Lantus Solostar User manual

Please see additional Important Safety Information for Lantus®on page 9.

Please see accompanying full prescribing information for Lantus ®

How to Use the

Lantus®SoloSTAR®

Pre-filled Insulin Pen

A Quick Reference Guide

Go online to www.lantussolostar.com for a free video

demonstration or call the 24-hour helpline

1-800-633-1610 to talk to a Lantus®SoloSTAR®experta

a Leave a message and a Lantus®SoloSTAR®expert will call you back.

STARring the #1- rescribed 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 Safety Information for Lantus®

Do not take Lantus®if you are allergic to insulin or any of the inactive ingredients in Lantus®.

bBased on TRx data fro IMS Health,NPATMMonthly database, ti e period fro

May 2003 to Nove ber 2011.

1 0

Please see additional Important Safety Information for

Lantus ®on page 9.

Please see accompanying full prescribing information

for Lantus ®

Congratulations on using the Lantus®SoloSTAR®insulin

pen. Lantus® SoloSTAR®is easy to use and easy to inject.

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. therwise, you may get

too little or too much insulin, and that can affect your blood

sugar levels.

• If you are using a new or unopened pen, remember to

take it out of the refrigerator 1 to 2 hours before using it.

There is less discomfort when you inject your insulin if it

is at room temperature

• Do not use the pen past the expiration date on the box

These instructions are supplied as a guide only. Read the

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

at the Lantus®SoloSTAR®

en and its arts

Filled with

Lantus®, a long-

lasting insulin

Has a flat,

smooth button

Lantus®

SoloSTAR®

pen is grey

Outer

needle cap

Inner needle

cap

eedle

Protective

seal

Rubber

seal

Pen cap

Insulin

reservoir

Dose

selector

Dose

window

Injection

button

*Sanofi US recommends using the BD Ultra-Fine™ pen needles.

Pen

Pen needle

(not included)*

Important Safety Information

for Lantus® SoloSTAR®

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.

Visit www.lantushelpteam.com to sign up for

FREE online educational sessions

For additional help, visit

www.lantussolostar.com

or call 1-800-633-1610

Please see additional Important Safety Information for

Lantus ®on page 9.

Please see accompanying full prescribing information

for Lantus ®

How to get ready for

an injection

DOs and DON’Ts

DO check the expiration date on the pen box.

DO ’T use the pen past the expiration date on the box.

DO ’T refrigerate the pen after opening it.

DO ’T use the pen if it has been open for longer than

28 days.

How to do it

1. Remove pen cap

2. Before beginning, check to see that the insulin in the pen

is clear and colorless. If it is not clear or has particles, do

not use that Lantus®SoloSTAR®pen. Use another pen or

call the 24-hour helpline at 1-800-633-1610

What to do

Always store U OPE ED 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

uncomfortable. But it’s not dangerous

Always wash your hands with soap and water

before an injection

Why? Washing your hands will kill a lot of bacteria on

them. That will help prevent getting an infection

or contaminating the pen

Important Safety Information

for Lantus®

You must 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.

USE DO ’T USE

For additional help, visit

www.lantussolostar.com

or call 1-800-633-1610

How to correctly attach

a needle

How to do it

1. Keep the needle straight and not on an angle when you

screw it on. Don’t make the needle too tight. If you have

a push-on needle, keep it straight as you push it on

2. After you have attached the needle, take off the outer

needle cap

— Don’t throw the outer needle cap away; you will need

it to safely remove the needle after your injection

3. Remove the inner needle cap and throw it away

DOs and DON’Ts

DO throw away the inner needle cap.

DO use a new needle for each injection.

DO hold the needle straight when attaching it.

DO ’T throw away the outer needle cap.

What 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

Important Safety Information

for Lantus®

Do OT 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. Do not share needles, insulin pens or

syringes with others.

RIGHT WRO G

Please see additional Important Safety Information for

Lantus ®on page 9.

Please see accompanying full prescribing information

for Lantus ®

Please see additional Important Safety Information for

Lantus ®on page 9.

Please see accompanying full prescribing information

for Lantus ®

How to do a safety test

How to do it

1. Dial a test dose of 2 Units

2. Hold the pen with the needle pointing up. Then gently tap

the reservoir so the air bubbles rise up to the needle

3. Press the injection button all the way in (A) and check to

see that insulin comes out of the needle (B)

—The dial will automatically go back to zero after you

perform the test

4. If no insulin comes out, repeat the test 2 more times

5. If there is still no insulin coming out, use a new needle

and do the safety test again

1 0

IMPORTA T! If there is still no insulin coming out after the

fourth test, DO OT USE THAT PE ; USE A OTHER PE .

If you don’t have any pens left, call your pharmacy. You can

also call the 24-hour helpline at 1-800-633-1610.

1 0

DOs and DON’Ts

DO hold the pen with the needle pointing up.

DO use another needle if no insulin comes out after doing

the test 3 times.

DO ’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 (there is a little extra insulin in the pen

for the tests)

Important Safety Information

for Lantus®(insulin glargine [rDNA origin] injection)

The most common side effect of insulin, including

Lantus®, is low blood sugar (hypoglycemia), which may

be serious. Some 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. ther 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 life threatening.

For additional help, visit

www.lantussolostar.com

or call 1-800-633-1610

Please see additional Important Safety Information for

Lantus ®on page 9.

Please see accompanying full prescribing information

for Lantus ®

How to select the dose

How to do it

1. Dial your dose (This example shows a dose of 10 units)

2. If you don’t dial the right dose, you can dial back

up or down

—Dose cannot be dialed past the number of units left

in the pen

3. You cannot dial more than 80 units because the

pen automatically has a safety stop. If you need a

dose of more than 80 units you must give yourself

another injection

If you have enough insulin left in the pen, you can redial

the rest of your dose. If you don’t have enough insulin,

use a new pen

—You must attach a new needle and discard the one you

just used (See step 6 on page 8)

DOs and DON’Ts

DO ’T force the dose selector when dialing your dose.

DO ’T push the injection button while dialing your dose.

DO ’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 your dose. Try dialing your dose. If the pen

doesn’t let you dial your dose, then you don’t

have enough insulin left. Your dose cannot be

dialed past the number of units left in the pen

Important Safety Information

for Lantus®

Tell your doctor about other medicines and supplements

you are taking because they can change the way insulin

works. Before starting Lantus®, tell your doctor about all

your medical conditions including if you have liver or kidney

problems, are pregnant or planning to become pregnant, or

are breast-feeding or planning to breast-feed.

For additional help, visit

www.lantussolostar.com

or call 1-800-633-1610

How to inject your dose

How to do it

1. Keeping the pen straight, insert the needle into your skin

2. Using your thumb, press the injection button all

the way down

3. Then slowly count to 10. Counting to 10 ill make sure

that you get your full insulin dose

4. After counting a full 10 seconds, release the button and

remove the needle from your skin

1 0

10 secs

DOs and DON’Ts

DO count to 10 after pressing the button.

DO take the needle from your skin if you dial another dose.

DO ’T rub the injection spot after an injection.

DO ’T inject in the same spot every time.

What to do

Inject your dose into one of the

3 areas shown in the picture

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

ever force the needle

Why? Forcing the needle can hurt and may damage

it. It can also affect how much insulin you get

Important Safety Information

for Lantus® SoloSTAR®

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.

abdomen

upper arms

thighs

For additional help, visit

www.lantussolostar.com

or call 1-800-633-1610

Please see additional Important Safety Information for

Lantus ®on page 9.

Please see accompanying full prescribing information

for Lantus ®

DOs and DON’Ts

DO use the outer needle cap to remove the needle.

DO ’T reuse the needle; discard it safely.

DO ’T refrigerate the pen after using it.

What to do

Always remove the needle from the pen after

each injection

Why? Removing the needle helps prevent

contamination and infection. It also prevents

insulin from leaking

Throw away the needle. Rules for throwing away

needles are different in each state. So check

with your healthcare provider. You can also

visit www.safeneedledisposal.org for

state-by-state instructions

Why? A needle can hurt someone else if it is not

thrown away right. Also, bacteria can spread

from the needle to another person, which could

cause infection

ever share your needle or pen with

another person

Why? Sharing your needle can spread bacteria 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 needle cap the way your

healthcare provider told you to do it. Also visit

www.safeneedledisposal.org

4. Put the pen cap back on the pen and store it in

a safe place, such as your medicine cabinet

Important Safety Information

for Lantus®

You must 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.

1 0

For additional help, visit

www.lantussolostar.com

or call 1-800-633-1610

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 Safety Information

for Lantus®

Do not take Lantus®if you are allergic to insulin or any of

the inactive ingredients in Lantus®.

You must 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®ith 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. Do not share needles, insulin pens or

syringes ith others.

The most common side effect of insulin, including

Lantus®, is lo blood sugar (hypoglycemia), hich

may be serious. Some 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.

ther 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 life threatening.

