What is the most important information I should know about insulin degludec?
Never share an injection pen with another person, even if the needle has been changed.
What is insulin degludec?
Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. Insulin degludec is a long-acting insulin that starts to work several hours after injection and keeps working evenly for 24 hours.
Insulin degludec is used to improve blood sugar control in adults with diabetes mellitus. This medicine may be used for type 1 or type 2 diabetes.
Insulin degludec may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before using insulin degludec?
You should not use insulin degludec if you are allergic to it, or if you are having an episode of hypoglycemia (low blood sugar) or diabetic ketoacidosis (call your doctor for treatment).
Insulin degludec 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 insulin 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 insulin degludec?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Insulin degludec 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.
Insulin degludec 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 this medicine 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.
Insulin degludec 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) insulin degludec:
- Refrigerate and use until expiration date; or
- Store at room temperature and use within 8 weeks (56 days).
Storing opened (in use) insulin degludec:
- 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.
What happens if I miss a dose?
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.
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 insulin degludec?
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.
What are the possible side effects of insulin degludec?
Get emergency medical help if you have signs of an allergic reaction: 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 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.
What other drugs will affect insulin degludec?
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.
Insulin degludec 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.
Where can I get more information?
Your pharmacist can provide more information about insulin degludec.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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