Toujeo

Toujeo is a prescription medication used to treat type 1 and type 2 diabetes. Toujeo, a long-acting form of insulin, can be found under the names Toujeo Solostar and Toujeo Max Solostar. These work by replacing the insulin that is normally produced by the body and by helping the body to use sugar for energy. It also stops the liver from producing more sugar.

This medication comes in an injectable prefilled pen to be injected under the skin. Toujeo is usually injected once daily.

Common side effects include low blood sugar, redness and skin thickening at the injection site, and weight gain.

Toujeo is a prescription medication used to treat people with type 1 and type 2 diabetes for the control of high blood sugar. Toujeo may be used along with fast-acting insulin or oral medications to control blood sugar.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Sanofi-Aventis U.S. LLC

Serious side effects have been reported with Toujeo. See the "Toujeo Precautions" section. 

Common side effects include the following:

• Hypoglycemia (low blood sugar)
• Hyperglycemia (high blood sugar)
• Allergic reactions
• Injection site reactions (you can reduce the chance of getting an injection site reaction if you change (rotate) the injection site each time. An injection site reaction should clear up in a few days or a few weeks)
• Itching
• Rash
• Edema
• Weight gain 
• Skin thickening (lipohypertrophy)

This is not a complete list of Toujeo side effects. Ask your doctor or pharmacist for more information. 

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects for the FDA at 1-800-FDA-1088. 

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins and herbal supplements. Toujeo and other medicines may affect each other. Always check with your doctor before starting or stopping any medicines. Especially tell your doctor if you take:

• oral medicines for diabetes
• angiotensin converting enzyme (ACE) inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), and trandolapril (Mavik)
• beta-blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal)
• certain cholesterol-lowering medications such as fenofibrate (Antara, Lofibra, TriCor, Triglide), gemfibrozil (Lopid), and niacin (Niacor, Niaspan, in Advicor)
• clonidine (Catapres, Catapres-TTS, in Clorpres)
• danazol; disopyramide (Norpace)
• diuretics ('water pills')
• fluoxetine (Prozac, Sarafem, in Symbyax)
• glucagon
• hormone replacement therapy
• isoniazid (INH, Nydrazid)
• lithium (Eskalith, Lithobid)
• medications for asthma and colds
• medications for mental illness and nausea
• monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl) and tranylcypromine (Parnate)
• octreotide (Sandostatin)
• oral contraceptives (birth control pills)
• oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone)
• pentamidine (NebuPent, Pentam)
• pentoxifylline (Trental)
• reserpine 
• guanethidine
• salicylate pain relievers such as aspirin, choline magnesium trisalicylate (Tricosal, Trilisate), choline salicylate (Arthropan), diflunisal (Dolobid), magnesium salicylate (Doan's, others), and salsalate (Argesic, Disalcid, Salgesic)
• somatropin (Nutropin, Serostim, others)
• sulfa antibiotics
• sulfinpyrazone (Anturane)
• thyroid medications

This is not a complete list of Toujeo drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Toujeo including the following:

Hypoglycemia (low blood sugar): Early warning signs of hypoglycemia may be different, less noticeable or not noticeable at all in some people. That is why it is important to check your blood sugar as you have been advised by your doctor.

Symptoms of hypoglycemia may include:

• anxiety, irritability, restlessness, trouble concentrating, personality changes, mood changes, or other abnormal behavior
• tingling in your hands, feet, lips, or tongue
• dizziness, light-headedness, or drowsiness
• nightmares or trouble sleeping
• headache
• blurred vision
• slurred speech
• palpitations (fast heart beat)
• sweating
• tremor (shaking)
• unsteady gait (walking)

If you have hypoglycemia often or it is hard for you to know if you have the symptoms of hypoglycemia, talk to your doctor.

Mild to moderate hypoglycemia is treated by eating or drinking carbohydrates, such as fruit juice, raisins, sugar candies, milk or glucose tablets. Talk to your doctor about the amount of carbohydrates you should eat to treat mild to moderate hypoglycemia.

Severe hypoglycemia may require the help of another person or emergency medical people. A person with hypoglycemia who is unable to take foods or liquids with sugar by mouth, or is unconscious needs medical help fast and will need treatment with a glucagon injection or glucose given intravenously (IV). Without medical help right away, serious reactions or even death could happen.

Hyperglycemia (high blood sugar): Hyperglycemia happens when you have too much sugar in your blood. Usually, it means there is not enough insulin to break down the food you eat into energy your body can use. Hyperglycemia can be caused by a fever, an infection, stress, eating more than you should, taking less Toujeo than prescribed, or it can mean your diabetes is getting worse.

Hyperglycemia can be mild or severe. Hyperglycemia can progress to diabetic ketoacidosis (DKA) or very high glucose levels (hyperosmolar coma) and result in unconsciousness and death.

Although diabetic ketoacidosis occurs most often in patients with type 1 diabetes, it can also happen in patients with type 2 diabetes who become very sick. Because some patients get few symptoms of hyperglycemia, it is important to check your blood sugar/urine sugar and ketones regularly.

Symptoms of hyperglycemia include:

• confusion or drowsiness
• increased thirst
• decreased appetite, nausea, or vomiting
• rapid heart rate
• increased urination and dehydration (too little fluid in your body).

Symptoms of DKA also include:

• fruity smelling breath
• fast, deep breathing
• stomach area pain

Severe or continuing hyperglycemia or DKA needs evaluation and treatment right away from your doctor. Do not use Toujeo to treat diabetic ketoacidosis.

Serious allergic reactions: Sometimes severe, life-threatening allergic reactions can happen with Toujeo. If you think you are having a severe allergic reaction, get medical help right away.

