Insulin Glargine (rDNA origin) Injection (patient information)

# Why this medication is prescribed
Insulin glargine 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 long-acting insulin to control their diabetes. Insulin glargine is a long-acting, man-made version of human insulin. Insulin is a hormone made in the pancreas. Insulin helps move sugar from the blood into other body tissues where it is used for energy. It also helps the body break down carbohydrates, fats, and proteins from the diet. In a person with diabetes, the pancreas does not produce enough insulin for the body's needs, so additional insulin is required. People with diabetes may gradually develop serious nerve, blood vessel, kidney, and eye problems if the diabetes is not controlled properly.
This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

# How this medication should be used
Insulin glargine comes as an injection to inject subcutaneously (beneath the skin, not into a vein). It is injected once a day at bedtime. The medication comes in vials (bottles) and also prefilled containers called cartridges. The amount of insulin glargine you need depends on diet, other diseases, exercise, and other drugs you are taking and may change with time. Your doctor will tell you how much you should take. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take insulin glargine exactly as directed. Do not take more or less of it or take it more often than directed by the package label or prescribed by your doctor.
Insulin glargine controls diabetes but does not cure it. It must be taken regularly. Continue to take insulin glargine even if you feel well. Do not stop taking insulin glargine without talking to your doctor.
You do not have to shake the vial or cartridge of insulin glargine before use. Do not dilute or mix insulin glargine with any other insulin or solution. The syringe must not have any other medicine or residue in it.
If your insulin glargine comes in cartridges, the medication will already be inside. You must only use the OptiPen One Insulin Delivery Device with the cartridges. Before you use the device for the first time, read the written directions that come with it. Ask your doctor, pharmacist, or nurse to show you the right way to use this device. Practice while your health care provider watches.
If your insulin glargine comes in vials, you will have to withdraw (draw up) the medication into a syringe. Before you do this for the first time, read the written directions that come with it. Ask your doctor or pharmacist to show you the right way to withdraw the insulin glargine and to inject the medication subcutaneously. Practice while your health care provider watches.
If your insulin glargine comes in vials you will need to use syringes. Always use a syringe that is marked for U-100 insulin products. If you use the wrong syringe, you may get the wrong dose, and your blood glucose level may end up being too low or too high.
Plastic syringes are disposable; use a new one for each injection. Used needles will hurt more and may cause an infection. Never share needles and syringes. To withdraw insulin glargine into the syringe, follow these steps:
- Wash your hands.
- Hold the vial in your hands to warm the medicine. Look at the medicine in the vial. Make sure it is clear and colorless. If it is cloudy or has particles (specks) in it, throw the vial away and get a new one.
- If you are using a new vial, remove the protective cap. Do not remove the stopper (the rubber inside the cap).
- Wipe the top of the vial with an alcohol swab or cotton dipped in rubbing alcohol.
- It is easier to withdraw insulin glargine if you first inject air into the vial. To do this, pull the plunger (the cylinder inside the syringe) back to the number of insulin glargine units you will have to take. Now your syringe is filled with the right amount of air. Insert the needle through the rubber cap and push on the plunger to inject the air into the vial.
- Keep the syringe in the vial and turn both upside down. Hold the syringe and vial firmly with one hand.
- Make sure the tip of the needle is in the insulin. With your free hand, pull back on the plunger to withdraw insulin glargine into the syringe, and measure the correct number of units of insulin glargine.
- Before you take the needle out of the vial, be sure that there are no bubbles in the syringe. #If there are bubbles in the syringe, hold the syringe straight up and tap the side of the syringe until the bubbles float to the top. Push the bubbles out with the plunger and draw insulin glargine back in until you have the correct dose.
- Remove the needle from the vial. Do not let the needle touch anything. You are now ready to inject.
- If you have trouble seeing the small markings on the syringe, have someone help you. Also, let your doctor and pharmacist know about this problem. They can provide syringes that are easier to read, special tools to help you fill the syringe, or prefilled syringes.
To inject your insulin glargine dose, follow these steps:
- Decide on an injection areaeither your abdomen, buttocks, thighs, or arms.
- Clean the skin at the injection site with an alcohol pad or cotton dipped in rubbing alcohol.
- Pinch a fold of skin with your fingers at least 3 inches apart and insert the needle at a 45- to 90-degree angle.
- Then slowly push the plunger of the syringe all the way, making sure you have injected all the insulin glargine. Leave the needle in the skin for several seconds.
- Pull the needle straight out and press lightly on the spot where you injected yourself for several seconds. Do not rub the area.
- Follow the directions given to you for throwing away the needle and syringe.
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.

