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Soliqua 100/33 insulin glargine and lixisenatide 100 U/mL; 33 ug/mL Injection, Solution — NDC 00024-5761-01 package photo

Soliqua 100/33 insulin glargine and lixisenatide 100 U/mL; 33 ug/mL Injection, Solution

by Sanofi-Aventis U.S. LLC · 1 SYRINGE in 1 CARTON (0024-5761-01) / 3 mL in 1 SYRINGE
NDC 00024-5761-01
🏷️ FDA NDC (as labeled) 0024-5761-01 billing pads the labeler segment with a zero
This package
Contains3 mL in 1 syringe Pack sizes2 compare ↓
Also priced by: Part D plans $57.22/unit — full pricing hub ↓
Also comes in: 5 syringes 00024-5761-05
Rx only Brand On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 0024-5761-01
Product NDC 0024-5761
11-digit billing NDC 00024576101
RxCUI 1858995, 1859000
UNII 2ZM8CX04RZ, 74O62BB01U
Application # BLA208673
SPL Set ID 4bba538b-cf7c-4310-ae8f-cb711ed21bcc
Established class (EPC) Insulin Analog; GLP-1 Receptor Agonist
Mechanism of action Glucagon-like Peptide-1 (GLP-1) Agonists
Chemical class Insulin; Glucagon-Like Peptide 1
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-11-21
Route SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance INSULIN GLARGINE; LIXISENATIDE
GPI-14 2799100235D220
GPI class Soliqua
GCN Seq No 076864
GCN 42676
HICL code 043944
Ingredient (HICL) Insulin Glargine/Lixisenatide
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C4
Therapeutic class — intermediate (HIC2) Antihyperglycemics
HIC3 code C4X
Therapeutic class — specific (HIC3) Antihypergly,Insulin,Long Act-Glp-1 Recept.agonist
AHFS code 28:20.08.92
AHFS class Anorexigenic Agents, Miscellaneous
FDB label name SOLIQUA 100 UNIT-33 MCG/ML PEN
FDB brand name Soliqua 100-33
Legend status F — Federal legend — prescription drug or device
Biologic (Purple Book) 351(a)
Why two NDCs? The FDA registers this code as 0024-5761-01 — 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 → 00024-5761-01. 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 GLP-1 Receptor Agonist class.

Pharmacologic class GLP-1 Receptor Agonist
Drug family (ATC) Glucagon-like peptide-1 (GLP-1) analogues, Insulins and analogues for injection, long-acting
How it works Glucagon-like Peptide-1 (GLP-1) Agonists
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.

🏭 Manufacturer & labeler

LabelerSanofi-Aventis U.S. LLC
FDA applicationBLA208673 (BLA)
Labeler code00024
First marketedNov 2016
Product typeHuman Prescription Drug
Portfolio84 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.

🩺 Clinical

Label name SOLIQUA 100 UNIT-33 MCG/ML PEN Ingredient Insulin Glargine/Lixisenatide

Supplement & herbal interactions

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

🧪 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.

  • 20 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.
  • 2.7 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.
  • 3 mg / 1 mL UNII AE28F7PNPL
    Methionine is an amino acid used as a nutrient supplement and pH buffer in medicines. It helps stabilize the formulation and supports the product's overall composition.
  • 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.
  • 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.
  • 30 ug / 1 mL UNII 86Q357L16B
    Zinc chloride is a mineral salt used as a buffer and pH regulator in medications. It helps maintain the chemical stability and proper acidity level of the drug formulation.

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.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $57.22 $171.65 / 3 ml
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Soliqua 100/33 100 U/mL; 33 ug/mLthis 00024-5761-01 Sanofi-Aventis 1 syringe — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & biosimilar status

🏛️
2016
First FDA approval
Nov 2016
📍
2026
Currently FDA-listed
10 years listed
🛡️
2028
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 Nov 2028. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved Nov 21, 2016 ⏳ ~2.2 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
Soliqua 100/33insulin glargine and lixisenatide
🔒 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
2016 2018 2020 2022 2024 2026 2028
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 dateNov 21, 2028
Common questions
Is there a biosimilar for SOLIQUA 100 UNIT-33 MCG/ML PEN?
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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
5 syringes00024-5761-05 4,625 Rx · $4,000,276
1 syringe this page00024-5761-01 No Medicaid data
Drug total (last 4 qtrs): 4,625 Rx · 69,903 units · $4,000,276 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Soliqua 100-33 — 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 Soliqua 100-33. 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
$59.32M
Claims incl. refills
52.1K
Beneficiaries
33.7K
Spend / beneficiary
$1,762.88
Spend / claim
$1,138.70
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.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
00024-5761-01 You're viewing this 1 SYRINGE in 1 CARTON (0024-5761-01) / 3 mL in 1 SYRINGE — — 2016-11-21 Active
00024-5761-05 5 SYRINGE in 1 CARTON (0024-5761-05) / 3 mL in 1 SYRINGE (0024-5761-02) $57.09 / mL $856.31 2016-11-21 Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 00024-5761-01?
NDC 00024-5761-01 is listed by the FDA — 1 syringe in 1 carton / 3 ml in 1 syringe.
What NDC number is used to bill for this package of Soliqua 100/33 insulin glargine and lixisenatide 100 U/mL; 33 ug/mL Injection, Solution?
Bill NDC 00024-5761-01 — the 11-digit billing format is 00024576101. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 0024-5761-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00024-5761-01, written without dashes as 00024576101. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 00024-5761-01, the first segment (00024) is the labeler code FDA assigned to Sanofi-Aventis U.S. LLC; the middle segment (5761) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Sanofi-Aventis U.S. LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 5 syringes (00024-5761-05). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Sanofi-Aventis U.S. LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. 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 💬 Medication Guide
🎯 Indications and Usage 170 words ▾

1 INDICATIONS AND USAGE SOLIQUA 100/33 is a combination of insulin glargine and lixisenatide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. SOLIQUA 100/33 is a combination of insulin glargine, an insulin analog, and lixisenatide, a glucagon-like peptide-1 (GLP-1) receptor agonist, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use ( 1 ) : Concomitant use in combination with any other product containing a GLP-1 receptor agonist is not recommended.

Not recommended for the treatment of diabetic ketoacidosis. Has not been studied in combination with prandial insulin. Limitations of Use : SOLIQUA 100/33 contains lixisenatide.

Coadministration with any other product containing lixisenatide or another glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended [see Warnings and Precautions (5.5) ] . SOLIQUA 100/33 is not recommended for the treatment of diabetic ketoacidosis. SOLIQUA 100/33 has not been studied in combination with prandial insulin.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Inject subcutaneously once a day within the hour prior to the first meal of the day. ( 2.1 ) SOLIQUA 100/33 pen delivers 15 units to 60 units per injection. ( 2.1 , 2.2 ) Maximum daily dosage is 60 units (60 units of insulin glargine and 20 mcg of lixisenatide).

( 2.1 ) Discontinue basal insulin or GLP-1 receptor agonist prior to initiation. ( 2.2 ) In patients naive to basal insulin or to a GLP-1 receptor agonist, currently on less than 30 units of basal insulin, or on a GLP-1 receptor agonist, the recommended starting dosage is 15 units subcutaneously once daily. ( 2.2 ) In patients inadequately controlled on 30 to 60 units of basal insulin, the starting dosage is 30 units subcutaneously once daily.

( 2.2 ) See Full Prescribing Information for titration recommendations. ( 2.3 ) Inject subcutaneously in abdominal area, thigh, or upper arm and rotate injection sites within the same region from one injection to the next to reduce risk of lipodystrophy and localized cutaneous amyloidosis. ( 2.5 ) Do not administer intravenously, or via an infusion pump.

( 2.5 ) Do not dilute or mix with any other insulin products or solutions. ( 2.5 )

2.1Important Dosage Information SOLIQUA 100/33 is a combination of insulin glargine and lixisenatide. Administer SOLIQUA 100/33 subcutaneously once a day within the hour prior to the first meal of the day. The SOLIQUA 100/33 pen delivers doses from 15 to 60 units in a single injection.

Table 1 presents the units of insulin glargine and the micrograms of lixisenatide in each dosage of SOLIQUA 100/33 [see Dosage and Administration (2.2) ] . The maximum dose of SOLIQUA 100/33 is 60 units daily (60 units insulin glargine and 20 mcg lixisenatide) [see Warnings and Precautions (5.5) ] .

2.2Recommended Starting Dose In patients naive to basal insulin or to a GLP-1 receptor agonist, currently on a GLP-1 receptor agonist or currently on less than 30 units of basal insulin daily: Discontinue therapy with basal insulin or a GLP-1 receptor agonist prior to initiation of SOLIQUA 100/33. The recommended starting dosage of SOLIQUA 100/33 is 15 units (15 units insulin glargine and 5 mcg lixisenatide) given subcutaneously once daily. In patients currently on 30 to 60 units of basal insulin daily, with or without a GLP-1 receptor agonist: Discontinue therapy with basal insulin or GLP-1 receptor agonist prior to initiation of SOLIQUA 100/33.

The recommended starting dosage of SOLIQUA 100/33 is 30 units (30 units insulin glargine and 10 mcg lixisenatide) given subcutaneously once daily. Table 1: Units of Insulin Glargine and Micrograms of Lixisenatide in Each Dosage of SOLIQUA 100/33 SOLIQUA 100/33 (dose window display) The dose window on the SOLIQUA 100/33 pen displays numbers for the even units and displays lines for the odd units. Insulin glargine component dose Lixisenatide component dose Comment 2 --- --- Safety test dose – not for injection 15 15 units 5 mcg Recommended starting dosage for patients naive to basal insulin or GLP-1 receptor agonist, currently on GLP-1 receptor agonist, or currently on less than 30 units of basal insulin daily 16 16 units 5.3 mcg 17 17 units 5.7 mcg 18 18 units 6 mcg 19 19 units 6.3 mcg 20 20 units 6.7 mcg 21 21 units 7 mcg 22 22 units 7.3 mcg 23 23 units 7.7 mcg 24 24 units 8 mcg 25 25 units 8.3 mcg 26 26 units 8.7 mcg 27 27 units 9 mcg 28 28 units 9.3 mcg 29 29 units 9.7 mcg 30 30 units 10 mcg Recommended starting dosage for patients currently on 30 to 60 units of basal insulin daily, with or without a GLP-1 receptor agonist: 31 31 units 10.3 mcg 32 32 units 10.7 mcg 33 33 units 11 mcg 34 34 units 11.3 mcg 35 35 units 11.7 mcg 36 36 units 12 mcg 37 37 units 12.3 mcg 38 38 units 12.7 mcg 39 39 units 13 mcg 40 40 units 13.3 mcg 41 41 units 13.7 mcg 42 42 units 14 mcg 43 43 units 14.3 mcg 44 44 units 14.7 mcg 45 45 units 15 mcg 46 46 units 15.3 mcg 47 47 units 15.7 mcg 48 48 units 16 mcg 49 49 units 16.3 mcg 50 50 units 16.7 mcg 51 51 units 17 mcg 52 52…

