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What is the most important information I should know about LANTUS?

Do not change the insulin you are using without talking to your healthcare provider.

Any

change of insulin should be made cautiously and only under medical supervision. Changes in
insulin strength, manufacturer, type (for example: Regular, NPH, analogs), species (beef, pork,
beef-pork, human) or method of manufacture (recombinant DNA versus animal source insulin) may
need a change in the dose. This dose change may be needed right away or later on during the
first several weeks or months on the new insulin. Doses of oral anti-diabetic medicines may also
need to change, if your insulin is changed.

You must test your blood sugar levels while using an insulin, such as LANTUS.

Your

healthcare provider will tell you how often you should test your blood sugar level, and what to do
if it is high or low.

Do NOT dilute or mix LANTUS with any other insulin or solution.

It will not work and you may

lose blood sugar control, which could be serious.

LANTUS

comes as U-100 insulin and contains 100 units of LANTUS per milliliter (mL). One

milliliter of U-100 insulin contains 100 units of insulin. (1 mL = 1 cc).

What is Diabetes?

Your body needs insulin to turn sugar (glucose) into energy. If your body does not make enough
insulin, you need to take more insulin so you will not have too much sugar in your blood.

Insulin injections are important in keeping your diabetes under control. But the way you live, your
diet, careful checking of your blood sugar levels, exercise, and planned physical activity, all work
with your insulin to help you control your diabetes.

What is LANTUS?

LANTUS (insulin glargine [recombinant DNA origin]) is a long-acting insulin. Because LANTUS is
made by recombinant DNA technology (rDNA) and is chemically different from the insulin made
by the human body, it is called an insulin analog. LANTUS is used to treat patients with diabetes
for the control of high blood sugar. It is used once a day to lower blood sugar.

LANTUS is a clear, colorless, sterile solution for injection under the skin (subcutaneously).

The active ingredient in LANTUS is insulin glargine. The concentration of insulin glargine is 100
units per milliliter (mL), or U-100. LANTUS also contains zinc, metacresol, glycerol, polysorbate
20 and water for injection as inactive ingredients. Hydrochloric acid and/or sodium hydroxide may
be added to adjust the pH.

You need a prescription to get LANTUS. Always be sure you receive the right insulin from the
pharmacy.

Who should NOT take LANTUS?
Do not take LANTUS if you are allergic to insulin glargine

or any of the inactive ingredients in

LANTUS. Check with your healthcare provider if you are not sure.

Before starting LANTUS, tell your healthcare provider about all your medical conditions
including if you:

have liver or kidney problems.

Your dose may need to be adjusted.

are pregnant or plan to become pregnant.

It is not known if LANTUS may harm your unborn

baby. It is very important to maintain control of your blood sugar levels during pregnancy. Your
healthcare provider will decide which insulin is best for you during your pregnancy.

are breast-feeding or plan to breast-feed.

It is not known whether LANTUS passes into your

milk. Many medicines, including insulin, pass into human milk, and could affect your baby. Talk
to your healthcare provider about the best way to feed your baby.

about all the medicines you take including

prescription and non-prescription medicines,

vitamins, and herbal supplements.

How should I use LANTUS?

See the

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Instructions for Use

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including the

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How do I draw the insulin into the syringe?

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section

for additional information.

Follow the instructions given by your healthcare provider about the type or types of insulin you
are using. Do not make any changes with your insulin unless you have talked to your healthcare
provider. Your insulin needs may change because of illness, stress, other medicines, or changes
in diet or activity level. Talk to your healthcare provider about how to adjust your insulin dose.

You may take LANTUS at any time during the day but you must take it at the same time every
day.

Only use LANTUS that is clear and colorless. If your LANTUS is cloudy or slightly colored, return
it to your pharmacy for a replacement.

Follow your healthcare provider’s instructions for testing your blood sugar.

Inject LANTUS under your skin (subcutaneously) in your upper arm, abdomen (stomach area), or
thigh (upper leg). Never inject it into a vein or muscle.

Change (rotate) injection sites within the same body area.

What kind of syringe should I use?

Always use a syringe that is marked for U-100 insulin. If you use other than U-100 insulin syringe,
you may get the wrong dose of insulin causing serious problems for you, such as a blood sugar
level that is too low or too high. Always use a new needle and syringe each time you give LANTUS
injection.

NEEDLES AND SYRINGES MUST NOT BE SHARED.

Disposable syringes and needles should be used only once. Used syringe and needle should be
placed in sharps containers (such as red biohazard containers), hard plastic containers (such as
detergent bottles), or metal containers (such as an empty coffee can). Such containers should be
sealed and disposed of properly.

Mixing with 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.

Instructions for Use
How do I draw the insulin into the syringe?

The syringe must be new and does not contain any other medicine.

Do not mix LANTUS with any other type of insulin.

Follow these steps:

1. Wash your hands with soap and water or with alcohol.
2. Check the insulin to make sure it is clear and colorless. Do not use the insulin after the expiration

date stamped on the label, if it is colored or cloudy, or if you see particles in the solution.

