Trumprx Insulin Glargine (U-300) Details
300 units/mL (U-300)This product is TOUJEO® (insulin glargine).
Do not share your Insulin Glargine, U-300 SoloStar® or Insulin Glargine, U-300 Max SoloStar® pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them
• Insulin Glargine, U-300 is not for the treatment of diabetic ketoacidosis.
• It is not known if Insulin Glargine, U-300 is safe and effective in children under 6 years of age.
• are having an episode of low blood sugar (hypoglycemia).
• have an allergy to insulin glargine or any of the ingredients in Insulin Glargine, U-300. See the end of this Patient Information leaflet for a complete list of ingredients in Insulin Glargine, U-300.
• have liver or kidney problems.
• take other medicines, especially ones called TZDs (thiazolidinediones).
• have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with Insulin Glargine, U-300.
• are pregnant, planning to become pregnant, or are breastfeeding. It is not known if Insulin Glargine, U-300 may harm your unborn or breastfeeding baby.Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Before you start using Insulin Glargine, U-300, talk to your healthcare provider about low blood sugar and how to manage it.
• Read the detailed Instructions for Use that come with your Insulin Glargine, U-300 SoloStar or Insulin Glargine, U-300 Max SoloStar single-patient-use prefilled pen.
• Use Insulin Glargine, U-300 exactly as your healthcare provider tells you to. Your healthcare provider should tell you how much Insulin Glargine, U-300 to use and when to use it.
• Know the amount of Insulin Glargine, U-300 you use. Do not change the amount of Insulin Glargine, U-300 you use unless your healthcare provider tells you to.
• Check your insulin label each time you give your injection to make sure you are using the correct insulin.
• Do not use a syringe to remove Insulin Glargine, U-300 from your Insulin Glargine, U-300 SoloStar or Insulin Glargine, U-300 Max SoloStar single-patient-use prefilled pen. This can cause you to give yourself too much insulin. Insulin Glargine, U-300 has 3 times as much insulin (300 units/mL) in 1 mL as compared to insulin glargine (U-100 units/mL) pens.
• Do not re-use needles. Always use a new needle for each injection. Reusing needles increases your chance of having blocked needles, which can cause you to get the wrong dose of Insulin Glargine, U-300. Using a new needle for each injection also lowers your risk of getting an infection. If your needle is blocked, follow the instructions in Step 3 of the Instructions for Use.
• Insulin Glargine, U-300 should be used 1 time each day and at the same time each day.
• Insulin Glargine, U-300 is injected under the skin (subcutaneously) of your upper legs (thighs), upper arms, or stomach area (abdomen).
• Do not use Insulin Glargine, U-300 in an insulin pump or inject Insulin Glargine, U-300 into your vein (intravenously).
• Change (rotate) your injection sites within the area you choose with each dose to reduce your risk of getting pits or thickening of the skin (lipodystrophy) and lumps in the skin (localized cutaneous amyloidosis) at the injection sites.
◦ Do not use the exact same spot for each injection.
◦ Do not inject where the skin has pits, is thickened, or has lumps.
◦ Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.
• Do not mix Insulin Glargine, U-300 with any other type of insulin or liquid medicine.
• Check your blood sugar levels. Ask your healthcare provider what your blood sugar should be and when you should check your blood sugar levels.Keep Insulin Glargine, U-300 and all medicines out of the reach of children.
Your dose of Insulin Glargine, U-300 may need to change because of:
• a change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or because of other medicines you take.
• drive or operate heavy machinery, until you know how Insulin Glargine, U-300 affects you.
• drink alcohol or use over-the-counter medicines that contain alcohol.
• low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include:
◦ dizziness or light-headedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability or mood change, and hunger.
• severe allergic reaction (whole body reaction). Get medical help right away if you have any of these signs or symptoms of a severe allergic reaction:
◦ a rash over your whole body, trouble breathing, a fast heartbeat, or sweating.
• low potassium in your blood (hypokalemia).
• heart failure. Taking certain diabetes pills called TZDs (thiazolidinediones) with Insulin Glargine, U-300 may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure it may get worse while you take TZDs with Insulin Glargine, U-300. Your healthcare provider should monitor you closely while you are taking TZDs with Insulin Glargine, U-300. Tell your healthcare provider if you have any new or worse symptoms of heart failure including:
◦ shortness of breath, swelling of your ankles or feet, sudden weight gain.Treatment with TZDs and Insulin Glargine, U-300 may need to be changed or stopped by your healthcare provider if you have new or worse heart failure.
Get emergency medical help if you have:
• trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, confusion.
The most common side effects of Insulin Glargine, U-300 include:
• low blood sugar (hypoglycemia), weight gain, itching, rash, swelling, allergic reactions, including reactions at your injection site, skin thickening or pits at the injection site (lipodystrophy).
These are not all the possible side effects of Insulin Glargine, U-300. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Insulin Glargine, U-300 for a condition for which it was not prescribed. Do not give Insulin Glargine, U-300 to other people, even if they have the same symptoms that you have. It may harm them.
This Patient Information leaflet summarizes the most important information about Insulin Glargine, U-300. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Insulin Glargine, U-300 that is written for health professionals.
• Inactive ingredients: glycerin, metacresol, zinc and Water for Injection, USP. Hydrochloric acid and sodium hydroxide may be added to adjust the pH.Manufactured by: sanofi-aventis U.S. LLC, Morristown, NJ 07960, U.S. License No. 1752
Manufactured for: Winthrop U.S., a business of sanofi-aventis U.S., LLC, Morristown, NJ 07960, A SANOFI COMPANY
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