Insulin Glargine 300 Units/Ml Pen - Injection

Uses

Insulin glargine is used with a proper diet and exercise program to control high blood sugar in people with diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke.

Insulin glargine is a man-made product that is similar to human insulin. It replaces the insulin that your body would normally make. It acts longer than regular insulin, providing a low, steady level of insulin. It works by helping blood sugar (glucose) get into cells so your body can use it for energy. Insulin glargine may be used with a shorter-acting insulin product. It may also be used alone or with other diabetes drugs.

How To Use

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor, diabetes educator, or pharmacist.

This insulin product is a concentrated form of standard insulin (3 times as much insulin in each milliliter). Learn all preparation and usage instructions from your health care professional and the product package. Check that you are using the correct insulin before injecting this medication.

Before using, check this product visually for particles or discoloration. If either is present, do not use the insulin. Insulin glargine should be clear and colorless.

Before injecting each dose, clean the injection site with rubbing alcohol. Change where you inject each time to lessen the risk of problems or damage under the skin (for example, pits/lumps or thickened skin). Insulin glargine may be injected in the stomach area, the thigh, or the upper arm. Do not inject into a vein or muscle because very low blood sugar (hypoglycemia) may occur. Do not rub the area after the injection. Do not inject into skin that is red, swollen, itchy, or damaged. Do not inject cold insulin because this can be painful. The pen device you are currently using can be kept at room temperature (see also Storage section).

Inject this medication under the skin as directed by your doctor, usually once daily. Use a new needle for each injection. Do not use a syringe to remove insulin from your pen device.

This product should not be mixed with any other insulin. Do not use insulin glargine in an infusion pump.

Do not change brands or types of insulin without directions on how to do so from your doctor.

Do not share your pen device with another person, even if the needle is changed. You may give other people a serious infection, or get a serious infection from them. Learn how to store and discard medical supplies safely.

The dosage is based on your medical condition and response to treatment. Measure each dose very carefully because even small changes in the amount of insulin may have a large effect on your blood sugar.

Check your blood sugar regularly as directed by your doctor. Keep track of your results and share them with your doctor. This is very important in order to determine the correct insulin dose.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.

Tell your doctor if your condition does not improve or if it worsens (your blood sugar is too high or too low).

Side Effects

Injection site reactions (such as pain, redness, irritation) or weight gain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• signs of low potassium level in the blood (such as muscle cramps, weakness, irregular heartbeat)

This medication can cause low blood sugar (hypoglycemia). This may occur if you do not consume enough calories from food or if you do unusually heavy exercise. Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor right away about the reaction and the use of this product. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.

Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor right away. Your dosage may need to be increased.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using insulin glargine, tell your doctor or pharmacist if you are allergic to it; or to other types of insulins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Do not use this medication when you have low blood sugar (hypoglycemia).

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• kidney disease
• liver disease

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely.

Limit alcohol while using this medication because it can increase the risk of developing low blood sugar.

It may be harder to control your blood sugar when your body is stressed (such as due to fever, infection, injury, or surgery). Consult your doctor because this may require a change in your treatment plan, medications, or blood sugar testing.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Check your blood sugar before and after exercise. You may need a snack before exercising.

If traveling across time zones, ask your doctor about how to adjust your insulin schedule. Take extra insulin and supplies with you.

Older adults may be more sensitive to the side effects of this drug, especially low blood sugar.

Children may be more sensitive to the side effects of this drug, especially low blood sugar.

Tell your doctor right away if you are pregnant. Pregnancy may cause or worsen diabetes. Discuss a plan with your doctor for managing your blood sugar while pregnant. Your doctor may change your diabetes treatment during your pregnancy (such as diet and medications including insulin).

This medication passes into breast milk, but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding. Your insulin needs may change while breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Beta-blocker medications (such as metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar falls too low (hypoglycemia). Other symptoms of low blood sugar such as dizziness, hunger, or sweating are unaffected by these drugs.

Many drugs can affect your blood sugar levels, making it more difficult to control your blood sugar. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar regularly as directed by your doctor. Tell your doctor about the results and of any symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 9-1-1. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: signs of low blood sugar such as sweating, shakiness, loss of consciousness, fast heartbeat.

Notes

Do not share this medication or needles with others.

Attend a diabetes education program to learn more about how to manage your diabetes with medications, diet, exercise, and regular medical exams.

Learn the symptoms of high and low blood sugar and how to treat low blood sugar. Check your blood sugar regularly as directed and share the results with your doctor.

Lab and/or medical tests (such as liver and kidney function tests, fasting blood glucose, hemoglobin A1c, complete blood counts) should be done while you are taking this medication. Keep all medical and lab appointments.

Keep extra supplies of insulin and needles on hand.

Missed Dose

It is very important to follow your insulin regimen exactly. Ask your doctor ahead of time what you should do if you miss a dose of insulin.

Storage

Store the unopened insulin pen in the refrigerator. Do not freeze, and do not use insulin that has been frozen. After opening, store the insulin glargine pen at room temperature. Throw away the insulin glargine pen in use after the time specified in your product's Instructions for Use, even if there is insulin left. Different brands of this medication have different storage needs. Also throw away all insulin products after the expiration date on the package. Protect insulin from light and heat. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Medical Alert

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).