3. If you are using a new vial, remove the protective cap.

Do not

remove the stopper.

4. Wipe the top of the vial with an alcohol swab. You do not have to shake the vial of LANTUS before

use.

5. Use a new needle and syringe every time you give an injection. Use disposable syringes and

needles only once. Throw them away properly.

Never

share needles and syringes.

6. Draw air into the syringe equal to your insulin dose. Put the needle through the rubber top of the

vial and push the plunger to inject the air into the vial.

7. Leave the syringe in the vial and turn both upside down. Hold the syringe and vial firmly in one

hand.

8. Make sure the tip of the needle is in the insulin. With your free hand, pull the plunger to withdraw

the correct dose into the syringe.

9. Before you take the needle out of the vial, check the syringe for air bubbles. If bubbles are in

the syringe, hold the syringe straight up and tap the side of the syringe until the bubbles float to
the top. Push the bubbles out with the plunger and draw insulin back in until you have the correct
dose.

10. Remove the needle from the vial. Do not let the needle touch anything. You are now ready to

inject.

How do I inject LANTUS?

Inject LANTUS under your skin. Take LANTUS as prescribed by your healthcare provider.
Follow these steps:

1. Decide on an injection area - either upper arm, thigh or abdomen. Injection sites within an injection

area must be different from one injection to the next.

2. Use alcohol or soap and water to clean the injection site. The injection site should be dry before

you inject.

3. Pinch the skin. Stick the needle in the way your healthcare provider showed you. Release the

skin.

4. Slowly push in the plunger of the syringe all the way, making sure you have injected all the insulin.

Leave the needle in the skin for about 10 seconds.

5. Pull the needle straight out and gently press on the spot where you injected yourself for several

seconds.

Do not rub the area.

6. Follow your healthcare providers instructions for throwing away the used needle and syringe. Do

not recap the used needle. Used needle and syringe should be placed in sharps containers (such

7

Lantus PI.April.2010

Summary of Contents for SoloSTAR

Page 1: ... back STARring the 1 prescribed insulinb Indications and Usage for Lantus Prescription Lantus is a long acting insulin used to treat adults with type 2 diabetes and adults and children 6 years and older with type 1 diabetes for the control of high blood sugar It should be taken once a day at the same time each day to lower blood glucose Do not use Lantus to treat diabetic ketoacidosis Important Sa...

Page 2: ...he full instruction leaflet accompanying the 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 providers You can also go online to www lantussolostar com or call the 24 hour support line at 1 800 633 1610 Before starting take a look...

Page 3: ...re UNOPENED Lantus SoloSTAR pens in the refrigerator Why The cooler temperature will protect the insulin in the pen until you are ready to use it Don t inject cold insulin Wait until the pen has been out of the refrigerator and warms up to room temperature After opening the pen you should not refrigerate it and you can use it for up to 28 days Why Injecting cold insulin could make it feel more unc...

Page 4: ...to do Always use a new needle Remember needles are not supplied with the pen See page 11 or talk to your healthcare provider Why Re using a needle can block the insulin from injecting correctly and can also cause contamination and infection Also the needle can become dull and make the injection less comfortable The needle for the pen is available as a screw on needle or as a push on needle Importa...

Page 5: ...another needle if no insulin comes out after doing the test 3 times DON T use the pen if no insulin comes out after using a second needle What to do It is very important to always do a safety test before an injection Why The safety test removes air bubbles which helps you get the most accurate dose It also makes sure that the pen and needle are working right The safety test does not waste insulin ...

Page 6: ...the injection button while dialing your dose DON T try to set the dose selector to half units or the pen may jam What to do Make sure the dose window is at 0 before dialing your dose Why If the dose window is not at 0 you will inject more insulin than you need That can affect your blood sugar level Make sure to remove the protective seal Check to see that you have enough insulin in the pen for you...

Page 7: ...e Why These areas have more fat and less nerve endings You may feel less discomfort in these areas Choose a new spot in the area each time you inject a dose Why Injecting in the same spot can make a small depression in your skin or make it thicken This may cause more discomfort Never force the needle Why Forcing the needle can hurt and may damage it It can also affect how much insulin you get Impo...

Page 8: ...eria and infection from you to another person or from another person to you Please see additional Important Safety Information for Lantus on page 9 Please see accompanying full prescribing information for Lantus How to remove the needle How to do it 1 Put the outer needle cap back on the needle 2 Use the outer needle cap to unscrew or pull the needle from the pen 3 Discard the needle and the needl...

Page 9: ...people may experience symptoms such as shaking sweating fast heartbeat and blurred vision Severe hypoglycemia may be serious and life threatening It may cause harm to your heart or brain Other possible side effects may include injection site reactions including changes in fat tissue at the injection site and allergic reactions including itching and rash In rare cases some allergic reactions may be...

Page 10: ...st always use a new needle Storing and Caring for the Pen 7 What should I do with the pen if I have been using it for 28 days You should throw the pen away if you have opened it and have been using it for 28 days even if there is still insulin left in the pen 8 Does the 28 day limit for using the pen also apply to unopened pens Unopened pens can be stored at room temperature for up to 28 days and ...

