Important Safety Information

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Do not take Toujeo if you have low blood sugar or if you are allergic to insulin or any of the ingredients in Toujeo.

Do not share your pen(s) 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.

Before starting Toujeo, tell your doctor about all your medical conditions, including if you have liver or kidney problems, if you are pregnant or planning to become pregnant, or if you are breastfeeding or planning to breastfeed.

Change (rotate) your injection sites within the area you chose with each dose to reduce your risk of getting lipodystrophy (pitted or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites. Do not use the same spot for each injection or inject where the skin is pitted, thickened, lumpy, tender, bruised, scaly, hard, scarred or damaged.

Heart failure can occur if you are taking insulin together with pills called TZDs (thiazolidinediones), even if you have never had heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with Toujeo. Your treatment with TZDs and Toujeo may need to be changed or stopped by your doctor if you have new or worsening heart failure. Tell your doctor if you have any new or worsening symptoms including:

  • Shortness of breath
  • Sudden weight gain
  • Swelling of your ankles or feet

Tell your doctor about all the medications you take, including OTC medicines, vitamins, and supplements, and herbal supplements.

Toujeo should be taken at the same time once a day. Test your blood sugar levels daily while using any insulin. Do not change your dose or type of insulin without talking to your doctor. Verify you have the correct insulin before each injection. Do NOT use a syringe to remove Toujeo from your pen. Your dose for Toujeo may be different from other insulins you have taken. Any change of insulin should be made cautiously and only under medical supervision.

Do NOT dilute or mix Toujeo with any other insulin or solution. It will not work as intended and you may lose blood sugar control, which could be serious. Use Toujeo only if the solution is clear and colorless with no particles visible.

While using Toujeo, do not drive or operate heavy machinery until you know how Toujeo affects you. Don’t drink alcohol or use other medicines that contain alcohol.

The most common side effect of any insulin, including Toujeo, is low blood sugar (hypoglycemia), which may be serious and life-threatening. Severe hypoglycemia may cause harm to your heart or brain. Symptoms of serious low blood sugar may include shaking, sweating, fast heartbeat, and blurred vision.

Toujeo may cause severe allergic reactions that can lead to death. Get medical help right away if you have:

  • A rash over your whole body
  • Shortness of breath
  • Swelling of your face, tongue, or throat
  • Extreme drowsiness, dizziness, or confusion
  • Trouble breathing
  • Fast heartbeat
  • Sweating

Toujeo may have additional side effects including swelling, weight gain, low potassium, and injection site reactions which may include change in fat tissue, skin thickening, redness, swelling, and itching.

Toujeo® SoloStar® and Toujeo® Max SoloStar® are single-patient-use prefilled insulin pens. It is important to perform a safety test when using a new pen for the first time. Talk to your doctor about proper injection technique and follow instructions in the Instruction Leaflet that comes with the pen.