Toujeo (insulin glargine injection pen)

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

Uses

What is Toujeo used for?

The Toujeo injection pens are used to improve blood sugar control in adults and children with diabetes mellitus. Some brands of this medicine are for use only in adults. Carefully follow all instructions for the brand of insulin glargine you are using.

Toujeo is used to treat type 2 diabetes in adults.

Toujeo is also used to treat type 1 diabetes in adults and children who are at least 6 years old.

How should I take Toujeo?

Use Toujeo exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Insulin is injected under the skin. You will be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of used needles and injection pens.

Toujeo must not be given with an insulin pump, or mixed with other insulins. Do not inject insulin glargine into a vein or a muscle.

Toujeo is usually injected once per day at the same time each day. You will be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of used needles and injection pens.

Use only the SoloStar injection pen that comes with Toujeo. Attach a new needle before each use. Do not transfer the insulin from the SoloStar pen into a syringe.

Never share an injection pen with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.

Use a disposable needle only once. Follow any state or local laws about throwing away used needles and injection pens. Use a puncture-proof “sharps” disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Toujeo is only part of a treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor’s instructions very closely.

How do I store Toujeo?

Keep this medicine in its original container protected from heat and light. Do not freeze insulin or store it near the cooling element in a refrigerator. Throw away any insulin that has been frozen.

Storing unopened (not in use) Toujeo pens:

• Refrigerate (at 2°C-8°C) and use it before the expiration date.
• Never freeze Toujeo pens.
• Protect the product from light.

Storing opened (in use) Toujeo pens:

• Store the injection pen at room temperature (do not refrigerate) and use it within 42 days.
• Do not store a Toujeo SoloStar injection pen with the needle attached.

Do not use the medicine if it looks cloudy, has changed colors, or has any particles in it. Call your pharmacist for new medicine.

Precautions & warnings

What should I know before using Toujeo?

Before using this drug, tell your doctor if you are/have:

• Pregnant or breastfeeding.
• Taking any other medicines. This includes any medicines you are taking which are available to buy without a prescription, such as herbal and complementary medicines.
• Allergy with any of active or inactive ingredients of Toujeo or other medications.
• Any other illnesses, disorders, or medical conditions.

You should not use Toujeo if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar).

Toujeo should not be given to a child younger than 6 years old. Toujeo should not be used to treat type 2 diabetes in a child of any age.

To make sure Toujeo is safe for you, tell your doctor if you have:

• Liver or kidney disease
• Low levels of potassium in your blood (hypokalemia)
• Diabetic ketoacidosis (call your doctor for treatment)

Is it safe during pregnancy or breastfeeding?

There are no adequate studies in women for determining risk when using Toujeo during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Toujeo. Toujeo is a pregnancy risk category C, according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

• A=No risk
• B=No risk in some studies
• C=There may be some risk
• D=Positive evidence of risk
• X=Contraindicated
• N=Unknown

Side effects

What side effects can occur from Toujeo?

Get emergency medical help if you have signs of an allergy reaction to Toujeo: redness or swelling where an injection was given, itchy skin rash over the entire body, trouble breathing, fast heartbeats, feeling like you might pass out, or swelling in your tongue or throat.

Call your doctor at once if you have:

• Fluid retention – weight gain, swelling in your hands or feet, feeling short of breath
• Low potassium – leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling

Common side effects may include:

• Low blood sugar
• Itching, mild skin rash
• Thickening or hollowing of the skin where you injected the medicine

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Toujeo?

Toujeo may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs, and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Toujeo?

Toujeo may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Toujeo?

Toujeo may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. Therefore, you should always consult with your doctor or pharmacist before using any medication.

What is the dose for an adult?

Starting Dose in Insulin-Naïve Patients

Type 1 Diabetes:

The recommended starting dose of Toujeo in insulin naïve 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 total daily insulin dose in insulin naïve patients with type 1 diabetes.

The maximum glucose-lowering effect of a dose of Toujeo may take five days to fully manifest and the first Toujeo dose may be insufficient to cover metabolic needs in the first 24 hours of use. To minimize risks associated with insufficient insulin uptake when initiating Toujeo, monitor glucose daily, titrate Toujeo per instructions, and adjust co-administered glucose-lowering therapies per standard of care.

Type 2 Diabetes

The recommended starting dose of Toujeo in insulin naïve patients with type 2 diabetes is 0.2 units per kilogram of body weight once daily. The dosage of other anti-diabetic drugs may need to be adjusted when starting Toujeo® to minimize the risk of hypoglycemia.

Starting Dose in Patients with either Type 1 or Type 2 Diabetes Already on Insulin Therapy

To minimize the risk of hypoglycemia when changing patients from a once-daily long-acting or intermediate-acting insulin product to Toujeo, the starting dose of Toujeo can be the same as the once-daily long-acting dose. For patients controlled on Lantus® (insulin glargine, 100 units/mL) expect that a higher daily dose of Toujeo will be needed to maintain the same level of glycemic control.

To minimize the risk of hypoglycemia when changing patients from twice-daily NPH insulin to once-daily Toujeo, the recommended starting Toujeo dose is 80% of the total daily NPH dosage.

To minimize the risk of hyperglycemia when changing patients to Toujeo, monitor glucose frequently in the first weeks of therapy titrate the dose of Toujeo per instructions and the dose of other glucose-lowering therapies per standard of care.

What is the dose for a child?

Children 6 years and older, the dose should be individualized.

For children under 6 years, Toujeo is not recommended. It may not be safe to administer it to a child. Talk to your child’s pediatrician for more information.

How is Toujeo available?

Toujeo is available in the following dosage forms and strengths:

• SoloStar Pen with 450 units of insulin per pen
• Max SoloStar Pen with 900 units of insulin per pen

 What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to the nearest emergency room.

What should I do if I miss a dose?

If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.