Insulin Detemir (rDNA Origin) Injection

Insulin detemir 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 detemir may be used with another type of insulin (a short-acting insulin). In patients with type 2 diabetes, insulin detemir also may be used with another type of insulin or with oral medication(s) for diabetes. Insulin detemir is a long-acting, man-made version of human insulin. Insulin detemir 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 detemir comes as a solution (liquid) to inject subcutaneously (under the skin). It is usually injected once a day, with the evening meal or at bedtime.Sometimes insulin detemir may be injected twice a day, in the morning before breakfast and in the evening with the evening meal or at bedtime about 12 hours later. Inject insulin detemir at around the same time(s) 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 detemir exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Never use insulin detemir when you have symptoms of hypoglycemia (low blood sugar) or if you have checked your blood sugar and found it to be low. Do not inject insulin into a skin area that is red, swollen, itchy, or thickened.

Insulin detemir should not be used in an external insulin pump.

Insulin detemir should not be diluted or mixed with other insulin products.

Insulin detemir controls diabetes but does not cure it. Continue to use insulin detemir even if you feel well. Do not stop using insulin detemir 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.

Insulin detemir comes in vials and in dosing pens that contain cartridges of medication. Be sure you know what type of container your insulin detemir comes in and what other supplies, such as needles, syringes, or pens, you will need to inject your medication.

If your insulin detemir comes in vials, you will need to use syringes to inject your dose. Ask your doctor or pharmacist to show you how to inject insulin detemir using a syringe. Ask your doctor or pharmacist if you have questions about the type of syringe you should use.

If your insulin detemir comes in pens, 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 prime the pen before use.

Never reuse needles or syringes and never share needles, syringes, or pens. If you are using an insulin pen, always remove the needle right after you inject your dose. Dispose of needles and syringes in a puncture-resistant container. Ask your doctor or pharmacist how to dispose of the puncture-resistant container.

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

You can inject your insulin detemir in your upper arm, thigh, or stomach. Never inject insulin detemir 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 1–2 weeks.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

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

Before using insulin detemir,

• tell your doctor and pharmacist if you are allergic to insulin (Humulin, Novolin, others), any of the ingredients of insulin detemir, 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. Be sure to mention any of the following: angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), and trandolapril (Mavik); beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal); certain cholesterol-lowering medications such as fenofibrate (Antara, Lofibra, TriCor, Triglide) and gemfibrozil (Lopid); clonidine (Catapres, Catapres-TTS, in Clorpres); danazol; disopyramide (Norpace, Norpace CR); diuretics ('water pills'); fluoxetine (Prozac, Sarafem, in Symbyax); hormone replacement therapy; isoniazid (INH, Nydrazid); lithium (Eskalith, Lithobid); medications for asthma and colds; medications for mental illness and nausea; monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl), and tranylcypromine (Parnate); octreotide (Sandostatin); oral contraceptives (birth control pills); oral medications for diabetes such as pioglitazone (Actos, in Actoplus Met and others) and rosiglitazone (Avandia, in Avandamet and others); oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone); pentamidine (NebuPent, Pentam); reserpine; salicylate pain relievers such as aspirin, choline magnesium trisalicylate (Tricosal, Trilisate), choline salicylate (Arthropan), diflunisal (Dolobid), magnesium salicylate (Doan's, others), and salsalate (Argesic, Disalcid, Salgesic); somatropin (Nutropin, Serostim, others); sulfa antibiotics; and thyroid medications. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had nerve damage caused by your diabetes; heart failure; or any other medical conditions, including heart, kidney or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using insulin detemir, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are using insulin detemir.
• alcohol may cause a change in blood sugar. Ask your doctor about the safe use of alcoholic beverages while you are using insulin detemir.
• 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 dosing schedule 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.

If you remember your dose shortly after the time you were supposed to use it, inject the missed dose as soon as you remember it. If some time has passed since your regular dosing time, follow the directions provided by your doctor or call your doctor to find out whether you should inject the missed dose. Do not inject 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 detemir injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• redness, swelling, or itching at the site of the injection
• changes in the feel of your skin, skin thickening (fat build-up), or a little depression in the skin (fat breakdown)
• vision changes
• weight gain
• constipation

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

• rash and/or itching over the whole body
• shortness of breath
• wheezing
• dizziness
• low blood pressure
• blurred vision
• fast heartbeat
• sweating
• weakness
• muscle cramps
• abnormal heartbeat
• large weight gain in a short period of time
• swelling of the hands, feet, ankles, or lower legs

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

Store unopened insulin detemir vials and pens in the original carton in the refrigerator. Do not freeze. Do not use insulin detemir if it has been frozen. Unopened refrigerated insulin detemir can be stored until the date shown on the company's label.

If no refrigerator is available (for example, when on vacation), store the vials, or pens at room temperature and away from direct heat and light. Unrefrigerated vials and pens can be used within 42 days or after that time they must be discarded. Opened vials can be stored for 42 days at room temperature or in the refrigerator. Opened pens may be stored at room temperature for up to 42 days; do not refrigerate them. Discard any insulin detemir 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 detemir overdose can occur if you use too much insulin detemir or if you use the right amount of insulin detemir but eat less than usual or exercise more than usual. Insulin detemir 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:

• seizure
• loss of consciousness

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 detemir. Your doctor will also tell you how to check your response to insulin 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.

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