Lantus

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.

Lantus - Pharmacology:

Insulin binds to the insulin receptor (IR), a heterotetrameric protein consisting of two extracellular alpha units and two transmembrane beta units. The binding of insulin to the alpha subunit of IR stimulates the tyrosine kinase activity intrinsic to the beta subunit of the receptor. The bound receptor is able to autophosphorylate and phosphorylate numerous intracellular substrates such as insulin receptor substrates (IRS) proteins, Cbl, APS, Shc and Gab 1. These activated proteins, in turn, lead to the activation of downstream signaling molecules including PI3 kinase and Akt. Akt regulates the activity of glucose transporter 4 (GLUT4) and protein kinase C (PKC) which play a critical role in metabolism and catabolism.

Lantus mini report

Lantus NDA
NDA - A product marketed under an approved New Drug Application
Lantus SUBCUTANEOUS
SUBCUTANEOUS
Lantus INJECTION, SOLUTION
INJECTION, SOLUTION
Lantus HUMAN PRESCRIPTION DRUG
HUMAN PRESCRIPTION DRUG
Lantus global name
insulin glargin
Lantus global name
insulin glargine
Start - Stop data
START DATA:
2002-Jun-04
Start - Stop data
STOP DATA
not occurred

Lantus for patients

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?

· Mixing with LANTUS

· Instructions for Use

· What can affect how much insulin I need?

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

· How should I store LANTUS?

· What are the ingredients in 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.

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 glucose.

· 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, 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. The carton and cartridge system should look like the ones in this picture.

lantus3.gif

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 "Instructions for OptiClikTM Use" section for additional information.

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

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

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

· Follow your healthcare providers 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 insulin Pen should I use?

· Always use the OptiClik™ device distributed by Aventis Pharmaceuticals. If you use any other device than OptiClik™ insulin Pen with this cartridge, 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 each time you give LANTUS injection.

· NEEDLES AND INSULIN PEN MUST NOT BE SHARED.

· Disposable needle should be used only once. Used 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 Opticlik Use

It is important to read, understand, and follow the step-by-step instructions in the "OptiClik Instruction Leaflet" before using OptiClik insulin Pen. Failure to follow the instructions may result in getting too much or too little insulin. If you have lost your leaflet or have a question, go to www.opticlik.com or call 1-800-633-1610.

The following general notes should be taken into consideration before injecting Lantus:

· Always wash your hands before handling the cartridge system and/or the OptiClik™ insulin Pen.

· Always attach a new needle before use.

· Always perform the safety test before use.

· Check the insulin solution in the cartridge system to make sure it is clear, colorless, and free of particles. If it is not, throw it away.

· Do NOT mix or dilute LANTUS with any other insulin or solution. LANTUS will not work if it is mixed or diluted and you may lose blood sugar control, which could be serious.

· Decide on an injection area - either upper arm, thigh, or abdomen. Do not use the same injection site as your last injection.

· After injecting LANTUS, leave the needle in the skin for an additional 10 seconds. Then pull the needle straight out. Gently press on the spot where you injected yourself for a few seconds. Do not rub the area.

· Do not drop the OptiClik™ insulin Pen.

If your blood glucose reading is high or low, tell your healthcare provider so the dose can be adjusted.

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 and pharmacists anytime you get a new medicine or refill. Your healthcare provider will tell you if your insulin dose needs to be changed.

Meals. The amount of food 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 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. It 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 cartridge system

Store new unopened LANTUS cartridge systems in a refrigerator (not the freezer) between 36F to 46F (2C to 8C). Do not freeze LANTUS. Keep LANTUS out of direct heat and light. If a cartridge system has been frozen or overheated, throw it away.

· Open (In-Use) cartridge system

Once a cartridge system is opened, you can keep it at room temperature (below 86F [30C]) but away from direct heat and light for 28 days. Cartridge system in OptiClik™ insulin Pen must be discarded 28 days after the first use even if it still contains LANTUS. The opened cartridge system in OptiClik™ insulin Pen should be kept at room temperature (below 86F [30C]) and away from direct heat and light for up to 28days For example, do not leave it in a car on a summer day. Do not store OptiClik, with or without cartridge system, in a refrigerator at any time.

