Toujeo

Approved Uses

Toujeo is an injectable prescription medicine used to manage blood glucose levels in people with diabetes. It is classified as a basal, or long-acting, insulin glargine.

Type 1 Diabetes

For individuals with type 1 diabetes, Toujeo helps replace the insulin the body is unable to produce. In these cases, it is typically used as part of a treatment plan that includes a separate fast-acting insulin taken at mealtimes.

Type 2 Diabetes

For individuals with type 2 diabetes, Toujeo is used when diet, exercise, and oral medications are not sufficient to maintain healthy blood sugar levels. It can be used alone or in combination with other glucose-lowering medications.

Important Limitations

• Toujeo is not used to treat diabetic ketoacidosis, a serious and potentially life-threatening complication of diabetes that requires rapid-acting insulin treatment.
• It is not recommended for use in children under the age of 6.

How Toujeo Manages Blood Sugar

Toujeo contains insulin glargine, a man-made version of the hormone insulin that the body naturally produces. Insulin is essential for regulating blood sugar (glucose) levels. It works in two primary ways:

• Glucose Uptake: It signals cells in the body, such as muscle and fat cells, to take in glucose from the blood to use for energy.
• Liver Regulation: It tells the liver to stop producing and releasing more glucose into the bloodstream.

Slow and Steady Release

Toujeo is a highly concentrated form of insulin (300 units/mL). When it is injected into the fatty tissue under the skin, it forms a small deposit called a microprecipitate. Because of its high concentration, this deposit has a smaller surface area than standard-strength insulins, which causes the insulin to dissolve and enter the bloodstream very slowly.

This slow absorption provides several benefits for blood sugar management:

• Basal Coverage: It provides a low, steady level of insulin throughout the day and night, mimicking the way a healthy pancreas releases small amounts of insulin continuously.
• No Pronounced Peak: Unlike short-acting insulins, Toujeo does not have a sharp peak in activity. Instead, it maintains a relatively flat and stable level of action for at least 24 hours, and sometimes up to 36 hours.
• Reduced Fluctuations: The gradual release helps prevent significant swings in blood sugar levels between meals and during sleep.

Common Side Effects

The most common side effect of Toujeo is low blood sugar (hypoglycemia). Other frequent side effects may include:

• Redness, swelling, or itching at the injection site
• Skin thickening or pits at the injection site (lipodystrophy)
• Weight gain
• Swelling in the hands and feet (edema)
• Common cold symptoms or sore throat

Serious Side Effects

Some side effects can be serious and may require medical care. Seek help immediately for:

• Severe low blood sugar: Symptoms include extreme confusion, seizures, or passing out.
• Severe allergic reactions: Signs include a rash over the whole body, difficulty breathing, rapid pulse, or swelling of the face and throat.
• Low potassium levels: This can lead to muscle weakness, cramping, or an irregular heartbeat.
• Heart failure: New or worsening shortness of breath, swelling of the ankles or feet, or sudden weight gain, particularly when used with medications called thiazolidinediones (TZDs).

Hypoglycemia

Hypoglycemia, or low blood sugar, is the most frequent side effect and can become life-threatening. The risk increases with changes in dosage, meal timing, or physical activity levels. Severe cases may lead to seizures, loss of consciousness, or death.

Never Share Pens

Toujeo SoloStar and Max SoloStar pens are intended for use by a single patient only. Sharing pens or needles between people increases the risk of spreading bloodborne pathogens, even if the needle is changed.

Medication Errors

To prevent accidental mix-ups with other insulin products, the medication label should be verified before each injection. Toujeo must never be drawn from the pen into a syringe; doing so can lead to a severe overdose because the concentration is higher than standard insulin.

Hypersensitivity Reactions

Severe allergic reactions, including anaphylaxis, can occur. Symptoms may include a whole-body rash, shortness of breath, fast pulse, or sweating. If a serious reaction is suspected, the medication should be stopped and medical help sought immediately.

Hypokalemia

Insulin use can lead to low potassium levels in the blood (hypokalemia). If not monitored and treated, this can cause serious heart rhythm problems or respiratory issues.

Fluid Retention and Heart Failure

Using Toujeo alongside certain other diabetes medications, such as thiazolidinediones (TZDs), may cause fluid retention and heart failure. Monitoring for symptoms like sudden weight gain, swelling, or shortness of breath is recommended.

Pregnancy

Managing blood sugar levels is critical during pregnancy to reduce the risk of complications for both the parent and the developing baby. Poorly controlled diabetes during pregnancy can increase the risk of birth defects, pregnancy loss, and high blood pressure (preeclampsia).

Available data from studies do not show a clear link between insulin glargine and an increased risk of major birth defects or other negative outcomes. However, insulin needs typically fluctuate throughout pregnancy:

• Requirements often decrease during the first trimester.
• Requirements generally increase during the second and third trimesters.

Close monitoring of blood glucose levels is recommended for anyone using Toujeo while pregnant.

Breastfeeding

It is generally considered safe to use Toujeo while breastfeeding. While insulin glargine may pass into breast milk, it is a protein that is expected to be broken down in the infant's digestive system. There are no known reports of harm to breastfed infants.

Individuals who are breastfeeding may need to adjust their insulin dosage and diet, as breastfeeding can affect blood sugar levels.

Available Forms

Toujeo is a sterile solution for injection under the skin. It is available in prefilled, disposable pen devices designed for single-patient use.

Prefilled Pen Options

The medication is supplied in two different pen formats:

• SoloStar: A disposable prefilled pen used for subcutaneous administration.
• Max SoloStar: A disposable prefilled pen designed to deliver a higher volume of insulin per injection than the standard pen.

Both pen types are used with compatible disposable needles. These devices are not designed to be refilled and must be disposed of according to safety guidelines once they are empty or have reached their expiration date.

FDA Approval and Indications

Toujeo (insulin glargine injection, 300 units/mL) is approved by the U.S. Food and Drug Administration (FDA) to manage blood sugar levels in adults and pediatric patients aged 6 years and older with diabetes mellitus. It is a prescription medication intended for once-daily injection under the skin.

Safety Monitoring and Regulatory History

The FDA monitors the safety of Toujeo through the FDA Adverse Event Reporting System (FAERS). In 2018, the FDA identified a potential signal regarding medication errors associated with the drug. This led to continued monitoring and evaluation of labeling to ensure that dosing instructions are clear, especially given that Toujeo is more concentrated than standard U-100 insulin products.

Boxed Warnings and REMS

Toujeo does not carry a Boxed Warning, which is the FDA's most serious warning for significant safety risks. Additionally, there is no Risk Evaluation and Mitigation Strategy (REMS) required for this medication. Regulatory oversight focuses on standard insulin safety, including warnings against sharing injection pens between patients and the risks of hypoglycemia (low blood sugar).

Insurance Coverage

Most commercial insurance and Medicare Part D plans cover Toujeo, though the medication may be placed on a specific tier that determines your out-of-pocket copay. Some insurance providers may require prior authorization before they will cover the cost of the prescription.

Financial Assistance

The manufacturer may offer savings cards or copay assistance for patients with commercial insurance to help reduce monthly costs. For individuals without insurance or those who meet specific income requirements, patient assistance programs may be available to provide the medication at a lower cost or for free.

Generic Availability

There is currently no generic version of Toujeo available. While biosimilar versions of insulin glargine exist for the standard U-100 concentration, Toujeo is a concentrated U-300 formulation and does not have a direct biosimilar equivalent.

Pharmacy Variations

Prices can differ between retail pharmacies. Using mail-order services through your insurance provider or comparing prices at different local pharmacies may help identify the most cost-effective option.