Tell your doctor about other medicines and supplements

you are taking because they can change the way insulin

works. Before starting Lantus®, tell your doctor about all

your medical conditions including if you have liver or

kidney problems, are pregnant or planning to become

pregnant, or are breast-feeding or planning to breast-feed.

Important Safety Information

for Lantus®SoloSTAR®

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.

Please see full prescribing information for Lantus ®

on page 12.

Visit www.lantushelpteam.com to sign up for

FREE online educational sessions

Go online to

www.lantussolostar.com for

a free video demonstration or call

the 24-hour helpline

1-800-633-1610 to talk

to a Lantus®SoloSTAR®experta

a Leave a message and a Lantus®SoloSTAR®expert

will call you back.

Frequently asked

questions

Getting Started

1. Why must I always wash my hands before using the

Lantus®SoloSTAR®pen?

Many bacteria live on the surfaces of your hands.

Bacteria can cause infection if they get into the skin.

Washing your hands before injecting yourself will greatly

reduce the chance of your getting an infection.

In ecting with the Pen

2. Does using the Lantus®SoloSTAR®pen hurt?

The pen uses a small and very thin needle. The insulin is

injected into the fatty layers just under your skin, where

there are fewer nerve endings than in other places.

3. Do I need to use a new pen each time I give myself

an injection?

No, you do not need to use a new pen each time you

give yourself an injection. Each Lantus®SoloSTAR®pen

contains 300 Units of insulin. Use the same pen until

there is no more insulin left. The pen can be used for

28 days once you open it and start to use it.

4. Can I use the same needle more than one time?

No, always attach a new, sterile needle. Using the same

needle may cause contamination, air bubbles, or spread

infection.

5. What do I do if my Lantus®SoloSTAR®pen jams?

You can call a Lantus®SoloSTAR®pen expert at the

24-hour hotline 1-800-633-1610 and leave a

message. You will be called back. In the meantime,

use another pen to inject your insulin.

6. What do I do if there’s not enough insulin

in the pen?

If there is not enough insulin in the pen for your dose,

you can use another pen to finish your dose.

Remember, the pen will not let you dial more than the

number of insulin units left in the pen. You must 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 should be discarded after that. If

unopened pens are kept refrigerated they may be used

until their expiration date.

9. Is there any special way that the Lantus®SoloSTAR®

pen has to be discarded?

Always discard the pen with the pen cap on. You can

discard it in regular trash. But always discard the

needles the way your healthcare provider told you to do

it. Also visit www.safeneedledisposal.org.

10. Do I need to keep my Lantus®SoloSTAR®pen in the

refrigerator after I have opened it?

No, do not refrigerate the pen after you have started

using it. nly pens that have not been opened should be

stored in the refrigerator.

11. How do I take care of my Lantus®SoloSTAR®pen?

Protect your pen from dust and dirt. Clean the outside of

the pen with a damp cloth. Do not run it under water or

use any soap or other cleansers.

Insurance

12. Is the Lantus®SoloSTAR®pen covered

by insurance?

Yes, most insurance plans cover the pen. The co-pay is

the same for the pen as it is for a vial and syringe. And

with the Lantus®SoloSTAR®pen, you can get up to 500

more units of insulin with each prescription. But that

depends on how the prescription is filled. Ask your

pharmacist or healthcare provider for more information.

FAQs

Please see Important Safety Information for Lantus®

on page 9.

Please see accompanying full prescribing information

for Lantus ®

The Lantus®SoloSTAR®insulin en can be

used with BD Ultra-Fine™ en needlesa

aUltra-Fine is a trade ark of Becton, Dickinson and Co pany.

Your healthcare provider may prescribe Ultra-Fine™

pen needles. They come in the following sizes:

4 mm (5/32") 32G ano 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

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LANTUS safely and

effectively. See full prescribing information for LANTUS.

LANTUS

(insulin glargine [rDNA origin] injection) solution for subcutaneous injection

Initial U.S. Approval: 2000

—————————————— INDICATIONS AND USAGE ——————————————

LANTUS is a long- acting human insulin analog indicated to improve glycemic control in adults and

children with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. (1)

Important Limitations of Use:

•Not recommended for treating diabetic ketoacidosis. Use intravenous, short-acting insulin

instead.

————————————— DOSAGE AND ADMINISTRATION —————————————

•The starting dose should be individualized based on the type of diabetes and whether the

patient is insulin-naïve (2.1, 2.2, 2.3)

•Administer subcutaneously once daily at any time of day, but at the same time every day. (2.1)

•Rotate injection sites within an injection area (abdomen, thigh, or deltoid) to reduce the risk

of lipodystrophy. (2.1)

•Converting from other insulin therapies may require adjustment of timing and dose of LANTUS.

Closely monitor glucoses especially upon converting to LANTUS and during the initial weeks

thereafter. (2.3)

———————————— DOSAGE FORMS AND STRENGTHS ————————————

Solution for injection 100 units/mL (U-100) in

•10 mL vials

•3 mL cartridge system for use in OptiClik (Insulin Delivery Device)

•3 mL SoloStar disposable insulin device (3)

——————————————— CONTRAINDICATIONS ———————————————

Do not use in patients with hypersensitivity to LANTUS or one of its excipients (4)

————————————— WARNINGS AND PRECAUTIONS —————————————

•Dose adjustment and monitoring: Monitor blood glucose in all patients treated with insulin.

Insulin regimens should be modiﬁed cautiously and only under medical supervision (5.1)

•Administration: Do not dilute or mix with any other insulin or solution. Do not administer

subcutaneously via an insulin pump or intravenously because severe hypoglycemia can occur

(5.2)

•Do not share reusable or disposable insulin devices or needles between patients (5.2)

•Hypoglycemia: Most common adverse reaction of insulin therapy and may be life-threatening

(5.3, 6.1)

•Allergic reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can

occur (5.4, 6.1)

•Renal or hepatic impairment: May require a reduction in the LANTUS dose (5.5, 5.6)

——————————————— ADVERSE REACTIONS ———————————————

Adverse reactions commonly associated with Lantus are:

•Hypoglycemia, allergic reactions, injection site reaction, lipodystrophy, pruritus, and rash. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact sanoﬁ-aventis at 1-800-633-1610 or

FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

——————————————— DRUG INTERACTIONS ———————————————

•Certain drugs may affect glucose metabolism, requiring insulin dose adjustment and close

monitoring of blood glucose. (7)

•The signs of hypoglycemia may be reduced or absent in patients taking anti-adrenergic drugs

(e.g., beta-blockers, clonidine, guanethidine, and reserpine). (7)

———————————— USE IN SPECIFIC POPULATIONS ————————————

•Pregnancy category C: Use during pregnancy only if the potential beneﬁt justiﬁes the potential

risk to the fetus (8.1)

•Pediatric: Has not been studied in children with type 2 diabetes. Has not been studied in

children with type 1 diabetes <6 years of age (8.4)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling

Revised: 04/2010

FULL PRESCRIBING INFORMATION: CONTENTS*

1. INDICATIONS AND USAGE

2. DOSAGE AND ADMINISTRATION

2.1 Dosing

2.2 Initiation of LANTUS therapy

2.3 Converting to LANTUS from other insulin therapies

3. DOSAGE FORMS AND STRENGTHS

4. CONTRAINDICATIONS

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

8.5 Geriatric Use

10. OVERDOSAGE

11. DESCRIPTION

12. CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13. NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14. CLINICAL STUDIES

16. HOW SUPPLIED/STORAGE AND HANDLING

16.1 How supplied

16.2 Storage

16.3 Preparation and handling

17. PATIENT COUNSELING INFORMATION

17.1 Instructions for patients

17.2 FDA approved patient labeling

*Sections or subsections omitted from the full prescribing information are not listed

FULL PRESCRIBING INFORMATION

1. INDICATIONS AND USAGE

LANTUS is indicated to improve glycemic control in adults and children with type 1 diabetes mellitus

and in adults with type 2 diabetes mellitus.

Important Limitations of Use:

•LANTUS is not recommended for the treatment of diabetic ketoacidosis. Intravenous short-acting

insulin is the preferred treatment for this condition.

2. DOSAGE AND ADMINISTRATION

2.1 Dosing

LANTUS is a recombinant human insulin analog for once daily subcutaneous administration with

potency that is approximately the same as the potency of human insulin. LANTUS exhibits a relatively

constant glucose-lowering proﬁle over 24 hours that permits once-daily dosing.

LANTUS may be administered at any time during the day. LANTUS should be administered

subcutaneously once a day at the same time every day. The dose of LANTUS must be individualized

based on clinical response. Blood glucose monitoring is essential in all patients receiving insulin

therapy.

Patients adjusting the amount or timing of dosing with LANTUS, should only do so under medical

supervision with appropriate glucose monitoring [see Warnings and Precautions (5.1).]

