Drug Information for Lantus (Physicians Total Care, Inc.): 17 PATIENT COUNSELING INFORMATION

  • 17.1 Instructions for patients

    Patients should be informed that changes to insulin regimens must be made cautiously and only under medical supervision.

    Patients should be informed about the potential side effects of insulin therapy, including lipodystrophy (and the need to rotate injection sites within the same body region), weight gain, allergic reactions, and hypoglycemia. Patients should be informed that the ability to concentrate and react may be impaired as a result of hypoglycemia. This may present a risk in situations where these abilities are especially important, such as driving or operating other machinery. Patients who have frequent hypoglycemia or reduced or absent warning signs of hypoglycemia should be advised to use caution when driving or operating machinery.

    Accidental mix-ups between LANTUS and other insulins, particularly short-acting insulins, have been reported. To avoid medication errors between LANTUS and other insulins, patients should be instructed to always check the insulin label before each injection.

    LANTUS must only be used if the solution is clear and colorless with no particles visible. Patients must be advised that LANTUS must NOT be diluted or mixed with any other insulin or solution.

    Patients should be advised not to share disposable or reusable insulin devices or needles with other patients, because doing so carries a risk for transmission of blood-borne pathogens.

    Patients should be instructed on self-management procedures including glucose monitoring, proper injection technique, and management of hypoglycemia and hyperglycemia. Patients must be instructed on handling of special situations such as intercurrent conditions (illness, stress, or emotional disturbances), an inadequate or skipped insulin dose, inadvertent administration of an increased insulin dose, inadequate food intake, and skipped meals.

    Patients with diabetes should be advised to inform their health care professional if they are pregnant or are contemplating pregnancy.

    Refer patients to the LANTUS "Patient Information" for additional information.

    17.2 FDA approved patient labeling

    See attached document at end of Full Prescribing Information.

    Rev. September 2009

    sanofi-aventis U.S. LLC

    Bridgewater, NJ 08807

    ©2009 sanofi-aventis U.S. LLC

    Patient InformationLANTUS® 10 mL vial (1000 units per vial) 100 units per mL (U-100)(insulin glargine [recombinant DNA origin] injection)

    • What is the most important information I should know about LANTUS?
    • What is LANTUS?
    • Who should NOT take LANTUS?
    • How should I use LANTUS?
    • What kind of syringe should I use?
    • Mixing with LANTUS
    • Instructions for Use
      • How do I draw the insulin into the syringe?
      • How do I inject LANTUS?
    • What can affect how much insulin I need?
    • What are the possible side effects of LANTUS and other insulins?
    • How should I store LANTUS?
    • General Information about LANTUS

    Read this "Patient Information" that comes with LANTUS (LAN-tus) before you start using it and each time you get a refill because there may be new information. This leaflet does not take the place of talking with your healthcare provider about your condition or treatment. If you have questions about LANTUS or about diabetes, talk with your healthcare provider.

    • Do not change the insulin you are using without talking to your healthcare provider. Any change of insulin should be made cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type (for example: Regular, NPH, analogs), species (beef, pork, beef-pork, human) or method of manufacture (recombinant DNA versus animal source insulin) may need a change in the dose. This dose change may be needed right away or later on during the first several weeks or months on the new insulin. Doses of oral anti-diabetic medicines may also need to change, if your insulin is changed.
    • You must test your blood sugar levels while using an insulin, such as LANTUS. Your healthcare provider will tell you how often you should test your blood sugar level, and what to do if it is high or low.
    • Do NOT dilute or mix LANTUS with any other insulin or solution. It will not work and you may lose blood sugar control, which could be serious.
    • LANTUS comes as U-100 insulin and contains 100 units of LANTUS per milliliter (mL). One milliliter of U-100 insulin contains 100 units of insulin. (1 mL = 1 cc).

    What is Diabetes?

    • Your body needs insulin to turn sugar (glucose) into energy. If your body does not make enough insulin, you need to take more insulin so you will not have too much sugar in your blood.
    • Insulin injections are important in keeping your diabetes under control. But the way you live, your diet, careful checking of your blood sugar levels, exercise, and planned physical activity, all work with your insulin to help you control your diabetes.
    • LANTUS (insulin glargine [recombinant DNA origin]) is a long-acting insulin. Because LANTUS is made by recombinant DNA technology (rDNA) and is chemically different from the insulin made by the human body, it is called an insulin analog. LANTUS is used to treat patients with diabetes for the control of high blood sugar. It is used once a day to lower blood sugar.
    • LANTUS is a clear, colorless, sterile solution for injection under the skin (subcutaneously).
    • The active ingredient in LANTUS is insulin glargine. The concentration of insulin glargine is 100 units per milliliter (mL), or U-100. LANTUS also contains zinc, metacresol, glycerol, polysorbate 20 and water for injection as inactive ingredients. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH.
    • You need a prescription to get LANTUS. Always be sure you receive the right insulin from the pharmacy.

    Do not take LANTUS if you are allergic to insulin glargine or any of the inactive ingredients in LANTUS. Check with your healthcare provider if you are not sure.

    Before starting LANTUS, tell your healthcare provider about all your medical conditions including if you:

    • have liver or kidney problems. Your dose may need to be adjusted.
    • are pregnant or plan to become pregnant. It is not known if LANTUS may harm your unborn baby. It is very important to maintain control of your blood sugar levels during pregnancy. Your healthcare provider will decide which insulin is best for you during your pregnancy.
    • are breast-feeding or plan to breast-feed. It is not known whether LANTUS passes into your milk. Many medicines, including insulin, pass into human milk, and could affect your baby. Talk to your healthcare provider about the best way to feed your baby.
    • about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

    See the "Instructions for Use" including the "How do I draw the insulin into the syringe?" section for additional information.

    • Follow the instructions given by your healthcare provider about the type or types of insulin you are using. Do not make any changes with your insulin unless you have talked to your healthcare provider. Your insulin needs may change because of illness, stress, other medicines, or changes in diet or activity level. Talk to your healthcare provider about how to adjust your insulin dose.
    • You may take LANTUS at any time during the day but you must take it at the same time every day.
    • Only use LANTUS that is clear and colorless. If your LANTUS is cloudy or slightly colored, return it to your pharmacy for a replacement.
    • Follow your healthcare provider's instructions for testing your blood sugar.
    • Inject LANTUS under your skin (subcutaneously) in your upper arm, abdomen (stomach area), or thigh (upper leg). Never inject it into a vein or muscle.
    • Change (rotate) injection sites within the same body area.
    • Always use a syringe that is marked for U-100 insulin. If you use other than U-100 insulin syringe, you may get the wrong dose of insulin causing serious problems for you, such as a blood sugar level that is too low or too high. Always use a new needle and syringe each time you give LANTUS injection.
    • Disposable syringes and needles should be used only once. Used syringe and needle should be placed in sharps containers (such as red biohazard containers), hard plastic containers (such as detergent bottles), or metal containers (such as an empty coffee can). Such containers should be sealed and disposed of properly.
    • Do NOT dilute or mix LANTUS with any other insulin or solution. It will not work as intended and you may lose blood sugar control, which could be serious.
  • Drug Information Provided by National Library of Medicine (NLM).