Insulin Degludec (rDNA Origin) Injection

Insulin degludec is used to treat type 1 diabetes (condition in which the body does not produce insulin and therefore cannot control the amount of sugar in the blood). It is also used to treat people with type 2 diabetes (condition in which the body does not use insulin normally and, therefore, cannot control the amount of sugar in the blood) who need insulin to control their diabetes. In patients with type 1 diabetes, insulin degludec must be used with another type of insulin (a short-acting insulin). In patients with type 2 diabetes, insulin degludec may be used with another type of insulin or with oral medication(s) for diabetes. Insulin degludec is a long-acting, man-made version of human insulin. Insulin degludec works by replacing the insulin that is normally produced by the body and by helping move sugar from the blood into other body tissues where it is used for energy. It also stops the liver from producing more sugar.

Over time, people who have diabetes and high blood sugar can develop serious or life-threatening complications, including heart disease, stroke, kidney problems, nerve damage, and eye problems. Using medication(s), making lifestyle changes (e.g., diet, exercise, quitting smoking), and regularly checking your blood sugar may help to manage your diabetes and improve your health. This therapy may also decrease your chances of having a heart attack, stroke, or other diabetes-related complications such as kidney failure, nerve damage (numb, cold legs or feet; decreased sexual ability in men and women), eye problems, including changes or loss of vision, or gum disease. Your doctor and other healthcare providers will talk to you about the best way to manage your diabetes.

Insulin degludec comes as a solution (liquid) to inject subcutaneously (under the skin). It is injected once a day. You should use insulin degludec at the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use insulin degludec exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Insulin degludec controls diabetes, but does not cure it. Continue to use insulin degludec even if you feel well. Do not stop using insulin degludec without talking to your doctor. Do not switch to another brand or type of insulin or change the dose of any type of insulin you are using without talking to your doctor. Always check the insulin label to make sure you received the right type of insulin from the pharmacy.

Insulin degludec comes in prefilled dosing pens. Be sure you know what type of container your insulin degludec comes in and what other supplies, such as needles, you will need to inject your medication. Be sure to read and understand the manufacturer's instructions. Ask your doctor or pharmacist to show you how to use the pen. Follow the directions carefully, and always perform the safety test before use.

Never reuse needles or pens. Do not transfer the medication to a syringe. When you are using an insulin pen, always remove the needle right after you inject your dose. Throw away needles and syringes in a puncture-resistant container. Ask your doctor or pharmacist how to dispose of the puncture-resistant container.

Do not dilute insulin degludec and do not mix insulin degludec with any other type of insulin.

You can inject your insulin degludec in your upper arm, thigh, or stomach area. Never inject insulin degludec into a vein or muscle. Change (rotate) the injection site within the chosen area with each dose; try to avoid injecting the same site more often than once every 1 to 2 weeks.

Always look at your insulin degludec before you inject it. It should be clear and colorless. Do not use your insulin degludec if it is colored, cloudy, or contains solid particles, or if the expiration date on the bottle has passed.

Do not use insulin degludec in an external insulin pump.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before using insulin degludec,

• tell your doctor and pharmacist if you are allergic to insulin (Humulin, Novolin, others), any of the ingredients in insulin degludec, or any other medications. Ask your pharmacist or check the manufacturer's patient information for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking while using insulin degludec. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• the following nonprescription product may interact with insulin degludec: niacin. Be sure to let your doctor and pharmacist know that you are taking this medication before you start using insulin degludec. Do not start this medication while using insulin degludec without discussing with your healthcare provider.
• tell your doctor if you have or have ever had nerve damage caused by your diabetes, or any other medical conditions, including heart, liver or kidney disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using insulin degludec, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are using insulin degludec.
• alcohol may cause a change in blood sugar. Ask your doctor about the safe use of alcoholic beverages while you are using insulin degludec.
• ask your doctor what to do if you get sick, experience unusual stress, or change your diet, exercise, or activity schedule. These changes can affect your blood sugar and the amount of insulin you will need.
• ask your doctor how often you should check your blood sugar. Be aware that hypoglycemia may affect your ability to perform tasks such as driving and ask your doctor if you need to check your blood sugar before driving or operating machinery.

Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. It is important to eat a healthful diet and to eat about the same amounts of the same kinds of food at about the same times each day. Skipping or delaying meals or changing the amount or kind of food you eat can cause problems with your blood sugar control.

Inject the missed dose as soon as you remember it. However, if it is less than 8 hours before the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

This medication may cause changes in your blood sugar. You should know the symptoms of low and high blood sugar and what to do if you have these symptoms. Insulin degludec may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• redness, swelling, pain, or itching at the injection site
• skin thickening (fat build-up) or a little depression in the skin (fat breakdown)
• weight gain

Some side effects can be serious. If you experience these symptoms, call your doctor immediately or get emergency treatment:

• rash, hives, or itching all over the body
• wheezing
• difficulty breathing or swallowing
• shortness of breath
• sweating
• swelling of the eyes, face, lips, tongue, throat, hands, or feet
• muscle weakness

Insulin degludec may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in and out of reach of children. Store unopened insulin degludec pens in the refrigerator. Never allow insulin degludec to freeze; do not use insulin degludec that has been frozen and thawed. Unopened refrigerated insulin degludec can be stored until the date shown on the company's label.

If a refrigerator is unavailable (for example, when on vacation), store the pens at room temperature, away from direct sunlight and extreme heat for up to 56 days. Opened pens must be stored at room temperature and may be used for up to 56 days after the first use. Dispose of any insulin that has been exposed to extreme heat or cold.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Insulin degludec overdose can occur if you use too much insulin degludec or if you use the right amount of insulin degludec, but eat less than usual or exercise more than usual. Insulin degludec overdose can cause hypoglycemia. If you have symptoms of hypoglycemia, follow your doctor's instructions for what you should do if you develop hypoglycemia. Other symptoms of overdose:

• loss of consciousness
• seizures

Keep all appointments with your doctor and the laboratory. Your blood sugar and glycosylated hemoglobin (HbA1c) should be checked regularly to determine your response to insulin degludec. Your doctor will also tell you how to check your response to this medication by measuring your blood sugar levels at home. Follow these instructions carefully.

You should always wear a diabetic identification bracelet to be sure you get proper treatment in an emergency. Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Tresiba^®
• Ryzodeg^® (as a combination product containing Insulin Degludec and Insulin Aspart)
• Xultophy^® (as a combination product containing Insulin Degludec and Liraglutide)