These storage conditions are summarized in the following table:
Not in-use (unopened) Refrigerated Not in-use (unopened) Room Temperature In-use (opened)
3 mL Cartridge system Until expiration date 28 days 28 days Refrigerated or roomtemperature
3 mL Cartridge system inserted into OptiClik™ 28 days Room temperature only(Do not refrigerate)

· Do not use a cartridge system 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 healthcare provider 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.

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.

Aventis Pharmaceuticals Inc., Kansas City, MO 64137 USA, ©2004 Aventis Pharmaceuticals Inc.

Lantus® is a registered trademark of Aventis Pharmaceuticals Inc.

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.

lantus5.gif

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

lantus6.gif

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.

lantus7.gif

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.

lantus8.gif

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.

lantus9.gif

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.

lantus10.gif

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.

lantus11.gif

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 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 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 yourhealthcare 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 36F to 46F (2C to 8C). 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 86F [30C]) 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) Refrigerated Not in-use (unopened) Room Temperature In-use (opened) Refrigerated or RoomTemperature
10 mL Vial Until expiration date 28 days 28 days

· 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.

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.

Aventis Pharmaceuticals Inc., Kansas City, MO 64137 USA, ©2004 Aventis Pharmaceuticals Inc.

Lantus® is a registered trademark of Aventis Pharmaceuticals Inc.

OpticlikTM

INSTRUCTION LEAFLET

OptiClik™ is a reusable insulin delivery device (insulin Pen) for use with 3 mL LANTUS cartridge (U-100) system.

OptiClik™ allows you to dial the dose in one-unit step increments between one unit and a maximum of 80 units per injection.

This instruction leaflet explains how to use OptiClik™. It is important for you to read and follow all the instructions in this leaflet carefully. If you do not follow these instructions completely, you may get too much or too little insulin. Keep this leaflet for future reference for each time you use OptiClik™.

You will find further useful information on the back side of this leaflet in the chapters: (A.) General Notes

(B.) Troubleshooting

(C.) Storage Instructions

(D.) Other Information

Please read this Instruction Leaflet carefully and completely before using OptiClik™ for the first time. Keep this leaflet for future reference for each time you use OptiClik™.

Talk with your healthcare provider before using OptiClik™ about proper injection technique.

If you have visual problems, use OptiClik™ only if you have help from a trained person with good vision.

Additional items needed for use with OptiClik™

· Alcohol swabs

· Appropriate needles

· Cartridge System, at room temperature

If you have any questions about OptiClik™ or about diabetes, ask your healthcare professional, go to www.opticlik.com or call Aventis at 1-800-633-1610.

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General Warnings and Precautions

Needles

You must use a new sterile needle (intact protective seal) for each injection. This prevents a blocked needle and air bubbles.

In order to avoid injuries, replace Outer Needle Cap before removing and disposing of used needles.

Safety test

Before each injection, carry out the Safety Test (Step3). If you do not follow the instructions completely, you may get too much or too little insulin. Injecting too much or too little insulin dose may lead to unwanted blood sugar changes. Do not perform the safety test without the needle attached.

Damage to OptiClik™

OptiClik™ may become damaged by rough handling, dropping, or turning of the Dosage Knob by force. Make sure that no dirt gets in contact with the mechanical parts. You should always make sure that:

a) The Cartridge System is undamaged.

b) The Start Button, Dosage Knob, and Digital Dose Display operate properly.

Do not use tools on OptiClik™. If you are not sure whether or not your OptiClik™ is damaged, contact your healthcare professional or call 1-800-633-1610. If damaged, it is no longer safe to use. In an emergency, you can draw up the insulin from the Cartridge System using a U-100 insulin syringe.

OptiClik™ should not be used near electrical and electronic equipment.

