LEVEMIR®
(LEV–uh-mere)
(insulin detemir [rDNA origin]) Solution for Subcutaneous Injection

Read the Patient Information that comes with LEVEMIR® before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your diabetes or your treatment. Make sure that you know how to manage your diabetes. Ask your healthcare provider, if you have any questions about managing your diabetes.

What is LEVEMIR®?

LEVEMIR® is a man-made long-acting insulin used to control high blood sugar in adults and children with diabetes mellitus.

It is not recommended to use LEVEMIR® to treat diabetic ketoacidosis.

Who should not use LEVEMIR®?

Do not use LEVEMIR® if:

• you are allergic to any of the ingredients in LEVEMIR®. See the end of this leaflet for a complete list of ingredients in LEVEMIR®.

What should I tell my healthcare provider before using LEVEMIR®?

Before you use LEVEMIR®, tell your healthcare provider if you:

• have liver or kidney problems
• take any other medicines, especially ones commonly called TZDs (thiazolidinediones).
• have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with LEVEMIR®.
• have any other medical conditions. Some medical conditions can affect your insulin needs and your dose of LEVEMIR®.
• are pregnant or plan to become pregnant. It is not known, if LEVEMIR® would harm your unborn baby. Talk to your healthcare provider, if you are pregnant or plan to become pregnant. You and your healthcare provider should talk about the best way to manage your diabetes while you are pregnant.
• are breastfeeding or plan to breast-feed. It is not known if LEVEMIR® passes into breast milk. You and your healthcare provider should decide if you will take LEVEMIR® while you breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. LEVEMIR® may affect the way other medicines work, and other medicines may affect how LEVEMIR® works.

Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist when you get a new medicine.

How should I use LEVEMIR®?

• Use LEVEMIR® exactly as your healthcare provider told you to use it.
• Your healthcare provider will tell you how much LEVEMIR® to use and when to use it.
• Do not make any changes to your dose or type of insulin unless you are told to do so by your healthcare provider.
  Know your insulin. Make sure you know:
  • the type and strength of insulin prescribed for you.
  • the amount of insulin you take.
  • the best time for you to take your insulin. This may change if you take a different type of insulin.
• Do not dilute or mix LEVEMIR® with any other insulin or injectable diabetes medicine. Your LEVEMIR® will not work the right way and you may lose control of your blood sugar, which can be serious. Give yourself separate injections. You may give the separate injections in the same body area (for example, your stomach area), but you should not give the injections right next to each other.
• Do not use LEVEMIR® in an insulin pump.
• Inject LEVEMIR® under your skin (subcutaneously) in your upper arm, abdomen (stomach area), or thigh. Never inject LEVEMIR® into a vein or muscle.
• Change injection sites within the area you choose with each dose. Do not inject into the exact same spot for each injection.
• Read the instructions for use that comes with your LEVEMIR®. Talk to your healthcare provider if you have any questions. Your healthcare provider should show you how to inject LEVEMIR® before you start taking it.
• Your healthcare provider will decide which type of LEVEMIR® to prescribe for you.
  LEVEMIR® comes in:
  • 10 mL vials (small bottles) for use with a syringe
  • 3 mL LEVEMIR® FlexPen®

Ask your healthcare provider how you should use LEVEMIR®.

• If you use too much LEVEMIR®, your blood sugar may fall low (hypoglycemia). You can treat mild low blood sugar (hypoglycemia) by drinking or eating something sugary right away (fruit juice, sugar candies, or glucose tablets). It is important to treat low blood sugar (hypoglycemia) right away because it could get worse and you could pass out (lose consciousness).
  If you pass out you will need help from another person or emergency medical services right away. See “What are the possible side effects of LEVEMIR®?” for more information on low blood sugar (hypoglycemia).
• If you forget to take your dose of LEVEMIR®, your blood sugar may go too high (hyperglycemia). If high blood sugar (hyperglycemia) is not treated it can lead to serious problems, like loss of consciousness (passing out), coma or even death.
  Follow your healthcare provider's instructions for treating high blood sugar.
  Know your symptoms of high blood sugar, which may include:
  • increased thirst
  • frequent urination
  • drowsiness
  • loss of appetite
  • a hard time breathing
  • fruity smell on the breath
  • high amounts of sugar and ketones in your urine
  • nausea, vomiting (throwing up) or stomach pain
• Do not share needles, insulin pens or syringes with others.
• Check your blood sugar levels. Ask your healthcare provider what your blood sugars should be and when you should check your blood sugar levels.