💊 Dosage Forms and Strengths 60 words ▾

3 DOSAGE FORMS AND STRENGTHS SOLIQUA 100/33 is a clear, colorless to almost colorless solution available as: Injection: 100 units of insulin glargine and 33 mcg of lixisenatide per mL in a 3 mL prefilled, disposable, single-patient-use SoloStar ® pen. Injection: 100 units insulin glargine and 33 mcg lixisenatide per mL in a 3 mL single-patient-use pen. ( 3 )

⛔ Contraindications 81 words ▾

4 CONTRAINDICATIONS SOLIQUA 100/33 is contraindicated: During episodes of hypoglycemia [see Warnings and Precautions (5.6) ] . In patients with serious hypersensitivity to insulin glargine, lixisenatide, or any of the excipients in SOLIQUA 100/33. Hypersensitivity reactions including anaphylaxis have occurred with both lixisenatide and insulin glargine [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ] .

During episodes of hypoglycemia. ( 4 ) Serious hypersensitivity to insulin glargine, lixisenatide, or any of the excipients in SOLIQUA 100/33 ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Anaphylaxis and Serious Hypersensitivity Reactions : Severe, life-threatening, and generalized allergic reactions can occur. Instruct patients to discontinue use if a reaction occurs and promptly seek medical attention. ( 5.1 ) Acute Pancreatitis : Has been observed in patients treated with GLP-1 receptor agonists, including SOLIQUA 100/33.

Discontinue if pancreatitis is suspected. ( 5.2 ) Never share a SOLIQUA 100/33 prefilled pen between patients, even if the needle is changed. ( 5.3 ) 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.

( 5.4 ) Overdose Due to Medication Errors : SOLIQUA 100/33 contains two drugs. Instruct patients to always check the label before each injection since accidental mix-ups with insulin products can occur. Do not exceed the maximum dose or use with other GLP-1 receptor agonists.

( 5.5 ) Hypoglycemia : May be life-threatening. Increase frequency of glucose monitoring with changes to insulin dosage, coadministered glucose lowering medications, meal pattern, physical activity; and in patients with renal or hepatic impairment and hypoglycemia unawareness. ( 5.6 ) Acute kidney injury Due to Volume Depletion : Monitor renal function in patients reporting adverse reactions that could lead to volume depletion.

SOLIQUA 100/33 is not recommended in patients with end-stage renal disease. ( 5.7 ) Severe Gastrointestinal Adverse Reactions: Use has been associated with gastrointestinal adverse reactions, sometimes severe. SOLIQUA 100/33 is not recommended in patients with severe gastroparesis ( 5.8 ).

Immunogenicity : Patients may develop antibodies to insulin glargine and lixisenatide. If there is worsening glycemic control or failure to achieve targeted glycemic control, significant injection-site reactions or allergic reactions, alternative antidiabetic therapy should be considered. ( 5.9 ) Hypokalemia : May be life-threatening.

Monitor potassium levels in patients at risk of hypokalemia and treat if indicated. ( 5.10 ) Fluid Retention and Heart Failure with Use of PPAR-gamma agonists : Observe for signs and symptoms of heart failure; consider dosage reduction or discontinuation if heart failure occurs. ( 5.11 ) Acute Gallbladder Disease : If cholelithiasis or cholecystitis are suspected, gallbladder studies are indicated.

( 5.12 ) Pulmonary Aspiration During General Anesthesia or Deep Sedation: Has been reported in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures. Instruct patients to inform healthcare providers of any planned surgeries or procedures . ( 5.13 )

5.1Anaphylaxis and Serious Hypersensitivity Reactions In clinical trials of lixisenatide there have been cases of anaphylaxis (frequency of 0.1% or 10 cases per 10,000 patient-years) and other serious hypersensitivity reactions including angioedema. Severe, life-threatening, generalized allergic reactions, including anaphylaxis, generalized skin reactions, angioedema, bronchospasm, hypotension, and shock can occur with insulins, including insulin glargine. There have been postmarketing reports of serious hypersensitivity reactions, including anaphylactic reactions and angioedema, in patients treated with SOLIQUA 100/33 [see Adverse Reactions (6.1) ] .

Inform and closely monitor patients with a history of anaphylaxis or angioedema with another GLP-1 receptor agonist for allergic reactions, because it is unknown whether such patients will be predisposed to anaphylaxis with SOLIQUA 100/33. SOLIQUA 100/33 is contraindicated in patients with known serious hypersensitivity to lixisenatide or insulin glargine [see Contraindications (4) ] . If a hypersensitivity reaction occurs, the patient should discontinue SOLIQUA 100/33 and promptly seek medical attention.

