Insulin Glargine (rDNA origin) Injection

Insulin glargine products are 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). Insulin glargine products are 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 people with type 1 diabetes, insulin glargine products must be used with another type of insulin (a short-acting insulin). In people with type 2 diabetes, insulin glargine products also may be used with another type of insulin or with oral medication(s) for diabetes. Insulin glargine is a long-acting, synthetic version of human insulin. Insulin glargine products work 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.

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

Insulin glargine products come as a solution (liquid) to inject subcutaneously (under the skin). They are injected once a day. You should use insulin glargine products 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 glargine products exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Never use insulin glargine products when you have symptoms of hypoglycemia (low blood sugar) or if you have checked your blood sugar and found it to be low.

Insulin glargine products control diabetes but do not cure it. Continue to use insulin glargine products even if you feel well. Do not stop using insulin glargine products 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 glargine products come in vials and in dosing pens that contain cartridges of medication. Be sure you know what type of container your insulin glargine product comes in and what other supplies, such as needles, syringes, or pens, you will need to inject your medication.

If your insulin glargine product 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 glargine using a syringe. Ask your doctor or pharmacist if you have questions about the type of syringe you should use.

If your insulin glargine product 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 perform the safety test 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. Discard 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 glargine products and do not mix insulin glargine products with any other type of insulin.

You can inject your insulin glargine in your upper arm, thigh, or stomach. Never inject insulin glargine into a vein or muscle. Do not inject where the skin is thick, lumpy, tender, bruised, scaly, or hard, or into areas of skin where there are scars or skin is damaged. 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 check your insulin glargine product label to make sure you are using the correct insulin and look at your insulin glargine product before you inject it. It should be clear and colorless. Do not use your insulin glargine product if it is colored, cloudy, or contains solid particles, or if the expiration date on the bottle has passed.

Do not use insulin glargine products in an external insulin pump.

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

Before using insulin glargine products,

• tell your doctor and pharmacist if you are allergic to insulin (Humulin, Novolin, others), insulin glargine, any other medications, or any of the ingredients of insulin glargine products. Ask your pharmacist 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 pioglitazone (Actos, in Actoplus Met, in Duetact, in Oseni) and rosiglitazone (Avandia). 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; low blood levels of potassium; vision problems; 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 an insulin glargine product, call your doctor.

• alcohol may cause a change in blood sugar. Ask your doctor about the safe use of alcoholic beverages while you are using an insulin glargine product.

• 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.

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

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 glargine products 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
• changes in the feel of your skin, skin thickening (fat build-up), or a little depression in the skin (fat breakdown)
• fever, cough, sore throat, or other signs of infection

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
• fast pulse
• sweating
• swelling of the eyes, face, lips, tongue, or throat
• hoarseness
• weakness
• muscle cramps
• abnormal heartbeat
• sudden weight gain
• swelling of ankles or feet
• shortness of breath
• vision changes

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

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

If a refrigerator is unavailable (for example, when on vacation), store the vials or pens at room temperature and away from direct sunlight and extreme heat. Unrefrigerated vials or pens can be used within 28 days; after that time they must be discarded. Opened vials can be stored for 28 days at room temperature or in the refrigerator. Opened pens must be stored at room temperature and may be used for up to 28 days after the first use. Dispose of any insulin that has been exposed to extreme heat or cold.

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. http://www.upandaway.org

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 (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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 glargine overdose can occur if you use too much insulin glargine or if you use the right amount of insulin glargine but eat less than usual or exercise more than usual. Insulin glargine 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 glargine. 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.