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ADMELOG insulin lispro 100 U/mL Injection, Solution — NDC 00024-5924-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

ADMELOG insulin lispro 100 U/mL Injection, Solution — NDC 0024-5924-10 (Billing 00024-5924-10) · Product 0024-5924

by Sanofi-Aventis U.S. LLC · 1 VIAL, MULTI-DOSE in 1 CARTON (0024-5924-10) / 10 mL in 1 VIAL, MULTI-DOSE

NDC 0024-5924-10 (billing 00024-5924-10) is a package of ADMELOG insulin lispro 100 U/mL Injection, Solution from Sanofi-Aventis U.S. LLC, marketed since Dec 2017 and currently FDA-listed; retail pharmacies pay about $9.39 per mL (NADAC). It is the main listing for product NDC 0024-5924, its only package size.

NDC 00024-5924-10
🏷️ FDA NDC (as labeled) 0024-5924-10 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

🚨
Active recall for this product.
Class II · Apr 11, 2023 — Lack of Assurance of Sterility: Malformed crimped collar seal (Sanofi-Aventis U.S. LLC) · FDA recall D-0575-2023
Lots / codes: Lot # 3F497B, EXP 12-31-2025 · reported May 24, 2023
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0024-5924-10
Product NDC 0024-5924
11-digit billing NDC 00024592410
NCPDP billing unit ML — per mL (volume)
RxCUI 242120, 1652639, 1992169, 1992171
UNII GFX7QIS1II
Application # BLA209196
SPL Set ID 0691def8-4a7b-4de3-866f-a280989f47f1
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 2017-12-11
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 Admelog
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 ADMELOG 100 UNIT/ML VIAL
FDB brand name Admelog
Legend status F — Federal legend — prescription drug or device
Quick answers for NDC 0024-5924-10
  • 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
  • 11-digit billing NDC: 00024592410
Why two NDCs? The FDA registers this code as 0024-5924-10 — 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 → 00024-5924-10. 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 ADMELOG 100 UNIT/ML VIAL 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 $9.394 $93.94 / 10 ml
Medicaid paysCMS SDUD · 12 mo $8.96 $89.64 / 10 ml
Medicare drug plans payPart D · Q2 2026 $9.16 $91.56 / 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 Jan 2026 May 2026 Sep 2026 $12.570 $9.392
▼ Down 25% over the last 13 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)0024-5924-10
11-digit billing NDC00024-5924-10
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 MG, 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
00024-5924-10 0024-5924-10 You're viewing this Main listing 1 VIAL, MULTI-DOSE in 1 CARTON (0024-5924-10) / 10 mL in 1 VIAL, MULTI-DOSE 2017-12-11 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Insulin Lispro 100 [iU]/mL 00002-7737-01 Eli 1 vial $2.403 — Availability likely save 74%
Humalog 100 [iU]/mL 00002-7510-01 Eli 1 vial $6.357 — Availability likely save 32%
Admelog 100 U/mLthis 00024-5924-10 Sanofi-Aventis 1 vial $9.394 — Availability likely —
Admelog 100 U/mL 00024-5926-05 Sanofi-Aventis 1 vial $12.561 — Availability likely +34%
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 —
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

🏛️
2017
First FDA approval
Dec 2017
📍
2026
Currently FDA-listed
9 years listed
🛡️
2029
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 Dec 2029. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved Dec 11, 2017 ⏳ ~3.2 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
2017 2019 2021 2023 2025 2027 2029
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 dateDec 11, 2029
Common questions
Is there a biosimilar for ADMELOG 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.

💡 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 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.
  • 1.88 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.
  • 0.0197 mg / 1 mL 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.

7 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

LabelerSanofi-Aventis U.S. LLC
FDA applicationBLA209196 (BLA)
Labeler code00024
First marketedDec 2017
Product typeHuman Prescription Drug
Portfolio85 products on file
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 42 words ▾

1 INDICATIONS AND USAGE ADMELOG is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. ADMELOG 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 preparation and administration instructions. ( 2.1 , 2.2 , 2.3 , 2.4 ) Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis. ( 2.2 ) Subcutaneous injection ( 2.2 ): Administer ADMELOG 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 ADMELOG can be used. Use in accordance with the insulin pump instructions for use.

Administer ADMELOG 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. Do not mix with other insulins or diluents in the pump.

Intravenous Infusion: Administer ADMELOG by intravenous infusion ONLY after dilution and under medical supervision. ( 2.2 ) The dosage of ADMELOG must be individualized based on the route of administration and the patient's metabolic needs, blood glucose monitoring results and glycemic control goal. ( 2.3 )

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

Do not use ADMELOG if particulate matter or coloration is seen. Use ADMELOG SoloStar prefilled pen with caution in patients with visual impairment who may rely on audible clicks to dial their dose. Do NOT mix ADMELOG with other insulins when administering using a continuous subcutaneous infusion pump.

