• Toujeo indications
• Uses of Toujeo in details
• Toujeo description
• Toujeo dosage
• Toujeo interactions
• Toujeo side effects
• Toujeo contraindications

What is Toujeo?

Toujeo (Toujeo) is a man-made form of a hormone that is produced in the body. Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. Toujeo is a long-acting insulin that starts to work several hours after injection and keeps working evenly for 24 hours.

The Toujeo SoloStar injection pen is used to improve blood sugar control in adults with diabetes mellitus.

Toujeo is used to treat type 1 diabetes or type 2 diabetes in adults.

It is not known if Toujeo is safe and effective in children.

Toujeo indications

Toujeo injection is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

Limitations of Use

Toujeo injection is not recommended for the treatment of diabetic ketoacidosis.

How should I use Toujeo?

Use Toujeo cartridge systems as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Extra patient leaflets are available with Toujeo cartridge systems. Talk to your pharmacist if you have questions about this information.
• Use Toujeo cartridge systems at the same time each day, as directed by your doctor.
• A health care provider will teach you how to use Toujeo cartridge systems. Be sure you understand how to use it. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Wash your hands before you use Toujeo cartridge systems.
• Always check before each use to be sure you are injecting the correct dose of insulin. Using too much or too little insulin may result in serious side effects.
• Toujeo cartridge systems should be clear and colorless. Do not use Toujeo cartridge systems if it contains particles or is discolored, or if the container is cracked or damaged.
• Do NOT dilute Toujeo cartridge systems or mix it with other insulin. Do NOT use it in an insulin pump.
• Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into a vein or muscle.
• Injection sites within an injection area (abdomen, thigh, or upper arm) must be rotated from one injection to the next.
• Be sure you have purchased the correct insulin. Insulin comes in a variety of containers, including vials, cartridges, and pens. Make sure that you understand how to properly measure and prepare your dose. If you have any questions about measuring and preparing your dose, contact your doctor or pharmacist for information.
• The effect of Toujeo cartridge systems lasts for up to 24 hours.
• Toujeo cartridge systems begins lowering blood sugar about 1 to 2 hours after an injection. There is no peak effect. The effect lasts for up to 24 hours.
• Do not mix this insulin together with any other type of insulin or any other medicine in the same syringe.
• Do not share pen or cartridge devices with another person. Sharing these devices may pass infections from one person to another. This includes infections you may not know you have.
• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• It is very important to follow your insulin regimen exactly. Do NOT miss any doses. Ask your doctor for specific instructions to follow in case you ever miss a dose of insulin.

Ask your health care provider any questions you may have about how to use Toujeo cartridge systems.

Uses of Toujeo in details

Toujeo is used to reduce high blood sugar (glucose) levels in people with diabetes mellitus.

Toujeo description

Each mL contains 100 IU Toujeo, 0.27% w/v m-cresol as preservative and water for injection.

Toujeo injection [ribosomal deoxyribonucleic acid (rDNA)] is a recombinant human insulin analogue produced by recombinant DNA technology. Toujeo differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and 2 arginines are added to the C-terminus of B-chain.

Chemically, it is 21^A-Gly-30^Ba-L-Arg-30^Bb-L-Arg-human insulin and has the empirical formula C₂₆₇H₄₀₄N₇₂O₇₈S₆ and a molecular weight of 6,063.

Toujeo is an insulin analogue, equipotent to human insulin, with a peakless glucose lowering profile and a prolonged duration of action that permits once daily dosing.

Toujeo dosage

Toujeo Dosage

Generic name: Toujeo 100[iU] in 1mL

Dosage form: injection, solution

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Important Administration Instructions

• Always check insulin labels before administration.
• Train patients on proper use and injection technique before initiating Toujeo.
• Visually inspect Toujeo KwikPen for particulate matter and discoloration prior to administration. Only use if the solution is clear and colorless with no visible particles.
• ​Inject between 1 and 80 units per injection.
• Administer Toujeo subcutaneously into the abdominal area, thigh, or deltoid, and rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy.
• Do not dilute or mix Toujeo with any other insulin or solution as the onset of action or time to peak effect of Toujeo and the mixed insulin may be altered in an unpredictable manner.
• Do not administer intravenously or via an insulin pump because this could result in severe hypoglycemia.

General Dosing Instructions

• In patients with type 1 diabetes, Toujeo must be used concomitantly with short-acting insulin.
• Inject Toujeo subcutaneously once daily at any time of day but at the same time every day.
• Individualize and titrate the dosage of Toujeo based on the individual's metabolic needs, blood glucose monitoring results and glycemic control goal.
• Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), during acute illness, or changes in renal or hepatic function and should be made under medical supervision with appropriate glucose monitoring.