Your insulin dosage may need to change because of:

• illness
• stress
• other medicines you take
• change in diet or exercise
• change in physical activity

What should I avoid while taking LEVEMIR®?

• Alcohol. Drinking alcohol may affect your blood sugar when you use LEVEMIR®.
• Driving and operating machinery. You may have trouble paying attention or reacting if you have low blood sugar (hypoglycemia). Be careful when you drive a car or operate machinery. Ask your healthcare provider if it is alright for you to drive if you often have:
  • low blood sugar (hypoglycemia)
  • decreased or no warning signs of low blood sugar

What are the possible side effects of LEVEMIR®?

LEVEMIR® can cause serious side effects, including:

• Low blood sugar (hypoglycemia). Signs and symptoms of low blood sugar may include:
  • dizziness or lightheadedness
  • shakiness
  • hunger
  • fast heart beat
  • tingling in your hands, feet, lips or tongue
  • trouble concentrating or confusion
  • blurred vision
  • slurred speech
  • anxiety or mood changes
  • headache
  • sweating

Very low blood sugar (hypoglycemia) can cause loss of consciousness (passing out), seizures, and death. In some people their blood sugar may get so low that they need another person to help them. Talk to your healthcare provider about how to tell if you have low blood sugar and what to do if this happens while taking LEVEMIR®. Know your symptoms of low blood sugar. Follow your healthcare provider's instructions for treating low blood sugar.

If you are using LEVEMIR® with another diabetes medicine, your LEVEMIR® dose may need to be changed to reduce your chance of getting low blood sugar.

Talk to your healthcare provider if low blood sugar is a problem for you. Your dose of LEVEMIR® may need to be changed.

• Skin thickening or pits at the injection site (lipodystrophy). Change (rotate) the area where you inject your insulin to help prevent these skin changes from happening. Do not inject insulin into areas of skin that have thickening or pits.
• Serious allergic reactions. LEVEMIR® can cause life threatening symptoms. Get medical help right away if you have any of these symptoms of an allergic reaction:
  • a rash all over your body
  • itching
  • shortness of breath
  • trouble breathing (wheezing)
  • fast heartbeat
  • sweating
  • feel faint
• Swelling of your hands and feet
• Heart Failure. Taking certain diabetes pills called thiazolidinediones or “TZDs” with LEVEMIR® may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure it may get worse while you take TZDs with LEVEMIR®. Your healthcare provider should monitor you closely while you are taking TZDs with LEVEMIR®. Tell your healthcare provider if you have any new or worse symptoms of heart failure including:
  • shortness of breath
  • swelling of your ankles or feet
  • sudden weight gain

Treatment with TZDs and LEVEMIR® may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.

Common side effects of LEVEMIR® include:

• Low blood sugar (hypoglycemia). See “What are the possible side effects of LEVEMIR®?” for more information on low blood sugar (hypoglycemia).
• Reactions at the injection site (local allergic reaction). You may get redness, swelling, and itching at the injection site. If you keep having skin reactions or they are serious, talk to your healthcare provider.
• Weight gain. This can occur with any insulin therapy. Talk to your healthcare provider about how LEVEMIR® can affect your weight.

Tell your healthcare provider if you have any side effect that bothers you or does not go away.

These are not all of the possible side effects from LEVEMIR®. Ask your healthcare provider or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store LEVEMIR®?

