Toustar Pen For Toujeo

The TOUSTAR PEN FOR TOUJEO by SANOFI INDIA LIMITED is a medical device designed for the subcutaneous administration of Toujeo (insulin glargine) solution. It is a reusable insulin pen that provides precise and comfortable delivery of a long-acting insulin analogue for managing diabetes.

Name

• Common Name: TOUSTAR PEN FOR TOUJEO
• Brand Names: Toujeo SoloStar, Toujeo Max SoloStar (referring to the pre-filled pens containing the medicine, compatible with Toustar)
• Generic Name: Insulin Glargine (rDNA origin)

Composition

• Active Ingredient: Insulin glargine 300 units/mL. Insulin glargine is a human insulin analog produced by recombinant DNA technology.
• Formulation: Toujeo is a clear, colorless solution for injection. The Toustar pen is compatible with Toujeo 1.5 mL (450 units) U-300 insulin cartridges from Sanofi.

Uses

Toujeo is a long-acting basal insulin indicated to improve glycemic control in adults and pediatric patients 6 years of age and older with diabetes mellitus (Type 1 and Type 2). It is not recommended for the treatment of diabetic ketoacidosis.

Dosage and Administration

Toujeo is administered subcutaneously once daily, preferably at the same time each day, into the abdominal wall, thigh, or deltoid. Injection sites should be rotated within the chosen area to reduce the risk of lipodystrophy.

• Dose Individualization: Dosage must be individualized based on the patient's metabolic needs, blood glucose monitoring results, and glycemic control goals.
• Starting Dose (Insulin-Naïve):
  • Type 1 Diabetes: Approximately 1/3 to 1/2 of the total daily insulin dose, typically 0.2 to 0.4 units/kg, with the remainder covered by mealtime insulin.
  • Type 2 Diabetes: A recommended daily starting dose is 0.2 units/kg once daily.
• Pen Specifics: The Toujeo SoloStar pen delivers 1 to 80 units in 1-unit increments, while the Toujeo Max SoloStar pen delivers 2 to 160 units in 2-unit increments.
• Important: Always check the insulin label before each injection to avoid medication errors. Do not dilute or mix Toujeo with any other insulin or solution. Never use a syringe to remove Toujeo from the pen. Do not reuse needles.

Side Effects

• Common Side Effects: Hypoglycemia (low blood sugar) is the most common side effect. Other common side effects include upper respiratory tract infection (e.g., common cold, flu, bronchitis), injection site reactions (pain, rash, swelling, itching, redness, skin thickening or pits), lipodystrophy, edema (swelling of extremities), and weight gain.
• Serious Side Effects: Severe hypoglycemia, hypokalemia (low potassium level), and serious allergic reactions.

Precautions

• Hypoglycemia: Severe hypoglycemia can be life-threatening. Patients should be aware of symptoms and carry fast-acting carbohydrates.
• Medication Errors: Always verify the insulin label before each injection to avoid accidental mix-ups.
• Hypokalemia: Toujeo can cause or worsen hypokalemia, potentially leading to serious heart problems.
• Heart Failure: Concomitant use with thiazolidinediones (TZDs) can worsen heart failure.
• Allergic Reactions: Do not use if allergic to insulin glargine or any excipients.
• Impaired Renal/Hepatic Function: Patients with kidney or liver problems may have an increased risk of low blood sugar.
• Alcohol: Alcohol consumption can affect blood sugar levels and may mask hypoglycemia symptoms; it's generally best to avoid or limit alcohol during Toujeo treatment.
• Sharing Pens: Never share pens between patients, even if the needle is changed, due to the risk of transmitting blood-borne pathogens.

Storage

• Unopened Pens/Cartridges: Store in a refrigerator between 2°C and 8°C (36°F and 46°F). Do not freeze.
• Opened (In-Use) Pens/Cartridges: Do not store in the refrigerator. Keep at room temperature below 30°C (86°F), away from direct heat and light. Discard after 56 days (8 weeks) of first use, even if insulin remains. The Toustar pen itself should not be stored in the refrigerator between injections once a cartridge is attached.

TOUSTAR Pen is a reusable insulin delivery device designed for use with Toujeo (insulin glargine 300 units/mL) cartridges from Sanofi India Limited. Toujeo is a long-acting insulin used to manage blood sugar levels in people with diabetes.

What is Toujeo used for?

Toujeo (insulin glargine) is a long-acting insulin analog prescribed to improve blood sugar control in adults and children aged 6 years and older with type 1 or type 2 diabetes mellitus. It is not used for treating diabetic ketoacidosis.

