TOUJEO Max insulin glargine 300 U/mL Injection, Solution — NDC 0024-5871-02 (Billing 00024-5871-02)
This is a package of TOUJEO Max insulin glargine 300 U/mL Injection, Solution from Sanofi-Aventis U.S. LLC, marketed since Feb 2015 and currently FDA-listed; retail pharmacies pay about $91.30 per mL (NADAC). It is the main listing for this product, which comes in 2 package sizes.
NDC database record
One package, one record: these facts belong to NDC 0024-5871-02 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0024 labeler · 5871 product · 02 package
- Package marketed since
- Mar 26, 2018
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 0024587102 2
- Medicaid fills, this package
- 48,402 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 078265
- GCN: 44561
- GPI-14 (Medi-Span): 2710400300D236
- HICL (First Databank): 022025
- AHFS class code: 68:20.08.00
- RxCUI (RxNorm): 1604539
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Insulin Analog class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Insulin glargine is used to treat type 1 diabetes (condition in which the body does not produce insulin and therefore cannot control the amount of sugar in the blood) and type 2 diabetes (condition in which the body does not use insulin normally and, therefore, cannot control the amount of sugar in the blood) . Insulin glargine is in a class of medications called long-acting insulin. Insulin glargine works by replacing the insulin that is normally produced by the body and by helping move sugar from the blood into other body tissues where it is used for energy. It also stops th...
Read the full MedlinePlus article ↗- Insulin glargine is a long-acting insulin — it's designed to provide a slow, steady background level of insulin over the course of the day, rather than a quick spike like short-act...
- What exactly is insulin glargine and why did my doctor prescribe it instead of regular insulin?
- You can take insulin glargine at any time of day that works for your routine — morning, evening, whenever. The key is to take it at the same time every single day. Consistency help...
- Does it matter what time of day I take my injection?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Insulin Glargine — tap one for details:
Insulin Glargine may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $91.300 | $547.80 / 6 ml |
| Medicaid paysCMS SDUD · 12 mo | $90.86 | $545.19 / 6 ml |
| Medicare drug plans payPart D · Q2 2026 | $91.60 | $549.62 / 6 ml |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 00024-5871-01 0024-5871-01 | 1 SYRINGE in 1 CARTON / 3 mL in 1 SYRINGE Sample | — | — | 2018-03-26 | — | Active |
| 00024-5871-02 You're viewing this Main listing | 2 SYRINGE in 1 CARTON / 3 mL in 1 SYRINGE | $91.30 / mL | $547.80 | 2018-03-26 | — | Active |
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of TOUJEO Max insulin glargine 300 U/mL Injection, Solution?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Insulin glargine U-300 Max 300 [iU]/mL 00955-2900-02 | Sanofi-Aventis | 2 syringes | $27.007 | — | Availability likely | save 70% |
| TOUJEO Max 300 U/mLthis 00024-5871-02 | Sanofi-Aventis | 2 syringes | $91.300 | — | Availability likely | — |
| TOUJEO Max 300 U/mL 50090-4177-00 | A-S | 2 syringes | — | — | FDA listed | — |
| Toujeo 300 U/mL 50090-2193-00 | A-S | 3 syringes | — | — | FDA listed | — |
| Toujeo 300 U/mL 00024-5869-00 | Sanofi-Aventis | 1 syringe | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Purple Book · refreshed Oct 5, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & biosimilar status
1 interchangeable is FDA-licensed for this reference biologic — see the list below. (Biologics have no small-molecule generics.)
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.
🛈 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.
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | Feb 25, 2027 |
Is there a biosimilar for TOUJEO MAX SOLOSTR 300 UNIT/ML?
Why do different websites show different biosimilar dates?
Can a biosimilar launch before the last patent expires?
What does “current Purple Book estimate” mean?
What does “FDA listed” mean?
What does a patent or protection date mean here?
Where does this data come from?
- FDA Purple Book · refreshed Oct 5, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Insulin Glargine (rDNA origin) Injection inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Sanofi-Aventis U.S. LLC labeler code 00024
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- Praluent alirocumab 75 mg/mL Injection, Solution NDC 0024-5901-00
- Praluent alirocumab 150 mg/mL Injection, Solution NDC 0024-5902-00
- KEVZARA sarilumab 150 mg/1.14mL Injection, Solution NDC 0024-5908-01
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- Dupixent Dupilumab 100 mg/.67mL Injection, Solution NDC 0024-5911-02
- Dupixent Dupilumab 300 mg/2mL Injection, Solution NDC 0024-5914-01
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE TOUJEO is indicated to improve glycemic control in adults and pediatric patients 6 years of age and older with diabetes mellitus. TOUJEO is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients 6 years and older with diabetes mellitus. ( 1 ) Limitations of Use : Not recommended for the treatment of diabetic ketoacidosis.
( 1 ) Limitations of Use: TOUJEO is not recommended for the treatment of diabetic ketoacidosis.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Individualize dose based on type of diabetes, metabolic needs, blood glucose monitoring results and glycemic control goal. ( 2.2 ) Administer subcutaneously into the abdominal area, thigh, or deltoid once daily at any time during the day, at the same time every day. ( 2.1 ) Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis.
( 2.1 ) Do not dilute or mix with any other insulin or solution. ( 2.1 ) See Full Prescribing Information for the recommended starting dosage in patients with type 2 diabetes and how to switch to TOUJEO from other insulins ( 2.3 , 2.4 ) Closely monitor glucose when switching to TOUJEO and during initial weeks thereafter. ( 2.4 )
2.1Important Administration Instructions Always check insulin labels before administration [see Warnings and Precautions (5.4) ] . Visually inspect the TOUJEO solution for particulate matter and discoloration prior to administration and only use if the solution is clear and colorless with no visible particles. Inject TOUJEO subcutaneously into the abdominal area, thigh, or deltoid.
Rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis [see Warnings and Precautions (5.2) , Adverse Reactions (6) ] . Use TOUJEO with caution in patients with visual impairment who may rely on audible clicks to dial their dose.
Do not administer TOUJEO intravenously or in an insulin pump. Do not dilute or mix TOUJEO with any other insulin products or solutions. Never transfer TOUJEO from the cartridges of the TOUJEO SoloStar or TOUJEO Max SoloStar prefilled pen into a syringe for administration [see Warnings and Precautions (5.4) ] .
2.2General Dosing Instructions TOUJEO is available in 2 single-patient-use prefilled pens: The TOUJEO SoloStar prefilled pen contains 450 units of insulin glargine. It delivers doses in 1-unit increments and can deliver up to 80 units in a single injection. The TOUJEO Max SoloStar prefilled pen contains 900 units of insulin glargine.
It delivers doses in 2-unit increments and can deliver up to 160 units in a single injection. It is recommended for patients requiring at least 20 units per day. When changing between TOUJEO SoloStar and TOUJEO Max SoloStar, if the patient's previous dose was an odd number, the dose should be increased or decreased by 1 unit to match the dose increments dialable on each prefilled pen.
The dose counter of the TOUJEO SoloStar or TOUJEO Max SoloStar prefilled pen shows the number of units of TOUJEO to be injected and no conversion is required. Inject TOUJEO subcutaneously once a day at the same time of day. During changes to a patient's insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions (5.2) ] .
Individualize and titrate the dosage of TOUJEO based on the patient's metabolic needs, blood glucose monitoring results, and glycemic control goal. Titrate the dose of TOUJEO no more frequently than every 3 to 4 days. Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), changes in renal or hepatic function or during acute illness to minimize the risk of hypoglycemia or hyperglycemia [see Warnings and Precautions (5.2) and Use in Specific Populations (8.6 , 8.7) ] .
2.3Starting Dose in Insulin-Naive Pediatric and Adult Patients Recommended Starting Dosage in Patients with Type 1 Diabetes The recommended starting dose of TOUJEO in insulin-naive patients with type 1 diabetes is approximately one-third to one-half of the total daily insulin dose. The remainder of the total daily insulin dose should be given as a short-acting insulin and divided between each daily meal. As a general rule, 0.2 to 0.4 units of insulin per kilogram of body weight can be used to calculate the initial t… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Injection: 300 units/mL (U-300) of insulin glargine in a clear, colorless, solution available as: 1.5 mL SoloStar single-patient-use prefilled pen (450 units per 1.5 mL pen) 3 mL Max SoloStar single-patient-use prefilled pen (900 units per 3 mL pen) Injection: 300 units/mL (U-300) insulin glargine in: 1.5 mL SoloStar single-patient-use prefilled pen ( 3 ) 3 mL Max SoloStar single-patient-use prefilled pen ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS TOUJEO is contraindicated: During episodes of hypoglycemia [see Warnings and Precautions (5.3) ] . In patients with hypersensitivity to insulin glargine or any excipients in TOUJEO [see Warnings and Precautions (5.5) ] . During episodes of hypoglycemia ( 4 ) Hypersensitivity to insulin glargine or any excipients in TOUJEO ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Never share a TOUJEO SoloStar or TOUJEO Max SoloStar single-patient-use prefilled pen 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.
Increase frequency of glucose monitoring with changes to: insulin dosage, concomitant drugs, meal pattern, physical activity, and in patients with renal impairment or hepatic impairment or hypoglycemia unawareness. ( 5.3 , 6.1 ) 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: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue TOUJEO, monitor and treat if indicated. ( 5.5 , 6.1 ) 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 )
5.1Never Share a TOUJEO SoloStar or TOUJEO Max SoloStar Pen Between Patients TOUJEO SoloStar or TOUJEO Max SoloStar single-patient-use prefilled pens must never be shared between patients, even if the needle is changed. Pen sharing poses a risk for transmission of blood-borne pathogens.
5.2Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen Changes in Insulin Regimen Including Changes to Administration Site 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 oral antidiabetic products may be needed.
Changing to TOUJEO from other Insulin Therapies On a unit-to-unit basis, TOUJEO has a lower glucose lowering effect than LANTUS [see Clinical Pharmacology (12.2) ] . In clinical trials, patients who changed to TOUJEO from other basal insulins experienced higher average fasting plasma glucose levels in the first weeks of therapy compared to patients who were changed to LANTUS. Higher doses of TOUJEO were required to achieve similar levels of glucose control compared to LANTUS in clinical trials [see Clinical Studies (14.1) ] .
The onset of action of TOUJEO develops over 6 hours following an injection. In type 1 diabetes patients treated with IV insulin, consider the longer onset of action of TOUJEO before stopping IV insulin. The full glucose lowering effect may not be apparent for at least 5 days [see Dosage and Administration (2.2) and Clinical Pharmacology (12.2) ] .
To minimize the risk of hyperglycemia when initiating TOUJEO monitor glucose daily, titrate TOUJEO as described in this prescribing information, and adjust coadministered glucose-lowering therapies per standard of care [see Dosage and Administration (2.2 , 2.3) ] .
5.3Hypoglycemia Hypoglycemia is the most common adverse reaction asso… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions are discussed elsewhere: Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen [see Warnings and Precautions (5.2) ] 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 commonly associated with TOUJEO (≥5%) are: Hypoglycemia, allergic reactions, injection site reaction, lipodystrophy, pruritus, rash, edema, and weight gain.
( 6.1 , 6.2 ) 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 actually observed in clinical practice. The data in Table 1 reflect the exposure of 304 patients with type 1 diabetes to TOUJEO with mean exposure duration of 23 weeks. The type 1 diabetes population had the following characteristics: Mean age was 46 years and mean duration of diabetes was 21 years.
Fifty-five percent were male, 86% were White, 5% were Black or African American, and 5% were Hispanic or Latino. At baseline, the mean eGFR was 82 mL/min/1.73 m 2 and 35% of patients had eGFR ≥90 mL/min/1.73 m 2 . The mean body mass index (BMI) was 28 kg/m 2 .
HbA1c at baseline was greater than or equal to 8% in 58% of patients. The data in Table 2 reflect the exposure of 1242 patients with type 2 diabetes to TOUJEO with mean exposure duration of 25 weeks. The type 2 diabetes population had the following characteristics: Mean age was 59 years and mean duration of diabetes was 13 years.