Initiation of Toujeo Therapy

• The recommended starting dose of Toujeo in patients with type 1 diabetes should be approximately one-third of the total daily insulin requirements. Short- or rapid-acting, pre-meal insulin should be used to satisfy the remainder of the daily insulin requirements.
• The recommended starting dose of Toujeo in patients with type 2 diabetes is 0.2 units/kg or up to 10 units once daily. One may need to adjust the amount and timing of short- or rapid-acting insulins and dosages of any anti-diabetic drugs.

Changing to Toujeo from Other Insulin Therapies

• If changing patients from another Toujeo product, 100 units/mL, to Toujeo, the dose of Toujeo should be the same as the other Toujeo product, 100 units/mL, and the time of day for administration should be determined by the physician.
• If changing patients from a once-daily Toujeo product, 300 units/mL, to once-daily Toujeo, the recommended initial Toujeo dosage is 80% of the Toujeo product, 300 units/mL, dose that is being discontinued. This dosage reduction will lower the likelihood of hypoglycemia.
• If changing from a treatment regimen with an intermediate- or long-acting insulin (other than an Toujeo product, 100 units/mL) to a regimen with Toujeo, a change in the dose of the basal insulin may be required and the amount and timing of shorter-acting insulins and doses of any anti-diabetic drugs may need to be adjusted.
• If changing patients from twice-daily NPH insulin to once-daily Toujeo, the recommended initial Toujeo dosage is 80% of the total NPH dosage that is being discontinued. This dosage reduction will lower the likelihood of hypoglycemia.

More about Toujeo (Toujeo)

• Side Effects
• During Pregnancy
• Dosage Information
• Drug Interactions
• Support Group
• En Espanol
• 0 Reviews - Add your own review/rating

Consumer resources

• Toujeo
• Toujeo KwikPen
• Toujeo (Advanced Reading)

• Other brands: Lantus, Toujeo, Toujeo Solostar, Lantus Solostar

Professional resources

• Toujeo (FDA)
• Toujeo (AHFS Monograph)

Related treatment guides

• Diabetes, Type 1
• Diabetes, Type 2

Toujeo interactions

See also:
What other drugs will affect Toujeo?

Drugs That May Increase The Risk Of Hypoglycemia

The risk of hypoglycemia associated with TOUJEO use may be increased with antidiabetic agents, (ACE) inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, propoxyphene, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics. Dose adjustment and increased frequency of glucose monitoring may be required when TOUJEO is co-administered with these drugs.

Drugs That May Decrease The Blood Glucose Lowering Effect Of TOUJEO

The glucose lowering effect of TOUJEO may be decreased when co-administered with atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isonazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline) and thyroid hormones. Dose adjustment and increased frequency of glucose monitoring may be required when TOUJEO is co-administered with these drugs.

Drugs That May Increase Or Decrease The Blood Glucose Lowering Effect Of TOUJEO

The glucose lowering effect of TOUJEO may be increased or decreased when co-administered with alcohol, beta-blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia. Dose adjustment and increased frequency of glucose monitoring may be required when TOUJEO is co-administered with these drugs.

Drugs That May Affect Signs And Symptoms Of Hypoglycemia

The signs and symptoms of hypoglycemia may be blunted when beta-blockers, clonidine, guanethidine, and reserpine are co-administered with TOUJEO.

Toujeo side effects

See also:
What are the possible side effects of Toujeo?

The following adverse reactions are discussed elsewhere:

• Hypoglycemia.
• Hypersensitivity and allergic reactions.
• Hypokalemia.

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Two clinical trials with Toujeo were conducted: one in type 1 diabetes and one in type 2 diabetes.

The type 1 diabetes population had the following characteristics: Mean age was 41 years and mean duration of diabetes was 16 years. 58% were male. 75% were Caucasian, 2% Black or African American and 4% American Indian or Alaskan native. 4% were Hispanic. At baseline, mean eGFR was 109 mL/min/1.73m². 73.5 percent of patients had eGFR > 90 mL/min/1.73m². The mean BMI was approximately 26 kg/m². HbA1c at baseline was 7.8%. The data in Table 1 reflect exposure of 268 patients to Toujeo with a mean exposure duration of 49 weeks.

The type 2 diabetes population had the following characteristics: Mean age was 59 years and mean duration of diabetes was 11 years. 50% were male. 78% were Caucasian, 8% Black or African American and 5% American Indian or Alaskan native. 28% were Hispanic. At baseline, mean eGFR was 109 mL/min/1.73m². 67.5 percent of patients had eGFR > 90 mL/min/1.73m². The mean BMI was approximately 32 kg/m². HbA1c at baseline was 8.3%. The data in Table 2 reflect exposure of 376 patients to Toujeo with a mean exposure duration of 22 weeks.

