blood Glucose Concentrations (mg/dL) During Intravenous Infusions of Insulin Lispro a Results shown as mean ± SD Time from Start of Infusion (minutes) Mean Blood Glucose (mg/dL) Intravenous 0 224 ± 16 30 205 ± 21 60 195 ± 20 120 165 ± 26 180 140 ± 26 240 123 ± 20 300 120 ± 27 360 122 ± 25

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The safety and efficacy of Insulin Lispro were studied in pediatric and adult patients with type 1 diabetes (n=789) and adult patients with type 2 diabetes (n=722).

14.1Type 1 Diabetes – Adults and Pediatric Patients Aged 12 Years and Older A 12-month, randomized, parallel, open-label, active-controlled study was conducted in patients with type 1 diabetes to assess the safety and efficacy of Insulin Lispro (n=81) compared with Humulin ® R [insulin human injection (100 units/mL)] (n=86). Insulin Lispro was administered by subcutaneous injection immediately prior to meals and Humulin R was administered 30 to 45 minutes before meals. Humulin ® U [ULTRALENTE ® human insulin (rDNA origin) extended zinc suspension] was administered once or twice daily as the basal insulin.

There was a 2- to 4-week run-in period with Humulin R and Humulin U before randomization. Most patients were Caucasian (97%). Forty-seven percent of the patients were male.

The mean age was 31 years (range 12 to 70 years). Glycemic control, the total daily doses of Insulin Lispro and Humulin R, and the incidence of severe hypoglycemia (as determined by the number of events that were not self-treated) were similar in the two treatment groups. There were no episodes of diabetic ketoacidosis in either treatment group.

Table 5: Type 1 Diabetes Mellitus – Adults and Pediatric Patients Aged 12 years and Older a Values are Mean ± SD b Severe hypoglycemia refers to hypoglycemia for which patients were not able to self-treat. Treatment Duration Treatment in Combination with: 12 months Humulin U Insulin Lispro Humulin R N 81 86 Baseline HbA 1c (%) a 8.2 ± 1.4 8.3 ±

1.7Change from baseline HbA 1c (%) a -0.1 ± 0.9 0.1 ±

1.1Treatment Difference in HbA 1c Mean (95% confidence interval) 0.4 (0.0, 0.8) Baseline short-acting insulin dose (units/kg/day) 0.3 ± 0.1 0.3 ±

0.1End-of-Study short-acting insulin dose (units/kg/day) 0.3 ± 0.1 0.3 ±

0.1Change from baseline short-acting insulin dose (units/kg/day) 0.0 ± 0.1 0.0 ±

0.1Baseline Body weight (kg) 72 ± 12.7 71 ±

11.3Weight change from baseline (kg) 1.4 ± 3.6 1.0 ±

2.6 Patients with severe hypoglycemia (n, %) b 14 (17%) 18 (21%)

14.2Type 1 Diabetes – Pediatric Patients An 8-month, crossover study of pediatric patients with type 1 diabetes (n=463), aged 9 to 19 years, compared two subcutaneous multiple-dose treatment regimens: Insulin Lispro or Humulin R, both administered with Humulin N (NPH human insulin) as the basal insulin. Insulin Lispro achieved glycemic control comparable to Humulin R, as measured by HbA 1c ( see Table 6 ), and both treatment groups had a comparable incidence of hypoglycemia. In a 9-month, crossover study of pediatric patients (n=60) with type 1 diabetes, aged 3 to 11 years, Insulin Lispro administered immediately before meals, Insulin Lispro administered immediately after meals and Humulin R administered 30 minutes before meals resulted in similar glycemic control, as measured by HbA 1c , and incidence of hypoglycemia, regardless of treatment group.

