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Toujeo pens

Generic Name: insulin glargine (IN-su-lin GLAR-jeen)
Brand Name: Toujeo

Toujeo pens are used for:

Treating diabetes mellitus.

Toujeo pens are a long-acting form of the hormone insulin. It works by helping your body to use sugar properly. This lowers the amount of glucose in the blood, which helps to treat diabetes.

Do NOT use Toujeo pens if:

  • you are allergic to any ingredient in Toujeo pens
  • you have low blood sugar or high blood ketone or acid levels (eg, diabetic ketoacidosis)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Toujeo pens:

Some medical conditions may interact with Toujeo pens. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you drink alcoholic beverages
  • if you have heart problems (eg, heart failure), liver or kidney problems, or nerve problems
  • if you are in poor health

Some MEDICINES MAY INTERACT with Toujeo pens. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Beta-blockers (eg, propranolol) or clonidine because they may increase the risk of high or low blood sugar or may hide the signs and symptoms of low blood sugar, if it occurs
  • Lithium or pentamidine because they may increase the risk of high or low blood sugar
  • Guanethidine or reserpine because they may hide the signs and symptoms of low blood sugar if it occurs
  • Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), angiotensin receptor blockers (eg, valsartan), disopyramide, fibrates (eg, clofibrate, gemfibrozil), fluoxetine, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), oral medicine for diabetes (eg, glipizide, metformin, nateglinide), pentoxifylline, pramlintide, propoxyphene, salicylates (eg, aspirin), somatostatin analogues (eg, octreotide), or sulfonamide antibiotics (eg, sulfamethoxazole) because the risk of low blood sugar may be increased
  • Thiazolidinediones (eg, pioglitazone, rosiglitazone) because the risk of heart failure may be increased
  • Atypical antipsychotics (eg, olanzapine), corticosteroids (eg, prednisone), danazol, diuretics (eg, furosemide, hydrochlorothiazide), estrogen, glucagon, hormonal contraceptives (eg, birth control pills), isoniazid, niacin, phenothiazines (eg, chlorpromazine), progesterones (eg, medroxyprogesterone), protease inhibitors (eg, ritonavir), somatropin, sympathomimetics (eg, albuterol, epinephrine, terbutaline), or thyroid hormones (eg, levothyroxine) because they may decrease Toujeo pens's effectiveness, resulting in high blood sugar

This may not be a complete list of all interactions that may occur. Ask your health care provider if Toujeo pens may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Toujeo pens:

Use Toujeo pens as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Toujeo pens. Talk to your pharmacist if you have questions about this information.
  • Use Toujeo pens at the same time each day, as directed by your doctor.
  • A health care provider will teach you how to use Toujeo pens. Be sure you understand how to use it. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Wash your hands before you use Toujeo pens. Always attach a new needle and perform the safety test as directed before each use.
  • Check the dose window before each use to be sure you have dialed the correct dose of insulin. Using too much or too little insulin may result in serious side effects.
  • Use extreme caution when you measure your dose of Toujeo pens. Toujeo pens contains more insulin per unit than other types of insulin. Accidental overdose may cause serious and sometimes fatal side effects.
  • Toujeo pens should be clear and colorless. Do not use Toujeo pens if it contains particles or is discolored, or if the container is cracked or damaged.
  • Do NOT dilute Toujeo pens or mix it with other insulin or liquid medicine.
  • Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into a vein or muscle.
  • Injection sites within an injection area (abdomen, thigh, or upper arm) must be rotated from one injection to the next.
  • Be sure you have purchased the correct insulin. Insulin comes in a variety of containers, including vials, cartridges, and pens. Make sure that you understand how to properly measure and prepare your dose. If you have any questions about measuring and preparing your dose, contact your doctor or pharmacist for information.
  • Do not share pen or cartridge devices with another person even if the needle has been changed. Sharing these devices may pass infections from one person to another. This includes infections you may not know you have.
  • Remove the needle after each injection. Store this device without a needle on it.
  • Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse or share needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • It is very important to follow your insulin regimen exactly. Do NOT miss any doses. Ask your doctor for specific instructions to follow in case you ever miss a dose of insulin.