Common adverse reactions were defined as reactions occurring in ≥ 5% of the population studied. Common adverse reactions during clinical trials in patients with type 1 diabetes mellitus and type 2 diabetes mellitus (other than hypoglycemia) are listed in Table 1 and Table 2, respectively.

Table 1: Adverse reactions occurring in ≥ 5% of adult patients with type 1 diabetes treated with Toujeo in a 52-week trial

The frequencies of adverse reactions during a clinical trial of 5 years duration with another Toujeo product, 100 units/mL, in patients with type 2 diabetes mellitus are listed in Table 3.

Table 3: Common adverse reactions in 5-year trial of adult patients with type 2 diabetes (adverse reactions with incidence ≥ 10% and higher with another Toujeo product, 100 units/mL, than comparator)

The frequencies of adverse reactions during clinical trials with another Toujeo product, 100 units/mL, in children and adolescents with type 1 diabetes mellitus are listed in Table 4.

Table 4: Adverse reactions in a 28-week clinical trial of children and adolescents with type 1 diabetes (adverse reactions with frequency ≥ 5% and the same or higher with another Toujeo product, 100 units/mL, than comparator)

Severe Hypoglycemia

Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including 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.

Severe symptomatic hypoglycemia was defined as an event with symptoms consistent with hypoglycemia requiring the assistance of another person and associated with either a blood glucose below 50 mg/dL ( ≤ 56 mg/dL in the 5-year trial and ≤ 36 mg/dL in the ORIGIN trial) or prompt recovery after oral carbohydrate, intravenous glucose or glucagon administration.

The incidence of severe symptomatic hypoglycemia in patients receiving Toujeo with type 1 diabetes mellitus and type 2 diabetes mellitus was 4% at 52 weeks and 1% at 24 weeks, respectively.

The incidence of severe symptomatic hypoglycemia in a clinical trial with another Toujeo product, 100 units/mL, in children and adolescents age 6 to 15 years with type 1 diabetes was 23% at 26 weeks.

Table 5 displays the proportion of patients experiencing severe symptomatic hypoglycemia in another Toujeo product, 100 units/mL, and Standard Care groups in the ORIGIN Trial.

Table 5: Severe Symptomatic Hypoglycemia in the ORIGIN Trial

Allergic Reactions

Some patients taking insulin therapy, including Toujeo have experienced erythema, local edema, and pruritus at the site of injection. These conditions were usually self-limiting. Severe cases of generalized allergy (anaphylaxis) have been reported.

Peripheral Edema

Some patients taking Toujeo have experienced sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.

Lipodystrophy

Administration of insulin subcutaneously, including Toujeo, has resulted in lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue) in some patients.

Weight Gain

Weight gain has occurred with some insulin therapies including Toujeo and has been attributed to the anabolic effects of insulin and the decrease in glycosuria.

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity.

In a 52-week study of type 1 diabetes patients, 42% of patients who received Toujeo once daily were positive for anti-drug antibodies (ADA) at least once during the study, including 17% that were positive at baseline and 25% of patients who developed ADA during the study. Sixty-five percent of the ADA positive patients on Toujeo with antibody testing at week 52 remained ADA positive at week 52.

In a 24-week study of type 2 diabetes patients, 17% of patients who received Toujeo once daily were positive for ADA at least once during the study. Among the subjects who were positive, 5% had ADA at baseline and 12% developed antibodies during the study. The percent binding of patients positive at baseline on Toujeo did not increase significantly during the study. Fifty-one percent of the ADA positive patients on Toujeo with antibody testing at week 24 remained ADA positive at week 24. There was no evidence that these antibodies had an impact on efficacy and safety outcomes.

The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay and may be influenced by several factors such as: assay methodology, sample handling, timing of sample collection, concomitant medication, and underlying disease. For these reasons, comparison of the incidence of antibodies to Toujeo with the incidence of antibodies in other studies or to other products may be misleading.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of another Toujeo product, 100 units/mL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure.

Medication errors have been reported in which other insulin products, particularly rapid-acting insulins, have been accidentally administered instead of an Toujeo product. To avoid medication errors between Toujeo products and other insulin products, patients should be instructed to always verify the insulin label before each injection.

Toujeo contraindications

See also:
What is the most important information I should know about Toujeo?

Toujeo injection is contraindicated:

•

during episodes of hypoglycemia.

•

in patients with hypersensitivity to Toujeo products or any of the excipients in Toujeo injection.

Active ingredient matches for Toujeo:

Insulin Glargine in Germany, Switzerland, United Kingdom.

Insulin glargine 300U in 1mL

References

1. PubChem. "Insulin glargine". https://pubchem.ncbi.nlm.nih.gov/sub... (accessed September 17, 2018).
2. DrugBank. "Insulin Glargine - DrugBank". http://www.drugbank.ca/drugs/DB00047 (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology