Generic name: insulin glargine (IN su lin GLAR gine)
Brand name: Toujeo SoloStar, Toujeo Max SoloStar
Drug class: Insulin
Toujeo (insulin glargine) 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. Insulin glargine 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 for use in adults with type 1 or type 2 diabetes, and in children at least 6 years old with type 1 diabetes.
It is not known if this medicine is safe and effective in children.
Toujeo is available in 2 disposable prefilled pens:
Toujeo SoloStar contains 450 units of Toujeo U-300. It delivers doses in 1 unit increments and can deliver up to 80 units in a single injection.
Toujeo Max SoloStar contains 900 units of Toujeo U-300. It delivers doses in 2 unit increments and can deliver up to 160 units in a single injection. Toujeo Max SoloStar is recommended for patients requiring at least 20 units per day.
Warnings
Toujeo SoloStar contains 3 times as much insulin per milliliter (mL) as regular insulin.
You should not use Toujeo if you are having an episode of hypoglycemia (low blood sugar), or if you are in a state of diabetic ketoacidosis (call your doctor for treatment).
Never share a Toujeo SoloStar injection or a Toujeo Max SoloStar injection pen with another person, even if the needle has been changed.
Sharing injection pens can allow disease such as hepatitis or HIV to pass from one person to another.
Toujeo is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.
Toujeo side effects
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; or
- low potassium - leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.
Common Toujeo side effects may include:
- low blood sugar;
- itching, mild skin rash; or
- thickening or hollowing of the skin where you injected the medicine.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Before taking this medicine
You should not use Toujeo if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar).
To make sure this medicine is safe for you, tell your doctor if you have:
- liver or kidney disease;
- low levels of potassium in your blood (hypokalemia); or
- diabetic ketoacidosis (call your doctor for treatment).
Tell your doctor if you also take pioglitazone or rosiglitazone (sometimes contained in combinations with glimepiride or metformin). Taking certain oral diabetes medicines while you are using Toujeo may increase your risk of serious heart problems.
Tell your doctor if you are pregnant or breastfeeding.
Follow your doctor's instructions about using Toujeo if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.
How should I use 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.
The Toujeo brand of insulin glargine contains 3 times as much insulin per milliliter (mL) as the Lantus or Basaglar brands. There are 300 units of insulin in 1 mL of Toujeo, and 100 units in 1 mL of Lantus or Basaglar. Toujeo SoloStar contains a total 450 units of U-300. It delivers doses in 1 unit increments. Toujeo Max SoloStar contains 900 units of U-300 and delivers doses in 2 unit increments.
If there are any changes in the brand, strength, or type of insulin you use, your dosage needs may change.
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.
Do not inject this medicine into skin that is damaged, tender, bruised, pitted, thickened, scaly, or has a scar or hard lump.
Toujeo SoloStar and Toujeo Max SoloStar are 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.
Your care provider will show you the best places on your body to inject this medicine. Use a different place each time you give an injection. Do not inject into the same place two times in a row.
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.
You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).
Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.
Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.
Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your insulin dose or schedule.
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.
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) SoloStar pens:
- Refrigerate and use until expiration date.
Storing opened (in use) SoloStar pens:
- Store the injection pen at room temperature (do not refrigerate) and use within 42 days.
Do not store a 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.
Wear a diabetes medical alert tag in case of emergency. Any medical care provider who treats you should know that you have diabetes.
What happens if I miss a dose?
Call your doctor for instructions if you miss a dose of Toujeo. You should not use more than one dose in a 24-hour period unless your doctor tells you to.
Keep insulin on hand at all times. Get your prescription refilled before you run out of medicine completely.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Insulin overdose can cause life-threatening hypoglycemia. Symptoms include drowsiness, confusion, blurred vision, numbness or tingling in your mouth, trouble speaking, muscle weakness, clumsy or jerky movements, seizure (convulsions), or loss of consciousness.
What should I avoid while using Toujeo?
Do not change the brand of insulin glargine you are using without first talking to your doctor or pharmacist.
Avoid medication errors by always checking the medicine label before injecting your insulin.
Avoid drinking alcohol. It can cause low blood sugar and may interfere with your diabetes treatment.
What other drugs will affect Toujeo?
Many other medicines can affect your blood sugar, and some medicines can increase or decrease the effects of insulin. Some drugs can also cause you to have fewer symptoms of hypoglycemia, making it harder to tell when your blood sugar is low. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products.