5.2…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed elsewhere: Anaphylaxis and Serious Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Acute Pancreatitis [see Warnings and Precautions (5.2) ] Hypoglycemia [see Warnings and Precautions (5.6) ] Acute Kidney Injury Due to Volume Depletion [see Warnings and Precautions (5.7) ] Severe Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.8) ] Hypokalemia [see Warnings and Precautions (5.10) ] Acute Gallbladder Disease [see Warnings and Precautions (5.12) ] Pulmonary Aspiration During General Anesthesia or Deep Sedation [see Warnings and Precautions (5.13) ] The most common adverse reactions, reported in ≥5% of patients treated with SOLIQUA 100/33 include hypoglycemia, nausea, nasopharyngitis, diarrhea, upper respiratory tract infection, and headache.

( 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 clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice. The safety of SOLIQUA 100/33 (n=834, with a mean treatment duration of 203 days) has been evaluated in two clinical studies (30 weeks duration) in type 2 diabetes patients. The studies, Study A and B [see Clinical Studies (14) ] , had the following characteristics: mean age was approximately 59 years; approximately 50% were male, 90% were Caucasian, 6% were Black or African American, and 18% were Hispanic.

The mean duration of diabetes was 10.3 years, mean HbA1c at screening for Study A was 8.2 and Study B was 8.5. The mean BMI at baseline was 32 kg/m 2 . Baseline eGFR was ≥60 mL/min in 87.2% of the pooled study population and mean baseline eGFR was 83.0 mL/min/1.73 m 2 .

Table 3: Adverse Reactions Occurring in ≥5% of SOLIQUA 100/33–Treated Patients with Type 2 Diabetes Mellitus from Two Pooled Clinical Trials SOLIQUA 100/33, % (n=834) Nausea

10.0 Nasopharyngitis

7.0 Diarrhea

7.0 Upper respiratory tract infection

5.5 Headache

5.4Hypoglycemia Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, and insulin-containing products including SOLIQUA 100/33 [see Warnings and Precautions (5.6) ] . 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 SOLIQUA 100/33 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 SOLIQUA 100/33 program, severe hypoglycemia was defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions and documented symptomatic hypoglycemia was defined as an event with typical symptoms of hypoglycemia accompanied by a self-monitored plasma glucose value equal to or less than 70 mg/dL (see Table 4 ). No clinically important differences in risk of severe hypoglycemia between SOLIQUA 100/33 and comparators were observed in clinical trials.

Table 4: Hypoglycemic Episodes in SOLIQUA 100/33-Treated Patients with T2DM SOLIQUA 100/33 Study A N=469 SOLIQUA 100/33 Study B N=365 Severe symptomatic hypoglycemia Defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. (%) 0

1.1Hypoglycemia (self-monitored plasma glucose <54 mg/dL) (%) 8.1

17.8Gastrointestinal Adverse Reactions Gastrointestinal adverse reactions are the most commonly observed adverse reaction in patients using lixisenatide. Gastrointestinal adverse reactions occur m…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Drugs that affect glucose metabolism : Adjustment of SOLIQUA 100/33 dosage may be needed; closely monitor blood glucose. ( 7.1 ) Antiadrenergic Drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine): Hypoglycemia signs and symptoms may be reduced. ( 7.1 ) Effects of delayed gastric emptying on oral medications : Lixisenatide delays gastric emptying which may impact absorption of concomitantly administered oral medications.

Oral contraceptives and other medications such as antibiotics and acetaminophen should be taken at least 1 hour prior to SOLIQUA 100/33 administration or 11 hours after. ( 7.2 )

7.1Medications that Can Affect Glucose Metabolism A number of medications affect glucose metabolism and may require dose adjustment of SOLIQUA 100/33 and particularly close monitoring. Drugs That May Increase the Risk of Hypoglycemia Drugs: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics. Intervention: Dose reductions and increased frequency of glucose monitoring may be required when SOLIQUA 100/33 is coadministered with these drugs.

Drugs That May Decrease the Blood Glucose Lowering Effect of SOLIQUA 100/33 Drugs: Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones. Intervention: Dose increases and increased frequency of glucose monitoring may be required when SOLIQUA 100/33 is coadministered with these drugs.

Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of SOLIQUA 100/33 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 SOLIQUA 100/33 is coadministered 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 SOLIQUA 100/33 is coadministered with these drugs.

7.2Effects of Delayed Gastric Emptying on Oral Medications Lixisenatide-containing products, including SOLIQUA 100/33, delay gastric emptying which may reduce the rate of absorption of orally administered medications. Use caution when coadministering oral medications that have a narrow therapeutic ratio or that require careful clinical monitoring. These medications should be adequately monitored when concomitantly administered with lixisenatide.

