Toujeo Max SoloStar

The active ingredient in Toujeo Max Solostar is insulin glargine. It is a long-acting basal insulin that helps manage hyperglycemia (high blood sugar levels). This type of insulin therapy works to lower high blood glucose levels by stimulating our muscles and our fat to take up glucose from the blood and by blocking our liver from making more. It also blocks fat and protein breakdown, leaving more fat and muscle for glucose to be absorbed from the bloodstream. If high blood sugar levels are left untreated, patients can develop several complications related to their heart, eyes, nerves, and kidneys. In Type 1 diabetes, it can increase the risk of diabetic ketoacidosis, a life-threatening condition that Toujeo Max Solostar should not be used to treat.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Toujeo Max SoloStar. However, the following is a synopsis of the general guidelines for the use of Toujeo Max SoloStar:

• Toujeo Max Solostar pens should be used exactly as prescribed. The insulin dose you use will depend on a number of factors, including (but not limited to) your age, blood glucose control, type of diabetes, and prior insulin use.
• There are many different types of insulin, and medication errors are common. Always check the label on your insulin to ensure it is the brand and strength you have been prescribed.
• Before using, check the insulin to ensure it is clear and colorless. Cloudy insulin pens or those that are past their expiration date should not be used and should be taken to your pharmacy to be disposed of.
• Toujeo is a subcutaneous injection that is injected in the abdominal area, thigh, or deltoid of the upper arm once daily. You should be injecting at the same time every day. Ensure you rotate your injection site each day to minimize the risk of injection site reactions such as lipodystrophy and cutaneous amyloidosis. Change the needle each time to prevent infection, and do not share needles with others. Dispose of used needles in a sharps container that you can get from your local pharmacy. If using syringes with the vial, do not attempt to remove the needle from the syringe after injecting. Simply dispose of both in your sharps container. Do not reuse needles.
• Do not mix the insulin with any other insulin or solutions.
• Do not use in an insulin pump.
• This medication may cause dizziness or drowsiness. Do not drive or operate heavy machinery until you know how Toujeo Max Solostar affects you. Sometimes, your daily dose may be too high and cause hypoglycemia or low blood sugar events that can affect your daily functioning.
• Do not drink alcohol or use over-the-counter medications that contain alcohol while on Toujeo Max Solostar. Alcohol lowers blood glucose, and when combined with insulin, could cause low blood sugar. Watch for symptoms of hypoglycemia.
• If you miss a dose of Toujeo, contact your prescriber or pharmacist. They will know or recommend what is best for you.

Some mild or common side effects of Toujeo Max SoloStar include:

• Hypoglycemia or low blood sugar. If left unaddressed, this could be life-threatening. Watch for symptoms such as dizziness, lightheadedness, sweating, confusion, headache, changes in vision, slurred speech, shakiness, fast heartbeat, anxiety, increased irritability, mood swings, or increased appetite.
• Injection site reactions, such as redness, swelling, or pain at the site of injection.
• Skin thickening or buildup of fat at the injection site (lipodystrophy).
• Weight gain.
• Swelling (edema).

Some individuals may experience serious side effects while using Toujeo Max SoloStar. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Severe hypoglycemia (low blood sugar)
• Signs of hypokalemia or low potassium levels in the blood, such as muscle weakness, cramping, spasms, and heart palpitations.
• New onset of trouble breathing, swelling of the lower limbs and feet, fluid retention, and sudden weight gain. These may be symptoms of heart failure, which can develop if Toujeo Solostar is used with TZDs.
• Signs of a severe allergic reaction such as difficulty breathing, hives, rash, or swelling of the face or body.

These are not all of the possible side effects of Toujeo Max SoloStar. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Toujeo Max SoloStar, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• Liver problems
• Kidney problems
• Use thiazolidinediones or TZDs
• Heart failure or any other heart problems
• Are pregnant or planning to become pregnant
• Are breastfeeding or planning to breastfeed

Do not use Toujeo Max Solostar if you have:

• Hypoglycemia or low blood sugar
• An allergy to insulin glargine or any of the other ingredients in Toujeo Max SoloStar

Toujeo Max Solostar is a long-acting insulin. It typically starts to work in about 1 to 2 hours, and levels will remain steady for up to 24 hours.

When Toujeo Max SoloStar is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Other diabetes medications including GLP1 agonists, DPP4 inhibitors, and SGLT-2 inhibitors
• ACE inhibitors
• ARBs
• Disopyramide
• Fibrates
• Fluoxetine
• MAOIs
• Pentoxifylline
• Pramlintide
• Salicylates
• Somatostatin analogs such as octreotide
• Sulfonamides
• Atypical antipsychotics such as olanzapine and clozapine
• Corticosteroids
• Danazol
• Diuretics
• Estrogens
• Glucagon
• Isoniazid
• Niacin
• Oral contraceptives
• Phenothiazines
• Progestogens
• Protease inhibitors
• Somatropin
• Sympathomimetic agents such as albuterol, epinephrine, and terbutaline
• Thyroid hormones
• Beta-blockers
• Clonidine
• Lithium
• Pentamidine
• Guanethidine
• Reserpine

Toujeo Max Solostar is available as a 3 mL prefilled pen that contains 300 units of insulin glargine per mL (or 900 units in total).

It is also available under another name called Toujeo Solostar Pen, which comes as a smaller pen size, containing 1.5 mL of solution with 300 units of insulin glargine per mL (or 450 units in total).

Both types of pens are meant for single-patient use only.

New pens that have not been used yet should be kept in the fridge. Do not freeze. If the pen is frozen, it should be discarded. Once opened, store the pen at room temperature and protect it from heat or light for up to 56 days. Keep the pen out of reach of children.

Toujeo Max Solostar is manufactured by the pharmaceutical company Sanofi-Aventis U.S. LLC.

Currently, there is no generic available for the brand-name Toujeo Max Solostar.

Consult your doctor or pharmacist before starting, stopping, or changing medications while using Toujeo Max Solostar.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.