Fifty-three percent were male, 88% were White, 7% were Black or African American, and 17% were Hispanic or Latino. At baseline, mean eGFR was 79 mL/min/1.73 m 2 and 27% of patients had an eGFR ≥90 mL/min/1.73 m 2 . The mean BMI was 35 kg/m 2 .
HbA1c at baseline was greater than or equal to 8% in 66% of patients. TOUJEO was studied in 233 pediatric patients (6–17 years of age) with type 1 diabetes for a mean duration of 26 weeks [see Clinical Studies (14.1) ] . Common adverse reactions (occurring ≥5%) in TOUJEO-treated subjects during clinical trials in adult patients with type 1 diabetes mellitus and type 2 diabetes mellitus are listed in Table 1 and Table 2, respectively.
Common adverse reactions for TOUJEO-treated pediatric subjects with type 1 diabetes mellitus were similar to the adverse reactions listed in Table 1. Hypoglycemia is discussed in a dedicated subsection below. Table 1: Adverse Reactions Occurring ≥5% in Two Pooled Clinical Trials of 26 Weeks and 16 Weeks Duration in Adults with Type 1 Diabetes TOUJEO + Mealtime Insulin "mealtime insulin" refers to insulin glulisine, insulin lispro, or insulin aspart. , % (n=304) Nasopharyngitis
12.8 Upper respiratory tract infection
9.5Table 2: Adverse Reactions Occurring ≥5% in Three Pooled Clinical Trials of 26 Weeks Duration in Adults with Type 2 Diabetes TOUJEO one of the trials in type 2 diabetes included mealtime insulin. , % (n=1242) Nasopharyngitis
7.1 Upper respiratory tract infection
5.7Hypoglycemia Hypoglycemia is the most commonly observed adverse reaction in patients treated with TOUJEO. 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 TOUJEO 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 TOUJEO adult program, severe hypoglycemia was… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Table 3 includes clinically significant drug interactions with TOUJEO. Table 3: Clinically Significant Drug Interactions with TOUJEO 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, GLP-1 receptor agonists, DPP-4 inhibitors, and SGLT-2 inhibitors.
Intervention: Dosage reductions and increased frequency of glucose monitoring may be required when TOUJEO is coadministered with these drugs. Drugs That May Decrease the Blood Glucose Lowering Effect of TOUJEO 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: Dosage increases and increased frequency of glucose monitoring may be required when TOUJEO is coadministered with these drugs. Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of TOUJEO Drugs: Alcohol, beta-blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia.
Intervention: Dosage adjustment and increased frequency of glucose monitoring may be required when TOUJEO 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 TOUJEO is coadministered with these drugs.
Drugs that Affect Glucose Metabolism: Adjustment of insulin dosage may be needed. ( 7 ) Antiadrenergic Drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine): Signs and symptoms of hypoglycemia may be reduced or absent. ( 5.3 , 7 )
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Published studies with use of insulin glargine during pregnancy have not reported a clear association with insulin glargine and adverse developmental outcomes (see Data ) . There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations ) . Rats and rabbits were exposed to insulin glargine in animal reproduction studies during organogenesis, respectively 50 times and 10 times the human subcutaneous dose of 0.2 unit/kg/day.
Overall, the effects of insulin glargine did not generally differ from those observed with regular human insulin (see Data ) . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The estimated background risk of major birth defects is 6% to 10% in women with pregestational diabetes with a peri-conceptional HbA1c >7 and has been reported to be as high as 20% to 25% in women with a peri-conceptional HbA1c >10.
The estimated background risk of miscarriage for the indicated population is unknown. Clinical Considerations Disease-Associated Maternal and/or Embryo/fetal Risk Hypoglycemia and hyperglycemia occur more frequently during pregnancy in patients with pre-gestational diabetes. 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 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 Subcutaneous reproduction and teratology studies have been performed with insulin glargine and regular human insulin in rats and Himalayan rabbits. Insulin glargine was given to female rats before mating, during mating, and throughout pregnancy at doses up to 0.36 mg/kg/day, which is approximately 50 times the recommended human subcutaneous starting dosage of
0.2Units/kg/day (0.007 mg/kg/day). In rabbits, doses of 0.072 mg/kg/day, which is approximately 10 times the recommended human subcutaneous starting dosage of
0.2Units/kg/day (0.007 mg/kg/day), were administered during organogenesis. The effects of insulin glargine did not generally differ from those observed with regular human insulin in rats or rabbits. However, in rabbits, five fetuses from two litters of the high-dose group exhibited dilation of the cerebral ventricles. Fertility and early embryonic development appeared normal.
8.2Lactation Risk Summary There are either no or only limited data on the presence of insulin glargine in human milk, the effects on breastfed infant, or the effects on milk production. Endogenous insulin is present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for TOUJEO, and any potential adverse effects on the breastfed child from TOUJEO or from the underlying maternal condition.
8.4Pediatric Use The safety and effectiveness of TOUJEO to improve glycemic control in pediatric patients 6 years of age and older with diabetes mellitus have been established. The use of TOUJEO for this indication is supported by evidence from an adequate and well-controlled study in 463 pediatric patients 6 to 17 years of age with type 1 diabetes mellitus [see Clinical Studies (14.2) ] and from studies in adults with diabetes mellitus [see Clinical Pharmacology (12.3) , Clinical Studies (14.3) ] . The safety and effectiveness of TOUJEO have not been establi… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Published studies with use of insulin glargine during pregnancy have not reported a clear association with insulin glargine and adverse developmental outcomes (see Data ) . There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations ) . Rats and rabbits were exposed to insulin glargine in animal reproduction studies during organogenesis, respectively 50 times and 10 times the human subcutaneous dose of 0.2 unit/kg/day.
Overall, the effects of insulin glargine did not generally differ from those observed with regular human insulin (see Data ) . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The estimated background risk of major birth defects is 6% to 10% in women with pregestational diabetes with a peri-conceptional HbA1c >7 and has been reported to be as high as 20% to 25% in women with a peri-conceptional HbA1c >10.