2.2Preparation and Administration Instructions for the Approved Routes of Administration Subcutaneous Injection Administer the dose of ADMELOG subcutaneously within fifteen minutes before a meal or immediately after a meal into the abdominal wall, thigh, upper arm, or buttocks. Rotate injection site within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis [see Warnings and Precautions (5.2) , Adverse Reactions (6) ] .

During changes to a patient's insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions (5.2) ] . ADMELOG administered by subcutaneous injection should generally be used in regimens with intermediate or long-acting insulin. The ADMELOG SoloStar prefilled pen dials in 1-unit increments.

Prior to subcutaneous use, ADMELOG may be diluted with sterile 0.9% Sodium Chloride Injection. Dilute one-part ADMELOG to one-part 0.9% Sodium Chloride Injection to yield a concentration one-half that of ADMELOG (equivalent to U-50). If diluted ADMELOG is not used immediately, refrigerate at 2°C to 8°C (36°F to 46°F) for no more than 24 hours or store at room temperature up to 30°C (86°F) for 4 hours.

Discard the unused diluted ADEMLOG after 24 hours if refrigerated or after 4 hours if stored at room temperature. Continuous Subcutaneous Infusion (Insulin Pump) Refer to the continuous subcutaneous insulin infusion pump user manual to see if ADMELOG can be used with the insulin pump. Use ADMELOG in accordance with the insulin pump system's instructions for use.

Administer ADMELOG by continuous subcutaneous infusion 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 inject into areas of lipodystrophy or localized cutaneous amyloidosis [see Warnings and Precautions (5.2) , Adverse Reactions (6) ] .

Train patients using continuous subcutaneous insulin infusion therapy to administer insu… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 56 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 100 units/mL (U-100) is a clear and colorless solution available as: 10 mL multiple-dose vials 3 mL multiple-dose vials 3 mL single-patient-use SoloStar prefilled pens Injection: 100 units/mL (U-100) is available as: ( 3 ) 10 mL multiple-dose vials 3 mL multiple-dose vials 3 mL single-patient-use SoloStar ® prefilled pens

⛔ Contraindications 68 words ▾

4 CONTRAINDICATIONS ADMELOG 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 ADMELOG [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 ADMELOG. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Never share an ADMELOG SoloStar disposable 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 , 6 , 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 ADMELOG, 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 ADMELOG by subcutaneous injection if pump malfunction occurs.

( 5.8 )

5.1Never Share an ADMELOG SoloStar Pen or Syringe Between Patients ADMELOG SoloStar prefilled pen must never be shared between patients, even if the needle is changed. Patients using ADMELOG 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 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 anti-diabetic products may be needed.

5.3Hypoglycemia Hypoglycemia is the most common adverse reaction associated with insulins, including ADMELOG. 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 lowering effect time cours… [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 ADMELOG include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis at 1-800-633-1610 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 observed in practice. Adverse Reactions with Subcutaneous Injections of ADMELOG Two clinical trials with ADMELOG were conducted: one in patients with type 1 diabetes and one in patients with type 2 diabetes [see Clinical Studies (14) ] . The data in Table 1 reflect the exposure of 252 patients with type 1 diabetes to ADMELOG with mean exposure duration of 49 weeks.

The type 1 diabetes population had the following characteristics: Mean age was 43 years and mean duration of diabetes was 20 years. Fifty-nine percent were male, 80% were White, 6% were Black or African American and 7% were Hispanic. At baseline, the mean eGFR was 90 mL/min/1.73 m 2 and 49% of patients had eGFR ≥90 mL/min/1.73 m 2 .

The mean BMI was 26 kg/m 2 . The mean HbA1c at baseline was 8.07%. Two hundred fifty-three patients with type 2 diabetes were exposed to ADMELOG with mean exposure duration of 25 weeks.

The type 2 diabetes population had the following characteristics: Mean age was 62 years and mean duration of diabetes was 17 years. Fifty-four percent were male, 90% were White, 6% were Black or African American and 17% were Hispanic. At baseline, the mean eGFR was 77 mL/min/1.73 m 2 and 27% of patients had eGFR ≥90 mL/min/1.73 m 2 .

The mean BMI was 32 kg/m 2 . The mean HbA1c at baseline was 7.99%. Common adverse reactions were defined as reactions that occurred in ≥5% of the population studied.

Common adverse reactions (other than hypoglycemia) during a clinical trial in patients with type 1 diabetes mellitus are listed in Table 1. In a 26-week clinical trial in patients with type 2 diabetes mellitus, no adverse reactions (other than hypoglycemia) occurred in ≥5% of ADMELOG-treated patients (n=253) were observed. Table 1: Adverse Reactions that Occurred in ≥5% of ADMELOG-Treated Patients with Type 1 Diabetes in a 52-Week Trial ADMELOG + Insulin Glargine (100 units/mL), % (n=252) Nasopharyngitis 13% Upper respiratory tract infection 6% Severe Hypoglycemia Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including ADMELOG [see Warnings and Precautions (5.3) ] .