If such medications are to be administered with food, patients should be advised to take them with a meal or snack when lixisenatide is not administered. Antibiotics, acetaminophen, or other medications that are particularly dependent on threshold concentrations for efficacy or for which a delay in effect is undesirable should be administered at least 1 hour before SOLIQUA 100/33 injection [see Clinical Pharmacology (12.3) ] . Oral contraceptives should be taken at least 1 hour before SOLIQUA 100/33 administration or 11 hours after [see Clinical Pharmacology (12.3) ] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy : SOLIQUA 100/33 should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. ( 8.1 )

8.1Pregnancy Risk Summary Based on animal reproduction studies, there may be risks to the fetus from exposure to lixisenatide, a component of SOLIQUA 100/33, during pregnancy. SOLIQUA 100/33 should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The limited available data with SOLIQUA 100/33 and lixisenatide in pregnant women is not sufficient to inform a drug-associated risk of major birth defects and miscarriage.

Published studies with insulin glargine use during pregnancy have not reported a clear association with insulin glargine and major birth defect or miscarriage risk [see Data ] . There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations ] . Lixisenatide administered to pregnant rats and rabbits during organogenesis was associated with visceral closure and skeletal defects at systemic exposures that decreased maternal food intake and weight gain during gestation, and that are 1-time and 6-times higher than the 20 mcg/day highest clinical dose, respectively, based on plasma AUC [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, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, still birth, and macrosomia related morbidity. Data Human data Insulin glargine Published data do not report a clear association with insulin glargine and major birth defects, miscarriage, or adverse maternal or fetal outcomes when insulin glargine is used during pregnancy.

However, these studies cannot definitely establish the absence of any risk because of methodological limitations including small sample size and some lacking comparator groups. Animal data Animal reproduction studies were not conducted with the combined products in SOLIQUA 100/33. The following data are based on studies conducted with the individual components of SOLIQUA 100/33.

Lixisenatide In pregnant rats receiving twice daily subcutaneous doses of 2.5, 35, or 500 mcg/kg during organogenesis (gestation day 6 to 17), fetuses were present with visceral closure defects (e.g., microphthalmia, bilateral anophthalmia, diaphragmatic hernia) and stunted growth. Impaired ossification associated with skeletal malformations (e.g., bent limbs, scapula, clavicle, and pelvis) were observed at ≥2.5 mcg/kg/dose, resulting in systemic exposure that is 1-time the 20 mcg/day clinical dose, based on plasma AUC.

Decreases in maternal body weight, food consumption, and motor activity were observed concurrent with the adverse fetal findings, which confounds the interpretation of relevance of these malformations to the human risk assessment. Placental transfer of lixisenatide to developing rat fetuses is low with a concentration ratio in fetal/maternal plasma of 0.1%. In pregnant rabbits receiving twice daily subcutaneous doses of 2.5, 25, 250 mcg/kg during organogenesis (gestation day 6 to 18), fetuses were present with multiple visceral and skeletal malformations, including closure defects, at ≥5 mcg/kg/day or systemic exposures that are 6-times the 20 mcg/day highest clinical dose, based on plasma AUC.

Decreases in maternal body…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Based on animal reproduction studies, there may be risks to the fetus from exposure to lixisenatide, a component of SOLIQUA 100/33, during pregnancy. SOLIQUA 100/33 should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The limited available data with SOLIQUA 100/33 and lixisenatide in pregnant women is not sufficient to inform a drug-associated risk of major birth defects and miscarriage.

Published studies with insulin glargine use during pregnancy have not reported a clear association with insulin glargine and major birth defect or miscarriage risk [see Data ] . There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations ] . Lixisenatide administered to pregnant rats and rabbits during organogenesis was associated with visceral closure and skeletal defects at systemic exposures that decreased maternal food intake and weight gain during gestation, and that are 1-time and 6-times higher than the 20 mcg/day highest clinical dose, respectively, based on plasma AUC [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, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, still birth, and macrosomia related morbidity. Data Human data Insulin glargine Published data do not report a clear association with insulin glargine and major birth defects, miscarriage, or adverse maternal or fetal outcomes when insulin glargine is used during pregnancy.

However, these studies cannot definitely establish the absence of any risk because of methodological limitations including small sample size and some lacking comparator groups. Animal data Animal reproduction studies were not conducted with the combined products in SOLIQUA 100/33. The following data are based on studies conducted with the individual components of SOLIQUA 100/33.

Lixisenatide In pregnant rats receiving twice daily subcutaneous doses of 2.5, 35, or 500 mcg/kg during organogenesis (gestation day 6 to 17), fetuses were present with visceral closure defects (e.g., microphthalmia, bilateral anophthalmia, diaphragmatic hernia) and stunted growth. Impaired ossification associated with skeletal malformations (e.g., bent limbs, scapula, clavicle, and pelvis) were observed at ≥2.5 mcg/kg/dose, resulting in systemic exposure that is 1-time the 20 mcg/day clinical dose, based on plasma AUC.

Decreases in maternal body weight, food consumption, and motor activity were observed concurrent with the adverse fetal findings, which confounds the interpretation of relevance of these malformations to the human risk assessment. Placental transfer of lixisenatide to developing rat fetuses is low with a concentration ratio in fetal/maternal plasma of 0.1%. In pregnant rabbits receiving twice daily subcutaneous doses of 2.5, 25, 250 mcg/kg during organogenesis (gestation day 6 to 18), fetuses were present with multiple visceral and skeletal malformations, including closure defects, at ≥5 mcg/kg/day or systemic exposures that are 6-times the 20 mcg/day highest clinical dose, based on plasma AUC.