In patients with type 1 diabetes, LANTUS must be used in regimens with short-acting insulin.

The intended duration of activity of LANTUS is dependent on injection into subcutaneous tissue [see

Clinical pharmacology (12.2)]. LANTUS should not be administered intravenously or via an insulin

pump. Intravenous administration of the usual subcutaneous dose could result in severe hypoglycemia

[see Warnings and Precautions (5.3)].

As with all insulins, injection sites should be rotated within the same region (abdomen, thigh, or deltoid)

from one injection to the next to reduce the risk of lipodystrophy [See Adverse Reactions (6.1)].

In clinical studies, there was no clinically relevant difference in insulin glargine absorption after

abdominal, deltoid, or thigh subcutaneous administration. As for all insulins, the rate of absorption, and

consequently the onset and duration of action, may be affected by exercise and other variables, such

as stress, intercurrent illness, or changes in co-administered drugs or meal patterns.

2.2 Initiation of LANTUS therapy

The recommended starting dose of LANTUS in patients with type 1 diabetes should be approximately

one-third of the total daily insulin requirements. Short-acting, premeal insulin should be used to satisfy

the remainder of the daily insulin requirements.

The recommended starting dose of LANTUS in patients with type 2 diabetes who are not currently

treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted to

the patient’s needs.

Lantus PI.April.2010

The dose of LANTUS should be adjusted according to blood glucose measurements. The dosage of

LANTUS should be individualized under the supervision of a healthcare provider in accordance with

the needs of the patient.

2.3 Converting to LANTUS from other insulin therapies

If changing from a treatment regimen with an intermediate- or long-acting insulin to a regimen with

LANTUS, the amount and timing of shorter-acting insulins and doses of any oral anti-diabetic drugs

may need to be adjusted.

•If transferring patients from once-daily NPH insulin to once-daily LANTUS, the recommended initial

LANTUS dose is the same as the dose of NPH that is being discontinued.

•If transferring patients from twice-daily NPH insulin to once-daily LANTUS, the recommended initial

LANTUS dose is 80% of the total NPH dose that is being discontinued. This dose reduction will

lower the likelihood of hypoglycemia [see Warnings and Precautions (5.3)].

3. DOSAGE FORMS AND STRENGTHS

LANTUS solution for injection 100 Units per mL is available as:

- 10 mL Vial (1000 Units/10 mL)

- 3 mL Cartridge systems for use only in OptiClik

(300 Units/3 mL)

- 3 mL SoloStar

disposable insulin device (300 Units/3 mL)

4. CONTRAINDICATIONS

LANTUS is contraindicated in patients with hypersensitivity to LANTUS or one of its excipients.

5. WARNINGS AND PRECAUTIONS

5.1 Dosage adjustment and monitoring

Glucose monitoring is essential for all patients receiving insulin therapy. Changes to an insulin regimen

should be made cautiously and only under medical supervision.

Changes in insulin strength, manufacturer, type, or method of administration may result in the need for

a change in insulin dose or an adjustment in concomitant oral anti-diabetic treatment.

As with all insulin preparations, the time course of action for LANTUS may vary in different individuals

or at different times in the same individual and is dependent on many conditions, including the local

blood supply, local temperature, and physical activity.

5.2 Administration

Do not administer LANTUS intravenously or via an insulin pump. The intended duration of activity of

LANTUS is dependent on injection into subcutaneous tissue

Intravenous administration of the usual subcutaneous dose could result in severe hypoglycemia [see

Warnings and Precautions (5.3)].

Do not dilute or mix LANTUS with any other insulin or solution. If LANTUS is diluted or mixed, the

solution may become cloudy, and the pharmacokinetic or pharmacodynamic proﬁle (e.g., onset of

action, time to peak effect) of LANTUS and the mixed insulin may be altered in an unpredictable

manner. When LANTUS and regular human insulin were mixed immediately before injection in dogs,

a delayed onset of action and a delayed time to maximum effect for regular human insulin was

observed. The total bioavailability of the mixture was also slightly decreased compared to separate

injections of LANTUS and regular human insulin. The relevance of these observations in dogs to

humans is unknown.

Do not share disposable or reusable insulin devices or needles between patients, because doing so

carries a risk for transmission of blood-borne pathogens.

5.3 Hypoglycemia

Hypoglycemia is the most common adverse reaction of insulin, including LANTUS. The risk of

hypoglycemia increases with intensive glycemic control. Patients must be educated to recognize and

manage hypoglycemia. Severe hypoglycemia can lead to unconsciousness or convulsions and may

result in temporary or permanent impairment of brain function or death. Severe hypoglycemia requiring

the assistance of another person or parenteral glucose infusion or glucagon administration has been

observed in clinical trials with insulin, including trials with LANTUS.

The timing of hypoglycemia usually reﬂects the time-action proﬁle of the administered insulin

formulations. Other factors such as changes in food intake (e.g., amount of food or timing of meals),

exercise, and concomitant medications may also alter the risk of hypoglycemia [See Drug Interactions

(7)].

The prolonged effect of subcutaneous LANTUS may delay recovery from hypoglycemia. Patients being

switched from twice daily NPH insulin to once-daily LANTUS should have their initial LANTUS dose

reduced by 20% from the previous total daily NPH dose to reduce the risk of hypoglycemia [see Dosage

and Administration (2.3)].

As with all insulins, use caution 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 machinery.

Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions,

such as longstanding diabetes, diabetic neuropathy, use of medications such as beta-blockers, or

intensiﬁed glycemic control. These situations may result in severe hypoglycemia (and, possibly, loss

of consciousness) prior to the patient’s awareness of hypoglycemia.

5.4 Hypersensitivity and allergic reactions

Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products,

including LANTUS.

5.5 Renal impairment

Due to its long duration of action, Lantus is not recommended during periods of rapidly declining renal

function because of the risk for prolonged hypoglycemia.

Although studies have not been performed in patients with diabetes and renal impairment, a reduction

in the LANTUS dose may be required in patients with renal impairment because of reduced insulin

metabolism, similar to observations found with other insulins. [See Clinical Pharmacology (12.3)].

5.6 Hepatic impairment

Due to its long duration of action, Lantus is not recommended during periods of rapidly declining hepatic

function because of the risk for prolonged hypoglycemia.

Although studies have not been performed in patients with diabetes and hepatic impairment, a reduction

in the LANTUS dose may be required in patients with hepatic impairment because of reduced capacity

for gluconeogenesis and reduced insulin metabolism, similar to observations found with other insulins.

[See Clinical Pharmacology (12.3)].

5.7 Drug interactions

Some medications may alter insulin requirements and subsequently increase the risk for hypoglycemia

or hyperglycemia [See Drug Interactions (7)].

6. ADVERSE REACTIONS

The following adverse reactions are discussed elsewhere:

•Hypoglycemia [See Warnings and Precautions (5.3)]

•Hypersensitivity and allergic reactions [See Warnings and Precautions (5.4)]

6.1 Clinical trial experience

Because clinical trials are conducted under widely varying designs, the adverse reaction rates reported

in one clinical trial may not be easily compared to those rates reported in another clinical trial, and may

not reﬂect the rates actually observed in clinical practice.

The frequencies of treatment-emergent adverse events during LANTUS clinical trials in patients with

type 1 diabetes mellitus and type 2 diabetes mellitus are listed in the tables below.

Table 1: Treatment –emergent adverse events in pooled clinical trials up to 28 weeks

duration in adults with type 1 diabetes (adverse events with frequency ≥5%)

LANTUS, %

(n=1257)

NPH, %

(n=1070)

Upper respiratory tract infection 22.4 23.1

Infection

9.4 10.3

Accidental injury 5.7 6.4

Headache 5.5 4.7

*Body System not Speciﬁed

Table 2: Treatment –emergent adverse events in pooled clinical trials up to 1 year

duration in adults with type 2 diabetes (adverse events with frequency ≥5%)

LANTUS, %

(n=849)

NPH, %

(n=714)

Upper respiratory tract infection 11.4 13.3

Infection

10.4 11.6

Retinal vascular disorder 5.8 7.4

*Body System not Speciﬁed

Table 3: Treatment –emergent adverse events in a 5-year trial of adults with type 2

diabetes (adverse events with frequency ≥10%)

LANTUS, %

(n=514)

NPH, %

(n=503)

Upper respiratory tract infection 29.0 33.6

Edema peripheral 20.0 22.7

Hypertension 19.6 18.9

Inﬂuenza 18.7 19.5

Sinusitis 18.5 17.9

Cataract 18.1 15.9

Bronchitis 15.2 14.1

Arthralgia 14.2 16.1

Pain in extremity 13.0 13.1

Back pain 12.8 12.3

Cough 12.1 7.4

Urinary tract infection 10.7 10.1

Diarrhea 10.7 10.3

Depression 10.5 9.7

Headache 10.3 9.3

Table 4: Treatment –emergent adverse events in a 28-week clinical trial of children and

adolescents with type 1 diabetes (adverse events with frequency ≥5%)

LANTUS, %

(n=174)

NPH, %

(n=175)

Infection

13.8 17.7

Upper respiratory tract infection 13.8 16.0

Pharyngitis 7.5 8.6

Rhinitis 5.2 5.1

*Body System not Speciﬁed

•Severe Hypoglycemia

Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including

LANTUS [See Warnings and Precautions (5.3)]. Tables 5 and 6 summarize the incidence of severe

hypoglycemia in the LANTUS individual clinical trials. Severe symptomatic hypoglycemia was deﬁned

Lantus PI.April.2010

as an event with symptoms consistent with hypoglycemia requiring the assistance of another person

and associated with either a blood glucose below 50 mg/dL (≤56 mg/dL in the 5-year trial) or prompt

recovery after oral carbohydrate, intravenous glucose or glucagon administration.