The rates of reported hypoglycemia depend on the definition of hypoglycemia used, diabetes type, insulin dose, intensity of glucose control, background therapies, and other intrinsic and extrinsic patient factors. For these reasons, comparing rates of hypoglycemia in clinical trials for ADMELOG with the incidence of hypoglycemia for other products may be misleading and also, may not be representative of hypoglycemia rates that will occur in clinical practice. In the ADMELOG trials, severe hypoglycemia was defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.

The incidence of severe hypoglycemia in patients receiving ADMELOG with type 1 diabetes mellitus and type 2 diabetes mellitus was 13.5% at 52 weeks and 2.4% at 26 weeks, respectively [see Clinical Studies (14) ] . Adverse Reactions Associated with Insulin Initiation and Intensification of Glucose Control Intensification or rapid improvement in glucose control has bee… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Table 2 presents clinically significant drug interactions with ADMELOG. Table 2: Clinically Significant Drug Interactions with ADMELOG 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 adjustment and increased frequency of glucose monitoring may be required when ADMELOG is concomitantly administered with these drugs.

Drugs That May Decrease the Blood Glucose Lowering Effect of ADMELOG 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 ADMELOG is concomitantly administered with these drugs.

Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of ADMELOG 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 ADMELOG is concomitantly 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 ADMELOG is concomitantly 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 another insulin lispro product 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 another insulin lispro product in animal reproduction studies during organogenesis.

Fetal growth retardation was observed in offspring of rats exposed to insulin lispro at a dose approximately 3 times the human subcutaneous dose of 1.0 unit/kg/day. No adverse effects on embryo-fetal development were observed in offspring of rabbits exposed to insulin lispro at doses up to approximately 0.24 times the human subcutaneous dose of 1.0 unit/kg/day [see Data ] . The estimated background risk of major birth defects is 6%–10% in women with pregestational 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, preeclampsia, 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 another insulin lispro product 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 with another insulin lispro product, female rats were 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, 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 observed 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 with another insulin lispro product, insulin lispro doses of 0.1, 0.25, and 0.75 unit/kg/day (0.03, 0.08, and 0.24 times the human subcutaneous dose of 1 unit/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 suggest 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 ADMELOG and any potential adverse effects on the breastfed child from ADMELOG or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of ADMELOG to improve glycemic c… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Published studies with another insulin lispro product 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 another insulin lispro product in animal reproduction studies during organogenesis.

Fetal growth retardation was observed in offspring of rats exposed to insulin lispro at a dose approximately 3 times the human subcutaneous dose of 1.0 unit/kg/day. No adverse effects on embryo-fetal development were observed in offspring of rabbits exposed to insulin lispro at doses up to approximately 0.24 times the human subcutaneous dose of 1.0 unit/kg/day [see Data ] . The estimated background risk of major birth defects is 6%–10% in women with pregestational 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, preeclampsia, 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 another insulin lispro product 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 with another insulin lispro product, female rats were 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, 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 observed 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 with another insulin lispro product, insulin lispro doses of 0.1, 0.25, and 0.75 unit/kg/day (0.03, 0.08, and 0.24 times the human subcutaneous dose of 1 unit/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 74 words ▾

8.4Pediatric Use The safety and effectiveness of ADMELOG to improve glycemic control have been established in pediatric patients with diabetes mellitus. Use of ADMELOG for this indication is supported by evidence from an adequate and well-controlled study with another insulin lispro product, 100 units/ml, in 60 pediatric patients 3 years of age and older with type 1 diabetes mellitus and studies in adult patients with diabetes mellitus [see Clinical Studies (14) ] .

🧓 Geriatric Use 114 words ▾

8.5Geriatric Use Of the total number of patients (n=2,834) in eight clinical studies of another insulin lispro product, 100 units/mL, 12% (n=338) were 65 years of age or over. The majority of these patients had type 2 diabetes. HbA1c values and hypoglycemia rates did not differ by age.

Of the total number of patients (n=1,011) in clinical studies of ADMELOG or another insulin lispro product, 100 units/mL, 26.5% (n=268) were 65 years of age or over. The majority of these patients had type 2 diabetes. HbA1c values and hypoglycemia rates did not differ by age.

Pharmacokinetic/pharmacodynamic studies to assess the effect of age on the onset of ADMELOG 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 products. 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 Pharmacodynamics of ADMELOG After Subcutaneous Injection The pharmacodynamic profile of a single 0.3 unit/kg dose of ADMELOG administered subcutaneously was evaluated in a euglycemic clamp study enrolling 30 patients with type 1 diabetes. In this study, the mean (SD) time to maximum effect of ADMELOG (measured by the peak rate of glucose infusion) was approximately 2.1 (0.8) hours. The mean (SD) area under the glucose infusion rate curves (measure of overall pharmacodynamic effect) and mean (SD) maximum glucose infusion rate were 1953.5 (547.3) mg/kg and 9.97 (2.37) mg/min/kg, respectively (see Figure 1 ).