Decreases in maternal body weight, food consumption, and motor activity were observed concurrent with the fetal findings, which confounds the interpretation of relevance of these malformations to…

🧒 Pediatric Use 16 words ▾

8.4Pediatric Use Safety and effectiveness of SOLIQUA 100/33 have not been established in pediatric patients.

🧓 Geriatric Use 100 words ▾

8.5Geriatric Use Of the total number of subjects (n=834) in controlled clinical studies of patients with type 2 diabetes, who were treated with SOLIQUA 100/33, 25.2% (n=210) were ≥65 years of age and 4% (n=33) were ≥75 years of age. No overall differences in effectiveness and safety were observed in the subgroup analyses across the age groups. Nevertheless, caution should be exercised when SOLIQUA 100/33 is administered to geriatric patients.

In elderly patients with diabetes, the initial dosing, dose increments, and maintenance dosage should be conservative to avoid hypoglycemic reactions. Hypoglycemia may be difficult to recognize in the elderly.

🆘 Overdosage 170 words ▾

10 OVERDOSAGE Insulin Glargine Excess insulin administration may cause hypoglycemia and hypokalemia [see Warnings and Precautions (5.6 , 5.10) ] . Mild episodes of hypoglycemia can usually be treated with oral carbohydrates. Adjustments in drug dosage, meal patterns, or exercise may be needed.

More severe episodes of hypoglycemia with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. After apparent clinical recovery from hypoglycemia, continued observation and additional carbohydrate intake may be necessary to avoid recurrence of hypoglycemia. Hypokalemia must be corrected appropriately.

Lixisenatide During clinical studies, doses up to 30 mcg of lixisenatide twice daily (3-times the daily recommended dose) were administered to type 2 diabetic patients in a 13-week study. An increased incidence of gastrointestinal disorders was observed. In case of overdose, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.

Initiate appropriate supportive treatment according to the patient's clinical signs and symptoms and the SOLIQUA 100/33 dose should be reduced to the prescribed dose.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action SOLIQUA 100/33 SOLIQUA 100/33 is a combination of insulin glargine, a basal insulin analog, and lixisenatide, a GLP-1 receptor agonist. Insulin glargine The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism. Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production.

Insulin inhibits lipolysis and proteolysis and enhances protein synthesis. Lixisenatide Lixisenatide is a GLP-1 receptor agonist that increases glucose-dependent insulin release, decreases glucagon secretion, and slows gastric emptying.

12.2Pharmacodynamics Insulin Glargine The combination of insulin glargine and lixisenatide has no impact on the pharmacodynamics of insulin glargine. The impact of the combination of insulin glargine and lixisenatide on the pharmacodynamics of lixisenatide has not been studied in phase 1 studies. Lixisenatide In a clinical pharmacology study in adults with type 2 diabetes mellitus, lixisenatide reduced fasting plasma glucose and postprandial blood glucose AUC 0–300min compared to placebo (-33.8 mg/dL and -387 mg∙h/dL, respectively) following a standardized test meal.

The effect on postprandial blood glucose AUC was most notable with the first meal, and the effect was attenuated with later meals in the day. Treatment with lixisenatide 20 mcg once daily reduced postprandial glucagon levels (AUC 0–300min ) compared to placebo by -15.6 h∙pmol/L after a standardized test meal in patients with type 2 diabetes. Cardiac electrophysiology (QTc) At a dose 1.5-times the recommended dose, lixisenatide does not prolong the QTc interval to any clinically relevant extent.

12.3Pharmacokinetics SOLIQUA 100/33 The insulin glargine/lixisenatide ratio has no relevant impact on the PK of insulin glargine in SOLIQUA 100/33. Compared to administration of lixisenatide alone, the C max is lower whereas the AUC is generally comparable when administered as SOLIQUA 100/33. The insulin glargine/lixisenatide ratio has no impact on the PK of lixisenatide in SOLIQUA 100/33.

The observed differences in the PK of lixisenatide when given as SOLIQUA 100/33 or alone are not considered to be clinically relevant. Absorption After subcutaneous administration of insulin glargine/lixisenatide combinations, insulin glargine showed no pronounced peak. Exposure to insulin glargine ranged from 86% to 101% compared to administration of insulin glargine alone.

After subcutaneous administration of insulin glargine/lixisenatide combinations, the median t max of lixisenatide was in the range of 2.5 to 3.0 hours. There was a small decrease in C max of lixisenatide of 22%–34% compared with separate simultaneous administration of insulin glargine and lixisenatide, which is not likely to be clinically significant. There are no clinically relevant differences in the rate of absorption when lixisenatide is administered subcutaneously in the abdomen, thigh, or arm.

Distribution The protein binding of lixisenatide is 55%. Metabolism and elimination A metabolism study in humans who received insulin glargine alone indicates that insulin glargine is partly metabolized at the carboxyl terminus of the B chain in the subcutaneous depot to form two active metabolites with in vitro activity similar to that of human insulin, M1 (21 A -Gly-insulin) and M2 (21 A -Gly-des-30 B -Thr-insulin). Unchanged drug and these degradation products are also present in the circulation.

Lixisenatide is presumed to be eliminated through glomerular filtration, and proteolytic degradation. After multiple dose administration in patients with type 2 diabetes, mean terminal half-life was approximately 3 hours and the mean apparent clearance (CL/F) about 35 L/h. Special populations Effects of age, body weight, gender, and race Insulin glargine: Effect of age, race, and gender on the pharmacokinetics of insulin glargine…

🧬 Mechanism of Action 91 words ▾

12.1Mechanism of Action SOLIQUA 100/33 SOLIQUA 100/33 is a combination of insulin glargine, a basal insulin analog, and lixisenatide, a GLP-1 receptor agonist. Insulin glargine The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism. Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production.

Insulin inhibits lipolysis and proteolysis and enhances protein synthesis. Lixisenatide Lixisenatide is a GLP-1 receptor agonist that increases glucose-dependent insulin release, decreases glucagon secretion, and slows gastric emptying.

📦 How Supplied / Storage and Handling 160 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied SOLIQUA 100/33 (insulin glargine and lixisenatide) injection is a clear, colorless to almost colorless solution in a 3 mL prefilled, disposable, single-patient-use pen: Dosage Unit/Strength Package size NDC # 3 mL SOLIQUA 100/33 single-patient-use pen 100 units/mL insulin glargine and 33 mcg/mL lixisenatide Package of 5 0024-5761-05 Needles are not included. Only use needles that are compatible for use with SOLIQUA 100/33 prefilled pen.

16.2Storage Dispense in the original sealed carton with the enclosed Instructions for Use. Prior to first use, SOLIQUA 100/33 pen should be stored in a refrigerator, 36°F–46°F (2°C–8°C). Do not freeze.

Discard SOLIQUA 100/33 if it has been frozen. Protect from light. After first use, store at room temperature up to 77°F (25°C).

Replace the pen cap after each use to protect from light. Discard pen 28 days after first use. Remove the needle after each injection and store the SOLIQUA 100/33 pen without a needle attached.

📦 Storage and Handling 88 words ▾

16.2Storage Dispense in the original sealed carton with the enclosed Instructions for Use. Prior to first use, SOLIQUA 100/33 pen should be stored in a refrigerator, 36°F–46°F (2°C–8°C). Do not freeze.

Discard SOLIQUA 100/33 if it has been frozen. Protect from light. After first use, store at room temperature up to 77°F (25°C).

Replace the pen cap after each use to protect from light. Discard pen 28 days after first use. Remove the needle after each injection and store the SOLIQUA 100/33 pen without a needle attached.

📋 Description ~1 min read ▾

11 DESCRIPTION SOLIQUA 100/33 is a combination of insulin glargine, an insulin analog, and lixisenatide, a GLP-1 receptor agonist. Insulin glargine is a human insulin analog produced by recombinant DNA technology utilizing a nonpathogenic laboratory strain of Escherichia coli (K12) as the production organism. The minimum potency of insulin glargine is NLT 15 units/mg.

Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added at the C-terminus of the B-chain. Insulin glargine has low aqueous solubility at neutral pH. At pH 4 insulin glargine is completely soluble.

It has a molecular weight of 6.063 kDa. Lixisenatide is a synthetic analogue of human GLP-1, which acts as a GLP-1 receptor agonist. Lixisenatide is a protein containing 44 amino acids, which is amidated at the C-terminal amino acid (position 44) and has a molecular weight of 4.8585 kDa.

SOLIQUA 100/33 (insulin glargine and lixisenatide) injection is a sterile, colorless to almost colorless solution for subcutaneous use. SOLIQUA 100/33 is supplied as a prefilled single-patient-use disposable pen contain 300 units of insulin glargine and 100 mcg of lixisenatide in 3 mL of a clear, colorless to almost colorless, sterile, and aqueous solution. Each mL contains 100 units of insulin glargine and 33 mcg of lixisenatide and the inactive ingredients: glycerol (20 mg), metacresol (2.7 mg), methionine (3 mg), zinc (30 mcg), and Water for Injection, USP.

Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH. The approximate pH is 4.5.

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Anaphylaxis and Serious Hypersensitivity Reactions Inform patients that serious hypersensitivity reactions, including anaphylaxis, have been reported with SOLIQUA 100/33. If symptoms of hypersensitivity reactions occur, instruct patients to stop taking SOLIQUA 100/33 and seek medical advice promptly [see Warnings and Precautions (5.1) ] .

Acute Pancreatitis Inform patients of the potential risk for acute pancreatitis and its symptoms: severe abdominal pain that may radiate to the back, and which may or may not be accompanied by nausea or vomiting. Instruct patients to discontinue SOLIQUA 100/33 promptly and contact their physician if pancreatitis is suspected [see Warnings and Precautions (5.2) ] . Never Share SOLIQUA 100/33 Prefilled Pen Between Patients Advise patients that they must never share a SOLIQUA 100/33 prefilled pen with another person, even if the needle is changed because doing so carries a risk for transmission of blood-borne pathogens [see Warnings and Precautions (5.3) ] .

Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen Inform patients that hypoglycemia is the most common adverse reaction with insulin-containing products. Inform patients of the symptoms of hypoglycemia. Inform patients that the ability to concentrate and react may be impaired as a result of hypoglycemia [see Warnings and Precautions (5.6) ] .

