"Nov. 15, 2012 -- The number of people diagnosed with diabetes in the U.S. jumped by 50% or more in 42 states and by more than 100% in 18 of those states in just under two decades, according to the latest snapshot from the CDC.
(insulin aspart [rDNA origin]) Injection
Know your insulin. Do not change the type insulin you use unless told to do so by your healthcare provider. The amount of insulin you take as well as the best time for you to take your insulin may need to change if you take a different type of insulin.
Make sure you know the type and strength of insulin prescribed for you.
Read the Patient Information that comes with NovoLog® 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 you know how to manage your diabetes. Ask your healthcare provider if you have any questions about managing your diabetes.
What is NovoLog®?
Who should not use NovoLog®?
Do not take NovoLog® if:
- Your blood sugar is too low (hypoglycemia).
- You are allergic to anything in NovoLog®. See the end of this leaflet for a complete list of ingredients in NovoLog®. Check with your healthcare provider if you are not sure.
Tell your healthcare provider:
- about all of your medical conditions. Medical conditions can affect your insulin needs and your dose of NovoLog®.
- if you are pregnant or breastfeeding. You and your healthcare provider should talk about the best way to manage your diabetes while you are pregnant or breastfeeding. NovoLog® has not been studied in nursing women.
- about all medicines you take, including prescriptions and nonprescription medicines, vitamins and herbal supplements. Your NovoLog® dose may change if you take other medicines.
- if you take any other medicines, especially ones commonly called TZDs (thiazolidinediones).
- if you have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with NovoLog®.
Know the medicines you take. Keep a list of your medicines with you to show your healthcare providers when you get a new medicine.
How should I take NovoLog®?
Only use NovoLog® 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 and call Novo Nordisk at 1-800-727-6500.
NovoLog® comes in:
- 10 mL vials (small bottles) for use with syringe
- 3 mL PenFill® cartridges for use with the Novo Nordisk 3 mL PenFill® cartridge compatible insulin delivery devices and NovoFine® disposable needles. The cartridge delivery device can be used with a NovoPen® 3 PenMate®
- 3 mL NovoLog® FlexPen®
Read the instructions for use that come with your NovoLog® product. Talk to your healthcare provider if you have any questions. Your healthcare provider should show you how to inject NovoLog® before you start taking it.
- Take NovoLog® exactly as prescribed. You should eat a meal within 5 to 10 minutes after using NovoLog® to avoid low blood sugar.
- NovoLog® is a fast-acting insulin. The effects of NovoLog® start working 10 to 20 minutes after injection or bolus pump infusion.
- Do not inject NovoLog® if you do not plan to eat right after your injection or bolus pump infusion.
- The greatest blood sugar lowering effect is between 1 and 3 hours after the injection or infusion. This blood sugar lowering lasts for 3 to 5 hours.
- While using NovoLog® you may have to change your total dose of insulin, your dose of longer-acting insulin, or the number of injections of longer-acting insulin you use. Pump users given NovoLog® may need to change the amount of total insulin given as a basal infusion.
- Do not mix NovoLog®:
- with any other insulins when used in a pump
- with any insulins other than NPH when used with injections by syringe
If your healthcare provider recommends diluting NovoLog®, follow your healthcare provider's instructions exactly so that you know:
- How to make NovoLog® more dilute (that is, a smaller number of units of NovoLog® for a given amount of liquid) and
- How to use this more dilute form of NovoLog®. Do not use dilute insulin in a pump.
- Inject NovoLog® into the skin of your stomach area, upper arms, buttocks or upper legs. NovoLog® may affect your blood sugarlevels sooner if you inject it into the skin of your stomach area. Never inject NovoLog® 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.
- If you take too much NovoLog®, 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 (become unconscious). If you pass out you will need help from another person or emergency medical services right away, and will need treatment with a glucagon injection or treatment at a hospital. See “What are the possible side effects of NovoLog®?” for more information on low blood sugar (hypoglycemia).