Unopened LEVEMIR®:

• Keep all unopened LEVEMIR® in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Unopened LEVEMIR® can be kept until the expiration date on the label if the medicine has been stored in a refrigerator.
• If refrigeration is not possible, you can keep the unopened LEVEMIR® at room temperature below 86°F (30°C).
• Throw away LEVEMIR® 42 days after it is first kept out of the refrigerator.
• Do not freeze. Do not use LEVEMIR® if it has been frozen.
• Keep unopened LEVEMIR® in the carton to protect it from light.

LEVEMIR® in use:

• Vials
  • Keep opened vials of LEVEMIR® in the refrigerator or at room temperature below 86°F (30°C) away from direct heat or light.
  • Throw away a vial that has always been kept in the refrigerator after 42 days of use, even if there is insulin left in the vial.
  • Throw away a vial that has been kept at room temperature 42 days after it is first kept out of the refrigerator, even if there is insulin left in the vial.
• LEVEMIR® FlexPen
  • Keep at room temperature below 86°F (30°C) for up to 42 days.
  • Do not store a LEVEMIR® FlexPen® that you are using in the refrigerator.
  • Do not store LEVEMIR® with the needle attached.
  • Keep LEVEMIR® FlexPen® away from direct heat or light.
  • Throw away used LEVEMIR® FlexPens after 42 days, even if there is insulin left in them.

Keep LEVEMIR® and all medicines out of the reach of children.

General information about LEVEMIR®

Medicines are sometimes prescribed for conditions that are not mentioned in the patient leaflet. Do not use LEVEMIR® for a condition for which it was not prescribed. Do not give LEVEMIR® to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about LEVEMIR®. If you would like more information about LEVEMIR® or diabetes, talk with your healthcare provider. You can ask your healthcare provider for information about LEVEMIR® that is written for healthcare professionals.

For more information about LEVEMIR®, call 1-800-727-6500 or go to www.novonordisk-us.com.

What are the ingredients in LEVEMIR®?

Active Ingredient: Insulin detemir

Inactive Ingredients: zinc, m-cresol, glycerol, phenol, disodium phosphate dihydrate, sodium chloride and water for injection. Hydrochloric acid or sodium hydroxide may be added.

Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark. For information about LEVEMIR® contact: Novo Nordisk Inc., 100 College Road West, Princeton, New Jersey 08540, www.novonordisk-us.com. 1-800-727-6500. Revised: Month2012

Patient Instructions For Use

LEVEMIR® 10 mL vial

Please read the following Instructions for use carefully before using your LEVEMIR® 10 mL vial and each time you get a refill. You should read the instructions in this manual even if you have used an insulin 10 mL vial before.

How should I use the LEVEMIR 10 mL vial?

Using the 10 mL vial:

1. Check to make sure that you have the correct type of insulin. This is especially important if you use different types of insulin.

2. Look at the vial and the insulin. The LEVEMIR insulin should be clear and colorless. The tamper-resistant cap should be in place before the first use. If the cap has been removed before your first use of the vial, or if the insulin is cloudy or colored, Do not use the insulin and return it to your pharmacy.

3. Wash your hands with soap and water.

4. If you are using a new vial, pull off the tamper-resistant cap.

Before each use, wipe the rubber stopper with an alcohol wipe.

5. Do not roll or shake the vial. Shaking the vial right before the dose is drawn into the syringe may cause bubbles or foam. This can cause you to draw up the wrong dose of insulin. The insulin should be used only if it is clear and colorless.

6. Pull back the plunger on your syringe until the black tip reaches the marking for the number of units you will inject.

7. Push the needle through the rubber stopper into the vial.

8. Push the plunger all the way in. This inserts air into the vial.

9. Turn the vial and syringe upside down and slowly pull the plunger back to a few units beyond the correct dose that you need.

10. If there are air bubbles, tap the syringe gently with your finger to raise the air bubbles to the top of the needle. Then slowly push the plunger to the correct unit marking for your dose.

11. Check to make sure you have the right dose of LEVEMIR in the syringe.

12. Pull the syringe out of the vial.

13. Inject your LEVEMIR right away as instructed by your healthcare provider.

How should I inject LEVEMIR with a syringe?

