Patient information: uses, side effects, how to take - NovoLOG Mix 70/30
What is NovoLog Mix 70/30?
- NovoLog Mix 70/30 is a man-made insulin that is used to control high blood sugar in people with diabetes mellitus.
- It is not known if NovoLog Mix 70/30 is safe and effective in children.
Who should not take NovoLog Mix 70/30?
Do not take NovoLog Mix 70/30 if you:
- are having an episode of low blood sugar (hypoglycemia).
- have an allergy to NovoLog Mix 70/30 or any of the ingredients in NovoLog Mix 70/30.
Before taking NovoLog Mix 70/30, 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 NovoLog Mix 70/30, talk to your healthcare provider about low blood sugar and how to manage it.
How should I take NovoLog Mix 70/30?
- Read the Instructions for Use that come with your NovoLog Mix 70/30.
- Take NovoLog Mix 70/30 exactly as your healthcare provider tells you to.
- NovoLog Mix 70/30 starts acting fast. If you have Type 1 diabetes, inject it up to 15 minutes before you eat a meal. Do not inject NovoLog Mix 70/30 if you are not planning to eat within 15 minutes. If you have Type 2 diabetes, you may inject NovoLog Mix 70/30 up to 15 minutes before or after starting your meal.
- Do not mix NovoLog Mix 70/30 with other insulin products or use in an insulin pump.
- 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.
- NovoLog Mix 70/30 is injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs, or upper arms.
Change (rotate) your injection sites within the same area you choose with each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
- Do not use the exact same spot for each injection.
- Do not inject where skin has pits, is thickened, or has lumps.
- Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.
What should I avoid while taking NovoLog Mix 70/30?
While taking NovoLog Mix 70/30 do not:
- Drive or operate heavy machinery, until you know how NovoLog Mix 70/30 affects you.
- Drink alcohol or use prescription or over-the-counter medicines that contain alcohol.
What are the possible side effects of NovoLog Mix 70/30?
NovoLog Mix 70/30 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
- sweating
- slurred speech
- hunger
- confusion
- shakiness
- headache
- 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
- illness
Other common side effects of NovoLog Mix 70/30 may include:
- low potassium in your blood (hypokalemia), 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 NovoLog Mix 70/30. 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 NovoLog Mix 70/30.
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 NovoLog Mix 70/30 that is written for health professionals. Do not use NovoLog Mix 70/30 for a condition for which it was not prescribed. Do not give NovoLog Mix 70/30 to other people, even if they have the same symptoms that you have. It may harm them.
What are the ingredients in NovoLog Mix 70/30?
Active Ingredient: 70% insulin aspart protamine and 30% insulin aspart.
Inactive Ingredients: disodium hydrogen phosphate dihydrate, glycerol, metacresol, phenol, protamine sulfate, sodium chloride, zinc, and Water for Injection, USP. Hydrochloric acid or sodium hydroxide may be added to adjust pH.
Manufactured by: Novo Nordisk Inc., Plainsboro, NJ 08536 U.S. License Number 1261
For more information, go to www.novonordisk-us.com or call 1-800-727-6500.
This Patient Information has been approved by the U.S. Food and Drug Administration
Revised: 2/2023
INSTRUCTIONS FOR USE
NovoLog ® Mix 70/30
(insulin aspart protamine and insulin aspart)
injectable suspension, for subcutaneous use
10 mL multiple-dose vial (100 Units/mL, U-100)
Read this Instructions for Use before you start taking NovoLog Mix 70/30 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 Mix 70/30 injection:
- 10 mL NovoLog Mix 70/30 vial
- insulin syringe and needle
- alcohol swabs
Preparing your NovoLog Mix 70/30 dose:
- Wash your hands with soap and water.
- Before you start to prepare your injection, check the NovoLog Mix 70/30 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 Mix 70/30 should look white and cloudy after mixing. Do not use NovoLog Mix 70/30 if it looks clear or contains any lumps or particles.
- NovoLog Mix 70/30 is easier to mix when it is at room temperature.
- After mixing NovoLog Mix 70/30, inject your dose right away. If you wait to inject your dose, the insulin will need to be mixed again.
- Do not use NovoLog Mix 70/30 past the expiration date printed on the label.
Step 1: If you are using a new vial, pull off the tamper-resistant cap (See Figure A).
Step 2: Wipe the rubber stopper with an alcohol swab (See Figure B).
Step 3: Roll the NovoLog Mix 70/30 vial between your hands 10 times. Keep the vial in a horizontal (flat) position (See Figure C). Roll the vial between your hands until the NovoLog Mix 70/30 looks white and cloudy. Do not shake the vial.
Step 4: 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 D).
Step 5: Push the needle through the rubber stopper of the NovoLog Mix 70/30 vial (See Figure E).
Step 6: Push the plunger all the way in. This puts air into the NovoLog Mix 70/30 vial (See Figure F).
