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

Tresiba is used to improve blood sugar control in adults with diabetes mellitus.

Tresiba may be used for type 1 or type 2 diabetes.

Tresiba is supplied in a multiple-dose vial or as a single-patient-use FlexTouch pen.

Tresiba FlexTouch is a disposable prefilled disposable pen available in two different strengths, U-100 (100 units/mL) containing 300 units of insulin and U-200 (200 units/mL) containing 600 units of insulin.

You should not use Tresiba if you are having an episode of hypoglycemia (low blood sugar).

Never share a Tresiba injection pen with another person, even if the needle has been changed.

Use Tresiba exactly as it was prescribed for you. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Tresiba is injected under the skin, usually once daily at any time of day. A healthcare provider will teach you how to properly use the medication by yourself.

Tresiba must not be given with an insulin pump, or mixed with other insulins. Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

A dose counter on the injection pen shows your dose in units. Do not convert your dose. Use the U-100 vial for a child whose dose is less than 5 units per day.

Do not inject Tresiba into skin that is damaged, tender, bruised, pitted, thickened, scaly, or has a scar or hard lump.

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.

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). Be sure you know how to use a glucagon injection kit if your doctor prescribes one.

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 dose or medication schedule.

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

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

Storing unopened (not in use) Tresiba:

• Refrigerate and use until expiration date; or

• Store at room temperature and use within 8 weeks (56 days).

Storing opened (in use) Tresiba:

• Refrigerate or store at room temperature and use within 8 weeks. Do not store the injection pen with a needle attached.

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

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Usual Adult Dose of Tresiba for Diabetes Type 1:

Dose should be individualized based on clinical response; this basal insulin should be used in regimens with short or rapid-acting insulin

Insulin-naive patients:
Initial dose: One-third to one-half the total daily insulin requirement subcutaneously once a day.
-The initial total daily insulin requirement in insulin naive patients is generally 0.2 to 0.4 units of insulin per kilogram of body weight.

Current insulin users:
Initiate at the same total daily dose of current long or intermediate-acting insulin subcutaneously once a day.

Comments:
-Adjust dosage according to metabolic needs, blood glucose measurements, and glycemic goals; dose increases should occur no sooner than every 3 to 4 days.
-When changing treatment regimens, the dose and frequency of short-acting insulin may need to be adjusted.
-To minimize hypoglycemia, closely monitor blood glucose, especially with changing regimens.

Usual Adult Dose of Tresiba for Diabetes Type 2:

Initial dose: 10 units subcutaneously once a day

Current insulin users:
Initiate at the same total daily dose of current long or intermediate-acting insulin subcutaneously once a day.

Comments:
-Adjust dosage according to metabolic needs, blood glucose measurements, and glycemic goals; dose increases should occur no sooner than every 3 to 4 days.
-When changing treatment regimens, the dose and frequency of short-acting insulin or other anti-diabetic medications may need to be adjusted.
-To minimize hypoglycemia, closely monitor blood glucose, especially with changing regimens.

You should not use Tresiba if you are allergic to insulin degludec, or if you are having an episode of hypoglycemia (low blood sugar) or diabetic ketoacidosis (call your doctor for treatment).

Tresiba should not be given to a child younger than 1 year old.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor's instructions about using Tresibaif 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.

Use the missed dose as soon as you remember. Then continue your regular dosing schedule, allowing at least 8 hours to pass between doses. Do not use two doses at one time.

Call your doctor for instructions if a child misses a dose.

Keep insulin on hand at all times. Get your prescription refilled before you run out of medicine completely.

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.

Avoid driving or operating machinery until you know how this medicine will affect you.

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.

Get emergency medical help if you have signs of an allergic reaction to Tresiba: hives, itching, skin rash; wheezing, tiredness, trouble breathing; feeling like you might pass out; nausea, diarrhea; swelling of your face, lips, 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 Tresiba side effects may include:

• low blood sugar;

• swelling, weight gain;

• itching, 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.

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 insulin may increase your risk of serious heart problems.

Tresiba may not work as well when you use other medicines at the same time. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all medicines you start or stop using.