7/19/2019
`
`Insulin Pen: Lantus SoloSTAR® | Lantus® (insulin glargine injection) 100 Units/mL
`
`(https://www.s
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`GET TO KNOW THE LANTUS SOLOSTAR INSULIN
`®
`®
`PEN
`
`The Lantus SoloStar insulin pen can help manage blood sugar levels with just
`one dose a day and delivers the precise dose you dial time after time. As
`always, follow the instructions for use
`(https://www.lantus.com:443/-/media/EMS/Conditions/Diabetes/Brands/Lantus2/Consumer/de
`SoloStar-Pen-Guide.pdf?la=en) that came with your pen.
`FEATURES OF LANTUS SOLOSTAR
`
`ONCE-A-DAY
`
`SMALL, THIN NEEDLES
`
`LARGE PRINT DOSING WINDOW
`
`DIAL-IN DOSE
`Important Safety Information for Lantus (insulin glargine
`®
`PUSH-BUTTON INJECTION
`injection) 100 Units/mL
`Do not take Lantus during episodes of low blood sugar or if you are allergic to insulin or any of the
`To learn how to use the Lantus SoloStar pen, watch this video. (/using-solostar-insulin-
`inactive ingredients in Lantus.
`pen#how_to_insulin)
`
`https://www.lantus.com/get-to-know-the-lantus-solostar-pen
`
`1/7
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`Mylan Ex.1081
`Mylan v. Sanofi - IPR2018-01676
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`

`

`7/19/2019
`Insulin Pen: Lantus SoloSTAR® | Lantus® (insulin glargine injection) 100 Units/mL
`Interested in learning about how to use Lantus with a vial and syringe? Learn how. (/using-
`solostar-insulin-pen#vial_syringe)
`
`0:00 / 0:37
`
`
`
`Full Prescribing Information (http://products.sanofi.us/lantus/lantus.html)
`Important Safety Information
`Download the Lantus SoloStar Injection Guide
`(https://www.lantus.com:443/-/media/EMS/Conditions/Diabetes/Brands/Lantus2/Consumer/desktop/PDF/Lantus-
`SoloStar-Pen-Guide.pdf?la=en)
`
`Read Full Transcript
`
`JOSÉ MASTERS HIS DAILY ROUTINE. WATCH NOW
`Important Safety Information for Lantus (insulin glargine
`®
`“It’s such a small needle…it is very thin, so I hardly feel a thing.”
`injection) 100 Units/mL
`Do not take Lantus during episodes of low blood sugar or if you are allergic to insulin or any of the
`JOSÉ, TREATING WITH LANTUS SINCE 2007
`inactive ingredients in Lantus.
`Individual results may vary.
`
`https://www.lantus.com/get-to-know-the-lantus-solostar-pen
`
`2/7
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`Mylan Ex.1081
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`
`
` 
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`7/19/2019
`
`Insulin Pen: Lantus SoloSTAR® | Lantus® (insulin glargine injection) 100 Units/mL
`Discomfort level associated with administration varies from person to person.
`
`PAY AS LOW AS
` COPAY
`with a maximum savings of $600 per pack.
`STARTING LANTUS? START SAVING, TOO.
`If eligible, you’ll pay as low as $0* copay on Lantus for 12 months,
`with a maximum savings of $600 per pack.
`
`SIGN UP NOW (/sign-up)
`
`Subject to eligibility. Restrictions apply.
`*
`
`NO INSURANCE? YOU CAN STILL SAVE ON LANTUS.
`We have
`an offer for you, too.
`
`LEARN MORE (/sign-up)
`Important Safety Information for Lantus (insulin glargine
`®
`injection) 100 Units/mL
`Subject to eligibility. Restrictions apply.
`*
`Do not take Lantus during episodes of low blood sugar or if you are allergic to insulin or any of the
`inactive ingredients in Lantus.
`®
`What is Lantus (insulin glargine injection) 100 Units/mL?
`
`https://www.lantus.com/get-to-know-the-lantus-solostar-pen
`
`3/7
`
`Mylan Ex.1081
`Mylan v. Sanofi - IPR2018-01676
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`

