"VANCOUVER, British Columbia â€” About 415 million adults have diabetes worldwide, or about one in every 11, according to the newly-released Diabetes Atlas, 7th edition, from the International Diabetes Federation (IDF).
(insulin detemir [rDNA origin] injection)
Do not share your Levemir® FlexTouch® with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.
What is Levemir®?
- Levemir® is a man-made insulin that is used to control high blood sugar in adults and children with diabetes mellitus.
- Levemir® is not meant for use to treat diabetic ketoacidosis.
Who should not take Levemir®?
Do not take Levemir® if you:
- have an allergy to Levemir® or any of the ingredients in Levemir®.
Before taking Levemir®, tell your healthcare provider about all your medical conditions including, if you are:
- pregnant, planning to become pregnant, or are breastfeeding.
- taking new prescription or over-the-counter medicines, vitamins, or herbal supplements.
Before you start taking Levemir®, talk to your healthcare provider about low blood sugar and how to manage it.
How should I take Levemir®?
- Read the Instructions for Use that come with your Levemir®.
- Take Levemir®exactly as your healthcare provider tells you to.
- Know the type and strength of insulin you take. Do not change the type of insulin you take unless your healthcare provider tells you to. The amount of insulin and the best time for you to take your insulin may need to change if you take different types of insulin.
- Check your blood sugar levels. Ask your healthcare provider what your blood sugars should be and when you should check your blood sugar levels.
- Do not reuse or share your needles or syringes with other people. You may give other people a serious infection, or get a serious infection from them.
- Never inject Levemir® into a vein or muscle.
What should I avoid while taking Levemir®?
While taking Levemir® do not:
- Drive or operate heavy machinery, until you know how Levemir® affects you.
- Drink alcohol or use prescription or over-the-counter medicines that contain alcohol.
What are the possible side effects of Levemir®?
Levemir® may cause serious side effects that can lead to death, including:
Low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include:
- dizziness or light-headedness
- blurred vision
- anxiety, irritability, or mood changes
- slurred speech
- fast heart beat
Your insulin dose may need to change because of:
- change in level of physical activity or exercise
- increased stress
- change in diet
- weight gain or loss
Other common side effects of Levemir® may include:
- Reactions at the injection site, itching, rash, serious allergic reactions (whole body reactions), skin thickening or pits at the injection site (lipodystrophy), weight gain, and swelling of your hands and feet.
Get emergency medical help if you have:
- trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, confusion.
These are not all the possible side effects of Levemir®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of Levemir®.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about Levemir®that is written for health professionals. 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 that you have. It may harm them.
What are the ingredients in Levemir®?
Active Ingredient: insulin detemir (rDNA origin)
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.
Read before first use
Instructions for Use
(insulin detemir [rDNA origin] injection)
- Do not share your Levemir® FlexTouch® Pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.
- Levemir® FlexTouch® Pen (“Pen”) is a prefilled disposable pen containing 300 units of U-100 Levemir® (insulin detemir [rDNA origin] injection) insulin. You can inject from 1 to 80 units in a single injection.
- This Pen is not recommended for use by the blind or visually impaired without the assistance of a person trained in the proper use of the product.
Supplies you will need to give your Levemir® injection:
Levemir® FlexTouch® Pen
- a new NovoFine®, NovoFine® Plus, or NovoTwist® needle
- alcohol swab
- 1 sharps container for throwing away used Pens and needles. See “Disposing of used Levemir® FlexTouch® Pens and needles” at the end of these instructions.
Preparing your Levemir® FlexTouch® Pen:
- Wash your hands with soap and water.
- Before you start to prepare your injection, check the Levemir® FlexTouch® Pen label to make sure 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. Do not use Levemir® if it is thick, cloudy, or is colored.
- Do not use Levemir® past the expiration date printed on the label or 42 days after you start using the Pen.
- Always use a new needle for each injection to help ensure sterility and prevent blocked needles. Do not reuse or share your needles with other people. You may give other people a serious infection, or get a serious infection from them.
- Pull Pen cap straight off (See Figure B).
- Check the liquid in the Pen (See Figure ). Levemir® should look clear and colorless. Do not use it if it looks cloudy or colored.
- Select a new needle.
- Pull off the paper tab from the outer needle cap (See Figure D).
- Push the capped needle straight onto the Pen and twist the needle on until it is tight (See Figure E).
- Pull off the outer needle cap. Do not throw it away (See Figure F).
- Pull off the inner needle cap and throw it away (See Figure G).
