~
`LANlUS"
`in1ulin ~lar~ine injection 100 Unit1/ml
`
`HOW TO USE YOUR LANTUS® SOLOSTAR® PEN
`A STEP BY STEP GUIDE TO USING YOUR LANTUS® SOLOSTAR® PEN
`
`For single patient use orrrj
`
`This quick reference guide is a short version of the instruction leaflet. It is designed to help make it easier to learn the steps.
`Reading this guide will help to make sure that you inject the right amount of insulin every time. Otherwise you may get too little or too much insulin,
`and that can affect your blood sugar levels.
`These instructions are supplied as a guide only. Read the full instruction leaflet accompanying this pen before you use Lantus® SoloSTAR®
`for the first time. To help ensure an accurate dose each time, follow all steps in the leaflet.
`
`~ If there's anything you don't understand or if you have any questions, ask your healthcare provider. You can also go online to Lantus.com
`\;!I or call the support line at 1-800-633-1610.
`
`GETTING TO KNOW YOUR PEN AND ITS PARTS
`
`The Lantus® SoloSTAR® pen was designed with a
`simple-to-push injection button and large dosing window.
`
`What is 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.
`
`Please click here for full Important Safety Information and here for full Prescribing Information for Lantus~
`
`h
`LANTUs·
`** in1ulin ~lar~ine injection rn~ Unit1/ml
`*soloSTAR
`
`Sanofi Exhibit 2133.001
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`CHOOSING AN INJECTION SITE
`
`The three possible injection sites are:
`O your abdomen, e your thighs, and e your upper arms. These
`areas have more fat and fewer nerve endings. You may feel less
`discomfort in these areas.
`
`INJECTION AREAS TO AVOID
`
`When injecting in these three areas:
`
`• Avoid the two-inch circle around the navel.
`
`• Avoid injecting too close to the bony area above the knee.
`
`• Each time you inject, use a different site within these three areas,
`because repeatedly injecting in the same spot can cause discomfort.
`
`• Avoid the forearm and only use the outer back area of the upper arm
`where there is fatty tissue.
`
`0
`
`Front
`
`@ View a step-by-step video on how to inject at Lantus.com .
`
`CD. Always rotate your injection sites as instructed by
`
`your doctor.
`
`• Never force the needle; this can hurt and may damage it.
`Too much force can also affect how much insulin you get.
`
`• Never inject into the muscle.
`
`• Never rub the injection spot after an injection.
`
`Important Safety Information for Lantus® (cont'd)
`
`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.
`
`Please click here for full Important Safety Information and here for full Prescribing Information for Lantus~
`
`2
`
`Lantus.com
`
`h
`LANTUs·
`** in1ulin ~lar~ine injection rn~ Unit1/ml
`*soloSTAR
`
`Sanofi Exhibit 2133.002
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`HOW TO DISPOSE OF NEEDLES
`
`HOW TO STORE YOUR UNOPENED
`LANTUS® SOLOSTAR® PEN
`
`Place used needles in sharps containers, which you can buy
`at your local drugstore.
`
`36• □ 46• Before opening, store Lantus® in the refrigerator (36°F - 46°F).
`I Keep pens in their outer package.
`
`Lantus® can be refrigerated until the expiration date. Once the
`expiration date has passed, Lantus® should be thrown away.
`
`•-
`
`0 Before you inject Lantus~ remove it from the refrigerator for an
`
`hour or two-cold insulin can be more painful to inject.
`
`If a sharps container isn't available, use a strong plastic
`bottle that cannot be punctured, such as a bleach or laundry
`detergent bottle. Make sure the cap is on tight. When you're
`ready to dispose of the bottle, put tape over the cap and be
`sure to write "SHARPS" on the bottle.
`
`Take your sharps container to appropriate collection sites that
`~ IIIIII
`may include doctors' offices, hospitals, pharmacies, health
`departments, fire stations, or other locations.
`
`Do not allow Lantus® to freeze. Do not put it in a freezer or
`next to a freezer pack. If you see frost or ice crystals in your
`Lantus® solution, throw it away.
`
`Visit the Centers for Disease Control's Safe Community
`Needle Disposal website.
`
`Don't flush used sharps down the toilet or drop them into a
`sewer drain.