`

`7/19/2019
`Insulin Pen: Lantus SoloSTAR® | Lantus® (insulin glargine injection) 100 Units/mL
`Prescription Lantus is a long-acting insulin used to treat adults with type 2 diabetes and adults and
`pediatric patients (children 6 years and older) with type 1 diabetes for the control of high blood
`sugar.
`Do not use Lantus to treat diabetic ketoacidosis.
`®
`Important Safety Information for Lantus (insulin glargine injection)
`100 Units/mL
`Do not take Lantus during episodes of low blood sugar or if you are allergic to insulin or any of the
`inactive ingredients in Lantus.
`Do not share needles, insulin pens, or syringes with others. Do NOT reuse needles.
`Before starting Lantus, 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 breast-feeding
`or planning to breast-feed.
`Heart failure can occur if you are taking insulin together with certain medicines called TZDs
`(thiazolidinediones), even if you have never had heart failure or other heart problems. If you already
`have heart failure, it may get worse while you take TZDs with Lantus. Your treatment with TZDs and
`Lantus 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 of heart failure, including:
`Shortness of breath
`Swelling of your ankles or feet
`Sudden weight gain
`Tell your doctor about all the medications you take, including OTC medicines, vitamins, and
`supplements, including herbal supplements.
`Lantus should be taken once a day at the same time every day. Test your blood sugar levels while
`using insulin, such as Lantus. Do not make any changes to your dose or type of insulin without
`talking to your healthcare provider. Any change of insulin should be made cautiously and only under
`medical supervision.
`Do NOT dilute or mix Lantus with any other insulin or solution. It will not work as intended and
`you may lose blood sugar control, which could be serious. Lantus must only be used if the solution
`is clear and colorless with no particles visible. Always make sure you have the correct insulin before
`each injection.
`While using Lantus, do not drive or operate heavy machinery until you know how Lantus affects you.
`You should not drink alcohol or use other medicines that contain alcohol.
`The most common side effect of insulin, including Lantus, is low blood sugar
`Important Safety Information for Lantus (insulin glargine
`®
`(hypoglycemia), which may be serious and life threatening. It may cause harm to your heart or
`injection) 100 Units/mL
`brain. Symptoms of serious low blood sugar may include shaking, sweating, fast heartbeat, and
`Do not take Lantus during episodes of low blood sugar or if you are allergic to insulin or any of the
`blurred vision.
`inactive ingredients in Lantus.
`Lantus may cause serious side effects that can lead to death, such as severe allergic reactions. Get
`medical help right away if you have:
`
`https://www.lantus.com/get-to-know-the-lantus-solostar-pen
`
`4/7
`
`Mylan Ex.1081
`Mylan v. Sanofi - IPR2018-01676
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`