Priming your Levemir® FlexTouch® Pen:
- Turn the dose selector to select 2 units (See Figure H).
- Hold the Pen with the needle pointing up. Tap the top of the Pen gently a few times to let any air bubbles rise to the top (See Figure I).
- Hold the Pen with the needle pointing up. Press and hold in the dose button until the dose counter shows “0”. The “0” must line up with the dose pointer.
- A drop of insulin should be seen at the needle tip (See
- If you do not see a drop of insulin, repeat steps 7 to 9, no more than 6 times.
- If you still do not see a drop of insulin, change the needle and repeat steps 7 to 9.
Selecting your dose:
- Turn the dose selector to select the number of units
you need to inject. The dose pointer should line up with your dose (See
- If you select the wrong dose, you can turn the dose selector forwards or backwards to the correct dose.
- The even numbers are printed on the dial.
- The odd numbers are shown as lines.
- The Levemir® FlexTouch® Pen insulin scale will show you how much insulin is left in your Pen (See Figure L).
- To see how much insulin is left in your Levemir® FlexTouch®
- Turn the dose selector until it stops. The dose counter will line up with the number of units of insulin that is left in your Pen. If the dose counter shows 80, there are at least 80 units left in your Pen.
- If the dose counter shows less than 80, the number shown in the dose counter is the number of units left in your Pen.
Giving your injection:
- Inject your Levemir® exactly as your healthcare provider has shown you. Your healthcare provider should tell you if you need to pinch the skin before injecting.
- Levemir® can be injected under the skin (subcutaneously) of your stomach area (abdomen), upper legs (thighs) or upper arms.
- For each injection, change (rotate) your injection site within the area of skin that you use. Do not use the same injection site for each injection.
- Choose your injection site and wipe the skin with an alcohol swab. Let the injection site dry before you inject your dose (See Figure M).
- Insert the needle into your skin (See Figure N).
- Make sure you can see the dose counter. Do not cover it with your fingers, this can stop your injection.
- Press and hold down the dose button until the dose counter shows “0” (See Figure O).
- The “0” must line up with the dose pointer. You may then hear or feel a click.
- Keep the needle in your skin after the dose
counter has returned to “0” and slowly count to 6 (See Figure P).
- When the dose counter returns to “0”, you will not get your full dose until 6 seconds later.
- If the needle is removed before you count to 6, you may see a stream of insulin coming from the needle tip.
- If you see a stream of insulin coming from the needle tip you will not get your full dose. If this happens you should check your blood sugar levels more often because you may need more insulin.
- Pull the needle out of your skin (See Figure Q).
- If you see blood after you take the needle out of your skin, press the injection site lightly with a piece of gauze or an alcohol swab. Do not rub the area.
- Carefully remove the needle from the Pen and throw it away (See Figure R).
- Do not recap the needle. Recapping the needle can lead to needle stick injury.
- If you do not have a sharps container, carefully
slip the needle into the outer needle cap (See Figure S). Safely remove the
needle and throw it away as soon as you can.
- Do not store the Pen with the needle attached. Storing without the needle attached helps prevent leaking, blocking of the needle, and air from entering the Pen.
- Replace the Pen cap by pushing it straight on (See Figure T).
After your injection:
- You can put your used Levemir® FlexTouch® Pen and needles in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and Pens in your household trash.
- If you do not have a FDA-cleared sharps disposal
container, you may use a household container that is:
- made of a heavy-duty plastic
- can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out
- upright and stable during use
- properly labeled to warn of hazardous waste inside the container
- When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. Do not reuse or share your needles or syringes with other people. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/ safesharpsdisposal.
- Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
How should I store my Levemir® FlexTouch® Pen?
- Store unused Levemir® FlexTouch® Pens in the refrigerator at 36°F to 46°F (2°C to 8°C).
- Store the Pen you are currently using out of the refrigerator below 86°F.
- Do not freeze Levemir®. Do not use Levemir® if it has been frozen.
- Keep Levemir® away from heat or light.
- Unused Pens may be used until the expiration date printed on the label, if kept in the refrigerator.
- The Levemir® FlexTouch® Pen you are using should be thrown away after 42 days, even if it still has insulin left in it.
General Information about the safe and effective use of Levemir®.
- Keep Levemir® FlexTouch® Pens and needles out of the reach of children.
- Always use a new needle for each injection.
- Do not share your Levemir® FlexTouch® Pen or needles with other people. You may give other people a serious infection, or get a serious infection from them.
Last reviewed on RxList: 2/3/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Levemir Information
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