The rates of severe symptomatic hypoglycemia in the LANTUS clinical trials (see Section 14 for a

description of the study designs) were comparable for all treatment regimens (see Tables 5 and 6). In

the pediatric phase 3 clinical trial, children and adolescents with type 1 diabetes had a higher incidence

of severe symptomatic hypoglycemia in the two treatment groups compared to the adult trials with type

1 diabetes. (see Table 5) [See Clinical Studies (14)].

Table 5: Severe Symptomatic Hypoglycemia in Patients with Type 1 Diabetes

Study A

Type 1

Diabetes Adults

28 weeks

In combination

with regular

insulin

Study B

Type 1

Diabetes Adults

28 weeks

In combination

with regular

insulin

Study C

Type 1

Diabetes Adults

16 weeks

In combination

with insulin

lispro

Study D

Type 1

Diabetes

Pediatrics

26 weeks

In combination

with regular

insulin

LANTUS NPH LANTUS NPH LANTUS NPH LANTUS NPH

Percent

patients

(n/total

10.6

(31/

292)

15.0

(44/

293)

8.7

(23/

264)

10.4

(28/

270)

6.5

(20/

310)

5.2

(16/

309)

23.0

(40/

174)

28.6

(50/

175)

Table 6: Severe Symptomatic Hypoglycemia in Patients with Type 2 Diabetes

Study E

Type 2

Diabetes Adults

52 weeks

In combination with

oral agents

Study F

Type 2

Diabetes Adults

28 weeks

In combination with

regular insulin

Study G

Type 2

Diabetes Adults

5 years

In combination with

regular insulin

LANTUS NPH LANTUS NPH LANTUS NPH

Percent

patients

(n/total

1.7

(5/289)

1.1

(3/281)

0.4

(1/259)

2.3

(6/259)

7.8

(40/513)

11.9

(60/504)

•Retinopathy

Retinopathy was evaluated in the LANTUS clinical studies by analysis of reported retinal adverse

events and fundus photography. The numbers of retinal adverse events reported for LANTUS and NPH

insulin treatment groups were similar for patients with type 1 and type 2 diabetes.

LANTUS was compared to NPH insulin in a 5-year randomized clinical trial that evaluated the

progression of retinopathy as assessed with fundus photography using a grading protocol derived from

the Early Treatment Diabetic Retinopathy Scale (ETDRS). Patients had type 2 diabetes (mean age 55

yrs) with no (86%) or mild (14%) retinopathy at baseline. Mean baseline HbA1c was 8.4%. The primary

outcome was progression by 3 or more steps on the ETDRS scale at study endpoint. Patients with

pre-speciﬁed post-baseline eye procedures (pan-retinal photocoagulation for proliferative or severe

nonproliferative diabetic retinopathy, local photocoagulation for new vessels, and vitrectomy for diabetic

retinopathy) were also considered as 3-step progressors regardless of actual change in ETDRS score

from baseline. Retinopathy graders were blinded to treatment group assignment. The results for the

primary endpoint are shown in Table 7 for both the per-protocol and Intent-to-Treat populations, and

indicate similarity of Lantus to NPH in the progression of diabetic retinopathy as assessed by this

outcome.

Table 7. Number (%) of patients with 3 or more step progression on ETDRS scale at

endpoint

Lantus (%) NPH (%) Difference

*,†

(SE)

95% CI for

difference

Per-protocol 53/374 (14.2%) 57/363 (15.7%) -2.0% (2.6%) -7.0% to +3.1%

Intent-to-Treat 63/502 (12.5%) 71/487 (14.6%) - 2.1% (2.1%) -6.3% to +2.1%

*Difference = Lantus – NPH

†using a generalized linear model (SAS GENMOD) with treatment and baseline HbA1c strata (cutoff

9.0%) as the classiﬁed independent variables, and with binomial distribution and identity link function

•Insulin initiation and intensiﬁcation of glucose control

Intensiﬁcation or rapid improvement in glucose control has been associated with a transitory, reversible

ophthalmologic refraction disorder, worsening of diabetic retinopathy, and acute painful peripheral

neuropathy. However, long-term glycemic control decreases the risk of diabetic retinopathy and

neuropathy.

•Lipodystrophy

Long-term use of insulin, including LANTUS, can cause lipodystrophy at the site of repeated insulin

injections. Lipodystrophy includes lipohypertrophy (thickening of adipose tissue) and lipoatrophy

(thinning of adipose tissue), and may affect insulin absorption. Rotate insulin injection or infusion sites

within the same region to reduce the risk of lipodystrophy. [See Dosage and Administration (2.1)].

•Weight gain

Weight gain can occur with insulin therapy, including LANTUS, and has been attributed to the anabolic

effects of insulin and the decrease in glucosuria.

•Peripheral Edema

Insulin, including LANTUS, may cause sodium retention and edema, particularly if previously poor

metabolic control is improved by intensiﬁed insulin therapy.

•Allergic Reactions

Local Allergy

As with any insulin therapy, patients taking LANTUS may experience injection site reactions, including

redness, pain, itching, urticaria, edema, and inﬂammation. In clinical studies in adult patients, there was

a higher incidence of treatment-emergent injection site pain in LANTUS-treated patients (2.7%)

compared to NPH insulin-treated patients (0.7%). The reports of pain at the injection site did not result

in discontinuation of therapy.

Rotation of the injection site within a given area from one injection to the next may help to reduce or

prevent these reactions. In some instances, these reactions may be related to factors other than insulin,

such as irritants in a skin cleansing agent or poor injection technique. Most minor reactions to insulin

usually resolve in a few days to a few weeks.

Systemic Allergy

Severe, life-threatening, generalized allergy, including anaphylaxis, 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 LANTUS, increases in titers of antibodies to insulin were observed in NPH

insulin and insulin glargine treatment groups with similar incidences.

6.2 Postmarketing experience

The following adverse reactions have been identiﬁed during post-approval use of LANTUS.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always

possible to estimate reliably their frequency or establish a causal relationship to drug exposure.

Medication errors have been reported in which other insulins, particularly short-acting insulins, have

been accidentally administered instead of LANTUS [See Patient Counseling Information (17)]. To avoid

medication errors between LANTUS and other insulins, patients should be instructed to always verify

the insulin label before each injection.

7. DRUG INTERACTIONS

A number of drugs affect glucose metabolism and may require insulin dose adjustment and particularly

close monitoring.

The following are examples of drugs that may increase the blood-glucose-lowering effect of insulins

including LANTUS and, therefore, increase the susceptibility to hypoglycemia: oral anti-diabetic

products, pramlintide, angiotensin converting enzyme (ACE) inhibitors, disopyramide, ﬁbrates, ﬂuox-

etine, monoamine oxidase inhibitors, propoxyphene, pentoxifylline, salicylates, somatostatin analogs,

and sulfonamide antibiotics.

The following are examples of drugs that may reduce the blood-glucose-lowering effect of insulins

including LANTUS: corticosteroids, niacin, danazol, diuretics, sympathomimetic agents (e.g., epineph-

rine, albuterol, terbutaline), glucagon, isoniazid, phenothiazine derivatives, somatropin, thyroid hor-

mones, estrogens, progestogens (e.g., in oral contraceptives), protease inhibitors and atypical

antipsychotic medications (e.g. olanzapine and clozapine).

Beta-blockers, clonidine, lithium salts, and alcohol may either potentiate or weaken the blood-glucose-

lowering effect of insulin. Pentamidine may cause hypoglycemia, which may sometimes be followed

by hyperglycemia.

The signs of hypoglycemia may be reduced or absent in patients taking sympatholytic drugs such as

beta-blockers, clonidine, guanethidine, and reserpine.

8. USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C: Subcutaneous reproduction and teratology studies have been performed with

insulin glargine and regular human insulin in rats and Himalayan rabbits. Insulin glargine was given to

female rats before mating, during mating, and throughout pregnancy at doses up to 0.36 mg/kg/day,

which is approximately 7 times the recommended human subcutaneous starting dose of 10 Units/day

(0.008 mg/kg/day), based on mg/m

. In rabbits, doses of 0.072 mg/kg/day, which is approximately 2

times the recommended human subcutaneous starting dose of 10 Units/day (0.008 mg/kg/day), based

on mg/m

, were administered during organogenesis. The effects of insulin glargine did not generally

differ from those observed with regular human insulin in rats or rabbits. However, in rabbits, ﬁve fetuses

from two litters of the high-dose group exhibited dilation of the cerebral ventricles. Fertility and early

embryonic development appeared normal.

There are no well-controlled clinical studies of the use of LANTUS in pregnant women. Because animal

reproduction studies are not always predictive of human response, this drug should be used during

pregnancy only if the potential beneﬁt justiﬁes the potential risk to the fetus. It is essential for patients

with diabetes or a history of gestational diabetes to maintain good metabolic control before conception

and throughout pregnancy. Insulin requirements may decrease during the ﬁrst trimester, generally

increase during the second and third trimesters, and rapidly decline after delivery. Careful monitoring

of glucose control is essential in these patients.

8.3 Nursing Mothers

It is unknown whether insulin glargine is excreted in human milk. Because many drugs, including human

insulin, are excreted in human milk, caution should be exercised when LANTUS is administered to a

nursing woman. Use of LANTUS is compatible with breastfeeding, but women with diabetes who are

lactating may require adjustments of their insulin doses.

8.4 Pediatric Use

The safety and effectiveness of subcutaneous injections of LANTUS have been established in pediatric

patients (age 6 to 15 years) with type 1 diabetes [see Clinical Studies (14)]. LANTUS has not been

studied in pediatric patients younger than 6 years of age with type 1 diabetes. LANTUS has not been

studied in pediatric patients with type 2 diabetes.

Based on the results of a study in pediatric patients, the dose recommendation when switching to

LANTUS is the same as that described for adults [see Dosage and Administration (2.3) and Clinical

Studies (14)]. As in adults, the dosage of LANTUS must be individualized in pediatric patients based

on metabolic needs and frequent monitoring of blood glucose.

8.5 Geriatric Use

In controlled clinical studies comparing LANTUS to NPH insulin, 593 of 3890 patients (15%) with type

1 and type 2 diabetes were ≥65 years of age and 80 (2%) patients were ≥75 years of age. The only

difference in safety or effectiveness in the subpopulation of patients ≥65 years of age compared to the

entire study population was a higher incidence of cardiovascular events typically seen in an older

population in both LANTUS and NPH insulin-treated patients.

Lantus PI.April.2010

Nevertheless, caution should be exercised when LANTUS is administered to geriatric patients. In

elderly patients with diabetes, the initial dosing, dose increments, and maintenance dosage should be

conservative to avoid hypoglycemic reactions. Hypoglycemia may be difficult to recognize in the elderly

[See Warnings and Precautions (5.3)].

10. OVERDOSAGE

An excess of insulin relative to food intake, energy expenditure, or both may lead to severe and

sometimes prolonged and life-threatening hypoglycemia. Mild episodes of hypoglycemia can usually

be treated with oral carbohydrates. Adjustments in drug dosage, meal patterns, or exercise may be

needed.

More severe episodes of hypoglycemia with coma, seizure, or neurologic impairment may be treated

with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. After apparent clinical

recovery from hypoglycemia, continued observation and additional carbohydrate intake may be

necessary to avoid recurrence of hypoglycemia.

11. DESCRIPTION

LANTUS (insulin glargine [rDNA origin] injection) is a sterile solution of insulin glargine for use as a

subcutaneous injection. Insulin glargine is a recombinant human insulin analog that is a long-acting (up

to 24-hour duration of action), parenteral blood-glucose-lowering agent [See Clinical Pharmacology

(12)]. LANTUS is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain

of Escherichia coli (K12) as the production organism. Insulin glargine differs from human insulin in that

the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the

C-terminus of the B-chain. Chemically, insulin glargine is 21

-Gly-30

a-L-Arg-30

b-L-Arg-human insulin

and has the empirical formula C

267

404

and a molecular weight of 6063. Insulin glargine has

the following structural formula:

LANTUS consists of insulin glargine dissolved in a clear aqueous ﬂuid. Each milliliter of LANTUS

(insulin glargine injection) contains 100 Units (3.6378 mg) insulin glargine.

The 10 mL vial presentation contains the following inactive ingredients per mL: 30 mcg zinc, 2.7 mg

m-cresol, 20 mg glycerol 85%, 20 mcg polysorbate 20, and water for injection.

The 3 mL cartridge presentation contains the following inactive ingredients per mL: 30 mcg zinc, 2.7

mg m-cresol, 20 mg glycerol 85%, and water for injection.

The pH is adjusted by addition of aqueous solutions of hydrochloric acid and sodium hydroxide.

LANTUS has a pH of approximately 4.

12. CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism. Insulin

and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal

muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis,

and enhances protein synthesis.

12.2 Pharmacodynamics

Insulin glargine is a human insulin analog that has been designed to have low aqueous solubility at

neutral pH. At pH 4, as in the LANTUS injection solution, insulin glargine is completely soluble. After

injection into the subcutaneous tissue, the acidic solution is neutralized, leading to formation of

microprecipitates from which small amounts of insulin glargine are slowly released, resulting in a

relatively constant concentration/time proﬁle over 24 hours with no pronounced peak. This proﬁle allows

once-daily dosing as a basal insulin.

In clinical studies, the glucose-lowering effect on a molar basis (i.e., when given at the same doses)

of intravenous insulin glargine is approximately the same as that for human insulin. In euglycemic clamp

studies in healthy subjects or in patients with type 1 diabetes, the onset of action of subcutaneous

insulin glargine was slower than NPH insulin. The effect proﬁle of insulin glargine was relatively constant

with no pronounced peak and the duration of its effect was prolonged compared to NPH insulin. Figure

1shows results from a study in patients with type 1 diabetes conducted for a maximum of 24 hours

after the injection. The median time between injection and the end of pharmacological effect was 14.5

hours (range: 9.5 to 19.3 hours) for NPH insulin, and 24 hours (range: 10.8 to >24.0 hours) (24 hours

was the end of the observation period) for insulin glargine.

Figure 1. Activity Proﬁle in Patients with Type 1 Diabetes

* Determined as amount of glucose infused to maintain constant plasma glucose levels (hourly mean

values); indicative of insulin activity.

The longer duration of action (up to 24 hours) of LANTUS is directly related to its slower rate of

absorption and supports once-daily subcutaneous administration. The time course of action of insulins,

including LANTUS, may vary between individuals and within the same individual.

12.3 Pharmacokinetics

Absorption and Bioavailability. After subcutaneous injection of insulin glargine in healthy subjects and

in patients with diabetes, the insulin serum concentrations indicated a slower, more prolonged

absorption and a relatively constant concentration/time proﬁle over 24 hours with no pronounced peak

in comparison to NPH insulin. Serum insulin concentrations were thus consistent with the time proﬁle

of the pharmacodynamic activity of insulin glargine.

After subcutaneous injection of 0.3 Units/kg insulin glargine in patients with type 1 diabetes, a relatively

constant concentration/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 (21

-Gly-insulin) and M2 (21

-Gly-des-30

-Thr-insulin). Unchanged

drug and these degradation products are also present in the circulation.

Special Populations

Age, Race, and Gender. Information on the effect of age, race, and gender on the pharmacokinetics

of LANTUS is not available. However, in controlled clinical trials in adults (n=3890) and a controlled

clinical trial in pediatric patients (n=349), subgroup analyses based on age, race, and gender did not

show differences in safety and efficacy between insulin glargine and NPH insulin [see Clinical Studies

(14)].

Smoking. The effect of smoking on the pharmacokinetics/pharmacodynamics of LANTUS has not been

studied.

Pregnancy. The effect of pregnancy on the pharmacokinetics and pharmacodynamics of LANTUS has

not been studied [see Use in Speciﬁc Populations (8.1)].

Obesity. In controlled clinical trials, which included patients with Body Mass Index (BMI) up to and

including 49.6 kg/m

, subgroup analyses based on BMI did not show differences in safety and efficacy

between insulin glargine and NPH insulin [see Clinical Studies (14)].

Renal Impairment. The effect of renal impairment on the pharmacokinetics of LANTUS has not been

studied. However, some studies with human insulin have shown increased circulating levels of insulin

in patients with renal failure. Careful glucose monitoring and dose adjustments of insulin, including

LANTUS, may be necessary in patients with renal impairment [See Warnings and Precautions (5.5)].

Hepatic Impairment. The effect of hepatic impairment on the pharmacokinetics of LANTUS has not

been studied. However, some studies with human insulin have shown increased circulating levels of

insulin in patients with liver failure. Careful glucose monitoring and dose adjustments of insulin,

including LANTUS, may be necessary in patients with hepatic impairment [See Warnings and

Precautions (5.6)].

13. NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

In mice and rats, standard two-year carcinogenicity studies with insulin glargine were performed at

doses up to 0.455 mg/kg, which was for the rat approximately 10 times and for the mouse

approximately 5 times the recommended human subcutaneous starting dose of 10 Units/day (0.008

mg/kg/day), based on mg/m

. The ﬁndings in female mice were not conclusive due to excessive

mortality in all dose groups during the study. Histiocytomas were found at injection sites in male rats

(statistically signiﬁcant) and male mice (not statistically signiﬁcant) in acid vehicle containing groups.

These tumors were not found in female animals, in saline control, or insulin comparator groups using

a different vehicle. The relevance of these ﬁndings to humans is unknown.

Insulin glargine was not mutagenic in tests for detection of gene mutations in bacteria and mammalian

cells (Ames- and HGPRT-test) and in tests for detection of chromosomal aberrations (cytogenetics in

vitro in V79 cells and in vivo in Chinese hamsters).

In a combined fertility and prenatal and postnatal study in male and female rats at subcutaneous doses

up to 0.36 mg/kg/day, which was approximately 7 times the recommended human subcutaneous

starting dose of 10 Units/day (0.008 mg/kg/day), based on mg/m

, maternal toxicity due to dose-

dependent hypoglycemia, including some deaths, was observed. Consequently, a reduction of the

rearing rate occurred in the high-dose group only. Similar effects were observed with NPH insulin.

14. CLINICAL STUDIES

The safety and effectiveness of LANTUS given once-daily at bedtime was compared to that of

once-daily and twice-daily NPH insulin in open-label, randomized, active-controlled, parallel studies of

2,327 adult patients and 349 pediatric patients with type 1 diabetes mellitus and 1,563 adult patients

with type 2 diabetes mellitus (see Tables 8–11). In general, the reduction in glycated hemoglobin

(HbA1c) with LANTUS was similar to that with NPH insulin. The overall rates of hypoglycemia did not

differ between patients with diabetes treated with LANTUS compared to NPH insulin [See Adverse

Reactions (6.1)].

Type 1 Diabetes–Adult (see Table 8).

In two clinical studies (Studies A and B), patients with type 1 diabetes (Study A; n=585, Study B; n=534)

were randomized to 28 weeks of basal-bolus treatment with LANTUS or NPH insulin. Regular human

insulin was administered before each meal. LANTUS was administered at bedtime. NPH insulin was

administered once daily at bedtime or in the morning and at bedtime when used twice daily.

In another clinical study (Study C), patients with type 1 diabetes (n=619) were randomized to 16 weeks

of basal-bolus treatment with LANTUS or NPH insulin. Insulin lispro was used before each meal.

LANTUS was administered once daily at bedtime and NPH insulin was administered once or twice daily.

In these 3 studies, LANTUS and NPH insulin had similar effects on HbA1c (Table 8) with a similar

overall rate of hypoglycemia [See Adverse Reactions (6.1)].

Table 8: Type 1 Diabetes Mellitus–Adult

Study A Study B Study C

Treatment duration

Treatment in

combination with

28 weeks

Regular insulin

28 weeks

Regular insulin

16 weeks

Insulin lispro

LANTUS NPH LANTUS NPH LANTUS NPH

Number of subjects

treated

292 293 264 270 310 309

Lantus PI.April.2010

Table 8: Type 1 Diabetes Mellitus–Adult (continued)

Study A Study B Study C

Treatment duration

Treatment in

combination with

28 weeks

Regular insulin

28 weeks

Regular insulin

16 weeks

Insulin lispro

LANTUS NPH LANTUS NPH LANTUS NPH

HbA1c

Baseline HbA1c 8.0 8.0 7.7 7.7 7.6 7.7

Adj. mean change from

baseline

+0.2 +0.1 -0.2 -0.2 -0.1 -0.1

LANTUS – NPH +0.1 +0.1 0.0

95% CI for Treatment

difference

(0.0; +0.2) (-0.1; +0.2) (-0.1; +0.1)

Basal insulin dose

Baseline mean 21 23 29 29 28 28

Mean change from

baseline

-2 0 -4 +2 -5 +1

Total insulin dose

Baseline mean 48 52 50 51 50 50

Mean change from

baseline

-1 0 0 +4 -3 0

Fasting blood glucose

(mg/dL)

Baseline mean 167 166 166 175 175 173

Adj. mean change from

baseline

-21 -16 -20 -17 -29 -12

Body weight (kg)

Baseline mean 73.2 74.8 75.5 75.0 74.8 75.6

Mean change from

baseline

0.1 -0.0 0.7 1.0 0.1 0.5

Type 1 Diabetes–Pediatric (see Table 9).

In a randomized, controlled clinical study (Study D), pediatric patients (age range 6 to 15 years) with

type 1 diabetes (n=349) were treated for 28 weeks with a basal-bolus insulin regimen where regular

human insulin was used before each meal. LANTUS was administered once daily at bedtime and NPH

insulin was administered once or twice daily. Similar effects on HbA1c (Table 9) and the incidence of

hypoglycemia were observed in both treatment groups [See Adverse Reactions (6.1)].

Table 9: Type 1 Diabetes Mellitus–Pediatric

Study D

Treatment duration 28 weeks

Treatment in combination with Regular insulin

LANTUS NPH

Number of subjects treated 174 175

HbA1c

Baseline mean 8.5 8.8

Adj. mean change from baseline +0.3 +0.3

LANTUS – NPH 0.0

95% CI for Treatment difference (-0.2; +0.3)

Basal insulin dose

Baseline mean 19 19

Mean change from baseline -1 +2

Total insulin dose

Baseline mean 43 43

Mean change from baseline +2 +3

Fasting blood glucose (mg/dL)

Baseline mean 194 191

Adj. mean change from baseline -23 -12

Body weight (kg)

Baseline mean 45.5 44.6

Mean change from baseline 2.2 2.5

Type 2 Diabetes–Adult (see Table 10).

In a randomized, controlled clinical study (Study E) (n=570), LANTUS was evaluated for 52 weeks in

combination with oral anti-diabetic medications (a sulfonylurea, metformin, acarbose, or combinations

of these drugs). LANTUS administered once daily at bedtime was as effective as NPH insulin

administered once daily at bedtime in reducing HbA1c and fasting glucose (Table 10). The rate of

hypoglycemia was similar in LANTUS and NPH insulin treated patients [See Adverse Reactions (6.1)].

In a randomized, controlled clinical study (Study F), in patients with type 2 diabetes not using oral

anti-diabetic medications (n=518), a basal-bolus regimen of LANTUS once daily at bedtime or NPH

insulin administered once or twice daily was evaluated for 28 weeks. Regular human insulin was used

before meals, as needed. LANTUS had similar effectiveness as either once- or twice-daily NPH insulin

in reducing HbA1c and fasting glucose (Table 10) with a similar incidence of hypoglycemia [See

Adverse Reactions (6.1)].

In a randomized, controlled clinical study (Study G), patients with type 2 diabetes were randomized to

5 years of treatment with once-daily LANTUS or twice-daily NPH insulin. For patients not previously

treated with insulin, the starting dose of LANTUS or NPH insulin was 10 units daily. Patients who were

already treated with 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 control in the 2 treatment groups was desired in order to not confound the

interpretation of the retinal data. Patients or study personnel used an algorithm to adjust the LANTUS

and NPH insulin doses to a target fasting plasma glucose ≤100 mg/dL. After the LANTUS or NPH

insulin dose was adjusted, other anti-diabetic agents, including pre-meal insulin were to be adjusted

or added. The LANTUS group had a smaller mean reduction from baseline in HbA1c compared to the

NPH insulin group, which may be explained by the lower daily basal insulin doses in the LANTUS group

(Table 10). Both treatment groups had a similar incidence of reported symptomatic hypoglycemia. The

incidences of severe symptomatic hypoglycemia are given in Table 6 [See Adverse Reactions (6.1)].

Table 10: Type 2 Diabetes Mellitus–Adult

Study E Study F Study G

Treatment duration 52 weeks 28 weeks 5 years

Treatment in combination

with Oral agents Regular insulin Regular insulin

LANTUS NPH LANTUS NPH LANTUS NPH

Number of subjects treated 289 281 259 259 513 504

HbA1c

Baseline mean 9.0 8.9 8.6 8.5 8.4 8.3

Adj. mean change from

baseline -0.5 -0.4 -0.4 -0.6 -0.6 -0.8

LANTUS – NPH -0.1 +0.2 +0.2

95% CI for Treatment

difference (-0.3; +0.1) (0.0; +0.4) (+0.1, +0.4)

Basal insulin dose

Baseline mean 14 15 44.1 45.5 39 44

Mean change from baseline +12 +9 -1 +7 +23 +30

Total insulin dose

Baseline mean 14 15 64 67 48 53

Mean change from baseline +12 +9 +10 +13 +41 +40

Fasting blood glucose (mg/dL)

Baseline mean 179 180 164 166 190 180

Adj. mean change from

baseline -49 -46 -24 -22 -45 -44

Body weight (kg)

Baseline mean 83.5 82.1 89.6 90.7 100 99

Adj. mean change from

baseline 2.0 1.9 0.4 1.4 3.7 4.8

*In Study G, the baseline dose of basal or total insulin was the ﬁrst available on-treatment dose

prescribed during the study (on visit month 1.5).

