Toujeo SoloStar

Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. Insulin glargine is a long-acting insulin that starts to work several hours after injection and keeps working evenly for 24 hours.

Insulin glargine is used to improve blood sugar control in adults and children with diabetes mellitus. Insulin glargine is used to treat type 1 or type 2 diabetes in adults, and type 1 diabetes children who are at least 6 years old.

Some brands of this medicine are for use only in adults. Carefully follow all instructions for the brand of insulin glargine you are using.

Insulin glargine may also be used for purposes not listed in this medication guide.

Call your doctor for instructions if you miss a dose of insulin glargine. You should not use more than one dose in a 24-hour period unless your doctor tells you to.

Keep insulin on hand at all times. Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Insulin overdose can cause life-threatening hypoglycemia. Symptoms include drowsiness, confusion, blurred vision, numbness or tingling in your mouth, trouble speaking, muscle weakness, clumsy or jerky movements, seizure (convulsions), or loss of consciousness.

Many other medicines can affect your blood sugar, and some medicines can increase or decrease the effects of insulin. Some drugs can also cause you to have fewer symptoms of hypoglycemia, making it harder to tell when your blood sugar is low. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

• If you have an allergy to insulin or any other part of Toujeo SoloStar (insulin glargine (U-300) pens).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Acidic blood problem or low blood sugar.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Toujeo SoloStar with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Allergic reactions have happened with Toujeo SoloStar. Rarely, some reactions can be very bad or life-threatening. Talk with the doctor.
• Low blood sugar may happen with this medicine. Very low blood sugar can lead to seizures, passing out, long lasting brain damage, and sometimes death. Talk with the doctor.
• Low blood potassium may happen with Toujeo SoloStar. If not treated, this can lead to a heartbeat that is not normal, very bad breathing problems, and sometimes death. Talk with the doctor.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
• Some diabetes drugs like pioglitazone or rosiglitazone may cause heart failure or make it worse in people who already have it. Using insulin with these drugs may increase this risk. If you also take one of these drugs, talk with the doctor.
• Be sure you have the right insulin product. Insulin products come in many containers like vials, cartridges, and pens. Be sure that you know how to measure and get your dose ready. If you have any questions, call your doctor or pharmacist.
• It may be harder to control your blood sugar during times of stress like when you have a fever, an infection, an injury, or surgery. A change in level of physical activity or exercise and a change in diet may also affect your blood sugar. Talk with your doctor.
• Wear disease medical alert ID (identification).
• Do not drive if your blood sugar has been low. There is a greater chance of you having a crash.
• Check your blood sugar as you have been told by your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Talk with your doctor before you drink alcohol.
• If you are 65 or older, use Toujeo SoloStar with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
• This brand of insulin has 3 times as much insulin as other brands. It comes in a prefilled pen that you must use to take your dose. Do not use a syringe to remove insulin from the pen. Doing so may lead to very bad side effects or life-threatening low blood sugar. Be sure to use the right dose of Toujeo SoloStar. Talk with the doctor.
• 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.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Change in eyesight.
• Very bad dizziness or passing out.
• Very bad headache.
• Seizures.
• Change in skin to thick or thin where the shot was given.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Low mood (depression).
• Low blood sugar may occur. Signs may be dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating. Call the doctor right away if any of these signs occur. Follow what you have been told to do if low blood sugar occurs. This may include taking glucose tablets, liquid glucose, or some fruit juices.

Applies to insulin glargine: subcutaneous solution

Along with its needed effects, insulin glargine (the active ingredient contained in Toujeo Solostar) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking insulin glargine:

• Anxiety
• behavior change similar to being drunk
• blurred vision
• chills
• cold sweats
• confusion
• convulsions (seizures)
• cool, pale skin
• difficulty with thinking
• dizziness or lightheadedness
• drowsiness
• excessive hunger
• fast heartbeat
• headache
• nausea
• nervousness
• nightmares
• restless sleep
• shakiness
• slurred speech
• tingling in the hands, feet, lips, or tongue
• unusual tiredness or weakness

• Fast pulse
• skin rash or itching over the entire body
• sweating
• trouble breathing

• Bloating or swelling of the face, hands, lower legs, or feet
• cough
• decreased urine
• difficulty with swallowing
• dry mouth
• hives
• increased thirst
• irregular heartbeat
• muscle pain or cramps
• numbness or tingling in the hands, feet, or lips
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid weight gain
• vomiting

Some side effects of insulin glargine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Fever
• sore throat
• stuffy or runny nose

• Depression of the skin at the injection site
• itching, pain, redness, or swelling at the injection site
• thickening of the skin at injection site