FDA approves Toujeo® Max SoloStar®
BRIDGEWATER, N.J., March 27, 2018 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) approved Sanofi's Toujeo® (insulin glargine 300 Units/mL) Max SoloStar®, 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 www.toujeo.com.
Toujeo Max SoloStar will launch in retail pharmacies across the U.S. in Q3 2018.
What is Toujeo® (insulin glargine injection) 300 Units/mL?
Prescription Toujeo® is a long-acting insulin used to control blood sugar in adults with diabetes mellitus.
- Toujeo® contains 3 times as much insulin in 1 mL as standard insulin (100 Units/mL)
- Toujeo® is not for use to treat diabetic ketoacidosis
- Toujeo® should not be used in children
Important Safety Information for Toujeo® (insulin glargine injection) 300 Units/mL
Do not take Toujeo® if you have low blood sugar or if you are allergic to insulin or any of the ingredients in Toujeo®.
Do NOT reuse needles or share insulin pens even if the needle has been changed. Do not share your Toujeo® SoloStar® or Toujeo® Max SoloStar® 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 Toujeo®, 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 Toujeo®. Your treatment with TZDs and Toujeo® 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.
Toujeo® should be taken at the same time once a day. Test your blood sugar levels daily while using any insulin, including Toujeo®. 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 Toujeo® from your SoloStar® pen or Toujeo® Max SoloStar® pen. This can cause you to give yourself too much insulin. Toujeo® has 3 times as much insulin in 1 mL compared to other standard insulin pens. Your dose for Toujeo® 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 Toujeo® with any other insulin or solution. It will not work as intended and you may lose blood sugar control, which could be serious. Use Toujeo® only if the solution is clear and colorless with no particles visible.
While using Toujeo®, do not drive or operate heavy machinery until you know how Toujeo® affects you. Don't drink alcohol or use other medicines that contain alcohol.
The most common side effect of any insulin, including Toujeo®, 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.
Toujeo® 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 Extreme drowsiness, throat dizziness, or confusion Trouble breathing Fast heartbeat Sweating
Toujeo® 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.
Toujeo® SoloStar® and Toujeo® Max SoloStar® 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 US Media Relations Investor Relations Ashleigh Koss George Grofik Tel. : +1 (908) 981-8745 Tel. : +33 (0)1 53 77 45 45 Mobile: +1 (908) 205-2572 firstname.lastname@example.org Ashleigh.Koss@sanofi.com Sanofi Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the absence of guarantee that the product will be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic conditions, as well as those risks discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2017. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. -------------------------------------------------------------------------------------
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