Table 6: Pediatric Subcutaneous Administration of Insulin Lispro in Type 1 Diabetes a Values are Mean ± SD b Severe hypoglycemia refers to hypoglycemia that required glucagon or glucose injection or resulted in coma. End point Baseline Insulin Lispro + NPH Humulin R + NPH HbA 1c (%) a 8.6 ± 1.5 8.7 ± 1.5 8.7 ±

1.6Change from baseline HbA 1c (%) a — 0.1 ± 1.1 0.1 ±

1.3Short-acting insulin dose (units/kg/day) a 0.5 ± 0.2 0.5 ± 0.2 0.5 ±

0.2Change from baseline short-acting insulin dose (units/kg/day) a — 0.01 ± 0.1 -0.01 ±

0.1Body weight (kg) a 59.1 ± 13.1 61.1 ± 12.7 61.4 ±

12.9Weight change from baseline (kg) a — 2.0 ± 3.1 2.3 ±

3.0Patients with severe hypoglycemia (n, %) b — 5 (1.1%) 5 (1.1%) Diabetic ketoacidosis (n, %) — 11 (2.4%) 9 (1.9%)

14.3Type 1 Diabetes – Adults: Continuous Subcutaneous Insulin Infusion To evaluate the administration of Insulin Lispro via external insulin pumps, two open-label, crossover design studies… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Standard 2-year carcinogenicity studies in animals have not been performed. 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.

13.2Animal Toxicology and/or Pharmacology In standard biological assays in fasted rabbits, 0.2 unit/kg of insulin lispro injected subcutaneously had the same glucose-lowering effect and had a more rapid onset of action as 0.2 unit/kg of regular human insulin.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 186 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Standard 2-year carcinogenicity studies in animals have not been performed. 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 ▾

Patient Package Insert This Patient Information has been approved by the U.S. Food and Drug Administration Revised: 07/2023 PATIENT INFORMATION Insulin Lispro [IHN-soo-lihn LIYS-proh] injection, for subcutaneous or intravenous use 100 units per mL This product is HUMALOG ® (insulin lispro). Do not share your Insulin Lispro prefilled pens or syringes 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 Insulin Lispro? Insulin Lispro is a man-made fast-acting insulin used to control high blood sugar in adults and children with diabetes mellitus.

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

What should I tell my healthcare provider before taking Insulin Lispro? Before taking Insulin Lispro, 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 TZDs (thiazolidinediones). have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with Insulin Lispro. 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. Talk with your healthcare provider about the best way to feed your baby while taking Insulin Lispro. 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 Insulin Lispro, talk to your healthcare provider about low blood sugar and how to manage it. How should I take Insulin Lispro? Read the Instructions for Use that comes with your Insulin Lispro.

Take Insulin Lispro exactly as your healthcare provider tells you to. Your healthcare provider should tell you how much Insulin Lispro to take and when to take it. Insulin Lispro starts acting fast.

Inject Insulin Lispro within 15 minutes before or right after you eat a meal. Know the type, strength and amount 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 taking the correct insulin. Inject Insulin Lispro under the skin (subcutaneously) of your stomach area, buttocks, upper legs or upper arms, or 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.

Change (rotate) your injection sites within the area you choose with 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. Always use a new needle for each injection to help prevent infections and blocked needles. Do not reuse or share your needles with other people.

You may give other people a serious infection or get a serious infection from them. Check your blood sugar levels. Ask your healthcare provider what your blood sugars should be and when you should check your blood sugar levels.

Keep Insulin Lispro and all medicines out of the reach of children. Your dose of Insulin Lispro may need to change because of a: change in physical activ… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

Vial Instructions for Use INSTRUCTIONS FOR USE Insulin Lispro [IHN-soo-lihn LIYS-proh] injection, for subcutaneous use 10 mL multiple-dose vial (100 units per mL, U-100) This product is HUMALOG ® (insulin lispro). Read this Instructions for Use before you start taking Insulin Lispro 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 needles or syringes 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.

Supplies needed to give your injection a multiple-dose Insulin Lispro vial a U-100 insulin syringe and needle 2 alcohol swabs gauze 1 sharps container for throwing away used needles and syringes. See “Disposing of used needles and syringes” at the end of these instructions. Vial Syringe Preparing your Insulin Lispro dose Wash your hands with soap and water.