Figure 1: Mean Smoothed Glucose Infusion Rate Body Weight Standardized after Subcutaneous Injection of ADMELOG (0.3 unit/kg) in Patients with Type 1 Diabetes The time course of action of insulin and insulin analogs, including insulin lispro products, may vary considerably in different individuals or within the same individual. 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 Pharmacodynamics of AMELOG after Intravenous Administration The glucose lowering effect of intravenous administration of another insulin lispro product, 100 units/mL, 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-hour run-in phase. The run-in phase was followed by a 6-hour assessment phase.

During the assessment phase, patients received intravenous infusion of another insulin lispro product, 100 units/mL, at an initial infusion rate of 0.5 units/hour. The infusion rate 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 another insulin lispro product, 100 units/mL, therapy are summarized below in Table 3.

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 another insulin lispro product, 100 units/mL. The average time (±SE) required to attain near normoglycemia was 129 ± 14 minutes for another insulin lispro product, 100 units/mL.

Table 3: Mean Blood Glucose Concentrations (mg/dL) During Intravenous Infusions of Another Insulin Lispro Product, 100 units/mL in Patients with Type 1 Diabetes Time from Start of Infusion (minutes) Mean Blood Glucose (mg/dL) Intravenous Results shown as mean ± SD. 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 The pharmacokinetic profile of a single 0.3 unit/kg dose of ADMELOG administered subcutaneously was evaluated in a study enrolling 30 patients with type 1 diabetes. In this study, the mean observed area under the plasma insulin lispro concentration-time curve from time zero to infinity and peak plasma insulin lispro concentration were 12800 pg∙hr/mL and 5070 pg/mL, respectively. The median time to maximum plasma insulin lispro concentration was 0.83 hours after injection (see Figure 2 ).

Figure 2: Mean Plasma Concentrations of ADMELOG after a Single Subcutaneous Administration of ADMELOG (0.3 unit/kg) in Patients with Type 1 Diabetes The absolute bioavailability of another insulin lispro product, 100 units… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 50 words ▾

12.1Mechanism of Action Regulation of glucose metabolism is the primary activity of insulins and insulin analogs, including insulin lispro products. 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 ADMELOG (insulin lispro) injection 100 units/mL (U-100) is available as a clear and colorless solution in: Dosage Unit Package Size NDC # 10 mL multiple-dose vials Carton of 1 0024-5924-10 3 mL multiple-dose vials Carton of 1 0024-5926-05 3 mL single-patient-use SoloStar prefilled pen Carton of 5 0024-5925-05 Each prefilled SoloStar pen is for use by a single patient. The ADMELOG SoloStar prefilled pen dials in 1-unit increments.

16.2Storage and Handling Dispense in the original sealed carton with the enclosed Instructions for Use. Store ADMELOG according to the table below. Do not freeze and do not use ADMELOG if it has been frozen.

Protect from direct heat and light. In-use (opened) ADMELOG vials and ADMELOG SoloStar pens must be used within 28 days or be discarded, even if they still contain ADMELOG. ADMELOG Not In-Use (Unopened) Room Temperature (Up to 86°F [30°C]) Not In-Use (Unopened) Refrigerated (36°F–46°F [2°C–8°C]) In-Use (Opened) Room Temperature (Up to 86°F [30°C]) 10 mL multiple-dose vial 28 days Until expiration date 28 days refrigerated/room temperature 3 mL multiple-dose vial 28 days Until expiration date 28 days refrigerated/room temperature 3 mL single-patient-use SoloStar prefilled pen 28 days Until expiration date 28 days Do not refrigerate.

Use in an External Insulin Pump Change the ADMELOG in the pump 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). Diluted ADMELOG for Subcutaneous Injection Diluted ADMELOG may remain in patient use for up to 24 hours when stored in a refrigerator (36°F–46°F [2°C–8°C]) or for up to 4 hours when stored at room temperature (86°F [30°C]). Do not dilute ADMELOG used in an external insulin pump.

Admixture for Intravenous Administration Infusion bags prepared with ADMELOG are stable when stored in a refrigerator (36°F–46°F [2°C–8°C]) for 24 hours or may be used at room temperature for up to 4 hours [see Dosage and Administration (2.2) ] .

📦 Storage and Handling ~1 min read ▾

16.2Storage and Handling Dispense in the original sealed carton with the enclosed Instructions for Use. Store ADMELOG according to the table below. Do not freeze and do not use ADMELOG if it has been frozen.

Protect from direct heat and light. In-use (opened) ADMELOG vials and ADMELOG SoloStar pens must be used within 28 days or be discarded, even if they still contain ADMELOG. ADMELOG Not In-Use (Unopened) Room Temperature (Up to 86°F [30°C]) Not In-Use (Unopened) Refrigerated (36°F–46°F [2°C–8°C]) In-Use (Opened) Room Temperature (Up to 86°F [30°C]) 10 mL multiple-dose vial 28 days Until expiration date 28 days refrigerated/room temperature 3 mL multiple-dose vial 28 days Until expiration date 28 days refrigerated/room temperature 3 mL single-patient-use SoloStar prefilled pen 28 days Until expiration date 28 days Do not refrigerate.