Step 1: Inserting the Cartridge System

Do not shake the cartridge system before use. You should look at the solution in the cartridge system before inserting it into OptiClik™. If the solution is cloudy, slightly colored, or has particles in it, do not use the cartridge. Before the next steps, remove the Cartridge Cover by pulling it out.

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A Make sure the Dosage Knob is pushed in.

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B Hold the Pen Body with the release button facing up.Insert the Cartridge System straight into the Pen Body. If you meet resistance, slightly raise and rotate the Cartridge System while inserting it. Make sure that it clicks in. Do not use force.

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C To make sure that the Cartridge System clicked in place properly, gently try pulling out the Cartridge System. The Cartridge System should not come out. Make sure you do not press the Cartridge Release button during or after this check.

OptiClik™ is now ready for Step 2 (Attaching the needle), or it can be stored with the attached Pen Cap.

DO NOT STORE YOUR OPTICLIK IN A REFRIGERATOR AFTER CARTRIDGE SYSTEM IS INSERTED IN OPTICLIK

Step 2: Attaching the needle

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A Peel off the Protective Seal on the needle.

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B Use an alcohol swab to wipe the rubber seal on the end of the cartridge. Connect a new needle without removing the Outer and Inner Needle Caps straight to the Cartridge System.

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C Remove Outer Needle Cap from the needle.

Save Outer Needle Cap for use later on in discarding the needle.

Step 3: Safety Test

Before each injection, carry out the Safety Test or you may get too much or too little insulin.

Make sure a needle is attached to OptiClik™ before you do the Safety Test. Do not press the Cartridge Release Button during these steps.

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A Press the Start Button.

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B The Dosage Knob must come out. "00"appears in the Digital Dose Display.

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C Turn the Dosage Knob to the right (clockwise) until it clicks. "01" appears in the Digital Dose Display.

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D Remove and discard the Inner Needle Cap.Handle the exposed needle carefully.

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E Hold OptiClik™ with the needle pointing up.

Press the Dosage Knob fully until it stays in.

Insulin must appear at the tip of the needle. If not, repeat the Safety Test. When replacing an empty cartridge system with a new one, it might require repeating this procedure several times. A Safety Test must be carried out before each injection.

Additional information about "Cartridge System" and "Removing air bubbles" is on the back side of this leaflet.

Step 4: Setting the dose

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A Press the Start Button.

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B Turn the Dosage Knob slowly to the right (clockwise) until you reach your required dosage. You must feel and hear a click.

If you have selected a dose that is too high, simply turn the Dosage Knob back (to the left). If you have dialed past 80 units, see (B.) TROUBLESHOOTING, Dose-setting on the back of this manual.

Step 5: Injecting the dose

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A Clean the injection area with alcohol. Insert the needle as recommended by your healthcare professional (e.g., lightly pinch a fold of skin on your stomach, thigh, or buttock. Insert the needle straight into the pinched skin).

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B Press the Dosage Knob slowly and completely. The Dosage Knob must stay in. Then slowly count to 10 while holding the Dosage Knob down before withdrawing the needle.

Do not press the Cartridge Release Button or the Start Button while injecting.

Step 6: Removing the needle

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A Replace Outer Needle Cap carefully.

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B Remove the needle after the injection. For safe disposal of needles see (A.) GENERAL NOTES, Needles for OptiClik™ on the back of this manual. Always replace Pen Cap on the Pen Body after use.

OptiClik™ can be stored with the attached Cartridge System until your next injection. See (C.) STORAGE INSTRUCTIONS.

Step 7: Replacing an empty Cartridge System

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A Make sure the Dosage Knob is pushed in.

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B Press the Cartridge Release Button, and remove the entire Cartridge System. Dispose of the Cartridge System.

Start again at Step 1 (Inserting the Cartridge System).

A. GENERAL NOTES

Cartridge System

The Cartridge System is sold separately. Before every injection, check the appearance of the solution in the Cartridge System and follow the instructions in the patient information leaflet for Lantus. It is important to follow the directions of this Instruction Leaflet closely to help avoid side effects (e.g., infections, improper dosing). Consult with your healthcare professional before using OptiClik™.

