Healthcare Industry News:  Sanofi 

Biopharmaceuticals Drug Delivery FDA

 News Release - March 27, 2018

FDA approves Toujeo(R) Max SoloStar(R)

Max SoloStar holds more insulin than any other long-acting insulin pen

New pen can potentially reduce the number of injections for people who need more long-acting insulin and lower copay costs

BRIDGEWATER, N.J., March 27, 2018 -- (Healthcare Sales & Marketing Network) -- The U.S. Food and Drug Administration (FDA) approved Sanofi's ToujeoŽ (insulin glargine 300 Units/mL) Max SoloStarŽ, the highest capacity long-acting insulin pen that will be available on the market.

The new Max SoloStar pen holds 900 Units of Toujeo, more than any other long-acting insulin pen in the U.S., and provides up to 160 Units/mL of Toujeo in a single injection.

Due to its higher capacity, Max SoloStar may reduce the number of pens adults prescribed Toujeo use, allowing for fewer refills and related copays, depending on the person's insurance coverage. The maximum dose of up to 160 Units/mL may also help reduce the number of injections needed to deliver the required Toujeo dosage for some adults with diabetes.

"This new high capacity pen has a broader range of doses than the original SoloStar, delivering Toujeo, a long-acting insulin with established safety and efficacy," said Michelle Carnahan, North America Diabetes and Cardiovascular Head, Sanofi. "By reducing the number of injections for people who need more long-acting insulin and lowering copay costs – both of which are important to patients – Toujeo Max SoloStar underscores Sanofi's continued commitment to help those living with diabetes."

To make Toujeo Max SoloStar as financially accessible as possible, it will be available at the same price as the original Toujeo SoloStar per insulin unit. Additionally, Sanofi will offer a savings program for Toujeo that includes both the SoloStar pen and Max SoloStar pen. Eligible commercially insured patients will pay a $0 copay if they are new to Toujeo for their first three prescription fills, and a $10 copay for their next 12 fills.

Sanofi will also offer support to adults with diabetes prescribed either SoloStar or Max SoloStar through the free Toujeo COACH program. For more information about these programs, visit

Toujeo Max SoloStar will launch in retail pharmacies across the U.S. in Q3 2018.

What is ToujeoŽ (insulin glargine injection) 300 Units/mL? Prescription ToujeoŽ is a long-acting insulin used to control blood sugar in adults with diabetes mellitus.
  • ToujeoŽ contains 3 times as much insulin in 1 mL as standard insulin (100 Units/mL)
  • ToujeoŽ is not for use to treat diabetic ketoacidosis
  • ToujeoŽ should not be used in children
Important Safety Information for ToujeoŽ (insulin glargine injection) 300 Units/mL

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

Do NOT reuse needles or share insulin pens even if the needle has been changed. Do not share your ToujeoŽ SoloStarŽ or ToujeoŽ Max SoloStarŽ pen 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. Reusing needles increases your chance of having blocked needles.

Before starting ToujeoŽ, 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.

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 ToujeoŽ. Your treatment with TZDs and ToujeoŽ 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.

ToujeoŽ should be taken at the same time once a day. Test your blood sugar levels daily while using any insulin, including ToujeoŽ. 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 ToujeoŽ from your SoloStarŽ pen or ToujeoŽ Max SoloStarŽ pen. This can cause you to give yourself too much insulin. ToujeoŽ has 3 times as much insulin in 1 mL compared to other standard insulin pens. Your dose for ToujeoŽ 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 ToujeoŽ with any other insulin or solution. It will not work as intended and you may lose blood sugar control, which could be serious. Use ToujeoŽ only if the solution is clear and colorless with no particles visible.

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

The most common side effect of any insulin, including ToujeoŽ, is low blood sugar (hypoglycemia), which may be serious and can be 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.

ToujeoŽ 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
ToujeoŽ 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.

ToujeoŽ SoloStarŽ and ToujeoŽ Max SoloStarŽ are disposable 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 pens.

Please see full Prescribing Information.

About Sanofi

Sanofi (EURONEXT: SAN) (NYSE: SNY) is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life Sanofi Forward-Looking Statements

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Source: Sanofi

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