`
`Don't put used sharps in soda cans, milk cartons, glass bottles,
`coffee cans, or containers that can be broken or punctured.
`
`Always discard the pen with the pen cap on. You can discard
`the pen in regular trash.
`
`' I ,0
`·•- Keep Lantus® away from direct heat and light.
`
`,
`
`I '
`
`Important Safety Information for Lantus® (cont'd)
`
`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
`• Sudden weight gain
`• Swelling of your ankles or feet
`
`Please click here for full Important Safety Information and here for full Prescribing Information for Lantus~
`
`3
`
`Lantus.com
`
`h
`LANTUs·
`** in1ulin ~lar~ine injection rn~ Unit1/ml
`*soloSTAR
`
`Sanofi Exhibit 2133.003
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`HOW TO STORE YOUR OPENED
`LANTUS® SOLOSTAR® PEN
`
`THE LANTUS® SOLOSTAR® INSULIN PEN CAN BE USED
`WITH THE BD ULTRA-FINE™ PEN NEEDLES*.
`
`36'i 46'
`
`After its first use, don't refrigerate the Lantus® SoloSTAR® pen.
`Keep it at room temperature only (below 86°F).
`
`Your healthcare provider may prescribe Ultra-Fine™ pen needles.
`They come in the following sizes:
`
`After 28 days, throw your opened Lantus® away-even if it
`still has insulin in it.
`
`• 4 mm (5/32")
`NDC/HRI No. 08290-3201-22
`
`• 5 mm (3/16")
`NDC/HRI No. 08290-3201-19
`
`• 8 mm (5/16")
`NDC/HRI No. 08290-3201-09
`
`32G Nano
`
`31 G Mini
`
`31 G Short
`
`*Ultra-Fine is a trademark of Becton, Dickinson and Company.
`
`Keep Lantus® away from direct heat and light.
`
`,
`
`I •
`
`__ '!
`-•-J* Don't leave Lantus® in a hot car in direct sun, or in a
`
`, ,
`
`freezing car overnight. If Lantus® gets too hot or freezes,
`it will have to be thrown away.
`
`Important Safety Information for Lantus® (cont'd)
`
`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.
`
`Please click here for full Important Safety Information and here for full Prescribing Information for Lantus~
`
`4
`
`Lantus.com
`
`h
`LANTUs·
`** in1ulin ~lar~ine injection rn~ Unit1/ml
`*soloSTAR
`
`Sanofi Exhibit 2133.004
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`HOW TO USE YOUR LANTUS® (INSULIN GLARGINE
`INJECTION) 100 UNITS/ML SOLOSTAR® PEN IN 6 STEPS
`
`These instructions are supplied as a guide only. Read the full
`instruction leaflet included in this kit before you use Lantus®
`SoloSTAR® for the first time. To help ensure an accurate dose each
`time, follow all steps in the leaflet.
`
`STEP 2. ATTACH THE NEEDLE
`• Wipe the pen tip (rubber seal) with an alcohol swab.
`• Remove the protective seal from the new needle, line the needle up straight
`with the pen, and screw the needle on.
`• Do not make the needle too tight. If you have a push-on needle, keep it
`straight as you push it on.
`
`STEP 1. GET READY
`• Remove the pen cap with clean hands.
`
`• Check the reservoir to make sure the insulin is clear and colorless and has
`no particles-if not, use another pen.
`
`• After you have attached the needle, take off the outer needle cap and save
`it (you will need it to remove the needle after your injection).
`• Remove the inner needle cap and throw it away.
`
`• Insulin pens, needles, or syringes must never be shared between
`patients. Do NOT reuse needles.
`
`• Always store UNOPENED Lantus® SoloSTAR®
`pens in the refrigerator.
`• Always wash your hands with soap and water before an injection.
`• Always check the expiration date of the pen.
`• Never inject cold insulin. Wait until pen warms up to
`room temperature.
`• Always use a new needle.
`• Never refrigerate the pen after opening it.
`• Never play with the dial before using it; this may prevent jamming.
`
`STEP 3. PERFORM A SAFETY TEST
`• Dial a test dose of 2 units.
`• Hold pen with the needle pointing up and lightly
`tap the insulin reservoir so the air bubbles rise to
`the top of the needle. This will help you get the
`most accurate dose.