Before the use of an unopened, refrigerated Cartridge System, take it out of the refrigerator and leave it at room temperature for about 1 to 2 hours. Do not remove the Cartridge System from packaging until ready to use. This will prevent dust or dirt from getting into the mechanical parts of the Cartridge System. Use an alcohol swab to wipe the rubber seal on the end of the cartridge before inserting the needle. Do not open or manipulate the Cartridge System in any way.

Needles for OptiClik™

Needles are available from BD Consumer Healthcare. Contact your healthcare professional for further information. Please note there are two types of needles available: one type which needs to be screwed on and another type which only needs to be pushed on ("clicks on"). Both needle types can be used. Please consult the manual of the needle package.

Needles may vary from country to country and may not be interchangeable. If you intend to travel abroad, make sure that you have sufficient needles and insulin with you.

Do not store OptiClik™ with a needle attached. Storing OptiClik™ with the needle attached may allow insulin to leak from OptiClik™ and air bubbles to form in the cartridge.

Used needles 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.

Removing air bubbles

Air bubbles must be removed before each injection during the Safety Test (Step 3 for Safety Test). If air bubbles still remain, repeat the Safety Test, turning the Dosage Knob to the right until "02" appears on the display. Gently tap the Cartridge System until the air rises to the top of the Cartridge System tip. Then press the Dosage Knob until it stays in. If necessary, keep repeating the Safety Test until insulin appears at the tip of the needle.

Setting the dose and Display feature

To set the dose, hold OptiClik™ as shown in Step 4 for setting the dose. The printed "I.U." must be legible left of the Digital Dose Display. The Digital Dose Display shows the delivered dose for 2 minutes after every injection. After 30 minutes the display will go off to conserve battery power. With the Dosage Knob released the display switches off after 2 minutes.

How long will OptiClik™ last

The expected lifetime of OptiClik™ is 3 years.

lantus32.jpg flashes when the Start Button is pressed OptiClik™ is reaching the end of its expected lifetime (3 years). The Digital Dose Display will continue to operate for about 4 more weeks. Please obtain a new OptiClik™.

lantus33.jpgstays when the Start Button is pressed

OptiClik™ has reached the end of its lifetime. When you continue to turn the Dosage Knob, the display still shows . lantus34.jpgPlease obtain a new OptiClik™.

B. TROUBLESHOOTING

Safety test

No insulin appears at the needle tip during the Safety Test (Step 3, Safety Test):

Repeat (Step 3 Safety Test). If no insulin appears this time either, confirm that:

1. The needle is firmly in position. Replace a blocked or defective needle with a new one.

2. The Dosage Knob has been set correctly (always turn the Dosage Knob to the right/clockwise to preselect the dose). Turn the Dosage Knob one click to the right, equal to one unit.

3. The Cartridge System has been inserted correctly. Check by trying to pull the Cartridge System gently out. If the Cartridge System comes out, reinsert it completely (Step 1 Inserting the Cartridge System,). Repeat (Step 3 Safety Test).

4. The Cartridge System is not empty. If it is empty, insert a new one. Repeat Step 3 Safety Test.

You hear no clicking sound during dose-setting

The Cartridge System may have been inserted incorrectly. Check by trying to pull the Cartridge System gently out. If the Cartridge System comes out, reinsert it completely (Step 1 Inserting the Cartridge System). Repeat (Step 3 Safety Test).

If you still hear no clicking sound, try a new Cartridge System and listen for clicking sound. In case there is still no clicking sound, obtain a new OptiClik™.

Dose-setting

Insulin drips from the needle tip during dose-setting

The maximum dose of OptiClik™ is 80 units. If you continue to dial after reaching 80 units, insulin will drip from the needle and the display will continue to show "80". In such a case, DO NOT turn back to the required dose, instead dial back (to the left) to "00". Press the Dosage Knob to expel excess insulin and to reset OptiClik™. OptiClik™ is now again ready for dose setting. If you need a dose greater than 80 units, you should give it as more than one injection.