If you clean your injection site with an alcohol swab, let the injection site dry before you inject. Talk with your healthcare provider about how to rotate injection sites and how to give an injection.

1. Pinch your skin between two fingers, push the needle into the skinfold, using a dart-like motion and push the plunger to inject the insulin under your skin. The needle will be straight in.

2. Keep the needle under your skin for at least 6 seconds to make sure you have injected all the insulin. After you pull the needle from your skin you may see a drop of Levemir at the needle tip. This is normal and has no effect on the dose you just received.

3. If blood appears after you pull the needle from your skin, press the injection site lightly with an alcohol swab. Do not rub the area.

4. After each injection, remove the needle without recapping and dispose of it in a puncture-resistant container. Used syringes, needles, and lancets 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.

Revised: January 2012. Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, For information about LEVEMIR® contact: Novo Nordisk Inc., 100 College Road West, Princeton, New Jersey 08540

Instructions For Use

LEVEMIR® FlexPen®

Please carefully read the following Instructions for use before using your LEVEMIR® FlexPen® and each time you get a refill. You should read the instructions in this manual even if you have used a LEVEMIR FlexPen before.

LEVEMIR FlexPen is a disposable dial-a-dose insulin pen. You can select doses from 1 to 60 units in increments of 1 unit. LEVEMIR FlexPen is designed to be used with NovoFine® needles.

LEVEMIR FlexPen should not be used by people who are blind or have severe eyesight problems without the help of a person who has good eyesight and who is trained to use the LEVEMIR FlexPen the right way.

Getting ready

Make sure you have the following items:

• LEVEMIR FlexPen
• NovoFine disposable needles
• Alcohol swab

PREPARING YOUR LEVEMIR FLEXPEN

Wash your hands with soap and water. Before you start to prepare your injection, check the label to make sure that you are taking the right type of insulin. This is especially important if you take more than 1 type of insulin. LEVEMIR should look clear and colorless.

A. Pull off the pen cap (see diagram A).

Wipe the rubber stopper with an alcohol swab.

B. Attaching the needle

Remove the protective tab from a new disposable needle.

Attach the needle tightly onto your FlexPen. It is important that the needle is put on straight (see diagram B).

Never place a disposable needle on your LEVEMIR FlexPen until you are ready to give your injection.

C. Pull off the big outer needle cap (see diagram C).

D. Pull off the inner needle cap and throw it away (see diagram D).

• Always use a new needle for each injection to cut down the chance of infection and to prevent blocked needles.
• Be careful not to bend or damage the needle before use.
• To reduce the risk of needle sticks, never put the inner needle cap back on the needle.

Giving the airshot before each injection

Before each injection, small amounts of air may collect in the cartridge during normal use. To avoid injecting air and to ensure you take the right dose of insulin:

E. Turn the dose selector to select 2 units (see diagram E).

F. Hold your LEVEMIR FlexPen with the needle pointing up. Tap the cartridge gently with your finger a few times to make any air bubbles collect at the top of the cartridge (see diagram F).

G. While you keep the needle pointing upwards, press the pushbutton all the way in (see diagram G). The dose selector returns to 0.

A drop of insulin should appear at the needle tip. If not, change the needle and repeat the procedure no more than 6 times.

If you do not see a drop of insulin after 6 times, do not use the LEVEMIR FlexPen and contact Novo Nordisk at 1-800-727- 6500.

A small air bubble may remain at the needle tip, but it will not be injected.

SELECTING YOUR DOSE

Check and make sure that the dose selector is set at 0.

H. Turn the dose selector to the number of units you need to inject. The pointer should line up with your dose.

The dose can be corrected either up or down by turning the dose selector in either direction until the correct dose lines up with the pointer (see diagram H). When turning the dose selector, be careful not to press the push-button as insulin will come out.

You cannot select a dose larger than the number of units left in the cartridge.

You will hear a click for every single unit dialed. Do not set the dose by counting the number of clicks you hear.