`• Press the injection button all the way in and
`check to see that insulin comes out of the needle.
`The dial will automatically go back to zero after you
`perform the test.
`• If no insulin comes out, repeat the test 2 more
`times. If there is still no insulin coming out, use a
`new needle and do the safety test again.
`
`Please click here for full Important Safety Information and here for full Prescribing Information for Lantus~
`
`5
`
`Lantus.com
`
`h
`LANTUs·
`** in1ulin ~lar~ine injection rn~ Unit1/ml
`*soloSTAR
`
`Sanofi Exhibit 2133.005
`Mylan v. Sanofi
`IPR2018-01676
`
`

`

`(I) • Always perform the safety test before each injection.
`
`• Never use the pen if no insulin comes out after using a second needle.
`
`STEP 4. SELECT THE DOSE
`• Make sure the window shows "0" and then select the dose. Otherwise you will
`inject more insulin than you need and that can affect your blood sugar level.
`• Dial back up or down if you dialed the wrong amount.
`• Check if you have enough insulin in the reservoir. If you cannot dial the dose
`you want it may be because you don't have enough insulin left.
`• You cannot dial more than 80 units because the pen has a safety stop.
`If your dose is more than 80 units, you will need to redial the rest of your
`dose. If you don't have enough insulin for the rest of your dose you will
`need to use a new pen.
`
`(I) • Never force the dose selector when dialing your dose.
`
`• Never set the dose selector to half units or the pen may jam.
`
`STEP 5. INJECT YOUR DOSE
`• Clean site with an alcohol swab. Please see injection site options on page 6.
`• Keep the pen straight, insert the needle into your skin.
`• Using your thumb, press the injection button all the way down, when the
`number in the dose window returns to Oas you inject, slowly count to 10 before
`removing. (Counting to 10 will make sure you get your full insulin dose.)
`• Release the button and remove the needle from your skin.
`
`Please click here for full Important Safety Information and here for full Prescribing Information for Lantus~
`
`6
`
`Lantus.com
`
`h
`LANTUs·
`** in1ulin ~lar~ine injection rn~ Unit1/ml
`*soloSTAR
`
`Sanofi Exhibit 2133.006
`Mylan v. Sanofi
`IPR2018-01676
`
`(D • Choose a new injection spot each time.
`
`• Take the needle from your skin if you dial
`another dose.
`
`___ r
`
`\--~
`
`0 ~/r:j
`
`STEP 6. REMOVE THE NEEDLE
`• Insulin pens, needles, or syringes must never be shared between
`patients. Do NOT reuse needles.
`• After injecting, always remove the needle to prevent contamination and leaking.
`• Put the outer needle cap back on the needle and unscrew (or pull) the
`needle from the pen.
`
`• Throw needle away in a sharps container. For more information on
`disposing needles please see page 8.
`
`• Put the pen cap back on the pen and store in a
`safe place at room temperature.
`
`~~ ::[~~ + I :5J
`CD Never share your needle or pen with
`
`another person.
`
`

`

`What is 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 condrtions,
`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
`• Sudden weight gain
`• Swelling of your ankles or feet
`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.
`
`Please click here for full Prescribing Information for Lantus'":
`
`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 (hypoglycemia), which may be serious. It may cause
`harm to your heart or brain. Symptoms of serious low blood sugar may
`include shaking, sweating, fast heartbeat, and blurred vision.
`Lant us® may cause serious side effects that can lead to death, such as
`severe allergic reactions. Get medical help right away if you have:
`
`• A rash over your whole body
`• Swelling of your face, tongue,
`or throat
`• Trouble breathing
`• Shortness of breath
`
`• A fast heartbeat
`• Extreme drowsiness, dizziness,
`or confusion
`• Sweating
`
`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.
`
`SANOFI ~
`
`7
`
`© 2017 sanofi-aventis U.S. LLC ALL RIGHTS RESERVED
`
`SAUS.GLA.17.09.7574
`
`Lanius.com
`
`h
`LANTUs·
`** in1ulin ~lar~ine injection rn~ Unit1/ml
`*soloSTAR
`
`Sanofi Exhibit 2133.007
`Mylan v. Sanofi
`IPR2018-01676
`
`