Signs of insulin allergy include:

• rash all over your body
• shortness of breath
• wheezing (trouble breathing)
• fast pulse
• sweating
• low blood pressure

Reactions at the injection site: Injecting Toujeo can cause the following reactions on the skin at the injection site:

• little depression in the skin (lipoatrophy)
• skin thickening (lipohypertrophy)
• red, swelling, itchy skin (injection site reaction)

You can reduce the chance of getting an injection site reaction if you change (rotate) the injection site each time. An injection site reaction should clear up in a few days or a few weeks. If injection site reactions do not go away or keep happening, call your doctor.

Low potassium levels. Your doctor will monitor your potassium levels. 

Fluid retention and heart failure, when used with another type of diabetes medication, called thiazolidinediones (TZDs). Tell your doctor immediately if you notice any of the following symptoms:

• sudden weight gain
• worsening shortness of breath
•  increased swelling of your feet, legs, or abdomen
• needing to use more pillows to go to sleep or sleeping in a recliner
•  waking from sleep to catch your breath
•  a cough that does not go away

Do not change the insulin you are using without talking to your doctor. Any change of insulin should be made cautiously and only under medical supervision. Illness, stress, changes in diet or exercise, and other medical conditions may affect your Toujeo dosage.

Accidental mix-ups between insulin products can happen. Make sure you check insulin levels before injection. Your dose of Toujeo may be different from other insulins you have taken. This is especially true because Toujeo contains 3 times as much insulin in 1 mL as standard insulin. 

In addition, do NOT use a syringe to remove Toujeo from your SoloStar^® pen or Toujeo^® Max SoloStar^® pen. This can cause you to give yourself too much insulin. 

Never share Toujeo with another person even if the needle is changed. Pen sharing poses a risk for transmission of blood-borne pathogens. 

You must test your blood sugar levels while using an insulin, such as Toujeo. Your doctor will tell you how often you should test your blood sugar level, and what to do if it is high or low. Any change of insulin should be made cautiously and only under medical supervision.

Do not take Toujeo if you are:

• allergic to Toujeo or any of its ingredients
• during episodes of hypoglycemia (low blood sugar)

Follow dietary (food) recommendations made by your doctor and dietitian which should include a healthy diet. Skipping meals should be avoided as this can cause problems maintaining blood sugar control. There are no specific foods to avoid while using Toujeo.

Tell your doctor if you are allergic to Toujeo or any other medicines.

Before starting Toujeo, tell your doctor about all your medical conditions including if you:

• have liver or kidney disease
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

There are no clinical studies of the use of Toujeo in pregnant women. Toujeo should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known whether Toujeo passes into your milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Toujeo.

Follow the instructions given by your doctor about the type or types of insulin you are using.

It is important to read, understand, and follow the step-by-step instructions before using Toujeo. Failure to follow the instructions may result in getting too much or too little insulin.

Administer Toujeo subcutaneously (under the fatty layer of the skin) once daily at any time during the day, at the same time every day. 

Do not make any changes to your insulin unless you have talked to your doctor. Your insulin needs may change because of illness, stress, other medicines, or changes in diet or activity level. Talk to your doctor about how to adjust your insulin dose.

Accidental mix-ups between insulin products can happen. Make sure you check insulin levels before injection. Your dose of Toujeo may be different from other insulins you have taken. This is especially true because Toujeo contains 3 times as much insulin in 1 mL as standard insulin. 

In addition, do NOT use a syringe to remove Toujeo from your SoloStar^® pen or Toujeo^® Max SoloStar^® pen. This can cause you to give yourself too much insulin. 

• You may use Toujeo at any time during the day but you must take it at the same time every day.
• Only use Toujeo that is clear and colorless. If your Toujeo is cloudy or slightly colored, return it to your pharmacy for a replacement.
• Follow your doctor's instructions for testing your blood sugar.
• Inject Toujeo under your skin (subcutaneously) in your upper arm, abdomen (stomach area), or thigh (upper leg). Never inject it into a vein or muscle.
• Never inject Toujeo into a vein or a muscle. It must always be injected just under the skin (subcutaneously).
• Do not mix Toujeo with any other type of insulin. It will not work as intended and you may lose blood sugar control, which could be serious.
• Change (rotate) injection sites within the same body area.

Never share Toujeo pen with another person even if the needle is changed. Pen sharing poses a risk for transmission of blood-borne pathogens. 

Use Toujeo exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. 

The dose of Toujeo will be individualized based on several factors including your medical conditions, other insulin doses you are receiving, other medicines you are taking, and how your body responds to Toujeo.

If you have taken too much insulin glargine, call your local Poison Control Center or seek emergency medical attention right away.

Overdose can occur if you use too much Toujeo or if you use the right amount of Toujeo but eat less than usual or exercise more than usual. Toujeo overdose can cause low blood sugar otherwise known as hypoglycemia. If you have symptoms of hypoglycemia, follow your doctor's instructions for what you should do if you develop hypoglycemia. 

Early symptoms of hypoglycemia can include:

• dizziness
• shakiness
• cold sweats
• blurry vision
• extreme hunger

More severe symptoms of hypoglycemia can include:

• irritability
• loss of coordination
• difficulty speaking
• confusion
• seizures
• loss of consciousness
• coma
• loss of life

Unopened vial: Store new (unopened) Toujeo vials in a refrigerator (not the freezer) between 36°F to 46°F (2°C to 8°C). Do not freeze Toujeo. Keep Toujeo out of direct heat and light. If a vial has been frozen or overheated, throw it away.

Open (In-Use) vial: Once a vial is opened, keep Toujeo at room temperature (below 86°F [30°C]) and away from direct heat and light. Opened vial should be discarded 28 days after being opened even if it still contains medication. Do not leave your Toujeo in a car on a summer day.

Discard Toujeo after the expiration date.