The estimated background risk of miscarriage for the indicated population is unknown. Clinical Considerations Disease-Associated Maternal and/or Embryo/fetal Risk Hypoglycemia and hyperglycemia occur more frequently during pregnancy in patients with pre-gestational diabetes. 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 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 Subcutaneous reproduction and teratology studies have been performed with insulin glargine and regular human insulin in rats and Himalayan rabbits. Insulin glargine was given to female rats before mating, during mating, and throughout pregnancy at doses up to 0.36 mg/kg/day, which is approximately 50 times the recommended human subcutaneous starting dosage of
0.2Units/kg/day (0.007 mg/kg/day). In rabbits, doses of 0.072 mg/kg/day, which is approximately 10 times the recommended human subcutaneous starting dosage of
0.2Units/kg/day (0.007 mg/kg/day), were administered during organogenesis. The effects of insulin glargine did not generally differ from those observed with regular human insulin in rats or rabbits. However, in rabbits, five fetuses from two litters of the high-dose group exhibited dilation of the cerebral ventricles. Fertility and early embryonic development appeared normal.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of TOUJEO to improve glycemic control in pediatric patients 6 years of age and older with diabetes mellitus have been established. The use of TOUJEO for this indication is supported by evidence from an adequate and well-controlled study in 463 pediatric patients 6 to 17 years of age with type 1 diabetes mellitus [see Clinical Studies (14.2) ] and from studies in adults with diabetes mellitus [see Clinical Pharmacology (12.3) , Clinical Studies (14.3) ] . The safety and effectiveness of TOUJEO have not been established in pediatric patients less than 6 years of age.
🧓 Geriatric Use ▾
8.5Geriatric Use In controlled clinical studies, 30 of 304 (9.8%) TOUJEO-treated patients with type 1 diabetes and 327 of 1242 (26.3%) TOUJEO-treated patients with type 2 diabetes were ≥65 years of age, among them 2.0% of the patients with type 1 and 3.0% of the patients with type 2 diabetes were ≥75 years of age. No overall differences in safety or effectiveness of TOUJEO have been observed between patients 65 years of age and older and younger adult patients. Nevertheless, caution should be exercised when TOUJEO is administered to geriatric patients.
In geriatric patients with diabetes, the initial dosing, dose increments, and maintenance dosage should be conservative to avoid hypoglycemia [see Warnings and Precautions (5.3) , Adverse Reactions (6) , and Clinical Studies (14) ] .
🆘 Overdosage ▾
10 OVERDOSAGE Excess insulin administration may cause hypoglycemia and hypokalemia [see Warnings and Precautions (5.3 , 5.6) ] . Mild episodes of hypoglycemia can be treated with oral glucose. Lowering the insulin dosage, and adjustments in meal patterns, or physical activity level may be needed.
More severe episodes of hypoglycemia with coma, seizure, or neurologic impairment may be treated with glucagon 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 ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action 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.
12.2Pharmacodynamics Onset of Action The pharmacodynamic profiles for TOUJEO given subcutaneously as a single dose of 0.4, 0.6, or
0.9U/kg in a euglycemic clamp study in patients with type 1 diabetes showed that on average, the onset of action develops over 6 hours post dose for all three single doses of TOUJEO. Single-Dose Pharmacodynamics The pharmacodynamics for single 0.4, 0.6, and
0.9U/kg doses of TOUJEO in 24 patients with type 1 diabetes mellitus was evaluated in a euglycemic clamp study. On a unit-to-unit basis, TOUJEO had a lower maximum (GIR max ) and 24-hour glucose lowering effect (GIR-AUC 0–24 ) compared to LANTUS. The overall glucose lowering effect of TOUJEO
0.4U/kg was 12% of the glucose lowering effect of an equivalent dose of LANTUS. Glucose lowering at least 30% of the effect of a single
0.4 U/kg dose of LANTUS was not observed until the single dose of TOUJEO exceeded
0.6U/kg. Multiple Once-Daily Dose Pharmacodynamics The pharmacodynamics of TOUJEO after 8 days of daily injection was evaluated in 30 patients with type 1 diabetes. At steady state, the 24-hour glucose lowering effect (GIR-AUC 0–24 ) of TOUJEO
0.4U/kg was approximately 27% lower with a different distribution profile than that of an equivalent dose of LANTUS [see Dosage and Administration (2) , Warnings and Precautions (5.2) , and Clinical Pharmacology (12.3) ] . The glucose lowering effect of a TOUJEO dose increased with each daily administration. The pharmacodynamic profile for TOUJEO given subcutaneously as multiple once-daily subcutaneous injections of
0.4U/kg in a euglycemic clamp study in patients with type 1 diabetes is shown in Figure 1. Figure 1: Glucose Infusion Rate in Patients with Type 1 Diabetes in Multiple-Dose Administration of TOUJEO Glucose infusion rate: determined as amount of glucose infused to maintain constant plasma glucose levels. Figure 1
12.3Pharmacokinetics Absorption The pharmacokinetic profiles for single 0.4, 0.6, and
0.9U/kg doses of TOUJEO in 24 patients with type 1 diabetes mellitus was evaluated in a euglycemic clamp study. The median time to maximum serum insulin concentration was 12 (8–14), 12 (12–18), and 16 (12–20) hours, respectively. Mean serum insulin concentrations declined to the lower limit of quantitation of 5.02 µU/mL by 16, 28, and beyond 36 hours, respectively.
Steady-state insulin concentrations are reached by at least 5 days of once-daily subcutaneous administration of
0.4 U/kg to
0.6U/kg doses of TOUJEO over 8 days in patients with type 1 diabetes mellitus. After subcutaneous injection of TOUJEO, the intra-subject variability, defined as the coefficient of variation for the insulin exposure during 24 hours, was 21.0% at steady state. Elimination After subcutaneous injection of TOUJEO in diabetic patients, insulin glargine is metabolized at the carboxyl terminus of the B-chain with formation of two active metabolites M1 (21 A -Gly-insulin) and M2 (21 A -Gly-des-30 B -Thr-insulin).