Step 7: Turn the NovoLog Mix 70/30 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 G).
- If there are air bubbles, tap the syringe gently a few times to let any air bubbles rise to the top (See Figure H).
Step 8: Slowly push the plunger up until the black tip reaches the line for your NovoLog Mix 70/30 dose (See Figure I).
Step 9: Check the syringe to make sure you have the right dose of NovoLog Mix 70/30.
Step 10: Pull the syringe out of the vial’s rubber stopper (See Figure J).
Giving your injection:
- Inject your NovoLog Mix 70/30 exactly as your healthcare provider has shown you. Your healthcare provider should tell you if you need to pinch the skin before injecting.
- NovoLog Mix 70/30 is injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs, or upper arms.
- Change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites. Do not use the same injection site for each injection. Do not inject where the skin has pits, thickened, or has lumps. Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.
Step 11: Choose your injection site and wipe the skin with an alcohol swab. Let the injection site dry before you inject your dose (See Figure K).
Step 12: Insert the needle into your skin. Push down on the plunger to inject your dose (See Figure L). The needle should remain in the skin for at least 6 seconds to make sure you have injected all the insulin.
Step 13: Pull the needle out of your skin. After that, you may see a drop of NovoLog Mix 70/30 at the needle tip. This is normal and does not affect the dose you just received (See Figure M).
- 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.
- Put the empty insulin vials, used needles and syringes in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes 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,
- leak-resistant, and
- 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. For more information about the 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 NovoLog Mix 70/30?
- Do not freeze NovoLog Mix 70/30. Do not use NovoLog Mix 70/30 if it has been frozen.
- Keep NovoLog Mix 70/30 away from heat or light.
- All unopened vials:
- Store unopened NovoLog Mix 70/30 vials in the refrigerator at 36°F to 46°F (2°C to 8°C).
- Unopened vials may be used until the expiration date printed on the label, if they have been stored in the refrigerator.
- Unopened vials should be thrown away after 28 days, if they are stored at room temperature.
- After vials have been opened:
- Opened NovoLog Mix 70/30 vials can be stored in the refrigerator 36°F to 46°F (2°C to 8°C) or at room temperature below 86°F (30°C) for up to 28 days.
- Throw away all opened NovoLog Mix 70/30 vials after 28 days, even if they still have insulin left in them.
General information about the safe and effective use of NovoLog Mix 70/30
- Always use a new syringe and needle for each injection.
- Do not share syringes or needles.
- Keep NovoLog Mix 70/30 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.
Manufactured by:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, New Jersey 08536
1-800-727-6500
U.S. License Number 1261
Revised: 2/2023
NovoLog® is a registered trademark of Novo Nordisk A/S.
PATENT Information: http://novonordisk-us.com/products/product-patents.html
© 2023 Novo Nordisk
For information about NovoLog Mix 70/30 contact:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, New Jersey 08536
1-800-727-6500
www.novonordisk-us.com
INSTRUCTIONS FOR USE
NovoLog® Mix 70/30 FlexPen®
(insulin aspart protamine and insulin aspart)
injectable suspension, for subcutaneous use
FlexPen®
Read the following instructions carefully before you start using your NovoLog Mix 70/30 FlexPen and each time you get a refill. There may be new information. You should read the instructions even if you have used NovoLog Mix 70/30 FlexPen before.
Do not share your NovoLog Mix 70/30 FlexPen 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.
NovoLog Mix 70/30 FlexPen is a disposable, single-patient-use dial-a-dose insulin pen. You can select doses from 1 to 60 units in increments of 1 unit. NovoLog Mix 70/30 FlexPen is designed to be used with NovoFine, NovoFine Plus or NovoTwist needles.
People who are blind or have vision problems should not use NovoLog Mix 70/30 FlexPen without help from a person trained to use NovoLog Mix 70/30 FlexPen.
Getting ready
Make sure you have the following items:
- NovoLog Mix 70/30 FlexPen
- New NovoFine, NovoFine Plus or NovoTwist needle
- Alcohol swabs
Preparing your NovoLog Mix 70/30 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 Mix 70/30 should look cloudy after mixing.
Before your first injection with a new NovoLog Mix 70/30 FlexPen you must mix the insulin:
A. Let the insulin reach room temperature before you use it. This makes it easier to mix.
Pull off the pen cap (see diagram A).
B. Roll the pen between your palms 10 times - it is important that the pen is kept horizontal (see diagram B).
C. Then gently move the pen up and down ten times between position 1 and 2 as shown, so the glass ball moves from one end of the cartridge to the other (see diagram C).
Repeat rolling and moving the pen until the liquid appears white and cloudy. Do not use the pen if the liquid appears discolored or contains particles.
For every following injection move the pen up and down between positions 1 and 2 at least ten times until the liquid appears white and cloudy.
After mixing, complete all the following steps of the injection right away. If there is a delay, the insulin will need to be mixed again.
