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Toujeo (insulin glargine) is a man-made form of a hormone that is produced in the body. 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.
The Toujeo SoloStar injection pen is used to improve blood sugar control in adults with diabetes mellitus.
Toujeo is used to treat type 1 diabetes or type 2 diabetes in adults.
It is not known if this medicine is safe and effective in children.
Toujeo is available in 2 disposable prefilled pens:
Toujeo SoloStar contains 450 units of Toujeo U-300. It delivers doses in 1 unit increments and can deliver up to 80 units in a single injection.
Toujeo Max SoloStar contains 900 units of Toujeo U-300. It delivers doses in 2 unit increments and can deliver up to 160 units in a single injection. Toujeo Max SoloStar is recommended for patients requiring at least 20 units per day.
Toujeo SoloStar contains 3 times as much insulin per milliliter (mL) as regular insulin.
You should not use Toujeo if you are having an episode of hypoglycemia (low blood sugar), or if you are in a state of diabetic ketoacidosis.
Never share a Toujeo SoloStar injection or a Toujeo Max SoloStar injection pen with another person, even if the needle has been changed.
Sharing injection pens can allow disease such as hepatitis or HIV to pass from one person to another.Toujeo is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.
Get emergency medical help if you have signs of an allergy reaction to Toujeo: redness or swelling where an injection was given, itchy skin rash over the entire body, trouble breathing, fast heartbeats, feeling like you might pass out, or swelling in your tongue or throat.
Call your doctor at once if you have:
fluid retention - weight gain, swelling in your hands or feet, feeling short of breath; or
low potassium - leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.
Common Toujeo side effects may include:
low blood sugar;
itching, mild skin rash; or
thickening or hollowing of the skin where you injected the medicine.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You should not use Toujeo if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar).
To make sure this medicine is safe for you, tell your doctor if you have:
liver or kidney disease;
low levels of potassium in your blood (hypokalemia); or
diabetic ketoacidosis (call your doctor for treatment).
Tell your doctor if you also take pioglitazone or rosiglitazone (sometimes contained in combinations with glimepiride or metformin). Taking certain oral diabetes medicines while you are using Toujeo may increase your risk of serious heart problems.
Follow your doctor's instructions about using insulin if you are pregnant or breast-feeding a baby. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester of pregnancy. Your dose needs may also be different while you are breast-feeding.
Use Toujeo exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.
Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.
The Toujeo brand of insulin glargine contains 3 times as much insulin per milliliter (mL) as the Lantus or Basaglar brands. There are 300 units of insulin in 1 mL of Toujeo, and 100 units in 1 mL of Lantus or Basaglar. Toujeo SoloStar contains a total 450 units of U-300. It delivers doses in 1 unit increments. Toujeo Max SoloStar contains 900 units of U-300 and delivers doses in 2 unit increments.
If there are any changes in the brand, strength, or type of insulin you use, your dosage needs may change.
Insulin is injected under the skin. You will be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of used needles and injection pens.
Toujeo must not be given with an insulin pump, or mixed with other insulins. Do not inject insulin glargine into a vein or a muscle.
Toujeo SoloStar and Toujeo Max SoloStar are usually injected once per day at the same time each day. You will be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of used needles and injection pens.
Your care provider will show you the best places on your body to inject this medicine. Use a different place each time you give an injection. Do not inject into the same place two times in a row.
Use only the SoloStar injection pen that comes with Toujeo. Attach a new needle before each use. Do not transfer the insulin from the SoloStar pen into a syringe.
Never share an injection pen with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.
Use a disposable needle only once. Follow any state or local laws about throwing away used needles and injection pens. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.
Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky. To quickly treat low blood sugar, always keep a fast-acting source of sugar with you such as fruit juice, hard candy, crackers, raisins, or non-diet soda.
Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and close friends know how to give you this injection in an emergency.
Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination, blurred vision, headache, and tiredness.
Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your insulin dose or schedule.
Toujeo is only part of a treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor's instructions very closely.
Keep this medicine in its original container protected from heat and light. Do not freeze insulin or store it near the cooling element in a refrigerator. Throw away any insulin that has been frozen.
Storing unopened (not in use) SoloStar pens:
Refrigerate and use until expiration date.
Storing opened (in use) SoloStar pens:
Store the injection pen at room temperature (do not refrigerate) and use within 42 days.
Do not store a SoloStar injection pen with the needle attached.
Do not use the medicine if it looks cloudy, has changed colors, or has any particles in it. Call your pharmacist for new medicine.
Wear a diabetes medical alert tag in case of emergency. Any medical care provider who treats you should know that you have diabetes.
Call your doctor for instructions if you miss a dose of Toujeo. 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.
Do not change the brand of insulin glargine you are using without first talking to your doctor or pharmacist.
Avoid medication errors by always checking the medicine label before injecting your insulin.
Avoid drinking alcohol. It can cause low blood sugar and may interfere with your diabetes treatment.