You feel resistance during dose-setting and the Dosage Knob will not turn further forward (to the right)

a) You are turning to the left and trying to dial down below zero. Turn the Dosage Knob to the right to dial your dose.

b) The Cartridge System is almost empty and no longer contains a sufficient amount of insulin for the dose you need. For example, if there are only 20 units left in the cartridge and you need 25 units, the dosage knob will stop at 20 units. You can choose to do one of the following:

1) Do not force the Dosage Knob any further (to the right). Inject the partial dose (20 units in the example), and replace the empty Cartridge System with a new one. Perform the Safety Test as described in Step 3, then inject the remainder of the dose to equal your total prescribed dose. In the above example the remaining dose is 5 units.

OR

2) Dial back (to the left) to "00". Follow Step 7 (Replacing an empty Cartridge System), Step 1(Inserting the Cartridge System), Step 2 (Attaching the needle), and Step 3 (Safety Test).

c) You have dialed (to the right) past the maximum dose of 80 units and have no needle (or a clogged needle) mounted. Dial completely back (to the left) to "00", and perform Step 2 (Attaching the needle) and Step 3 (Safety Test). Do not force the Dosage Knob to turn further.

The Dosage Knob does not stop at "00"

When turned back completely, the Dosage Knob should stop at "00", however, sometimes it may stop at "02" or "01".Make sure that a needle is attached; then press the Dosage Knob down (insulin will appear at the tip of the needle). OptiClik™ is now ready for dose setting.

The Dosage Knob no longer turns after a new Cartridge System has been inserted

Check that the Cartridge System is firmly clicked in. Reseat the Cartridge System and try again. If it still does not work, try again with a new Cartridge System (Step 1, Inserting the Cartridge System). Otherwise, get a new OptiClik™.

The Dosage Knob does not come out after you pressed the Start Button

Do not pull out the Dosage Knob. Check that the Cartridge System is firmly clicked in, see Step 1B-Inserting the Cartridge System.

Insulin injection

The Dosage Knob cannot be pressed down for the insulin injection or it does not stay down

1. In setting the dose, you have turned the Dosage Knob so that it is between two dose steps. Turn the Dosage Knob to the right or the left to the desired dose.

2. The needle may be blocked or defective. Use a new needle.

3. Avoid pushing the Start Button and Dosage Knob at the same time.

After withdrawing the needle from your skin, more than one drop of insulin drips from the needle

It is possible that you may not have injected your full insulin dose. DO NOT try to make up for the shortfall in your insulin dose by giving a second injection (otherwise you will be at risk for low blood sugar).

Please check your blood sugar and consult with your healthcare professional.

You can avoid the problem next time by taking the following steps:

1. Remove any air bubbles that may be present in the Cartridge System.

2. After delivering the insulin do

Lantus Interactions

A number of substances affect glucose metabolism and may require insulin dose adjustment and particularly close monitoring.

The following are examples of substances that may increase the blood-glucose-lowering effect and susceptibility to hypoglycemia: oral antidiabetes products, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAO inhibitors, propoxyphene, salicylates, somatostatin analog (e.g., octreotide), sulfonamide antibiotics.

The following are examples of substances that may reduce the blood-glucose-lowering effect of insulin: corticosteroids, danazol, diuretics, sympathomimetic agents (e.g., epinephrine, albuterol, terbutaline), isoniazid, phenothiazine derivatives, somatropin, thyroid hormones, estrogens, progestogens (e.g., in oral contraceptives).

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.

In addition, under the influence of sympatholytic medicinal products such as beta-blockers, clonidine, guanethidine, and reserpine, the signs of hypoglycemia may be reduced or absent.

Lantus Contraindications

LANTUS is contraindicated in patients hypersensitive to insulin glargine or the excipients.

Generic name, Overdose, Half Life Lantus, Food Interactions, Chemical, etc..

Lantus see also FDA report Anise

Diabetes Treatment