Wipe the rubber stopper with an alcohol swab.
Before you inject, there must be at least 12 units of insulin left in the cartridge to make sure the remaining insulin is evenly mixed. If there are less than 12 units left, use a new NovoLog Mix 70/30 FlexPen.
Attaching the needle
D. Remove the protective tab from a disposable needle.
Screw the needle tightly onto your NovoLog Mix 70/30 FlexPen. It is important that the needle is put on straight (see diagram D).
Never place a disposable needle on your NovoLog Mix 70/30 FlexPen until you are ready to take your injection.
E. Pull off the big outer needle cap (see diagram E).
F. Pull off the inner needle cap and throw it away (dispose of it) (see diagram F).
- Always use a new needle for each injection to make sure the needle is free of germs (sterile) and to prevent blocked needles. 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.
Be careful not to bend or damage the needle before use.
To reduce the risk of a needle stick, 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 make sure you take the right dose of insulin:
G. Turn the dose selector to select 2 units (see diagram G).
H. Hold your NovoLog Mix 70/30 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 H).
I. Keep the needle pointing upwards, press the push-button all the way in (see diagram I). 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 Mix 70/30 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.
J. 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 J). 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 because you may get an incorrect dose.
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.
- NovoLog Mix 70/30 can be injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs (thighs), or upper arms.
- Change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites. Do not use the same injection site for each injection. Do not inject where the skin has pits, is thickened, or has lumps. Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.
K. 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 K). Be careful only to push the button when injecting.
Turning the dose selector will not inject insulin.
L. 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 L). This will make sure that the full dose has been given.
You may see a drop of insulin 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
Do not recap the needle. Recapping can lead to a needle stick injury. Remove the needle from the NovoLog Mix 70/30 FlexPen after each injection and dispose of it. This helps to prevent infection, leakage of insulin, and will help to make sure you inject the right dose of insulin.
- Put your used needles in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles in your household trash.
If you do not have a FDA-cleared sharps disposal container, carefully slip the needle into the outer needle cap and throw it away in 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,
- leak-resistant, and
- 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. For more information about the 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.
- When there is not enough medicine left in your NovoLog Mix 70/30 FlexPen for your prescribed dose, the NovoLog Mix 70/30 FlexPen may be thrown away in your household trash after you have removed the needle. The NovoLog Mix 70/30 FlexPen prevents the cartridge from being completely emptied. It is designed to deliver 300 units.
M. Put the pen cap on the NovoLog Mix 70/30 FlexPen and store the NovoLog Mix 70/30 FlexPen without the needle attached (see diagram M). Storing without the needle attached helps prevent leaking, blocking of the needle, and air from entering the Pen.
How should I store NovoLog Mix 70/30 FlexPen?
- Do not freeze NovoLog Mix 70/30. Do not use NovoLog Mix 70/30 if it has been frozen.
- Keep NovoLog Mix 70/30 away from heat or light.
- Store the NovoLog Mix 70/30 FlexPen without the needle attached.
Unused NovoLog Mix 70/30 FlexPen:
- Store unused NovoLog Mix 70/30 FlexPen in the refrigerator at 36°F to 46°F (2°C to 8°C).
- Unused NovoLog Mix 70/30 FlexPen may be used until the expiration date printed on the label, if kept in the refrigerator.
- Unused NovoLog Mix 70/30 FlexPen should be thrown away after 14 days, if it is stored at room temperature.
In-Use NovoLog Mix 70/30 FlexPen:
- Store the FlexPen you are currently using at room temperature below 86°F (30°C) for up to 14 days.
- The NovoLog Mix 70/30 FlexPen you are using should be thrown away after 14 days, even if it still has insulin left in it.
Maintenance
For the safe and proper use of your NovoLog Mix 70/30 FlexPen be sure to handle it with care. Avoid dropping your NovoLog Mix 70/30 FlexPen as it may damage it. If you are concerned that your NovoLog Mix 70/30 FlexPen is damaged, use a new one. You can clean the outside of your NovoLog Mix 70/30 FlexPen by wiping it with a damp cloth. Do not soak or wash your NovoLog Mix 70/30 FlexPen as it may damage it. Do not refill your NovoLog Mix 70/30 FlexPen.
Remove the needle from the NovoLog Mix 70/30 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 Mix 70/30 FlexPen and needles out of the reach of children.
Use NovoLog Mix 70/30 FlexPen as directed to treat your diabetes.
Do not share your NovoLog Mix 70/30 FlexPen or needles with other people. You may give other people a serious infection, or get a serious infection from them.
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 Mix 70/30 FlexPen is lost or damaged.
Remember to keep the disposable NovoLog Mix 70/30 FlexPen with you. Do not leave it in a car or other location where it can get too hot or too cold.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured by:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, New Jersey 08536
1-800-727-6500
U.S. License Number 1261
Revised: 2/2023