- If you forget to take your dose of NovoLog®, 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
- 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
- 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:
- other medicines you take
- change in diet
- change in physical activity or exercise
What should I avoid while using NovoLog®?
- Alcohol. Alcohol, including beer and wine, may affect your blood sugar when you take NovoLog®.
- Driving and operating machinery. 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 healthcare
provider if it is alright to drive if you often have:
- low blood sugar
- decreased or no warning signs of low blood sugar
What are the possible side effects of NovoLog®?
- Low blood sugar (hypoglycemia). Symptoms of low
blood sugar may include:
- dizziness or lightheadedness
- fast heart beat
- tingling of lips and tongue
- trouble concentrating or confusion
- blurred vision
- slurred speech
- anxiety, irritability or mood changes
Severe low blood sugar can cause unconsciousness (passing out), seizures, and death. Know your symptoms of low blood sugar. Follow your healthcare provider's instructions for treating low blood sugar. Talk to your healthcare provider if low blood sugar is a problem for you.
- Serious allergic reaction (whole body reaction). Get medical help right away, if you develop a rash over your whole body, have trouble breathing, a fast heartbeat, or sweating.
- 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. You may need to stop using NovoLog® and use a different insulin. Do not inject insulin into skin that is red, swollen, or itchy.
- Skin thickens or pits at the injection site (lipodystrophy). Change (rotate) where you inject your insulin to help to prevent these skin changes from happening. Do not inject insulin into this type of skin.
- Swelling of your hands and feet
- Heart Failure. Taking certain diabetes pills
called thiazolidinediones or “TZDs” with NovoLog® 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 NovoLog®. Your healthcare provider should monitor you closely while you
are taking TZDs with NovoLog®. 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 NovoLog® may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.
- Vision changes
- Low potassium in your blood (hypokalemia)
- Weight gain
These are not all of the possible side effects from NovoLog®. Ask your healthcare provider or pharmacist for more information.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store NovoLog®?
All Unopened NovoLog®:
- Keep all unopened NovoLog® in the refrigerator between 36° to 46°F (2° to 8°C).
- Do not freeze. Do not use NovoLog® if it has been frozen.
- Keep unopened NovoLog® in the carton to protect from light.
NovoLog® in use:
- Keep in the refrigerator or at room temperature below 86°F (30°C) for up to 28 days.
- Keep vials away from direct heat or light.
- Throw away an opened vial after 28 days of use, even if there is insulin left in the vial.
- Do not draw up NovoLog® into a syringe and store for later use.
- Unopened vials can be used until the expiration date on the NovoLog® label, if the medicine has been stored in a refrigerator.
- PenFill® Cartridges or NovoLog® FlexPen®
- Keep at room temperature below 86°F (30°C) for up to 28 days.
- Do not store a PenFill® cartridge or NovoLog® FlexPen® that you are using in the refrigerator.
- Keep PenFill® cartridges and NovoLog® FlexPen® away from direct heat or light.
- Throw away a used PenFill® cartridge or NovoLog® FlexPen® after 28 days, even if there is insulin left in the cartridge or syringe.
- NovoLog® in the pump reservoir and the complete external
pump infusion set
- The infusion set and the infusion site should be changed at least every 3 days. The insulin in the reservoir should be changed at least every 6 days even if you have not used all of the insulin. Change the infusion set and the infusion site more often than every 3 days if you have high blood sugar (hyperglycemia), the pump alarm sounds, or the insulin flow is blocked (occlusion).
General advice about NovoLog®
Medicines are sometimes prescribed for conditions that are not mentioned in the patient leaflet. Do not use NovoLog® for a condition for which it was not prescribed. Do not give NovoLog® to other people, even if they have the same symptoms you have. It may harm them.
This leaflet summarizes the most important information about NovoLog®. If you would like more information about NovoLog® or diabetes, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about NovoLog® that is written for healthcare professionals. Call 1- 800-727-6500 or visit www.novonordisk-us.com for more information.
