Levemir

Levemir is a prescription medication used to treat type 1 and type 2 diabetes. Levemir, a long-acting form of insulin, works by replacing the insulin that is normally produced by the body and by helping the body to use sugar for energy. It also stops the liver from producing more sugar.

This medication comes in an injectable form and is typically injected under the skin once or twice daily.

Common side effects include redness and skin thickening at the injection site, weight gain, and constipation.

Levemir is a man-made long-acting insulin that is used to control high blood sugar in adults and children with type 1 and type 2 diabetes.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Novo Nordisk, Inc.

Levemir may cause serious side effects. See "Drug Precautions" section.

Common side effects of Levemir include:

• 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 doctor.
• Weight gain. This can occur with any insulin therapy. Talk to your doctor about how Levemir can affect your weight.

Tell your doctor 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 doctor or pharmacist for more information.

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

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), and trandolapril (Mavik)
• beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal)
• certain cholesterol-lowering medications such as fenofibrate (Antara, Lofibra, TriCor, Triglide) and gemfibrozil (Lopid)
• clonidine (Catapres, Catapres-TTS, in Clorpres)
• danazol
• disopyramide (Norpace, Norpace CR)
• diuretics ('water pills')
• fluoxetine (Prozac, Sarafem, in Symbyax)
• hormone replacement therapy
• isoniazid (INH, Nydrazid)
• lithium (Eskalith, Lithobid)
• medications for asthma and colds
• medications for mental illness and nausea
• monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl), and tranylcypromine (Parnate)
• octreotide (Sandostatin)
• oral contraceptives (birth control pills)
• oral medications for diabetes
• oral steroids such as dexamethasone (Decadron, Dexone)
• methylprednisolone (Medrol), and prednisone (Deltasone)
• pentamidine (NebuPent, Pentam)
• reserpine
• salicylate pain relievers such as aspirin, choline magnesium trisalicylate (Tricosal, Trilisate), choline salicylate (Arthropan), diflunisal (Dolobid), magnesium salicylate (Doan's, others), and salsalate (Argesic, Disalcid, Salgesic)
• somatropin (Nutropin, Serostim, others)
• sulfa antibiotics
• thyroid medications

This is not a complete list of Levemir drug interactions. Ask your doctor or pharmacist for more information.

Levemir can cause serious side effects, including:

• Low blood sugar (hypoglycemia). 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. Talk to your doctor 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 doctor’s instructions for treating low blood sugar.

Talk to your doctor 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

Do not use Levemir if:

• Your blood sugar is too low (hypoglycemia).
• You are allergic to anything in Levemir.

While using Levemir you should avoid alcohol. Alcohol, including beer and wine, may affect your blood sugar when you take Levemir.

You may have difficulty concentrating or reacting if you have low blood sugar (hypoglycemia). Be careful when you drive a car or operate machinery. Ask your doctor if it is alright to drive if you often have:

• low blood sugar
• decreased or no warning signs of low blood sugar

Follow dietary (food) recommendations made by your doctor and dietitian which should include a healthy diet. Skipping meals should be avoided as this can cause problems maintaining blood sugar control. There are no specific foods to avoid while using Levemir.

Before you use Levemir, tell your doctor if you:

• are allergic to Levemir or any of its ingredients
• have liver or kidney problems
• 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
• are breastfeeding or plan to breastfeed

Tell your doctor 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.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Levemir falls into category B. In animal studies, pregnant animals were given Levemir, and some babies had problems.

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

Tell your doctor if you are breastfeeding. You and your doctor should talk about the best way to manage your diabetes while you are breastfeeding. Levemir has not been studied in nursing women.

Use Levemir only as prescribed.  

This medication comes in an injectable form and is typically injected under the skin once or twice daily.

If Levemir will be injected once a day, it should be given with the evening meal or at bedtime

• Only use Levemir if it appears clear and colorless. There may be air bubbles. This is normal. If it looks cloudy, thickened, or colored, or if it contains solid particles do not use it.
• Inject Levemir into the skin of your stomach area, upper arms, or thighs. Levemir may affect your blood sugar levels sooner if you inject it into the skin of your stomach area or upper arm. Never inject Levemir into a vein or into a muscle.
• Change (rotate) your injection site within the chosen area (for example, stomach or upper arm) with each dose. Do not inject into the exact same spot for each injection.
• Check your blood sugar levels. Ask your doctor what your blood sugars should be and when you should check your blood sugar levels.
• Never mix Levemir with other insulin products.
• Never use Levemir in an insulin pump.

How to use the Levemir 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. Levemir 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 doctor.

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

Injecting Levemir with a syringe:

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.

Levemir FlexPen - Instructions For Use

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

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

C. Pull off the big outer needle cap.

D. Pull off the inner needle cap and throw it away. 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.

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.

G. While you keep the needle pointing upwards, press the push-button all the way in. 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. Check and make sure that the dose selector is set at 0.  

Selecting your dose

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. 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 doctor. Your doctor 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. 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. This will make sure that the full dose has been given. You may see a drop of insulin detemir 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 doctor 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. 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.

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 to ensure that the needle is not clogged.
• 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.

Function Check

The insulin should fill the lower part of the big outer needle cap to the marker. 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.

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 insulin detemir 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.

Use Levemir exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you.

Your insulin dosage may need to change because of:

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

The starting dose will be individualized based on the type of diabetes and whether you have been on insulin before. 

Do not change your dosage unless your doctor instructs you to do so.

• If you administer 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). You should know the symptoms of low blood sugar.
• If you pass out you will need help from another person or emergency medical services right away. 
• 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.

• Keep all unopened Levemir in the refrigerator between 36° to 46°F (2° to 8°C).
• Do not freeze. Do not use Levemir if it has been frozen.
• Keep unopened Levemir in the carton to protect 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.