Check the Insulin Lispro 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. Insulin Lispro should look clear and colorless.

Do not use Insulin Lispro if it is thick, cloudy, or colored, or if you see lumps or particles in it. Do not use Insulin Lispro 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 reuse or share your syringes or needles with other people. You may give other people a serious infection or get a serious infection from them. 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.

If you use Insulin Lispro with NPH insulin: NPH insulin is the only type of insulin that can be mixed with Insulin Lispro. Do not mix Insulin Lispro with any other type of insulin. Insulin Lispro should be drawn up into the syringe first, before you draw up your NPH insulin.

Talk to your healthcare provider if you are not sure about the right way to mix Insulin Lispro and NPH insulin. Give your injection right away. Giving your Insulin Lispro 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. Insulin Lispro starts acting fast, so give your injection within 15 minutes before or right after you eat 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 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.

Insulin… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel ~1 min read ▾

PACKAGE CARTON – Insulin Lispro Injection 10 mL vial NDC 0002-7737-01 Insulin Lispro Injection 100 units per mL (U-100) For subcutaneous or intrevenous use 10 mL multiple-dose vial Use only with a U-100 syringe This product is Humalog. Rx only Lilly PACKAGE CARTON – Insulin Lispro Injection 10 mL vial 1ct

PACKAGE CARTON – Insulin Lispro Injection KwikPen NDC 0002-8222-59 Insulin Lispro KwikPen ® Injection For Single Patient Use Only HP-8222 Dispense in this sealed carton. Needles not included 100 units per mL (U-100) This device is recommended for use with Becton, Dickinson and Company's insulin pen needles For subcutaneous use only. prefilled insulin delivery device Rx only This product is Humalog. 5 x 3 mL Prefilled Pens Read Insulin Delivery Device Instructions for Use PACKAGE CARTON – Insulin Lispro Injection KwikPen 5ct

PACKAGE CARTON – Insulin Lispro Injection Junior KwikPen Dispense in this sealed carton. NDC 0002-7752-05 Insulin Lispro Injection Junior KwikPen ® For Single Patient Use Only 100 units per mL (U-100) The pen can deliver 0.5 (½) to 30 units in one injection. 5 x 3 mL prefilled pens For subcutaneous use only. prefilled insulin delivery device Rx only This product is Humalog.

Read Insulin Lispro Injection Junior KwikPen ® Instructions for Use. NEEDLES NOT INCLUDED This device is recommended for use with Becton, Dickinson and Company's insulin pen needles. Lilly PACKAGE CARTON – Insulin Lispro Injection Junior KwikPen

