Insulin Glargine (rDNA origin) Injection

Insulin glargine is available as several different products that are biologic medications (medications made from living organisms). These biologic products are considered to be "biosimilar" to insulin glargine which means they work as well and are just as safe to use as insulin glargine. Insulin glargine mentioned in the monograph below refers to any of these products.

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) and type 2 diabetes (condition in which the body does not use insulin normally and, therefore, cannot control the amount of sugar in the blood) . Insulin glargine is in a class of medications called long-acting insulin. Insulin glargine 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.

Insulin glargine comes as a solution (liquid) to inject subcutaneously (under the skin). It is injected once a day. You should use insulin glargine at the same time every day.

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

You or a caregiver will be shown how to inject the medicine before your first dose. You will also be given the instructions for use. Read these carefully.Talk to your doctor or pharmacist if you have any questions on how to use the medicine.

Always check your insulin glargine label to make sure you are using the correct insulin. Inspect your insulin glargine before you inject it. It should be clear and colorless. Do not use your insulin glargine if it is colored, cloudy, or contains solid particles, or if the expiration date on the bottle has passed.

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.

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.

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

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

Do not use insulin glargine in an external insulin pump.

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

Before using insulin glargine,

• tell your doctor and pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods, or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while using insulin glargine. 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 insulin glargine, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are using insulin glargine.
• ask your doctor about the safe use of alcoholic beverages while you are using insulin glargine.  Alcohol may cause low blood sugar and make the risk for side effects from insulin glargine more likely.
• 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 insulin glargine, 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 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 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 vials and pens in the refrigerator. Never allow insulin glargine to freeze; do not use insulin glargine that has been frozen and thawed.

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.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

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 (low blood sugar). 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 doctor will order certain lab tests to check your body's response to insulin glargine.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are using insulin glargine.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

• Basaglar^®
• Langlara^®(Insulin Glargine-aldy)
• Lantus^®
• Rezvoglar^® (Insulin Glargine-aglr)
• Semglee^® (Insulin Glargine-yfgn)
• Toujeo^®

• Soliqua^® (containing Insulin Glargine and Lixisenatide),