• Do not use the cartridge scale printed on the cartridge to measure your dose of insulin.

GIVING THE INJECTION

Do the injection exactly as shown to you by your healthcare provider. Your healthcare provider should tell you if you need to pinch the skin before injecting. Wipe the skin with an alcohol swab and let the area dry.

I. Insert the needle into your skin.

Inject the dose by pressing the push-button all the way in until the 0 lines up with the pointer (see diagram I). Be careful only to push the button after the needle is in the skin.

Turning the dose selector will not inject insulin.

J. Keep the needle in the skin for at least 6 seconds, and keep the push-button pressed all the way in until the needle has been pulled out from the skin (see diagram J). This will make sure that the full dose has been given.

You may see a drop of LEVEMIR at the needle tip. This is normal and has no effect on the dose you just received. If blood appears after you take the needle out of your skin, press the injection site lightly with an alcohol swab. Do not rub the area.

After the injection

Carefully remove the needle from the pen after each injection. This helps to prevent infection and leakage of insulin. You can carefully recap the needle with the bigger outer cap to help make it easier to remove the needle.

• Do not recap the needle with the small inner cap. Recapping with this small part can increase your chances of having a needle stick injury.
• Put the needle in a sharps container or some type of hard plastic or metal container with a screw top such as a detergent bottle or empty coffee can. These containers should be sealed and thrown away the right way. Check with your healthcare provider about the right way to throw away used syringes and needles. There may be local or state laws about how to throw away used needles and syringes. Do not throw away used needles and syringes in household trash or recycling bins.

K. Put the pen cap on the LEVEMIR FlexPen and store the LEVEMIR FlexPen without the needle attached (see diagram K).

The LEVEMIR FlexPen prevents the cartridge from being completely emptied. It can deliver 300 units then you should throw it away in a sharps container or some type of hard plastic or metal container with a screw top, such as a detergent bottle or empty coffee can.

FUNCTION CHECK

L. If your LEVEMIR FlexPen is not working the right way, follow the steps below:

• Attach a new NovoFine needle.
• Remove the big outer needle cap and the inner needle cap.
• Do an airshot as described in “Giving the airshot before each injection” (see diagram E through G).
• Put the big outer needle cap onto the needle. Do not put on the inner needle cap.
• Turn the dose selector so the dose indicator window shows 20 units.
• Hold the LEVEMIR FlexPen so the needle is pointing down.
• Press the push-button all the way in.

The insulin should fill the lower part of the big outer needle cap to the marker (see diagram L). If LEVEMIR FlexPen has released too much or too little insulin, do the function check again. If the same problem happens again, do not use your LEVEMIR FlexPen and contact Novo Nordisk at 1-800-727-6500.

Maintenance

Your FlexPen is designed to work accurately and safely. It must be handled with care. If you drop your FlexPen it could get damaged. If you are concerned that your FlexPen is damaged, use a new one. You can clean the outside of your FlexPen by wiping it with a damp cloth. Do not soak or wash your FlexPen. Soaking or washing the FlexPen could damage it. Do not refill your FlexPen.

• Remove the needle from the LEVEMIR FlexPen after each injection. This helps to cut down your chance of infection, prevent leakage of insulin. Be careful when handling used needles to avoid needle sticks and transfer of infections.
• Keep your LEVEMIR FlexPen and needles out of the reach of children.
• Use LEVEMIR FlexPen as directed to treat your diabetes. Needles and
• LEVEMIR FlexPen must not be shared.
• Always use a new needle for each injection.
• Novo Nordisk is not responsible for harm due to using this insulin pen with products not recommended by Novo Nordisk.
• As a safety measure, always carry a spare insulin delivery device in case your LEVEMIR FlexPen is lost or damaged.
• Remember to keep the disposable LEVEMIR FlexPen with you. Do not leave it in a car or other location where it can get too hot or too cold.

Last reviewed on RxList: 3/28/2013
This monograph has been modified to include the generic and brand name in many instances.