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| Other drug names: | A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 0-9 |
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[Posted 7/1/2009] FDA notified healthcare professionals and patients that it is aware of four recently-published observational studies that looked at the use of insulin glargine (Lantus) and possible risk for cancer in patients with diabetes. Three of the four studies suggest an increased risk for cancer associated with use of insulin glargine. Based on the currently available data, the FDA recommends that patients should not stop taking their insulin therapy without consulting a physician, since uncontrolled blood sugar levels can have both immediate and long-term serious adverse effects. FDA is currently reviewing many sources of safety data for insulin glargine, including these newly published observational studies, data from all completed controlled clinical trials, and information about ongoing controlled clinical trials, to better understand the risk, if any, for cancer associated with use of insulin glargine. Discussions are also ongoing between FDA and the manufacturer of insulin glargine as to whether any additional studies evaluating the safety and efficacy of this drug will need to be performed. FDA will communicate the results on its ongoing review to the public, as appropriate, as our review continues. The FDA encourages both healthcare professionals and patients to report side effects from the use of insulin glargine to the FDA's MedWatch Adverse Event Reporting Program. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety. |
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.
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 use. 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 exactly as directed. Do not use more or less of it or use 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 used regularly. Continue to use insulin glargine even if you feel well. Do not stop using 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 healthcare 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 healthcare 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:
To inject your insulin glargine dose, follow these steps:
Use a different site for each injection, about 1 inch (2.5 centimeters) 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.
Before using insulin glargine,
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.
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.
You may experience hypoglycemia (low blood sugar) while you are using 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:
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.
Call your doctor immediately if you have any of the following symptoms of hyperglycemia (high blood sugar):
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:
Insulin glargine can cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
If you experience any of the following symptoms, call your doctor immediately:
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 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.
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 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.
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Last Reviewed - 02/01/2009
AHFS® Consumer Medication Information. © Copyright, 2009. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
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Page last updated: 18 November 2009 |