toujeo

Toujeo (insulin glargine) is a man-made form of a hormone that is produced in the body. It works by lowering levels of glucose (sugar) in the blood. Insulin glargine is a long-acting form of insulin that is slightly different from other forms of insulin that are not man-made.

Toujeo SoloStar disposable prefilled pen is an injection that is used to treat type 1 or type 2 diabetes.

Toujeo may also be used for purposes not listed in this medication guide.

Important information

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.

Never share a Toujeo SoloStar injection pen with another person. 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.

Before taking this medicine

You should not use Toujeo if you are allergic to insulin glargine, or:

• 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 with a short-acting insulin).

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

• congestive heart failure or other heart problems;

• liver or kidney disease; or

• if you also take oral diabetes medicine such as pioglitazone or rosiglitazone.

Tell your doctor about all other diabetes medications you use, especially pioglitazone or rosiglitazone (sometimes contained in combinations with glimepiride or metformin). Taking certain oral diabetes medications while you are using insulin may increase your risk of serious heart problems.

It is not known whether Toujeo will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether insulin glargine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I use Toujeo SoloStar?

Use Toujeo exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended. If you use more than one type of insulin: Avoid accidental mix-ups by carefully checking your medicine label each time you use insulin.

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 regular insulin. There are 300 units of insulin in 1 mL of Toujeo, and 100 units in 1 mL of standard insulin.

The Toujeo SoloStar 1.5 mL injection pen contains a total of 450 units of insulin (300 units/1 mL). The pen is designed to deliver from 1 to 80 units in steps of 1 unit. Do not press the button more than one time per injection unless your doctor has prescribed a dose greater than 80 units.

Using too much insulin glargine can cause severely low blood sugar (hypoglycemia), which could lead to seizures or death.

If there are any changes in the brand, strength, or type of insulin you use, your dosage needs may change. Always check your medicine when it is refilled to make sure you have received the correct brand and type prescribed by your doctor.

Toujeo is injected under the skin once per day, at the same time each day. You may be shown how to use injections at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles and syringes. Do not mix this medication with other insulins.

Your care provider will show you the best places on your body to inject Toujeo. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Never share a Toujeo injection pen with another person. Sharing injection pens can allow disease such as hepatitis or HIV 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 syringes. 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.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, confusion, irritability, dizziness, or feeling shaky. Always keep a source of sugar with you in case you have low blood sugar. Sugar sources include fruit juice, hard candy, crackers, raisins, and non-diet soda. Be sure your family and close friends know how to help you in an emergency.

If you have severe hypoglycemia and cannot eat or drink, use a glucagon injection. Your doctor can prescribe a glucagon emergency injection kit and tell you how to use it.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss.

Check your blood sugar carefully during times of stress, travel, illness, surgery or medical emergency, vigorous exercise, or if you drink alcohol or skip meals. These things can affect your glucose levels and your dose needs may also change. Do not change your medication dose or schedule without your doctor"s advice.

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.

Toujeo SoloStar disposable prefilled pens should not be stored in the freezer and should not be allowed to freeze. Discard the disposable prefilled pen if it has been frozen.

Unopened Toujeo SoloStar disposable prefilled pens should be stored in a refrigerator, 36°F – 46°F (2°C – 8°C). Discard after the expiration date on the label.

The opened (in-use) Toujeo SoloStar pen should NOT be refrigerated but should be kept at room temperature (below 86°F [30°C])and away from direct heat and light. The opened (in-use) Toujeo SoloStar pen must be discarded 28 days after being opened.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose. You should not use more than one dose in a 24-hour period unless your doctor tells you to.

Keep Toujeo 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. An insulin overdose can cause life-threatening hypoglycemia.

What should I avoid while using Toujeo SoloStar?

Do not change the brand of insulin glargine or syringe you are using without first talking to your doctor or pharmacist.

Avoid drinking alcohol. It lowers blood sugar and may interfere with your diabetes treatment.

Toujeo side effects

Get emergency medical help if you have signs of an allergy to Toujeo: itchy skin rash over the entire body; confusion, extreme drowsiness; wheezing, trouble breathing; fast heart rate, sweating; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• shortness of breath (even with mild exertion), swelling, rapid weight gain;

• itching, swelling, redness, thickening, or hollowing of the skin where you inject Toujeo; or

• low potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, extreme thirst, increased urination, numbness or tingling, muscle weakness or limp feeling.

Common Toujeo side effects may include:

• low blood sugar;

• swelling, weight gain;

• skin changes where the medicine was injected; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

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.

See also: Side effects (in more detail)

What other drugs will affect Toujeo?

Many other medicines can increase or decrease the effects of insulin glargine on lowering your blood sugar. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.