The in vitro activity of M1 and M2 were similar to that of human insulin. Specific Populations Pediatrics Population pharmacokinetic analysis was conducted for TOUJEO based on concentration data of its main metabolite M1 using data from 75 pediatric patients (6 to <18 years of age) with type 1 diabetes. The findings with regard to the effect of body weight on systemic exposure of M1 are generally consistent with findings in adults.
Elderly, Race, Sex, and Obesity Effect of age ≥65, race, and sex on the pharmacokinetics of TOUJEO has not been evaluated. When weight is taken into account as a covariate on clearance, BMI is n… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action 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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied TOUJEO (insulin glargine) injection, 300 units/mL (U-300), is a clear and colorless solution and is available as: TOUJEO Total volume Total units available in presentation Max dose per injection Dose increment NDC number Package size SoloStar single-patient-use prefilled pen 1.5 mL 450 units 80 units 1 unit 0024-5869-03 3 pens/pack Max SoloStar single-patient-use prefilled pen 3 mL 900 units 160 units 2 units 0024-5871-02 2 pens/pack Needles are not included in the packs of TOUJEO SoloStar or TOUJEO Max SoloStar single-patient-use prefilled pen.
BD (such as BD Ultra-Fine ® ), Ypsomed (such as Clickfine ® ) or Owen Mumford (such as Unifine ® Pentips ® ) needles ‡ can be used in conjunction with TOUJEO SoloStar or TOUJEO Max SoloStar single-patient-use prefilled pen and are sold separately. A new sterile needle must be attached before each injection. TOUJEO SoloStar or TOUJEO Max SoloStar single-patient-use prefilled pens must never be shared between patients, even if the needle is changed.
16.2Storage Dispense in the original sealed carton with the enclosed Instructions for Use. TOUJEO SoloStar or TOUJEO Max SoloStar prefilled pen should not be stored in the freezer and should not be allowed to freeze. Discard TOUJEO prefilled pen if it has been frozen.
Protect TOUJEO SoloStar/TOUJEO Max SoloStar from direct heat and light. Storage conditions are summarized in the following table: TOUJEO Not in-use (unopened) Refrigerated 36°F–46°F (2°C–8°C) In-use (opened) To prevent degradation, always store the prefilled pens with the cap on during in-use period. Room temperature only (Do not refrigerate) up to 86°F (30°C) 1.5 mL SoloStar single-patient-use prefilled pen Until expiration date 56 days 3 mL Max SoloStar single-patient-use prefilled pen Until expiration date 56 days
📦 Storage and Handling ▾
16.2Storage Dispense in the original sealed carton with the enclosed Instructions for Use. TOUJEO SoloStar or TOUJEO Max SoloStar prefilled pen should not be stored in the freezer and should not be allowed to freeze. Discard TOUJEO prefilled pen if it has been frozen.
Protect TOUJEO SoloStar/TOUJEO Max SoloStar from direct heat and light. Storage conditions are summarized in the following table: TOUJEO Not in-use (unopened) Refrigerated 36°F–46°F (2°C–8°C) In-use (opened) To prevent degradation, always store the prefilled pens with the cap on during in-use period. Room temperature only (Do not refrigerate) up to 86°F (30°C) 1.5 mL SoloStar single-patient-use prefilled pen Until expiration date 56 days 3 mL Max SoloStar single-patient-use prefilled pen Until expiration date 56 days
📋 Description ▾
11 DESCRIPTION Insulin glargine is a long-acting human insulin analog produced by recombinant DNA technology utilizing a nonpathogenic laboratory strain of Escherichia coli (K12) as the production organism. Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines remain at the C-terminus of the B-chain. Insulin glargine has a molecular weight of 6063 Da.
TOUJEO (insulin glargine) injection is a sterile, clear and colorless solution for subcutaneous injection. Each mL of TOUJEO contains 300 units of insulin glargine dissolved in a clear aqueous fluid. The 1.5 mL TOUJEO SoloStar prefilled pen presentation contains the following inactive ingredients per mL: glycerin (20 mg), metacresol (2.7 mg), zinc (90 mcg), and Water for Injection, USP.
The 3 mL TOUJEO Max SoloStar prefilled pen presentation contains the following inactive ingredients per mL: glycerin (20 mg), metacresol (2.7 mg), zinc (90 mcg), and Water for Injection, USP. The pH is adjusted by addition of aqueous solutions of hydrochloric acid and sodium hydroxide. TOUJEO has a pH of approximately 4.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). There are separate Instructions for Use for TOUJEO SoloStar and TOUJEO Max SoloStar. Never Share a TOUJEO SoloStar or TOUJEO Max SoloStar Pen Between Patients Advise patients that they must never share TOUJEO SoloStar or TOUJEO Max SoloStar pen with another person even if the needle is changed.
Pen sharing poses a risk for transmission of blood-borne pathogens [see Warnings and Precautions (5.1) ] . Hyperglycemia or Hypoglycemia Inform patients that hypoglycemia is the most common adverse reaction with insulin. Inform patients of the symptoms of hypoglycemia (e.g., impaired ability to concentrate and react).
This may present a risk in situations where these abilities are especially important, such as driving or operating other machinery. Advise patients who have frequent hypoglycemia or reduced or absent warning signs of hypoglycemia to use caution when driving or operating machinery [see Warnings and Precautions (5.2 , 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) ] .
Inform patients that if they change to TOUJEO from other basal insulins they may experience higher average fasting plasma glucose levels in the first weeks of therapy. Advise patients to monitor glucose daily when initiating TOUJEO [see Warnings and Precautions (5.2) ] . Hypoglycemia Due to Medication Errors Instruct patients to always check the insulin label before each injection [see Warnings and Precautions (5.4) ] .
The "300 units/mL (U-300)" is highlighted in honey gold on the labels of TOUJEO and TOUJEO Max SoloStar single-patient-use prefilled pens. Inform patients that TOUJEO contains 300 units of insulin glargine per mL (U-300) compared to formulations of insulin glargine that contain 100 units/mL (U-100). To avoid dosing errors and potential overdose, instruct patients to never use a syringe to remove TOUJEO from the TOUJEO SoloStar or TOUJEO Max SoloStar single-patient-use prefilled pen [see Warnings and Precautions (5.4) ] .
Inform patients that the dose counter of TOUJEO SoloStar or TOUJEO Max SoloStar single-patient-use prefilled pen shows the number of units of TOUJEO to be injected and no dose recalculation is required [see Dosage and Administration (2.1 , 2.4) ] . Hypersensitivity Reactions Advise patients that hypersensitivity reactions have occurred with TOUJEO. Inform patients on the symptoms of hypersensitivity reactions [see Warnings and Precautions (5.5) ].
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Absorption The pharmacokinetic profiles for single 0.4, 0.6, and
0.9U/kg doses of TOUJEO in 24 patients with type 1 diabetes mellitus was evaluated in a euglycemic clamp study. The median time to maximum serum insulin concentration was 12 (8–14), 12 (12–18), and 16 (12–20) hours, respectively. Mean serum insulin concentrations declined to the lower limit of quantitation of 5.02 µU/mL by 16, 28, and beyond 36 hours, respectively.
Steady-state insulin concentrations are reached by at least 5 days of once-daily subcutaneous administration of
0.4 U/kg to
0.6U/kg doses of TOUJEO over 8 days in patients with type 1 diabetes mellitus. After subcutaneous injection of TOUJEO, the intra-subject variability, defined as the coefficient of variation for the insulin exposure during 24 hours, was 21.0% at steady state. Elimination After subcutaneous injection of TOUJEO in diabetic patients, insulin glargine is metabolized at the carboxyl terminus of the B-chain with formation of two active metabolites M1 (21 A -Gly-insulin) and M2 (21 A -Gly-des-30 B -Thr-insulin).
The in vitro activity of M1 and M2 were similar to that of human insulin. Specific Populations Pediatrics Population pharmacokinetic analysis was conducted for TOUJEO based on concentration data of its main metabolite M1 using data from 75 pediatric patients (6 to <18 years of age) with type 1 diabetes. The findings with regard to the effect of body weight on systemic exposure of M1 are generally consistent with findings in adults.
Elderly, Race, Sex, and Obesity Effect of age ≥65, race, and sex on the pharmacokinetics of TOUJEO has not been evaluated. When weight is taken into account as a covariate on clearance, BMI is not an additional covariate.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Onset of Action The pharmacodynamic profiles for TOUJEO given subcutaneously as a single dose of 0.4, 0.6, or
0.9U/kg in a euglycemic clamp study in patients with type 1 diabetes showed that on average, the onset of action develops over 6 hours post dose for all three single doses of TOUJEO. Single-Dose Pharmacodynamics The pharmacodynamics for single 0.4, 0.6, and
0.9U/kg doses of TOUJEO in 24 patients with type 1 diabetes mellitus was evaluated in a euglycemic clamp study. On a unit-to-unit basis, TOUJEO had a lower maximum (GIR max ) and 24-hour glucose lowering effect (GIR-AUC 0–24 ) compared to LANTUS. The overall glucose lowering effect of TOUJEO
0.4U/kg was 12% of the glucose lowering effect of an equivalent dose of LANTUS. Glucose lowering at least 30% of the effect of a single
0.4 U/kg dose of LANTUS was not observed until the single dose of TOUJEO exceeded
0.6U/kg. Multiple Once-Daily Dose Pharmacodynamics The pharmacodynamics of TOUJEO after 8 days of daily injection was evaluated in 30 patients with type 1 diabetes. At steady state, the 24-hour glucose lowering effect (GIR-AUC 0–24 ) of TOUJEO
0.4U/kg was approximately 27% lower with a different distribution profile than that of an equivalent dose of LANTUS [see Dosage and Administration (2) , Warnings and Precautions (5.2) , and Clinical Pharmacology (12.3) ] . The glucose lowering effect of a TOUJEO dose increased with each daily administration. The pharmacodynamic profile for TOUJEO given subcutaneously as multiple once-daily subcutaneous injections of
0.4U/kg in a euglycemic clamp study in patients with type 1 diabetes is shown in Figure 1. Figure 1: Glucose Infusion Rate in Patients with Type 1 Diabetes in Multiple-Dose Administration of TOUJEO Glucose infusion rate: determined as amount of glucose infused to maintain constant plasma glucose levels. Figure 1
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
14.1Overview of Clinical Studies The efficacy of TOUJEO given once daily was compared to that of once-daily LANTUS in 26-week, open-label, randomized, active-control, parallel studies of 546 adult patients and 463 pediatric patients with type 1 diabetes mellitus and 2,474 patients with type 2 diabetes mellitus (Tables 4 and 5). At trial end, the reduction in glycated hemoglobin (HbA1c) and fasting plasma glucose with TOUJEO titrated to goal was similar to that with LANTUS titrated to goal. At the end of the trial, depending on the patient population and concomitant therapy, patients were receiving a higher dose of TOUJEO than LANTUS.
14.2Clinical Study in Adult and Pediatric Patients with Type 1 Diabetes Adult Patients with Type 1 Diabetes In an open-label, controlled study (Study A), patients with type 1 diabetes (n=546), were randomized to basal-bolus treatment with TOUJEO or LANTUS and treated for 26 weeks. TOUJEO and LANTUS were administered once daily in the morning (time period covering from pre-breakfast until pre-lunch) or in the evening (time period defined as prior to the evening meal until at bedtime). A mealtime insulin analogue was administered before each meal.
Mean age was 47 years and mean duration of diabetes was 21 years. Fifty-seven percent were male, 85% were White, 5% Black or African American, and 5% were Hispanic or Latino; 32% of patients had GFR >90 mL/min/1.73 m 2 . The mean BMI was approximately 27.6 kg/m 2 .
At week 26, treatment with TOUJEO provided a mean reduction in HbA1c that met the prespecified noninferiority margin of 0.4% (Table 4). Patients treated with TOUJEO used 18% more basal insulin than patients treated with LANTUS. There were no clinically important differences in glycemic control when TOUJEO was administered once daily in the morning or in the evening.
There were no clinically important differences in body weight between treatment groups. Table 4 : Type 1 Diabetes Mellitus – Adult Patients (TOUJEO plus mealtime insulin versus LANTUS plus mealtime insulin) TOUJEO + Mealtime Insulin "mealtime insulin" refers to insulin glulisine, insulin lispro or insulin aspart. LANTUS + Mealtime Insulin Treatment duration 26 weeks Treatment in combination with Fast-acting insulin analogue Number of subjects treated (mITT mITT: Modified intention-to-treat population. ) 273 273 HbA1c (%) Baseline mean 8.13
8.12Adjusted mean change from baseline -0.40 -0.44 Adjusted mean difference Treatment difference: TOUJEO – LANTUS. [95% Confidence Interval] 0.04 [-0.10 to 0.18] Fasting Plasma Glucose mg/dL Baseline mean 186 199 Adjusted mean change from baseline -17 -20 Adjusted mean difference [95% Confidence Interval] 3 [-10 to 16] Pediatric Patients with Type 1 Diabetes The efficacy of TOUJEO was evaluated in a 26-week, randomized, open-label, multicenter trial (Study B) in 463 pediatric patients with type 1 diabetes mellitus.
Patients were randomized to basal-bolus treatment with TOUJEO or LANTUS and treated for 26 weeks. TOUJEO and LANTUS were administered once daily in the morning or in the evening. A mealtime insulin analogue was administered before each meal.
The mean age of the trial population was 13 years; 31% were <12 years of age, 69% were ages ≥12 years of age. The mean duration of diabetes was 6 years. Of the 463 pediatric patients, 51% were male, 92% were White, 3% were Black or African American, and 30% were Hispanic or Latino.
The mean baseline BMI percentile was 68.32. At week 26, the difference in HbA1c reduction from baseline between TOUJEO and LANTUS was 0.02% with a 95% confidence interval (-0.16%; 0.20%) and met the prespecified noninferiority margin (0.3%). The results are presented in Table 5.
Table 5: Type 1 Diabetes Mellitus – Pediatric Patients at 26 weeks (TOUJEO plus mealtime insulin versus LANTUS plus mealtime insulin) TOUJEO + Mealtime Insulin "mealtime insulin" refers to insulin glulisine, insulin lispro or insulin aspart. LANTUS + Mealtime Insulin Number o… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In mice and rats, standard two-year carcinogenicity studies with insulin glargine were performed at doses up to 0.455 mg/kg, which was for the rat approximately 65 times the recommended human subcutaneous starting dosage of
0.2Units/kg/day (0.007 mg/kg/day). The findings in female mice were not conclusive due to excessive mortality in all dose groups during the study. Histiocytomas were found at injection sites in male rats (statistically significant) and male mice (not statistically significant) in acid vehicle containing groups.
These tumors were not found in female animals, in saline control, or insulin comparator groups using a different vehicle. The relevance of these findings to humans is unknown. Insulin glargine was not mutagenic in tests for detection of gene mutations in bacteria and mammalian cells (Ames and HGPRT test) and in tests for detection of chromosomal aberrations (cytogenetics in vitro in V79 cells and in vivo in Chinese hamsters).
In a combined fertility and prenatal and postnatal study in male and female rats at subcutaneous doses up to 0.36 mg/kg/day, which was approximately 50 times the recommended human subcutaneous starting dose of
0.2Units/kg/day (0.007 mg/kg/day), maternal toxicity due to dose-dependent hypoglycemia, including some deaths, was observed. Consequently, a reduction of the rearing rate occurred in the high-dose group only. Similar effects were observed with NPH insulin.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In mice and rats, standard two-year carcinogenicity studies with insulin glargine were performed at doses up to 0.455 mg/kg, which was for the rat approximately 65 times the recommended human subcutaneous starting dosage of
0.2Units/kg/day (0.007 mg/kg/day). The findings in female mice were not conclusive due to excessive mortality in all dose groups during the study. Histiocytomas were found at injection sites in male rats (statistically significant) and male mice (not statistically significant) in acid vehicle containing groups.
These tumors were not found in female animals, in saline control, or insulin comparator groups using a different vehicle. The relevance of these findings to humans is unknown. Insulin glargine was not mutagenic in tests for detection of gene mutations in bacteria and mammalian cells (Ames and HGPRT test) and in tests for detection of chromosomal aberrations (cytogenetics in vitro in V79 cells and in vivo in Chinese hamsters).
In a combined fertility and prenatal and postnatal study in male and female rats at subcutaneous doses up to 0.36 mg/kg/day, which was approximately 50 times the recommended human subcutaneous starting dose of
0.2Units/kg/day (0.007 mg/kg/day), maternal toxicity due to dose-dependent hypoglycemia, including some deaths, was observed. Consequently, a reduction of the rearing rate occurred in the high-dose group only. Similar effects were observed with NPH insulin.
📄 Patient Package Insert ▾
This Patient Information has been approved by the U.S. Food and Drug Administration Revised: May 2025 Patient Information TOUJEO ® U-300 [too-JAY-oh] (insulin glargine) injection, for subcutaneous use 300 units/mL (U-300) Do not share your TOUJEO SoloStar ® or TOUJEO Max SoloStar ® pen 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 TOUJEO? TOUJEO is a long-acting man-made insulin used to control high blood sugar in adults and children who are 6 years of age and older with diabetes mellitus. TOUJEO is not for the treatment of diabetic ketoacidosis.
It is not known if TOUJEO is safe and effective in children under 6 years of age. Who should not use TOUJEO? Do not use TOUJEO if you: are having an episode of low blood sugar (hypoglycemia). have an allergy to insulin glargine or any of the ingredients in TOUJEO.
See the end of this Patient Information leaflet for a complete list of ingredients in TOUJEO. What should I tell my healthcare provider before using TOUJEO? Before using TOUJEO, tell your healthcare provider about all your medical conditions, including if you: have liver or kidney problems. take other medicines, especially ones called TZDs (thiazolidinediones). have heart failure or other heart problems.
If you have heart failure, it may get worse while you take TZDs with TOUJEO. are pregnant, planning to become pregnant, or are breastfeeding. It is not known if TOUJEO may harm your unborn or breastfeeding baby. 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 TOUJEO, talk to your healthcare provider about low blood sugar and how to manage it. How should I use TOUJEO? TOUJEO is available in 2 single-patient-use prefilled pens: TOUJEO SoloStar and TOUJEO Max SoloStar.