Page 11: ...e in the following sizes 4 mm 5 32 32G Nano NDC HRI No 08290 3201 22 5 mm 3 16 31G Mini NDC HRI No 08290 3201 19 8 mm 5 16 31G Short NDC HRI No 08290 3201 09 For additional help visit www lantussolostar com or call 1 800 633 1610 Please see Important Safety Information for Lantus on page 9 Please see accompanying full prescribing information for Lantus US GLA 12 03 160 2012 Sanofi U S LLC A SANOFI...

Page 12: ...CATIONS 5 WARNINGS AND PRECAUTIONS 5 1 Dosage adjustment and monitoring 5 2 Administration 5 3 Hypoglycemia 5 4 Hypersensitivity and allergic reactions 5 5 Renal impairment 5 6 Hepatic impairment 5 7 Drug interactions 6 ADVERSE REACTIONS 6 1 Clinical trial experience 6 2 Postmarketing experience 7 DRUG INTERACTIONS 8 USE IN SPECIFIC POPULATIONS 8 1 Pregnancy 8 3 Nursing Mothers 8 4 Pediatric Use 8...

Page 13: ...aution in patients with hypoglycemia unawareness and in patients who may be predisposed to hypoglycemia e g the pediatric population and patients who fast or have erratic food intake The patient s ability to concentrate and react may be impaired as a result of hypoglycemia This may present a risk in situations where these abilities are especially important such as driving or operating other machin...

Page 14: ... generalized skin reactions an gioedema bronchospasm hypotension and shock may occur with any insulin including LANTUS and may be life threatening Antibody production All insulin products can elicit the formation of insulin antibodies The presence of such insulin antibodies may increase or decrease the efficacy of insulin and may require adjustment of the insulin dose In phase 3 clinical trials of...

Page 15: ...ration time profile has been demonstrated The duration of action after abdominal deltoid or thigh subcutaneous administration was similar Metabolism A metabolism study in humans indicates that insulin glargine is partly metabolized at the carboxyl terminus of the B chain in the subcutaneous depot to form two active metabolites with in vitro activity similar to that of insulin M1 21A Gly insulin an...

Page 16: ...NPH insulin either continued on the same total daily NPH insulin dose or started LANTUS at a dose that was 80 of the total previous NPH insulin dose The primary endpoint for this study was a comparison of the progression of diabetic retinopathy by 3 or more steps on the Early Treatment Diabetic Retinopathy Study ETDRS scale HbA1c change from baseline was a secondary endpoint Similar glycemic contr...

Page 17: ...rless with no particles visible Mixing and diluting LANTUS must NOT be diluted or mixed with any other insulin or solution See Warnings and Precautions 5 2 Vial The syringes must not contain any other medicinal product or residue Cartridge system SoloStar If OptiClik the Insulin Delivery Device used with the LANTUS cartridge system or SoloStar disposable insulin device malfunctions LANTUS may be d...

Page 18: ...her medicines or changes in diet or activity level Talk to your healthcare provider about how to adjust your insulin dose You may take LANTUS at any time during the day but you must take it at the same time every day Only use LANTUS that is clear and colorless If your LANTUS is cloudy or slightly colored return it to your pharmacy for a replacement Follow your healthcare provider s instructions fo...

Page 19: ... healthcare provider about the amount of carbohydrates you should eat to treat mild to moderate hypoglycemia Severe hypoglycemia may require the help of another person or emergency medical people A person with hypoglycemia who is unable to take foods or liquids with sugar by mouth or is unconscious needs medical help fast and will need treatment with a glucagon injection or glucose given intraveno...

Page 20: ...TUS under your skin subcutaneously in your upper arm abdomen stomach area or thigh upper leg Never inject it into a vein or muscle Change rotate injection sites within the same body area What kind of insulin Pen should I use Always use the OptiClik device distributed by sanofi aventis If you use any other device than OptiClik insulin Pen with this cartridge you may get the wrong dose of insulin ca...

Page 21: ...ave any side effects that bother you These are not all the side effects of LANTUS Ask your healthcare provider or pharmacist for more information How should I store LANTUS Unopened cartridge system Store new unopened LANTUS cartridge systems in a refrigerator not the freezer between 36 F to 46 F 2 C to 8 C Do not freeze LANTUS Keep LANTUS out of direct heat and light If a cartridge system has been...

Page 22: ...her medicines Know all the medicines you take including prescription and non prescription medicines vitamins and herbal supplements You may want to keep a list of the medicines you take You can show this list to your healthcare provider and pharmacists anytime you get a new medicine or refill Your healthcare provider will tell you if your insulin dose needs to be changed Meals The amount of food y...

Page 23: ...ay Open In Use SoloStar Once SoloStar is opened in use SoloStar should NOT be refrigerated but should be kept at room temperature below 86 F 30 C away from direct heat and light The opened in use SoloStar kept at room temperature must be discarded after 28 days These storage conditions are summarized in the following table Not in use unopened Refrigerated Not in use unopened Room Temperature In us...

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