This may present a risk in situations where these abilities are especially important, such as driving or operating other machinery. Advise patients who have frequent hypoglycemia or reduced or absent warning signs of hypoglycemia to use caution when driving or operating machinery. 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 (5.4) ] .

Overdose due to Medication Errors Inform patients that SOLIQUA 100/33 contains two drugs: insulin glargine and lixisenatide. Accidental mix-ups between insulin products have been reported. To avoid medication errors between SOLIQUA 100/33 and other insulin products, instruct patients to always check the label before each injection.

Advise patients that the administration of more than 60 units of SOLIQUA 100/33 daily can result in overdose of the lixisenatide component. Instruct patients not to administer concurrently with other GLP-1 receptor agonists [see Warnings and Precautions (5.5) ] . Acute Kidney Injury Due to Volume Depletion Inform patients of the potential risk of acute kidney injury due to dehydration associated with gastrointestinal adverse reactions.

Advise patients to take precautions to avoid fluid depletion. Inform patients of the signs and symptoms of acute kidney injury and instruct them to promptly report any of these signs or symptoms or persistent (or extended) nausea, vomiting, and diarrhea to their healthcare provider [see Warnings and Precautions (5.7) ] . Severe Gastrointestinal Adverse Reactions Inform patients of the potential risk of severe gastrointestinal adverse reactions.

Instruct patients to contact their healthcare provider if they have severe or persistent gastrointestinal symptoms [see Warnings and Precautions (5.8) ]. Acute Gallbladder Disease Inform patients of the potential risk for cholelithiasis or cholecystitis. Instruct patients to contact their physician if cholelithiasis or cholecystitis is suspected for appropriate clinical follow-up [see Warnings and Precautions (5.12) ] .

Pulmonary Aspiration During General Anesthesia or Deep Sedation Inform patients that SOLIQUA 100/33 may cause their stomach to empty more slowly which may lead to complications with anesthesia or deep sedation during planned surgeries or procedures. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if the…

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: March 2026 Medication Guide SOLIQUA ® 100/33 ( So - lee - kwa ) (insulin glargine and lixisenatide) injection, for subcutaneous use What is the most important information I should know about SOLIQUA 100/33?

SOLIQUA 100/33 can cause serious side effects including inflammation of the pancreas (pancreatitis) . Stop using SOLIQUA 100/33 and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. You may feel the pain from your abdomen to your back.

What is SOLIQUA 100/33? SOLIQUA 100/33 is an injectable prescription medicine that contains 2 diabetes medicines, insulin glargine and lixisenatide, that is used along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes. SOLIQUA 100/33 is not recommended for people who also take lixisenatide or other medicines called glucagon-like peptide-1 receptor agonists (GLP-1) receptor agonists.

SOLIQUA 100/33 is not for use in people with diabetic ketoacidosis. SOLIQUA 100/33 has not been studied in people who also take a short-acting (prandial) insulin. It is not known if SOLIQUA 100/33 is safe and effective in children.

Who should not use SOLIQUA 100/33? Do not use SOLIQUA 100/33 if you: are having an episode of low blood sugar (hypoglycemia). have had a serious allergic reaction to insulin glargine, lixisenatide or any of the other ingredients in SOLIQUA 100/33. See the end of this Medication Guide for a complete list of ingredients in SOLIQUA 100/33.

See " What are the possible side effects of SOLIQUA 100/33? " for symptoms of a serious allergic reaction. Before using SOLIQUA 100/33, tell your healthcare provider about all your medical conditions including if you: have or have had problems with your pancreas. have heart failure or other heart problems. If you have heart failure, it may get worse while you take thiazolidinediones (TZDs). have severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems with digesting food. are taking certain medicines called glucagon-like peptide-1 receptor agonists (GLP-1 receptor agonists). are scheduled to have surgery or other procedures that use general anesthesia or deep sleepiness (deep sedation). are pregnant or plan to become pregnant.

It is not known if SOLIQUA 100/33 will harm your unborn baby. Tell your healthcare provider if you are pregnant or plan to become pregnant while using SOLIQUA 100/33. are breastfeeding or plan to breastfeed. It is not known if SOLIQUA 100/33 passes into your breast milk.

Talk with your healthcare provider about the best way to feed your baby while you use SOLIQUA 100/33. Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. SOLIQUA 100/33 may affect the way some medicines work and some medicines may affect the way SOLIQUA 100/33 works.

Before using SOLIQUA 100/33, talk to your healthcare provider about low blood sugar and how to manage it. Especially tell your healthcare provider if you take: antibiotics or the pain reliever, acetaminophen. Take these medicines at least 1 hour before using SOLIQUA 100/33.

If you must take these medicines, take them with a meal or a snack. You should not take these medicines at the same time that you take SOLIQUA 100/33. birth control pills that are taken by mouth (oral contraceptives). SOLIQUA 100/33 may lower the amount of the medicine in your blood from your birth control pills and they may not work as well to prevent pregnancy.

Take your birth control pill at least 1 hour before your injection of SOLIQUA 100/33 or at least 11 hours after your SOLIQUA 100/33 injection. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.

How should I use SOLIQUA 10…

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