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
throat
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- Extreme
drowsiness,
dizziness, or confusion
- Trouble
breathing
- Fast
heartbeat
- Sweating
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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
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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.
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With more than
100,000 people in 100 countries, Sanofi is transforming scientific
innovation into healthcare solutions around the globe.
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Sanofi, Empowering
Life
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Investor
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Ashleigh
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ir@sanofi.com
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Sanofi
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