Helpful information for people with diabetes is published by the American Diabetes Association, 1701 N Beauregard Street, Alexandria, VA 22311 and on www.diabetes.org.
NovoLog® ingredients include:
- insulin aspart
- disodium hydrogen phosphate dihydrate
- sodium chloride
- water for injection
All NovoLog® vials, PenFill® cartridges and NovoLog® FlexPen® are latex free.
Instructions for Use
(insulin aspart [rDNA origin] injection) 10 mL vial (100 Units/mL, U-100)
Read this Instructions for Use before you start taking NovoLog® and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
Supplies you will need to give your NovoLog® injection:
- 10 mL NovoLog® vial
- insulin syringe and needle
- alcohol swab
Preparing your NovoLog® dose:
- Wash your hands with soap and water.
- Before you start to prepare your injection, check the NovoLog® label to make sure that you are taking the right type of insulin. This is especially important if you use more than 1 type of insulin.
- NovoLog® should look clear and colorless. Do not use NovoLog® if it is thick, cloudy, or is colored.
- Do not use NovoLog® past the expiration date printed on the label.
Step 1: Pull off the tamper resistant cap (See Figure A).
Step 2: Wipe the rubber stopper with an alcohol swab (See Figure B).
Step 3: Hold the syringe with the needle pointing up. Pull down on the plunger until the black tip reaches the line for the number of units for your prescribed dose (See Figure C).
Step 4: Push the needle through the rubber stopper of the NovoLog® vial (See Figure D).
Step 5: Push the plunger all the way in. This puts air into the NovoLog® vial (See Figure E).
Step 6: Turn the NovoLog® vial and syringe upside down and slowly pull the plunger down until the black tip is a few units past the line for your dose (See Figure F).
If there are air bubbles, tap the syringe gently a few times to let any air bubbles rise to the top (See Figure G).
Step 7: Slowly push the plunger up until the black tip reaches the line for your NovoLog® dose (See Figure H).
Step 8: Check the syringe to make sure you have the right dose of NovoLog®.
Step 9: Pull the syringe out of the vial's rubber stopper (See Figure I).
Giving your Injection:
- Inject your NovoLog® exactly as your healthcare provider has shown you. Your healthcare provider should tell you if you need to pinch the skin before injecting.
- NovoLog® can be injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs or upper arms, infused in an insulin pump, or given through a needle in your arm (intravenously) by your healthcare provider.
- If you inject NovoLog®, change (rotate) your injection sites within the area you choose for each dose. Do not use the same injection site for each injection.
- If you use NovoLog® in an insulin pump, you should change your insertion site every 3 days. The insulin in the reservoir should be changed at least every 6 days even if you have not used all of the insulin.
- If you use NovoLog® in an insulin pump, see your insulin pump manual for instructions or talk to your healthcare provider.
- NPH insulin is the only type of insulin that can be mixed with NovoLog®. Do not mix NovoLog® with any other type of insulin.
- NovoLog® should only be mixed with NPH insulin if it is going to be injected right away under your skin (subcutaneously).
- NovoLog® should be drawn up into the syringe before you draw up your NPH insulin.
- Talk to your healthcare provider if you are not sure about the right way to mix NovoLog® and NPH insulin.
Step 10: Choose your injection site and wipe the skin an alcohol swab. Let the injection site dry before you your dose (See Figure J).
Step 11: Insert the needle into your skin. Push down on the plunger to inject your dose (See Figure K). Needle should remain in the skin for at least 6 seconds to make sure you have injected all the insulin.
Step 12: Pull the needle out of your skin. After that, you may see a drop of NovoLog® at the needle tip. This is normal and does not affect the dose you just received (See Figure L).
- 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.
After your injection:
- Do not recap the needle. Recapping the needle can lead to a needle stick injury.