Ask your health care provider any questions you may have about how to use Toujeo pens.

Important safety information:

  • Tell your doctor or dentist that you take Toujeo pens before you receive any medical or dental care, emergency care, or surgery.
  • Drowsiness, dizziness, blurred vision, or light-headedness may occur while you use Toujeo pens. These effects may be worse if you take it with alcohol or certain medicines. Use Toujeo pens with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol without discussing it with your doctor. Drinking alcohol may increase your risk of developing high or low blood sugar.
  • Any change of insulin should be made cautiously and only under medical supervision. Changes in purity, strength, brand (manufacturer), type (regular, NPH, lente), species (beef, pork, beef-pork, human), and/or method of manufacture may require a change in dose.
  • Do not exceed the recommended dose, use Toujeo pens more often than prescribed, or change the type or dose of insulin you are taking without checking with your doctor.
  • Proper diet, regular exercise, and regular testing of blood sugar are important for best results when using Toujeo pens.
  • Toujeo pens may cause low blood sugar levels. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or nondiet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.
  • The risk of low blood sugar may be increased by heavy or prolonged exercise, drinking alcohol, or skipping meals.
  • Very low blood sugar can lead to seizures, passing out, permanent brain damage, and sometimes death. Discuss any questions or concerns with your doctor.
  • Fever, infection, injury, or surgery may increase your risk of high or low blood sugar levels. If any of these occur, check your blood sugar levels closely and tell your doctor right away.
  • Low blood potassium may happen with Toujeo pens. If not treated, this can lead to irregular heartbeat, serious breathing problems, and sometimes death. Discuss any questions or concerns with your doctor.
  • Serious and sometimes fatal allergic reactions have rarely happened. Discuss any questions or concerns with your doctor.
  • If you will be traveling across time zones, consult your doctor concerning adjustments in your insulin schedule.
  • Carry an ID card at all times that says you have diabetes.
  • Lab tests may be performed while you use Toujeo pens. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Toujeo pens with caution in the ELDERLY; they may be more sensitive to its effects.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Toujeo pens while you are pregnant. Toujeo pens are found in breast milk. If you are or will be breast-feeding while you use Toujeo pens, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Toujeo pens:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Irritation at the injection site.

Seek medical attention right away if any of these SEVERE side effects occur:

Seek immediate medical attention if any of the following SEVERE side effects occurs: Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); seizures; shortness of breath; skin thickening or thinning at the injection site; swelling of the hands, ankles, or feet; symptoms of low blood potassium (eg, irregular heartbeat, muscle pain or weakness); symptoms of low blood sugar (eg, chills, dizziness, drowsiness, fainting, fast heartbeat, headache, increased hunger, increased sweating, tremors, vision changes, weakness); unusual weight gain.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center or emergency room immediately.

Proper storage of Toujeo pens:

Store new (unopened) pens in a refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze Toujeo pens. Store used (open) pens at room temperature, below 86 degrees F (30 degrees C). Do NOT store used (open) pens in the refrigerator. Store away from heat and light. If Toujeo pens has been frozen or overheated, throw it away. Throw away unrefrigerated or used pens after 28 days, even if they still contain medicine.

Do not leave Toujeo pens in a car on a warm or sunny day. Do not use Toujeo pens after the expiration date stamped on the label. Keep Toujeo pens, as well as syringes and needles, out of the reach of children and away from pets.

General information:

  • If you have any questions about Toujeo pens, please talk with your doctor, pharmacist, or other health care provider.
  • Toujeo pens are to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Toujeo pens or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Toujeo pens. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Toujeo pens. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Toujeo pens.

Issue Date: June 3, 2015