How does Toujeo work?

Toujeo is a concentrated form of insulin glargine that mimics the body's natural insulin by providing a steady, continuous release of insulin for up to 36 hours. It works by helping muscle and fat cells absorb sugar from the bloodstream and by reducing the amount of sugar produced by the liver, thereby lowering blood glucose levels.

What is the usual dosage of Toujeo?

The dosage of Toujeo is individualized based on a patient's metabolic needs and blood glucose monitoring results. For patients new to insulin with Type 2 diabetes, a common starting dose is 0.2 units per kilogram of body weight once daily. For Type 1 diabetes, it is often initiated at 0.2 to 0.4 units per kilogram, typically making up one-third to one-half of the total daily insulin dose, used in conjunction with mealtime insulin. Toujeo is administered once daily, subcutaneously, at any time of day, but preferably at the same time each day. It can be injected up to 3 hours before or after the usual administration time if needed. The Toujeo SoloStar pen can deliver up to 80 units per injection, while the Toujeo Max SoloStar pen can deliver up to 160 units in a single injection.

What are the possible side effects of Toujeo?

The most common and significant side effect of Toujeo is low blood sugar (hypoglycemia), which can be serious. Other common side effects include symptoms similar to the common cold, upper respiratory tract infections, injection site reactions (such as pain, redness, swelling, or changes in fat tissue like lipodystrophy), itching, rash, swelling in the extremities, and weight gain. Less common but serious side effects can include severe allergic reactions and low blood potassium levels (hypokalemia).

Is Toujeo safe during pregnancy or breastfeeding?

Maintaining good blood sugar control is crucial throughout pregnancy for individuals with pre-existing or gestational diabetes. While there is no extensive clinical experience with Toujeo specifically in pregnant women, a large body of data on insulin glargine 100 units/mL suggests no specific adverse effects or toxicity during pregnancy. Toujeo may be considered during pregnancy if clinically necessary, and insulin requirements may change during this time. It is not known if insulin glargine passes into human breast milk, but its use during breastfeeding is generally not expected to cause problems for the infant.

Can Toujeo be taken with other medications?

Toujeo can interact with various medications that may either increase or decrease its blood sugar-lowering effect, potentially requiring adjustments to the Toujeo dose or more frequent blood glucose monitoring. Medications that may increase the risk of hypoglycemia include other antidiabetic drugs, certain blood pressure medications (like ACE inhibitors and angiotensin receptor blockers), and high doses of salicylates. Conversely, some medications, such as atypical antipsychotics, corticosteroids, diuretics, and thyroid hormones, may reduce Toujeo's effectiveness. Alcohol consumption can also impact blood sugar levels. Always inform your healthcare provider about all prescription and over-the-counter medicines, vitamins, and herbal products you are taking.

What precautions should be taken with Toujeo and the Toustar Pen?

It is essential to always check the insulin label before each injection to prevent medication errors. Do not share your Toustar pen with others, even if the needle is changed, as this poses a risk of transmitting blood-borne pathogens. Never reuse needles. Do not use a syringe to withdraw insulin from the Toustar pen, as this can lead to dosing errors. Rotate your injection sites within the recommended areas (abdomen, thigh, or upper arm) to minimize the risk of developing lipodystrophy (changes in fat tissue) or localized cutaneous amyloidosis. Monitor your blood glucose levels closely, especially if there are changes in your diet, exercise routine, or other medications. Toujeo is not for the treatment of diabetic ketoacidosis and should be used with caution in individuals with kidney or liver problems or those at risk of low potassium levels.

What happens if a dose of Toujeo is missed?

If you miss a dose of Toujeo, you can inject it up to three hours after your usual administration time. If more than three hours have passed, it is generally advised to check your blood sugar levels frequently and then resume your next scheduled dose at your regular time. Do not take a double or extra dose to compensate for the missed one. Always consult your healthcare provider for specific guidance if you miss a dose.

How should Toujeo and the Toustar Pen be stored?

Unopened Toujeo pens should be stored in a refrigerator (between 2°C and 8°C or 36°F and 46°F) until their expiration date. They should not be frozen, and any pen that has been frozen must be discarded. Once a Toujeo pen is opened, it should be stored at room temperature (below 30°C or 86°F) and used within 56 days (8 weeks). Do not refrigerate an opened pen. Always keep the pen cap on and store it in its original carton to protect it from light and direct heat. Do not store the pen with a needle attached. The Toustar reusable pen itself should not be used for more than 3 years after its first use.