Use in an External Insulin Pump Change the ADMELOG in the pump 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). Diluted ADMELOG for Subcutaneous Injection Diluted ADMELOG may remain in patient use for up to 24 hours when stored in a refrigerator (36°F–46°F [2°C–8°C]) or for up to 4 hours when stored at room temperature (86°F [30°C]). Do not dilute ADMELOG used in an external insulin pump.

Admixture for Intravenous Administration Infusion bags prepared with ADMELOG are stable when stored in a refrigerator (36°F–46°F [2°C–8°C]) for 24 hours or may be used at room temperature for up to 4 hours [see Dosage and Administration (2.2) ] .

📋 Description 153 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. Insulin lispro has a molecular weight of 5808 Da, identical to that of human insulin.

ADMELOG (insulin lispro) injection is a sterile, aqueous, clear, and colorless solution for subcutaneous or intravenous use. Each mL of ADMELOG contains 100 units of insulin lispro, and the inactive ingredients: dibasic sodium phosphate (1.88 mg), glycerin (16 mg), metacresol (3.15 mg), 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.

The pH is adjusted by addition of aqueous solutions of hydrochloric acid and/or sodium hydroxide. ADMELOG is latex free.

💬 Information for Patients ~2 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 ADMELOG SoloStar Prefilled Pen or Syringe Between Patients Advise patients that they must never share an ADMELOG SoloStar pen with another person, even if the needle is changed. Advise patients using ADMELOG 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 ADMELOG 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 [see Warnings and Precautions (5.4) ]. Hypersensitivity Reactions Advise patients that hypersensitivity reactions have occurred with ADMELOG.

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.

Refer to the continuous subcutaneous infusion pump user manual to see if ADMELOG 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 7 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 that infusion sets and infusion set insertion sites should be changed according to the manufacturer's user manual. 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) ].

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Absorption The pharmacokinetic profile of a single 0.3 unit/kg dose of ADMELOG administered subcutaneously was evaluated in a study enrolling 30 patients with type 1 diabetes. In this study, the mean observed area under the plasma insulin lispro concentration-time curve from time zero to infinity and peak plasma insulin lispro concentration were 12800 pg∙hr/mL and 5070 pg/mL, respectively. The median time to maximum plasma insulin lispro concentration was 0.83 hours after injection (see Figure 2 ).

Figure 2: Mean Plasma Concentrations of ADMELOG after a Single Subcutaneous Administration of ADMELOG (0.3 unit/kg) in Patients with Type 1 Diabetes The absolute bioavailability of another insulin lispro product, 100 units/mL, 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 0.2 unit/kg dose in two separate groups of healthy subjects, the mean volume of distribution of another insulin lispro product, 100 units/mL, appeared to decrease with increase in dose (1.55 and

0.72L/kg, respectively). Elimination Metabolism Human metabolism studies have not been conducted. However, animal studies indicate that the metabolism of another insulin lispro product, 100 units/mL, is identical to that of regular human insulin.

Excretion When administered intravenously, another insulin lispro product, 100 units/mL demonstrated dose-dependent clearance, with a mean clearance of 21.0 mL/min/kg (0.1 unit/kg dose), and 9.6 mL/min/kg (0.2 unit/kg dose). Another insulin lispro product, 100 units/mL, 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. Specific Populations The effects of age, gender, race, obesity, pregnancy, or smoking on the pharmacokinetics of ADMELOG have not been studied.

Patients with Renal Impairment Type 2 diabetic patients with varying degrees of renal impairment showed no difference in pharmacokinetics of another insulin lispro product, 100 units/mL. 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) ] .

Patients with Hepatic Impairment Type 2 diabetic patients with impaired hepatic function showed no effect on the pharmacokinetics of another insulin lispro product, 100 units/mL, 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 Pharmacodynamics of ADMELOG After Subcutaneous Injection The pharmacodynamic profile of a single 0.3 unit/kg dose of ADMELOG administered subcutaneously was evaluated in a euglycemic clamp study enrolling 30 patients with type 1 diabetes. In this study, the mean (SD) time to maximum effect of ADMELOG (measured by the peak rate of glucose infusion) was approximately 2.1 (0.8) hours. The mean (SD) area under the glucose infusion rate curves (measure of overall pharmacodynamic effect) and mean (SD) maximum glucose infusion rate were 1953.5 (547.3) mg/kg and 9.97 (2.37) mg/min/kg, respectively (see Figure 1 ).

Figure 1: Mean Smoothed Glucose Infusion Rate Body Weight Standardized after Subcutaneous Injection of ADMELOG (0.3 unit/kg) in Patients with Type 1 Diabetes The time course of action of insulin and insulin analogs, including insulin lispro products, may vary considerably in different individuals or within the same individual. 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 Pharmacodynamics of AMELOG after Intravenous Administration The glucose lowering effect of intravenous administration of another insulin lispro product, 100 units/mL, 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-hour run-in phase. The run-in phase was followed by a 6-hour assessment phase.

During the assessment phase, patients received intravenous infusion of another insulin lispro product, 100 units/mL, at an initial infusion rate of 0.5 units/hour. The infusion rate 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 another insulin lispro product, 100 units/mL, therapy are summarized below in Table 3.

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 another insulin lispro product, 100 units/mL. The average time (±SE) required to attain near normoglycemia was 129 ± 14 minutes for another insulin lispro product, 100 units/mL.

Table 3: Mean Blood Glucose Concentrations (mg/dL) During Intravenous Infusions of Another Insulin Lispro Product, 100 units/mL in Patients with Type 1 Diabetes Time from Start of Infusion (minutes) Mean Blood Glucose (mg/dL) Intravenous Results shown as mean ± SD. 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

14.1Overview of Clinical Studies The safety and effectiveness of ADMELOG to improve glycemic control in adult and pediatric patients with diabetes mellitus have been established based on adequate and well-controlled studies of ADMELOG in adult patients with type 1 and type 2 diabetes mellitus, and based on adequate and well-controlled studies of another insulin lispro product, 100 units/mL, in adult and pediatric patients 3 years of age and older with type 1 diabetes mellitus and adult patients with type 2 diabetes mellitus.

The safety and effectiveness of: ADMELOG were studied in 507 adult patients with type 1 diabetes and 505 adult patients with type 2 diabetes. Another insulin lispro product, 100 units/mL, were studied in 1,087 adult and pediatric patients with type 1 diabetes and in 722 adult patients with type 2 diabetes.

14.2Type 1 Diabetes Mellitus – Subcutaneous Injection ADMELOG: Study in Adult Patients A 26-week open-label, active-controlled study (NCT02273180) evaluated the glucose lowering effect of ADMELOG plus insulin glargine, 100 units/mL, compared to that of Comparator (another insulin lispro product, 100 units/mL, or a non–U.S.-licensed insulin lispro product, 100 units/mL), plus insulin glargine, 100 units/mL. A total of 507 patients with type 1 diabetes mellitus treated with insulin glargine 100 units/mL and rapid-acting mealtime insulin analogs participated in the study.

Patients were randomized to ADMELOG (n=253) or Comparator (n=254). ADMELOG or Comparator was administered by subcutaneous injection immediately prior to meals. The mean age of these patients was 43 years old, and 60% were male.

The population was 82% White, 5% Black or African American and 5% were Hispanic. The population had type 1 diabetes mellitus for a mean duration of 19 years. The mean eGFR was 90.6 mL/min/1.73 m 2 and 48.7% of patients had GFR ≥90 mL/min/1.73 m 2 .

The mean BMI was approximately 26 kg/m 2 . At baseline, 61%, 38% and 2% of the patients were using other insulin lispro products, 100 units/mL, insulin aspart, 100 units/mL, or both, respectively. At week 26, treatment with ADMELOG provided a mean reduction in HbA1c that was non-inferior to that achieved with the Comparator (see Table 4 ).

Table 4: 26 Week Type 1 Diabetes Mellitus Trial in Adults – Mean Change in HbA1c (ADMELOG plus Insulin Glargine, 100 units/mL, versus Comparator plus Insulin Glargine, 100 units/mL) ADMELOG + Insulin Glargine Comparator + Insulin Glargine N ITT: Intent-to-treat; all randomized patients. 253 254 HbA1c (%) Baseline (mean) 8.08

7.99Adjusted mean change from baseline Estimated using a multiple imputation method that models a "return to baseline" for patients having missing data who discontinued treatment. ANCOVA was used with treatment and stratification groups as fixed factors and baseline HbA1c as a covariate. -0.40 -0.46 Adjusted mean difference Treatment difference: ADMELOG - Comparator. (95% CI) 0.06 (-0.086 to 0.201) Another Insulin Lispro Product, 100 units/mL: Study in Adult and Pediatric Patients 12 Years of Age and Older A 12-month, randomized, parallel, open-label, active-controlled study was conducted in 167 patients with type 1 diabetes to assess the safety and efficacy of another insulin lispro product, 100 units/mL (n=81), compared with regular human insulin, 100 units/mL (n=86).

This other insulin lispro product was administered by subcutaneous injection immediately prior to meals and regular human insulin was administered 30 to 45 minutes before meals. Human insulin extended zinc suspension was administered once or twice daily as the basal insulin in both treatment groups. There was a 2 to 4-week run-in period with regular human insulin and human insulin extended zinc suspension before randomization.

The mean age of these patients was 31 years (range 12 to 70 years), and 47% were male. The population was 97% White. Table 5: 12 Month Type 1 Diabetes Mellitus Trial in Adults and Pediatric Patients 12 Ye… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 189 words ▾

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 (0.16, 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 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 (0.16, 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 ▾

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: May2025 PATIENT INFORMATION ADMELOG ® (ad-mah-log) (insulin lispro) injection, for subcutaneous or intravenous use 100 units/mL (U-100) Do not share your ADMELOG SoloStar ® Pen or syringe 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 ADMELOG? ADMELOG is a man-made fast-acting insulin used to control high blood sugar in adults and children with diabetes mellitus.

Do not use ADMELOG if you: are having an episode of low blood sugar (hypoglycemia). have an allergy to ADMELOG or any of the ingredients in ADMELOG. See the end of this Patient Information leaflet for a complete list of ingredients in ADMELOG. Before using ADMELOG, tell your healthcare provider about all of your medical conditions, including if you: have liver or kidney problems. take other medicines, especially ones commonly called TZDs (thiazolidinediones). have heart failure or other heart problems.

If you have heart failure, it may get worse while you take TZDs with ADMELOG. 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 to your healthcare provider about the best way to feed your baby while using ADMELOG.

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

Read the detailed Instructions for Use that come with your ADMELOG. Use ADMELOG exactly as your healthcare provider tells you to. Your healthcare provider should tell you how much ADMELOG to use and when to use it.

Know the type, strength, and amount of insulin you use. Do not change the type or amount of insulin you use 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 a different type of insulin.

Check your insulin label each time you give your injection to make sure you are using the correct insulin. ADMELOG comes in a vial or in a SoloStar single-patient-use prefilled pen. Do not reuse needles .

Always use a new needle for each injection . Reuse of needles increases your risk of having blocked needles, which may cause you to get the wrong dose of ADMELOG. Using a new needle for each injection also lowers your risk of getting an infection.

If your needle is blocked, follow the instructions in Step 3 of the Instructions for Use of your pen. ADMELOG starts acting fast. Inject ADMELOG within 15 minutes before eating or right after eating a meal.

Inject ADMELOG under the skin (subcutaneously) of your upper arms, thighs, buttocks, or stomach area (abdomen), 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 site 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. Check your blood sugar levels.

Ask your healthcare provider what your blood sugar should be and when you should check your blood sugar levels. Keep ADMELOG and all medicines out of the reach of children. Your dose of ADMELOG may need to change because of: a change in physical activity or exercise, weight gain or loss, increased stress, illness, change in d… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

INSTRUCTIONS FOR USE ADMELOG ® [ad-mah-log] (insulin lispro) injection, for subcutaneous use 10 mL or 3 mL Vial (100 units/mL, U-100) Read this Instructions for Use before you start using ADMELOG and each time you get a new ADMELOG 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 ADMELOG 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 an ADMELOG 10 mL or 3 mL vial a U-100 insulin syringe and needle 2 alcohol swabs 1 sharps container for throwing away used needles and syringes.

See " Disposing of used needles and syringes " at the end of these instructions. Preparing your ADMELOG dose Wash your hands with soap and water or with alcohol. Check the ADMELOG 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. Check the insulin to make sure it is clear and colorless. Do not use ADMELOG if it is colored or cloudy, or if you see particles in the solution.

Do not use ADMELOG after the expiration date stamped on the label or 28 days after you first use it. Always use a syringe that is marked for U-100 insulin. If you use a syringe other than a U-100 insulin syringe, you may get the wrong dose of insulin.

Always use a new syringe or needle for each injection to help ensure sterility and prevent 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, remove the protective cap. Do not remove the stopper. Step 2: Wipe the top of the vial with an alcohol swab.

You do not have to shake the vial of ADMELOG before use. Step 3: Draw air into the syringe equal to your insulin dose. Put the needle through the rubber top of the vial and push the plunger to inject the air into the vial.

Step 4: Leave the syringe in the vial and turn both upside down. Hold the syringe and vial firmly in one hand. Make sure the tip of the needle is in the insulin.

With your free hand, pull the plunger to withdraw the correct dose into the syringe. Step 5: Before you take the needle out of the vial, check the syringe for air bubbles. If bubbles are in the syringe, hold the syringe straight up and tap the side of the syringe until the bubbles float to the top.

Push the bubbles out with the plunger and draw insulin back in until you have the correct dose. Step 6: Remove the needle from the vial. Do not let the needle touch anything.

You are now ready to inject. Giving your ADMELOG injection with a syringe Inject your insulin exactly as your healthcare provider has shown you. ADMELOG starts acting fast, so give your injection within 15 minutes before or right after you eat a meal.

Step 7: Choose your injection site: ADMELOG is injected under the skin (subcutaneously) of your upper arms, thighs, buttocks, or stomach area (abdomen). Change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting pits in the skin or thickened skin (lipodystrophy) and skin with lumps (localized cutaneous amyloidosis) 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. Wipe the skin with an alcohol swab to clean the injection site. Let the injection site dry before you inject your dose.

Step 8: Pinch the skin. Insert the needle in the way your healthcare provider showed you. Release the skin.

Slowly push in the plunger of the syringe all the way, making sure you have injected all the insulin. Leave the needle in the skin for about 10 seconds. Step 9: Pull the needle straight out of your skin.

Gently press the injection site for… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 160 words ▾

PRINCIPAL DISPLAY PANEL - 10 mL Vial Carton NDC 0024-5924-10 Rx only Admelog ® (insulin lispro) injection 100 units/mL (U-100) For subcutaneous use For intravenous infusion after further dilution ONLY under direct medical supervision Use only with a U-100 syringe 10mL multiple-dose vial sanofi PRINCIPAL DISPLAY PANEL - 10 mL Vial Carton

PRINCIPAL DISPLAY PANEL - 3 mL Pen Carton Rx only NDC 0024-5925-05 Admelog ® SoloStar ® (insulin lispro) injection For Single Patient Use Only 100 units/mL (U-100) For subcutaneous use only Do not mix with other insulins Five 3 mL prefilled pens Dispense in this sealed carton sanofi PRINCIPAL DISPLAY PANEL - 3 mL Pen Carton

PRINCIPAL DISPLAY PANEL - 3 mL Vial Carton NDC 0024-5926-05 Rx only Admelog ® (insulin lispro) injection 100 units/mL (U-100) For subcutaneous use For intravenous infusion after further dilution ONLY under direct medical supervision Use only with a U-100 syringe 3mL multiple-dose vial sanofi PRINCIPAL DISPLAY PANEL - 3 mL Vial 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 00024-5924-10, 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
39.3K
Units reimbursed last 4 qtrs
1.1M
Gross reimbursed last 4 qtrs
$10.17M
Avg / prescription
$258.96
Avg / unit
$8.9642
Latest quarter Q1 2026
8.4KRx
Medicaid pays / mL
$8.9642
gross reimbursed
vs
NADAC / mL
$9.3938
acquisition cost
=
Spread
−$0.4296
-5% 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 ⓘ
35% FFS 65% MCO
Fee-for-service · 13,578 Rx Managed care · 25,689 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 1,430 units · 14.2 per 100k residents MI New York: 155,870 units · 796 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 100,100 units · 2,365 per 100k residents OR Nevada: 13,760 units · 431 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 47,990 units · 382 per 100k residents IL Indiana: 9,210 units · 134 per 100k residents IN Ohio: 1,050 units · 8.9 per 100k residents OH Pennsylvania: 6,760 units · 52.2 per 100k residents PA New Jersey: 17,550 units · 189 per 100k residents NJ Massachusetts: 2,185 units · 31.2 per 100k residents MA California: 242,013 units · 621 per 100k residents CA Utah: 23,810 units · 697 per 100k residents UT Colorado: 470 units · 8.0 per 100k residents CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 4,920 units · 109 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: 288,896 units · 4,675 per 100k residents MD Connecticut: 430 units · 11.9 per 100k residents CT Rhode Island: 5,580 units · 510 per 100k residents RI Arizona: no data reported AZ New Mexico: 173,531 units · 8,209 per 100k residents NM Kansas: 6,230 units · 212 per 100k residents KS Arkansas: no data reported AR Tennessee: 141 units · 2.0 per 100k residents TN North Carolina: 1,903 units · 17.6 per 100k residents NC South Carolina: 6,840 units · 127 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 16,840 units · 153 per 100k residents GA D.C.: 1,880 units · 277 per 100k residents DC Hawaii: 2,330 units · 162 per 100k residents HI Texas: 2,320 units · 7.6 per 100k residents TX Florida: 332 units · 1.5 per 100k residents FL
Units reimbursed · per 100k residents
1.58,209
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 New Mexico 8,209 /100k
2 Maryland 4,675 /100k
3 Oregon 2,365 /100k
4 New York 796 /100k
5 Utah 697 /100k
6 California 621 /100k
7 Rhode Island 510 /100k
8 Nevada 431 /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 Admelog — 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 Admelog. 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
$1.07M
Claims incl. refills
5.8K
Beneficiaries
3.8K
Spend / beneficiary
$284.39
Spend / claim
$184.34
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 ADMELOG (this brand).

Top reported reactions

Blood Glucose Increased2,378
Hypoglycaemia667
Visual Impairment604
Nausea582
Dyspnoea564
Blood Glucose Decreased463
Vomiting426

Age at onset

Neonate45
Infant9
Child62
Adolescent92
Adult2,499
Elderly2,280

Reporter sex

14,102 reports
Male · 47%
Female · 53%
Unknown · 0%

Serious outcomes

Hospitalization5,285
Life-threatening724
Disabling281
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 1,954 963
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.
← 00024-5922-01 · Sanofi-Aventis 00024-5925-00 · Sanofi-Aventis →
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.