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
557.8K
Units reimbursed last 4 qtrs
15.2M
Gross reimbursed last 4 qtrs
$39.83M
Avg / prescription
$71.40
Avg / unit
$2.6283
Latest quarter Q1 2026
142.1KRx
Medicaid pays / mL
$2.6283
gross reimbursed
vs
NADAC / mL
$2.4027
acquisition cost
=
Spread
+$0.2256
+9% 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 ⓘ
34% FFS 66% MCO
Fee-for-service · 190,533 Rx Managed care · 367,308 Rx
State Medicaid map
Alaska: 25,090 units · 3,423 per 100k residents AK Maine: 95,788 units · 6,867 per 100k residents ME Washington: 512,854 units · 6,565 per 100k residents WA Idaho: 82,856 units · 4,219 per 100k residents ID Montana: 44,722 units · 3,951 per 100k residents MT North Dakota: 37,252 units · 4,758 per 100k residents ND Minnesota: 109,296 units · 1,905 per 100k residents MN Wisconsin: 179,855 units · 3,043 per 100k residents WI Michigan: 574,904 units · 5,728 per 100k residents MI New York: 1,198,355 units · 6,123 per 100k residents NY Vermont: 42,070 units · 6,502 per 100k residents VT New Hampshire: 55,289 units · 3,944 per 100k residents NH Oregon: 281,565 units · 6,652 per 100k residents OR Nevada: 244,912 units · 7,668 per 100k residents NV Wyoming: 340 units · 58.2 per 100k residents WY South Dakota: 10,173 units · 1,107 per 100k residents SD Iowa: 199,635 units · 6,225 per 100k residents IA Illinois: 835,888 units · 6,661 per 100k residents IL Indiana: 317,232 units · 4,623 per 100k residents IN Ohio: 997,954 units · 8,468 per 100k residents OH Pennsylvania: 1,033,714 units · 7,976 per 100k residents PA New Jersey: 696,124 units · 7,493 per 100k residents NJ Massachusetts: 593,524 units · 8,478 per 100k residents MA California: 1,360,240 units · 3,491 per 100k residents CA Utah: 65,821 units · 1,926 per 100k residents UT Colorado: 343,730 units · 5,848 per 100k residents CO Nebraska: 61,995 units · 3,134 per 100k residents NE Missouri: 544,928 units · 8,795 per 100k residents MO Kentucky: 634,526 units · 14,020 per 100k residents KY West Virginia: 92,140 units · 5,206 per 100k residents WV Virginia: 449,372 units · 5,156 per 100k residents VA Maryland: 177,091 units · 2,866 per 100k residents MD Connecticut: 192,767 units · 5,329 per 100k residents CT Rhode Island: 101,178 units · 9,240 per 100k residents RI Arizona: 481,178 units · 6,475 per 100k residents AZ New Mexico: 32,380 units · 1,532 per 100k residents NM Kansas: 67,446 units · 2,294 per 100k residents KS Arkansas: 61,359 units · 2,001 per 100k residents AR Tennessee: 326,548 units · 4,582 per 100k residents TN North Carolina: 401,966 units · 3,710 per 100k residents NC South Carolina: 162,210 units · 3,019 per 100k residents SC Delaware: 32,705 units · 3,172 per 100k residents DE Oklahoma: 33,886 units · 836 per 100k residents OK Louisiana: 285,392 units · 6,239 per 100k residents LA Mississippi: 89,767 units · 3,053 per 100k residents MS Alabama: 24,509 units · 480 per 100k residents AL Georgia: 393,990 units · 3,572 per 100k residents GA D.C.: 24,250 units · 3,571 per 100k residents DC Hawaii: 9,920 units · 691 per 100k residents HI Texas: 224,184 units · 735 per 100k residents TX Florida: 307,529 units · 1,360 per 100k residents FL
Units reimbursed · per 100k residents
58.214,020
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 Kentucky 14,020 /100k
2 Rhode Island 9,240 /100k
3 Missouri 8,795 /100k
4 Massachusetts 8,478 /100k
5 Ohio 8,468 /100k
6 Pennsylvania 7,976 /100k
7 Nevada 7,668 /100k
8 New Jersey 7,493 /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.

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

Medicare Part D (outpatient prescription) spending for Insulin Lispro — 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 Insulin Lispro. 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
$6.81M
Claims incl. refills
101K
Beneficiaries
65.8K
Spend / beneficiary
$103.57
Spend / claim
$67.43
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.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Insulin lispro — the ingredient across all brands.

Top reported reactions

Blood Glucose Increased39,315
Blood Glucose Decreased8,942
Visual Impairment5,615
Nausea5,014
Malaise4,059
Fatigue3,904
Hypoglycaemia3,902

Age at onset

Neonate147
Infant52
Child495
Adolescent295
Adult10,444
Elderly10,988

Reporter sex

139,155 reports
Male · 44%
Female · 56%
Unknown · 0%

Serious outcomes

Hospitalization34,353
Death6,061
Life-threatening3,271
Disabling2,901
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 10,077 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
← 00002-7728-01 · Eli 00002-7752-05 · 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.