# Special precautions
Before taking insulin glargine:
- tell your doctor and pharmacist if you are allergic to insulin or any other drugs.
- tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially acetazolamide (Diamox); AIDS antiviral medications; albuterol (Proventil, Ventolin); allergy or cold medications; angiotensin-converting enzyme inhibitors (ACE inhibitors) such as captopril (Capoten), enalapril (Vasotec), or lisinopril (Prinivil, Zestril); antibiotics; antipsychotics such as fluphenazine (Prolixin), mesoridazine (Serentil), or thioridazine (Mellaril); beta-blockers such as propranolol (Inderal); calcitonin (Calcimar); chloroquine (Aralen); chlorpromazine (Thorazine); clofibrate (Atromid-S); clonidine (Catapres); corticosteroids such as dexamethasone (Decadron), methylprednisolone (Medrol), or prednisone (Deltasone, Orasone); danazol (Danocrine); disopyramide (Norpace); diuretics ('water pills'); epinephrine; estrogens; fenofibrate (TriCor); fluoxetine (Prozac, Sarafem); gemfibrozil (Lopid); guanethidine (Ismelin); isoniazid (INH); lithium (Eskalith, Lithobid); mebendazole (Vermox); medications that contain alcohol or sugar; morphine (MS Contin, others); niacin; nicotine; octreotide (Sandostatin); oral contraceptives (birth control pills); oral medications for diabetes; pentamidine (Pentam); phenelzine (Nardil); phenytoin (Dilantin); prochlorperazine (Compazine); promethazine (Phenergan); propoxyphene (Darvon); reserpine (Serpalan, others); salicylates such as aspirin, diflunisal (Dolobid), or salsalate (Disalcid); somatropin (human growth hormone); sulfa drugs; sulfinpyrazone (Anturane); terbutaline (Brethine, Bricanyl); thyroid medications; tranylcypromine (Parnate); trimeprazine (Temaril); and vitamins or herbal products.
- tell your doctor if you have or have ever had thyroid, liver, or kidney disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking insulin glargine, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking insulin glargine.
- tell your doctor if you have fever, infection, injury, or illness with vomiting or diarrhea. *These may affect your blood sugar level.

# Special dietary instructions
Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. It is important to eat a healthful diet. Do not start a diet or an exercise program without talking to your doctor. Your insulin dose may need to be changed.
Alcohol may cause a decrease in blood sugar. Ask your doctor about the safe use of alcoholic beverages while you are using insulin glargine.

# What to do if you forget a dose
Before you start taking insulin glargine, ask your doctor what to do if you forget to take a dose or if you accidentally take an extra dose. Write these directions down so you can refer to them later.

# 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 glargine can cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- redness, swelling, pain, and itching at the injection site
- changes in the feel of your skin, skin thickening (fat build-up), or a little depression in *the skin (fat breakdown)

## Severe side effects
If you experience any of the following symptoms, call your doctor immediately:
- exaggerated sunburn
- difficulty speaking or moving
- skin rash or hives all over the body
- itching or redness
- swelling of hands or feet
- difficulty swallowing
- wheezing (trouble breathing)
- fast pulse
- low blood pressure

# Storage conditions needed for this medication
Store unopened insulin glargine vials and cartridges in the refrigerator. Never allow insulin glargine to freeze; do not use insulin glargine that has been frozen and thawed. Never heat insulin glargine to warm it. Unopened refrigerated insulin glargine 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 10-mL vials or cartridges can be used within 28 days or they must be thrown away. Unrefrigerated 5-mL vials can be used for 14 days or they must be thrown away. Refrigerated 5-mL vials can be used for up to 28 days. Once the cartridge is placed in the OptiPen One Insulin Delivery Device, do not refrigerate. Throw away any insulin that has been exposed to extreme heat or cold.
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.

# 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 glargine. Your doctor will also tell you how to check your response to this medication by measuring your blood or urine sugar levels at home. Follow these instructions carefully.
Your dose of insulin glargine may need to be changed when you are ill (especially with fever, vomiting, or diarrhea), have emotional changes or stress, gain or lose weight, or change the amount of food you eat or amount of exercise you do. If any of these things happen, call your doctor.
See your dentist twice yearly; see your eye doctor regularly; get your blood pressure checked regularly.
If you travel across time zones, ask your doctor how to time your injections. When you travel, take extra insulin and supplies with you.
Keep yourself and your clothes clean. Wash cuts, scrapes, and other wounds quickly, and do not let them get infected. Wear medical alert identification (a bracelet or tag) that says you have diabetes.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

# Brand names
- Lantus