LANTUS Timing of Daily Dosing (see Table 11).

The safety and efficacy of LANTUS administered pre-breakfast, pre-dinner, or at bedtime were

evaluated in a randomized, controlled clinical study in patients with type 1 diabetes (study H, n=378).

Patients were also treated with insulin lispro at mealtime. LANTUS administered at different times of

the day resulted in similar reductions in HbA1c compared to that with bedtime administration (see Table

11). In these patients, data are available from 8-point home glucose monitoring. The maximum mean

blood glucose was observed just prior to injection of LANTUS regardless of time of administration.

In this study, 5% of patients in the LANTUS-breakfast arm discontinued treatment because of lack of

efficacy. No patients in the other two arms discontinued for this reason. The safety and efficacy of

LANTUS administered pre-breakfast or at bedtime were also evaluated in a randomized, active-

controlled clinical study (Study I, n=697) in patients with type 2 diabetes not adequately controlled on

oral anti-diabetic therapy. All patients in this study also received glimepiride 3 mg daily. LANTUS given

before breakfast was at least as effective in lowering HbA1c as LANTUS given at bedtime or NPH

insulin given at bedtime (see Table 11).

Lantus PI.April.2010

Table 11: LANTUS Timing of Daily Dosing in Type 1 (Study H) and Type 2 (Study I)

Diabetes Mellitus

Study H Study I

Treatment duration 24 weeks 24 weeks

Treatment in

combination with: Insulin lispro Glimepiride

LANTUS

Breakfast

LANTUS

Dinner

LANTUS

Bedtime

LANTUS

Breakfast

LANTUS

Bedtime

NPH

Bedtime

Number of subjects

treated

112 124 128 234 226 227

HbA1c

Baseline mean 7.6 7.5 7.6 9.1 9.1 9.1

Mean change from

baseline

-0.2 -0.1 0.0 -1.3 -1.0 -0.8

Basal insulin dose

(U)

Baseline mean 22 23 21 19 20 19

Mean change from

baseline

5 2 2 11 18 18

Total insulin dose (U) NA

†

NA NA

Baseline mean 52 52 49

Mean change from

baseline

232

Body weight (kg)

Baseline mean 77.1 77.8 74.5 80.7 82 81

Mean change from

baseline

0.7 0.1 0.4 3.9 3.7 2.9

**total number of patients evaluable for safety

*Intent to treat

†Not applicable

16. HOW SUPPLIED/STORAGE AND HANDLING

16.1 How supplied

LANTUS solution for injection 100 units per mL (U-100) is available as:

Dosage Unit/Strength Package size NDC #

0088

10 mL vials

100 Units/mL

Pack of 1 2220-33

3 mL cartridge system

100 Units/mL

package of 5 2220-52

3 mL SoloStar

disposable

insulin device

100 Units/mL

package of 5 2219-05

*Cartridge systems are for use only in OptiClik

(Insulin Delivery Device)

Needles are not included in the packs.

BD Ultra-Fine™ needles

to be used in conjunction with SoloStar and OptiClik are sold separately and

are manufactured by BD.

The brands listed are the registered trademarks of their respective owners and are not trademarks

of sanoﬁ-aventis U.S. LLC

16.2 Storage

LANTUS should not be stored in the freezer and should not be allowed to freeze. Discard LANTUS

if it has been frozen.

Unopened Vial/Cartridge system/SoloStar disposable insulin device:

Unopened LANTUS vials, cartridge systems and SoloStar device should be stored in a refrigerator,

36°F – 46°F (2°C – 8°C). Discard after the expiration date.

Open (In-Use) Vial:

Vials must be discarded 28 days after being opened. If refrigeration is not possible, the open vial can

be kept unrefrigerated for up to 28 days away from direct heat and light, as long as the temperature

is not greater than 86°F (30°C).

Open (In-Use) Cartridge system:

The opened (in-use) cartridge system in OptiClik 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) cartridge system

in OptiClik must be discarded 28 days after being opened. Do not store OptiClik , with or without

cartridge system, in a refrigerator at any time.

Open (In-Use) SoloStar disposable insulin device:

The 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 device must be

discarded 28 days after being opened.

These storage conditions are summarized in the following table:

Not in-use

(unopened)

Refrigerated

Not in-use

(unopened)

Room Temperature

In-use

(opened)

(See Temperature

Below)

10 mL Vial Until expiration date 28 days 28 days

Refrigerated or room

temperature

3 mL Cartridge

system

Until expiration date 28 days 28 days

Refrigerated or room

temperature

3 mL Cartridge

system inserted into

OptiClik

28 days

Room temperature

only (Do not

refrigerate)

3 mL SoloStar

disposable insulin

device

Until expiration date 28 days 28 days

Room temperature

only

(Do not refrigerate)

16.3 Preparation and handling

Parenteral drug products should be inspected visually prior to administration whenever the solution and

the container permit. LANTUS must only be used if the solution is clear and colorless 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 drawn from the cartridge

system or from SoloStar into a U-100 syringe and injected.

17. PATIENT COUNSELING INFORMATION

17.1 Instructions for patients

Patients should be informed that changes to insulin regimens must be made cautiously and only under

medical supervision.

Patients should be informed about the potential side effects of insulin therapy, including lipodystrophy

(and the need to rotate injection sites within the same body region), weight gain, allergic reactions, and

hypoglycemia. Patients should be informed that the 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 machinery. Patients who have frequent hypoglycemia or

reduced or absent warning signs of hypoglycemia should be advised to use caution when driving or

operating machinery.

Accidental mix-ups between LANTUS and other insulins, particularly short-acting insulins, have been

reported. To avoid medication errors between LANTUS and other insulins, patients should be instructed

to always check the insulin label before each injection.

LANTUS must only be used if the solution is clear and colorless with no particles visible.Patients must

be advised that LANTUS must NOT be diluted or mixed with any other insulin or solution.

Patients should be advised not to share disposable or reusable insulin devices or needles with other

patients, because doing so carries a risk for transmission of blood-borne pathogens.

Patients should be instructed on self-management procedures including glucose monitoring, proper

injection technique, and management of hypoglycemia and hyperglycemia. Patients must be instructed

on handling of special situations such as intercurrent conditions (illness, stress, or emotional

disturbances), an inadequate or skipped insulin dose, inadvertent administration of an increased insulin

dose, inadequate food intake, and skipped meals.

Patients with diabetes should be advised to inform their health care professional if they are pregnant

or are contemplating pregnancy.

Refer patients to the LANTUS ″Patient Information″for additional information.

17.2 FDA approved patient labeling

See attached document at end of Full Prescribing Information.

Rev. April 2010

sanoﬁ-aventis U.S. LLC

Bridgewater, NJ 08807

Patient Information

LANTUS

10 mL vial (1000 units per vial) 100 units per mL (U-100)

(insulin glargine [recombinant DNA origin] injection)

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

•What is LANTUS?

•Who should NOT take LANTUS?

•How should I use LANTUS?

•What kind of syringe should I use?

•Mixing with LANTUS

•Instructions for Use

ÁHow do I draw the insulin into the syringe?

ÁHow do I inject LANTUS?

•What can affect how much insulin I need?

•What are the possible side effects of LANTUS and other insulins?

•How should I store LANTUS?

•General Information about LANTUS

Read this ″Patient Information″that comes with LANTUS (LAN-tus) before you start using it and each

time you get a reﬁll because there may be new information. This leaﬂet does not take the place of

talking with your healthcare provider about your condition or treatment. If you have questions about

LANTUS or about diabetes, talk with your healthcare provider.

Lantus PI.April.2010

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 0Instructions for Use0including the 0How do I draw the insulin into the syringe?0section

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

Lantus PI.April.2010

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.

What can affect how much insulin I need?

Illness. Illness may change how much insulin you need. It is a good idea to think ahead and make

a″sick day″plan with your healthcare provider in advance so you will be ready when this happens.

Be sure to test your blood sugar more often and call your healthcare provider if you are sick.

Medicines. Many medicines can affect your insulin needs. Other medicines, including prescription

and non-prescription medicines, vitamins, and herbal supplements, can change the way insulin works.

You may need a different dose of insulin when you are taking certain other 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 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 you eat can affect your insulin needs. If you eat less food, skip meals, or

eat more food than usual, you may need a different dose of insulin. Talk to your healthcare provider

if you change your diet so that you know how to adjust your LANTUS and other insulin doses.