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.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Toujeo only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Toujeo Solostar (www.drugs.com/toujeo.html).
Note: This document contains side effect information about insulin glargine. Some of the dosage forms listed on this page may not apply to the brand name Toujeo SoloStar.
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:
More common
Less common or rare
Incidence not known
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:
More common
Less common or rare
Applies to insulin glargine: subcutaneous solution
Adverse reactions associated with insulin glargine (the active ingredient contained in Toujeo SoloStar) include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema, and weight gain.
The ORIGIN (Outcome Reduction with Initial Glargine Intervention) trial, an open-labeled, randomized study comparing insulin glargine (the active ingredient contained in Toujeo SoloStar) to standard care in persons 50 years or older with abnormal glucose levels (impaired fasting glucose and/or impaired glucose tolerance) or early type 2 diabetes mellitus and established cardiovascular (CV) disease or CV risk factors, found over the course of the 6 year study, severe hypoglycemia occurred in 5.7% of patients receiving insulin glargine compared to 1.9% in the standard care group. The median HbA1c values in the insulin glargine group ranged from 5.9% to 6.4% while the HbA1c values in the standard care group ranged from 6.2% to 6.6%. The incidence for all hypoglycemia was 58% and 26% in the insulin glargine and standard groups, respectively.
Weight gain has been reported with insulin therapy and has been attributed to the anabolic effects of insulin and the decrease in glucosuria. In the ORIGIN trial, the median change in body weight from baseline to the last treatment visit was 2.2 kg greater in the insulin glargine group (+1.4 kg vs -0.8 kg).
Very common (10% or more): Hypoglycemia
Frequency not reported: Weight gain
Injection site reactions include redness, pain, itching, hives, swelling, or inflammation. In some cases, these reactions may be caused by other factors, such as irritants in skin cleansing agents. In clinical studies, there was a higher incidence of treatment-emergent injection site pain in insulin-glargine treated patients compared to NPH-treated patients (2.7% vs 0.7%).
Common (1% to 10%): Injection site reactions, injection site pain
Hypersensitivity side effects have included both local and systemic reactions. Anaphylaxis has been reported. Local reactions have presented as erythema, local edema, and pruritus at the injection site. Most minor reactions to insulin at the injection site resolve in a few days to a few weeks.
Rare (less than 0.1%): Allergic reactions
Very common (10% or more): Hypertension (up to 19.6%)
Common (1% to 10%): Peripheral edema
Insulin may cause sodium retention and edema, especially as metabolic control is improving. The ORIGIN (Outcome Reduction with Initial Glargine Intervention) trial, an open-labeled, randomized study in persons 50 years or older with abnormal glucose levels (impaired fasting glucose and/or impaired glucose tolerance) or early type 2 diabetes mellitus and established cardiovascular (CV) disease or CV risk factors, found the time to first occurrence of a major adverse cardiovascular event (MACE) and the incidence of MACE to be similar between insulin glargine and standard care (n=12.537).
Postmarketing reports indicate children and adolescents may experience more skin reactions such as rash and urticaria, than adults.
Common (1% to 10%): Lipohypertrophy
Uncommon (0.1% to 1%): Lipoatrophy
Postmarketing reports: Rash urticaria
Frequency not reported: Cancer occurrence
The ORIGIN (Outcome Reduction with Initial Glargine Intervention) trial, an open-labeled, randomized study in persons 50 years or older with abnormal glucose levels (impaired fasting glucose and/or impaired glucose tolerance) or early type 2 diabetes mellitus and established cardiovascular (CV) disease or CV risk factors, comparing insulin glargine to standard care found the overall incidence of all types of cancer combined or death from cancers was similar between treatment groups (n=12,537). In July 2009, The US FDA reported on an ongoing safety review evaluating a possible increased risk of cancer. In February 2011, the FDA in an updated communication reported the evidence was inconclusive and it is not possible to conclude that the use of this insulin increases the risk of cancer.
Frequency not reported: Antibody formation
As with all therapeutic proteins, the potential for immunogenicity exits. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay and may be influenced by assay methodology, sample handling and collection, concomitant medications, and underlying disease. The presence of insulin antibodies may increase or decrease the efficacy of insulin and may require dose adjustment.
Rare (less than 0.1%): Visual impairment, retinopathy
Rapid improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder and worsening of diabetic retinopathy. However, long-term glycemic control decreases the risk.
Common (1% to 10%): Gastroenteritis
Rare (less than 0.1%): Myalgia
Common (1% to 10%): Headache
Very rare (less than 0.01%): Dysgeusia
Frequency not reported: Peripheral neuropathy
Rapid improvement in glucose control has been associated with a transitory, reversible acute painful peripheral neuropathy. However, long-term glycemic control decreases the risk.
Very common (10% or more): Upper respiratory infection (up to 22.4%)
Common (1% to 10%): Pharyngitis, rhinitis, sinusitis
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Toujeo Solostar (www.drugs.com/toujeo.html).
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