Your healthcare provider will tell you which TOUJEO pen is right for you. Read the detailed Instructions for Use that come with your TOUJEO SoloStar or TOUJEO Max SoloStar single-patient-use prefilled pen. Use TOUJEO exactly as your healthcare provider tells you to.
Your healthcare provider should tell you how much TOUJEO to use and when to use it. Know the amount of TOUJEO you use. Do not change the amount of TOUJEO you use unless your healthcare provider tells you to.
Check your insulin label each time you give your injection to make sure you are using the correct insulin. Do not use a syringe to remove TOUJEO from your TOUJEO SoloStar or TOUJEO Max SoloStar single-patient-use prefilled pen. This can cause you to give yourself too much insulin.
TOUJEO has 3 times as much insulin (300 units/mL) in 1 mL as compared to other insulin glargine products (U-100 units/mL) pens. Do not re-use needles. Always use a new needle for each injection.
Reusing needles increases your chance of having blocked needles, which can cause you to get the wrong dose of TOUJEO. 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 .
TOUJEO should be used 1 time each day and at the same time each day. TOUJEO is injected under the skin (subcutaneously) of your upper legs (thighs), upper arms, or stomach area (abdomen). Do not use TOUJEO in an insulin pump or inject TOUJEO into your vein (intravenously).
Change (rotate) your injection sites within the area you choose with each dose to reduce your risk of getting pits or thickening of the skin (lipodystrophy) and lumps in the skin (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. Do not mix TOUJEO with any other type of insulin or liquid medicine. Check your blood sugar levels.
As… [Excerpted — this section continues on DailyMed.]
📖 Instructions for Use ▾
Instructions for Use TOUJEO ® U-300 SoloStar ® [too-JAY-oh] (insulin glargine) injection, for subcutaneous use 300 units/mL (U-300) 1.5 mL single-patient-use prefilled pen Read this first Do not share your TOUJEO SoloStar pen 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. TOUJEO contains 300 units/mL of insulin glargine Do not re-use needles.
If you do, you might not get your dose (underdosing) or get too much (overdosing) as the needle could block. Do not use a syringe to remove insulin from your pen. If you do, you will get too much insulin.
The scale on most syringes is made for U-100 (non-concentrated) insulin only. The dose selector of your TOUJEO SoloStar pen dials by 1 unit. People who are blind or have vision problems should not use the TOUJEO SoloStar pen without help from a person trained to use the TOUJEO SoloStar pen.
Important information Do not use your pen if it is damaged or if you are not sure that it is working properly. Always perform a safety test (see Step 3 ). Always carry a spare pen and spare needles in case they are lost or stop working.
Change (rotate) your injection sites within the area you choose for each dose (see " Places to inject " ). Learn to inject Talk with your healthcare provider about how to inject, before using your pen. Read all of these instructions before using your pen.
If you do not follow all of these instructions, you may get too much or too little insulin. Need help? If you have any questions about your pen or about diabetes, ask your healthcare provider, go to www.Toujeo.com or call sanofi-aventis at 1-800-633-1610 .
Extra items you will need: a new sterile needle (not included with the pen) (see Step 2 ). an alcohol swab. a puncture-resistant container for used needles and pens (see " Throwing your pen away " ). Places to inject Inject your insulin exactly as your healthcare provider has shown you. Inject your insulin under the skin (subcutaneously) of your upper legs (thighs), upper arms, or stomach area (abdomen).
Change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting pits or thickening of the skin (lipodystrophy) and lumps in the skin (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.
Get to know your pen Step 1: Check your pen Take a new pen out of the refrigerator at least 1 hour before you inject. Cold insulin is more painful to inject. 1A Check the name and expiration date on the label of your pen.
Make sure you have the correct insulin. Do not use your pen after the expiration date printed on the label. 1B Pull off the pen cap.
1C Check that the insulin is clear. Do not use the pen if the insulin looks cloudy, colored or contains particles. 1D Wipe the rubber seal with an alcohol swab.
If you have other injector pens Making sure you have the correct medicine is especially important if you have other injector pens. Step 2: Attach a new needle Do not re-use needles. Always use a new sterile needle for each injection.
This helps stop blocked needles, contamination and infection. Always use needles* from BD (such as BD Ultra-Fine ® ), Ypsomed (such as Clickfine ® ), or Owen Mumford (such as Unifine ® Pentips ® ). 2A Take a new needle and peel off the protective seal.
2B Keep the needle straight and screw it onto the pen until fixed. Do not over-tighten. 2C Pull off the outer needle cap.
Keep this for later. 2D Pull off the inner needle cap and throw away. Handling needles Be careful when you are handling needles to help prevent accidental needle-stick injury.
You may give other people a serious infection, or get a serious infection from them. Step 3: Do a safety test Always do a safety test before each injection to: check your pen and the needle to make sure they… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 1.5 mL Pen Carton NDC 0024-5869-03 Rx only Toujeo ® SoloStar ® (insulin glargine) injection For Single Patient Use Only 300 units/mL (U-300) For subcutaneous use only Solution for injection in a disposable insulin delivery device Do not remove insulin with syringe Always use a new needle – Do not mix with other insulins Use only if solution is clear and colorless with no particles visible Use within 56 days after opening *Needles not included (see back panel) Three 1.5 mL prefilled pens – Dispense in this sealed carton sanofi PRINCIPAL DISPLAY PANEL - 1.5 mL Pen Carton
PRINCIPAL DISPLAY PANEL - 3 mL Pen Carton NDC 0024-5871-02 Rx only Toujeo Max SoloStar ® (insulin glargine) injection For Single Patient Use Only 300 units/mL (U-300) Adjusts by 2 units For subcutaneous use only Solution for injection in a disposable insulin delivery device Do not remove insulin with syringe Always use a new needle – Do not mix with other insulins Use only if solution is clear and colorless with no particles visible Use within 56 days after opening *Needles not included (see back panel) Two 3 mL prefilled pens – Dispense in this sealed carton sanofi PRINCIPAL DISPLAY PANEL - 3 mL Pen Carton