- Throw away empty insulin vials, used syringes, and needles in a sharps container or some type of hard plastic or metal container with a screw on cap such as a detergent bottle or empty coffee can. Check with your healthcare provider about the right way to throw away the container. There may be local or state laws about how to throw away used syringes and needles. Do not throw away used syringes and needles in household trash or recycling bins.
How should I store NovoLog®?
- Do not freeze NovoLog®. Do not use NovoLog® if it has been frozen.
- Keep NovoLog® away from heat or light.
- Store opened and unopened NovoLog® vials in the refrigerator at 36°F to 46°F (2°C to 8°C). Opened NovoLog® vials can also be stored out of the refrigerator below 86°F (30°C).
- Unopened vials may be used until the expiration date printed on the label, if they are kept in the refrigerator.
- Opened NovoLog® vials should be thrown away after 28 days, even if they still have insulin left in them.
General information about the safe and effective use of NovoLog®
- Always use a new syringe and needle for each injection.
- Do not share syringes or needles.
- Keep NovoLog® vials, syringes, and needles out of the reach of children.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Please read the following instructions carefully before using your NovoLog® FlexPen®.
NovoLog FlexPen is a disposable dial-a-dose insulin pen. You can select doses from 1 to 60 units in increments of 1 unit. NovoLog FlexPen is designed to be used with NovoFine® needles.
- NovoLog FlexPen should not be used by people who are blind or have severe visual problems without the help of a person who has good eyesight and who is trained to use the NovoLog FlexPen the right way.
Make sure you have the following items:
- NovoLog FlexPen
- New NovoFine needle
- Alcohol swab
Preparing Your NovoLog 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. NovoLog should look clear.
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 disposable needle.
Screw 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 NovoLog FlexPen until you are ready to take your injection.
C. Pull off the big outer needle cap (see diagram C).
D. Pull off the inner needle cap and dispose of it (see diagram D).
- Always use a new needle for each injection to help ensure sterility and prevent blocked needles.
- Be careful not to bend or damage the needle before use.
- To reduce the risk of unexpected 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 proper dosing:
E. Turn the dose selector to select 2 units (see diagram E).
F. Hold your NovoLog 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. Keep the needle pointing upwards, press the push-button 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 NovoLog 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.
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 when injecting.
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 NovoLog 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 a finger. Do not rub the area.
After the injection
Do not recap the needle. Recapping can lead to a needle stick injury. Remove the needle from the NovoLog FlexPen after each injection. This helps to prevent infection, leakage of insulin, and will help to make sure you inject the right dose of insulin.
- Put the needle and any empty NovoLog FlexPen or any used NovoLog FlexPen still containing insulin 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.
The NovoLog FlexPen prevents the cartridge from being completely emptied. It is designed to deliver 300 units.
K. Put the pen cap on the NovoLog FlexPen and store the NovoLog FlexPen without the needle attached (see diagram K).
L. Function Check
If your NovoLog FlexPen is not working the right way, follow the steps below:
- Screw on 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”.
- 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 NovoLog 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 (see diagram L). If the NovoLog FlexPen has released too much or too little insulin, do the function check again. If the same problem happens again, do not use your NovoLog FlexPen and contact Novo Nordisk at 1-800-727-6500.
Your FlexPen is designed to work accurately and safely. It must be handled with care. Avoid dropping your FlexPen as it may damage it. 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 as it may damage it. Do not refill your FlexPen.
- Remove the needle from the NovoLog FlexPen after each injection. This helps to ensure sterility, prevent leakage of insulin, and will help to make sure you inject the right dose of insulin for future injections.
- Be careful when handling used needles to avoid needle sticks and transfer of infectious diseases.
- Keep your NovoLog FlexPen and needles out of the reach of children.
- Use NovoLog FlexPen as directed to treat your diabetes.
- Needles and NovoLog 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 precautionary measure, always carry a spare insulin delivery device in case your NovoLog FlexPen is lost or damaged.
- Remember to keep the disposable NovoLog 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: 3/26/2013
This monograph has been modified to include the generic and brand name in many instances.
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