Insulin Detemir (rDNA Origin) Injection (patient information)

# Why this medication is prescribed
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. Insulin detemir is a long-acting, man-made version of human insulin. It works 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.

# How this medication should be used
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, or twice a day, in the morning and in the evening with the evening meal or at bedtime. 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.
Insulin detemir should not be used in insulin infusion pumps.
Insulin detemir should not be mixed or diluted 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, cartridges that contain medication and are to be placed in dosing pens, and 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 if you have questions about the type of syringe you should use.
If your insulin detemir comes in cartridges, you will need to buy an insulin pen separately. Check the manufacturer's information for the patient to see what type of pen is right for the cartridge size you are using. Carefully read the instructions that come with your pen, and ask your doctor or pharmacist to show you how to use it. Ask your doctor or pharmacist if you have questions about the type of pen 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. Never remove the cartridge from the pen or attempt to add any other type of insulin to the cartridge.
Never reuse needles or syringes and never share needles, syringes, cartridges, or pens. If 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.
Always look at your insulin detemir before you inject it. It should be as clear, colorless, and fluid as water. 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.
If your insulin detemir comes in vials, follow these steps to prepare your dose:
- Wash your hands.
- If you are using a new bottle, flip off the plastic cap, but do not remove the stopper.
- Wipe the top of the bottle with an alcohol swab.
- Pull back the plunger of the syringe until the top of the plunger is even with the dose your doctor told you to inject.
- Push the needle through the rubber stopper on the bottle.
- Push down on the plunger to inject the air into the bottle.
- Turn the bottle upside down without removing the syringe.
- Be sure the tip of the needle is under the liquid in the bottle. Slowly pull back on the plunger until the top of the plunger is even with the dose your doctor told you to inject.
- While the needle is still in the bottle, check whether there are air bubbles in the syringe. #If there are bubbles, hold the syringe upright and tap on it to push the bubbles to the top. #Push the plunger up to move the bubbles out of the syringe, and then pull the plunger back down to the correct dose.
- Remove the needle from the bottle and lay the syringe down so that the needle is not touching anything.
To inject a prepared dose of insulin detemir using a syringe or pen, follow these steps:
- Use an alcohol pad to wipe the area where you plan to inject your medication.
- Pinch up a large area of skin, or spread the skin flat with your hands.
- Insert the needle into your skin. Your doctor will tell you exactly how to do this.
- If you are using a syringe, push the plunger all the way down. If you are using a pen, follow the manufacturer's instructions for dispensing a dose.
- Pull the needle out and press down on the spot for several seconds, but do not rub it.
Use a different site for each injection, about 1 inch away from the previous injection but in the same general area (for example, the thigh). Use all available sites in the same general area before switching to a different area (for example, the upper arm). Do not use the same injection site more often than once every month.

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

# Special precautions
Before using insulin detemir:
- tell your doctor and pharmacist if you are allergic to insulin (Humulin, Iletin, Novolin, Velosulin, others) or any other medications.
- 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); antihistamines; beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal); clonidine (Catapres, Catapres-TTS); danazol (Danocrine); disopyramide (Norpace, Norpace CR); diuretics ('water pills'); fenofibrate (Lofibra, TriCor); fluoxetine (Prozac, Sarafem); gemfibrozil (Lopid); guanethidine (Ismelin); hormone replacement therapy; isoniazid (INH, Laniazid, Nydrazid); lithium (Eskalith, Lithobid, Lithotabs); medications for asthma, colds, mental illness, and nausea; monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl), and tranylcypromine (Parnate); oral contraceptives (birth control pills); oral medications for diabetes; oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone); pentamidine (NebuPent, Pentam 300); propoxyphene (Darvon); reserpine (Serpalan, Serpasil); salicylate pain relievers such as aspirin, choline magnesium trisalicylate (Tricosal, Trilisate), choline salicylate (Arthropan), diflunisal (Dolobid), magnesium salicylate (Doans, others), and salsalate (Argesic, Disalcid, Salgesic); 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 or 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.
- ask your doctor what to do if you get sick, experience unusual stress, plan to travel across more than two time zones, or change your exercise or activity schedule. These changes can affect your dosing schedule and the amount of insulin you will need.

# Special dietary instructions
Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. It is important to eat a healthy diet.
Alcohol may cause a decrease in blood sugar. Ask your doctor about the safe use of alcoholic beverages while you are using insulin detemir.

# What to do if you forget a dose
If you remember your dose shortly after the time you were supposed to take it, inject the missed dose as soon as you remember it. If some time has passed since your regular dosing time, 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.

# Side effects

## Minor side effects
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.
You may experience hypoglycemia (low blood sugar) while you are taking this medication. Your doctor will tell you what you should do if you develop hypoglycemia. He or she may tell you to check your blood sugar, eat or drink a food or beverage that contains sugar, such as hard candy or fruit juice, or get medical care. Follow these directions carefully if you have any of the following symptoms of hypoglycemia:
- shakiness
- dizziness or lightheadedness
- sweating
- nervousness or irritability
- sudden changes in behavior or mood
- headache
- numbness or tingling around the mouth
- weakness
- pale skin
- hunger
- clumsy or jerky movements
If hypoglycemia is not treated, severe symptoms may develop. Be sure that your family, friends, and other people who spend time with you know that if you have any of the following symptoms, they should get medical treatment for you immediately.
- confusion
- seizures
- loss of consciousness
Call your doctor immediately if you have any of the following symptoms of hyperglycemia (high blood sugar) :
- extreme thirst
- frequent urination
- extreme hunger
- weakness
- blurred vision
If high blood sugar is not treated, a serious, life-threatening condition called diabetic ketoacidosis could develop. Call your doctor immediately if you have any of the these symptoms:
- dry mouth
- upset stomach and vomiting
- shortness of breath
- breath that smells fruity
- decreased consciousness
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)

## Severe side effects
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:
- rash and/or itching over the whole body
- shortness of breath
- wheezing
- dizziness
- blurred vision
- fast heartbeat
- sweating
- 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 taking this medication.

# Storage conditions needed for this medication
Store unopened insulin detemir vials, cartridges, and pens 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 cartridges at room temperature and away from direct sunlight and extreme heat. Unrefrigerated vials, cartridges, and pens can be used within 42 days or they must be thrown away. Opened vials can be stored for 42 days at room temperature or in the refrigerator. Opened cartridges and pens may be stored at room temperature for up to 42 days; do not refrigerate them. Throw away any insulin detemir that has been exposed to extreme heat or cold.
When traveling, protect your insulin detemir vials, cartridges, and pens from bumps or other rough handling (wrap them in clothes in the middle of a suitcase). Do not keep insulin in hot areas of a car such as the glove compartment or trunk. When traveling by airplane, do not put insulin in checked luggage since the luggage may be lost. Always keep insulin with you or in carry-on luggage.
Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

# In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include the symptoms of hypoglycemia listed above and the following:
- seizure
- loss of consciousness
- confusion

# Other information
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 or urine 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.

# Brand names
- Levemir