`

`7/19/2019
`
`Insulin Pen: Lantus SoloSTAR® | Lantus® (insulin glargine injection) 100 Units/mL
`A rash over your whole body
`Trouble breathing
`A fast heartbeat
`Sweating
`Swelling of your face, tongue, or throat
`Shortness of breath
`Extreme drowsiness, dizziness, or confusion
`Other possible side effects may include swelling, weight gain, low potassium levels, injection site
`reactions, including changes in fat tissue at the injection site, and allergic reactions.
`Lantus SoloStar is a disposable prefilled insulin pen. Please talk to your healthcare provider about
`®
`proper injection technique and follow instructions in the Instruction Leaflet that accompanies the
`pen.
`
`Click here (http://products.sanofi.us/lantus/lantus.html) for Full Prescribing Information for
`Lantus.
`Click here (https://www.sanofi.us/-/media/project/one-sanofi-web/websites/north-
`america/sanofi-us/home/corporateresponsibility/sharps_and_medical_waste.pdf) for
`information on Sharps Medical Waste Disposal.
`Click here
`(http://products.sanofi.us/resources/US_COR_14_05_008_Counterfeit_Brochure.pdf) to learn
`more about Sanofi's commitment to fighting counterfeit drugs.
`
`Eligibility Restrictions & Offer Terms:
`*
`
`Insulins Valyou Savings Program:
`Sanofi insulins included in this program are: ADMELOG (insulin lispro injection) 100 Units/mL,
`®
`TOUJEO (insulin glargine injection) 300 Units/mL, LANTUS (insulin glargine injection) 100
`®
`®
`Units/mL and APIDRA (insulin glulisine injection) 100 Units/mL. This offer is not valid for
`®
`prescriptions covered by or submitted for reimbursement under Medicare, Medicaid, VA, DOD,
`TRICARE, similar federal or state programs, including any state pharmaceutical programs, or
`commercial / private insurance. Only people without prescription medication insurance can apply
`for this offer. Void where prohibited by law. For the duration of the program, eligible patients will
`pay $99 for up to 10 vials or packs of pens per fill. Offer is valid for one fill per month. To pay $99
`per month, you must fill all your Sanofi Insulin prescriptions at the same time, together each
`month. Not valid for SOLIQUA 100/33 (insulin glargine and lixisenatide injection) 100 Units/mL
`and 33 mcg/mL or Toujeo Max SoloStar pen. When using the Insulins Valyou Savings Card,
`Important Safety Information for Lantus (insulin glargine
`®
`prices are guaranteed for 12 consecutive monthly fills. The Insulins Valyou Savings Program
`injection) 100 Units/mL
`applies to the cost of medication. There are other relevant costs associated with overall
`Do not take Lantus during episodes of low blood sugar or if you are allergic to insulin or any of the
`treatment.
`inactive ingredients in Lantus.
`Sanofi Copay Program:
`
`https://www.lantus.com/get-to-know-the-lantus-solostar-pen
`
`5/7
`
`Mylan Ex.1081
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`Insulin Pen: Lantus SoloSTAR® | Lantus® (insulin glargine injection) 100 Units/mL
`7/19/2019
`This offer is not valid for prescriptions covered by or submitted for reimbursement under
`Medicare, Medicaid, VA, DOD, TRICARE, or similar federal or state programs including any state
`pharmaceutical assistance program. Important to note that if you have an Affordable Care (Health
`Care Exchange) plan, you may still be qualified to receive and use this savings card. Please note:
`the Federal Employees Health Benefits (FEHB) Program is not a federal or state government
`health care program for purposes of the savings program. Void where prohibited by law.
`Lantus: $0 copay with maximum savings up to $600 per pack up to 3 packs per fill;
`Toujeo: $0 copay for the first 3 fills, then $10 copay for the next 12 fills. Maximum savings up
`to $600 per pack up to 3 packs per fill;
`Soliqua 100/33: $0 copay with maximum savings up to $800 per pack up to 1 pack per fill;
`Savings may vary depending on patients' out-of-pocket costs. Upon registration, patients receive
`all program details. Sanofi US reserves the right to change the maximum cap amount, rescind,
`revoke or amend these programs without notice.
`
`If you are a patient experiencing problems with a Sanofi US product, please contact Sanofi
`US at 1-800-633-1610.
`
`The health information contained herein is provided for general education purposes only. Your
`healthcare professional is the single best source of information regarding your health. Please
`consult your healthcare professional if you have any questions about your health or treatment.
`
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`ALREADY ON INSULIN (/changing-insulin)
`Important Safety Information for Lantus (insulin glargine
`®
`Reasons to Consider Lantus (/changing-insulin#long_acting)
`injection) 100 Units/mL
`Other Treatment Options (/changing-insulin#switching_lantus)
`Do not take Lantus during episodes of low blood sugar or if you are allergic to insulin or any of the
`Questions for Your Doctor (/changing-insulin#conversation_sect2)
`inactive ingredients in Lantus.
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`LANTUS HOW-TO (/using-solostar-insulin-pen)
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`https://www.lantus.com/get-to-know-the-lantus-solostar-pen
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`6/7
`
`Mylan Ex.1081
`Mylan v. Sanofi - IPR2018-01676
`
`

`

`7/19/2019
`
`Insulin Pen: Lantus SoloSTAR® | Lantus® (insulin glargine injection) 100 Units/mL
`Insulin Injection Site (/using-solostar-insulin-pen#inject_insulin)
`Getting the Right Dose (/using-solostar-insulin-pen#getting_dosage_sect)
`How to Use Lantus SoloStar (/using-solostar-insulin-pen#how_to_insulin)
`®
`Using a Vial and Syringe (/using-solostar-insulin-pen#vial_syringe)
`Common Side Effects (/using-solostar-insulin-pen#side-effectSect)
`FAQs (/using-solostar-insulin-pen#faqs_section)
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`SAVINGS + SUPPORT (/sign-up/savings-and-support)
`Sign Up for Savings and Support (/sign-up/savings-and-support)
`Activate Your Copay Card (/sign-up/activate-savings-card)
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`Know Your Numbers (/diabetes-management#know_your_number)
`Recipes (/diabetes-management#recipes_sect)
`My 5 Point Profile (/diabetes-management#myfive_point)
`Support (/diabetes-management#support_sect)
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`This site is intended for use by US residents only.
`SAUS.GLA.18.02.0758n(1) Last Updated: May 2019
`
`Important Safety Information for Lantus (insulin glargine
`®
`injection) 100 Units/mL
`Do not take Lantus during episodes of low blood sugar or if you are allergic to insulin or any of the
`inactive ingredients in Lantus.
`
`https://www.lantus.com/get-to-know-the-lantus-solostar-pen
`
`7/7
`
`Mylan Ex.1081
`Mylan v. Sanofi - IPR2018-01676
`
`