Alcohol. Alcohol, including beer and wine, may affect the way LANTUS works and affect your blood

sugar levels. Talk to your healthcare provider about drinking alcohol.

Exercise or Activity level. Exercise or activity level may change the way your body uses insulin. Check

with your healthcare provider before you start an exercise program because your dose may need to

be changed.

Travel. If you travel across time zones, talk with your healthcare provider about how to time your

injections. When you travel, wear your medical alert identiﬁcation. Take extra insulin and supplies with

you.

Pregnancy or nursing. The effects of LANTUS on an unborn child or on a nursing baby are unknown.

Therefore, tell your healthcare provider if you are planning to have a baby, are pregnant, or nursing

a baby. Good control of diabetes is especially important during pregnancy and nursing.

What are the possible side effects of LANTUS and other insulins?

Insulins, including LANTUS, can cause hypoglycemia (low blood sugar), hyperglycemia (high blood

sugar), allergy, and skin reactions.

Hypoglycemia (low blood sugar):

Hypoglycemia is often called an ″insulin reaction″or ″low blood sugar″. It may happen when you do

not have enough sugar in your blood. Common causes of hypoglycemia are illness, emotional or

physical stress, too much insulin, too little food or missed meals, and too much exercise or activity.

Early warning signs of hypoglycemia may be different, less noticeable or not noticeable at all in some

people. That is why it is important to check your blood sugar as you have been advised by your

healthcare provider.

Hypoglycemia can happen with:

•Taking too much insulin. This can happen when too much insulin is injected.

•Not enough carbohydrate (sugar or starch) intake. This can happen if a meal or snack is

missed or delayed.

•Vomiting or diarrhea that decreases the amount of sugar absorbed by your body.

•Intake of alcohol.

•Medicines that affect insulin. Be sure to discuss all your medicines with your healthcare provider.

Do not start any new medicines until you know how they may affect your insulin dose.

•Medical conditions that can affect your blood sugar levels or insulin. These conditions

include diseases of the adrenal glands, the pituitary, the thyroid gland, the liver, and the kidney.

•Too much glucose use by the body. This can happen if you exercise too much or have a fever.

•Injecting insulin the wrong way or in the wrong injection area.

Hypoglycemia can be mild to severe. Its onset may be rapid. Some patients have few or no warning

symptoms, including:

•patients with diabetes for a long time

•patients with diabetic neuropathy (nerve problems)

•or patients using certain medicines for high blood pressure or heart problems.

Hypoglycemia may reduce your ability to drive a car or use mechanical equipment and you may risk

injury to yourself or others.

Severe hypoglycemia can be dangerous and can cause temporary or permanent harm to your heart

or brain. It may cause unconsciousness, seizures, or death.

Symptoms of hypoglycemia may include:

•anxiety, irritability, restlessness, trouble concentrating, personality changes, mood changes, or

other abnormal behavior

•tingling in your hands, feet, lips, or tongue

•dizziness, light-headedness, or drowsiness

•nightmares or trouble sleeping

•headache

•blurred vision

•slurred speech

•palpitations (fast heart beat)

•sweating

•tremor (shaking)

•unsteady gait (walking).

If you have hypoglycemia often or it is hard for you to know if you have the symptoms of hypoglycemia,

talk to your healthcare provider.

Mild to moderate hypoglycemia is treated by eating or drinking carbohydrates, such as fruit juice,

raisins, sugar candies, milk or glucose tablets. Talk to your 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 intravenously (IV).

Without medical help right away, serious reactions or even death could happen.

Hyperglycemia (high blood sugar):

Hyperglycemia happens when you have too much sugar in your blood. Usually, it means there is not

enough insulin to break down the food you eat into energy your body can use. Hyperglycemia can be

caused by a fever, an infection, stress, eating more than you should, taking less insulin than prescribed,

or it can mean your diabetes is getting worse.

Hyperglycemia can happen with:

•Insufficient (too little) insulin. This can happen from:

- injecting too little or no insulin

- incorrect storage (freezing, excessive heat)

- use after the expiration date.

•Too much carbohydrate intake. This can happen if you eat larger meals, eat more often, or

increase the amount of carbohydrate in your meals.

•Medicines that affect insulin. Be sure to discuss all your medicines with your healthcare provider.

Do not start any new medicines until you know how they may affect your insulin dose.

•Medical conditions that affect insulin. These medical conditions include fevers, infections, heart

attacks, and stress.

•Injecting insulin the wrong way or in the wrong injection area.

Testing your blood or urine often will let you know if you have hyperglycemia. If your tests are often

high, tell your healthcare provider so your dose of insulin can be changed.

Hyperglycemia can be mild or severe. Hyperglycemia can progress to diabetic ketoacidosis (DKA)

or very high glucose levels (hyperosmolar coma) and result in unconsciousness and death.

Although diabetic ketoacidosis occurs most often in patients with type 1 diabetes, it can also happen

in patients with type 2 diabetes who become very sick. Because some patients get few symptoms of

hyperglycemia, it is important to check your blood sugar/urine sugar and ketones regularly.

Symptoms of hyperglycemia include:

•confusion or drowsiness

•increased thirst

•decreased appetite, nausea, or vomiting

•rapid heart rate

•increased urination and dehydration (too little ﬂuid in your body).

Symptoms of DKA also include:

•fruity smelling breath

•fast, deep breathing

•stomach area (abdominal) pain.

Severe or continuing hyperglycemia or DKA needs evaluation and treatment right away by your

healthcare provider.

Do not use LANTUS to treat diabetic ketoacidosis.

Other possible side effects of LANTUS include:

Serious allergic reactions:

Some times severe, life-threatening allergic reactions can happen with insulin. If you think you are

having a severe allergic reaction, get medical help right away. Signs of insulin allergy include:

•rash all over your body

•shortness of breath

•wheezing (trouble breathing)

•fast pulse

•sweating

•low blood pressure.

Reactions at the injection site:

Injecting insulin can cause the following reactions on the skin at the injection site:

•little depression in the skin (lipoatrophy)

•skin thickening (lipohypertrophy)

•red, swelling, itchy skin (injection site reaction).

You can reduce the chance of getting an injection site reaction if you change (rotate) the injection site

each time. An injection site reaction should clear up in a few days or a few weeks. If injection site

reactions do not go away or keep happening, call your healthcare provider.

Tell your healthcare provider if you have 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 vial:

Store new (unopened) LANTUS vials 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 vial has been frozen

or overheated, throw it away.

•Open (In-Use) vial:

Once a vial is opened, you can keep it in a refrigerator or at room temperature (below 86°F [30°C])

but away from direct heat and light. Opened vial, either kept in a refrigerator or at room

temperature, should be discarded 28 days after the ﬁrst use even if it still contains LANTUS. Do

not leave your insulin in a car on a summer day.

These storage conditions are summarized in the following table:

Not in-use

(unopened)

Not in-use

(unopened)

In-use

(opened)

Refrigerated Room

Temperature

(See Temperature

Below)

10 mL Vial Until expiration date 28 days 28 days

Refrigerated or room

temperature

•Do not use a vial of LANTUS after the expiration date stamped on the label.

•Do not use LANTUS if it is cloudy, colored, or if you see particles.

General Information about LANTUS

•Use LANTUS only to treat your diabetes. Do not give or share LANTUS with another person, even

if they have diabetes also. It may harm them.

•This leaﬂet summarizes the most important information about LANTUS. If you would like more

information, talk with your healthcare provider. You can ask your doctor or pharmacist for

information about LANTUS that is written for healthcare professionals. For more information about

LANTUS call 1-800-633-1610 or go to website www.lantus.com.

Lantus PI.April.2010

ADDITIONAL INFORMATION

DIABETES FORECAST is a national magazine designed especially for patients with diabetes and their

families and is available by subscription from the American Diabetes Association (ADA), P.O.Box 363,

Mt. Morris, IL 61054-0363, 1-800-DIABETES (1-800-342-2383). You may also visit the ADA website at

www.diabetes.org.

Another publication, COUNTDOWN, is available from the Juvenile Diabetes Research Foundation

International (JDRF), 120 Wall Street, 19th Floor, New York, New York 10005, 1-800-JDF-CURE

(1-800-533-2873). You may also visit the JDRF website at www.jdf.org.

To get more information about diabetes, check with your healthcare professional or diabetes educator

or visit www.DiabetesWatch.com.

Additional information about LANTUS can be obtained by calling 1-800-633-1610 or by visiting

www.lantus.com.

Rev. March 2007

sanoﬁ-aventis U.S. LLC

Bridgewater, NJ 08807

Patient Information

LANTUS

3 mL cartridge system (300 units per cartridge system)

100 units per mL (U-100)

(insulin glargine [recombinant DNA origin] injection)

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

•What is LANTUS?

•Who should NOT take LANTUS?

•How should I use LANTUS?

•What kind of insulin Pen should I use?