Patient Information for Humalog 75-25
HUMALOG® (HU-ma-log) Mix75/25™
(insulin lispro protamine and insulin lispro injectable suspension) for
subcutaneous use
Do not share your HUMALOG Mix75/25 KwikPen, needles or
syringes 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 HUMALOG Mix75/25?
- HUMALOG Mix75/25 is a man-made insulin that is used to
control high blood sugar in people with diabetes mellitus.
- It is not known if HUMALOG Mix75/25 is safe and effective
in children under 18 years of age.
Who should not take HUMALOG Mix75/25?
Do not take HUMALOG Mix75/25 if you:
- are having an episode of low blood sugar (hypoglycemia).
- have an allergy to HUMALOG Mix75/25 or any of the ingredients
in HUMALOG Mix75/25. See the end of this Patient Information leaflet for a
complete list of ingredients in Humalog Mix75/25.
What should I tell my healthcare provider before
taking Humalog Mix75/25?
Before taking HUMALOG Mix75/25, tell your healthcare
provider about all of your medical conditions, including if you:
- have liver or kidney problems.
- take any other medicines, especially ones called TZDs
(thiazolidinediones).
- have heart failure or other heart problems. If you have
heart failure, it may get worse while you take TZDs with HUMALOG Mix75/25.
- are pregnant or plan to become pregnant. Talk with your
healthcare provider about the best way to control your blood sugar if you plan
to become pregnant or while you are pregnant.
- are breastfeeding or plan to breastfeed. Talk with your
healthcare provider about the best way to feed your baby while taking HUMALOG
Mix75/25.
Tell your healthcare provider about all the medicines
you take, including prescription and over-the-counter medicines, vitamins,
and herbal supplements.
Before you start taking HUMALOG Mix75/25, talk to your
healthcare provider about low blood sugar and how to manage it.
How should I take HUMALOG Mix75/25?
- Read the Instructions for Use that comes with your
HUMALOG Mix75/25.
- Take HUMALOG Mix75/25 exactly as your healthcare provider
tells you to. Your healthcare provider should tell you how much HUMALOG
Mix75/25 to take and when to take it.
- HUMALOG Mix75/25 starts acting fast. Inject HUMALOG
Mix75/25 within 15 minutes before you eat a meal.
- Know the type, strength, and amount of insulin you take.
Do not change the type or amount 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 insulin label each time you give your
injection to make sure you are taking the correct insulin.
- Inject HUMALOG Mix75/25 under your skin (subcutaneously).
Do not inject HUMALOG Mix75/25 into your vein (intravenously) or muscle
(intramuscularly) or use in an insulin infusion pump.
- Change (rotate) your injection site with each dose.
- Do not mix HUMALOG Mix75/25 with other insulins or
liquids.
- Check your blood sugar levels. Ask your healthcare
provider what your blood sugars should be and when you should check your blood
sugar levels.
Keep HUMALOG Mix75/25 and all medicines out of the
reach of children.
Your dose of HUMALOG Mix75/25 may need to change
because of a:
- change in physical activity or exercise, weight gain or
loss, increased stress, illness, change in diet, or because of other medicines
you take.
What should I avoid while taking HUMALOG Mix75/25?
While taking HUMALOG Mix75/25 do not:
- drive or operate heavy machinery until you know how
HUMALOG Mix75/25 affects you.
- drink alcohol or take prescription or over-the-counter
medicines that contain alcohol.
What are the possible side effects of HUMALOG
Mix75/25?
HUMALOG Mix75/25 may cause serious side effects that
can lead to death, including:
- low blood sugar (hypoglycemia). Signs and symptoms
of low blood sugar may include:
- dizziness or light-headedness
- sweating
- slurred speech
- shakiness
- confusion
- headache
- blurred vision
- fast heartbeat
- anxiety, irritability or mood changes
- hunger
Your healthcare provider may prescribe a glucagon
emergency kit so that someone else can give you glucagon if your blood sugar
becomes too low (severe hypoglycemia) and you are unable to take sugar by
mouth.
- severe allergic reaction (whole body reaction). Get
medical help right away, if you have any of these signs or symptoms of a severe
allergic reaction:
- a rash over your whole body
- trouble breathing
- a fast heartbeat
- sweating
- low potassium in your blood (hypokalemia).
- heart failure. Taking certain diabetes pills
called thiazolidinediones or “TZDs” with HUMALOG Mix75/25 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 HUMALOG Mix75/25. Your healthcare provider should monitor
you closely while you are taking TZDs with HUMALOG Mix75/25. 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 HUMALOG Mix75/25 may need to be
adjusted or stopped by your healthcare provider if you have new or worse heart
failure.
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
The most common side effects of HUMALOG Mix75/25
include:
- low blood sugar (hypoglycemia)
- reactions at your injection site
- skin thickening or pits at the injection site (lipodystrophy)
- weight gain
- swelling in your hands or feet
- itching
- rash
These are not all the possible side effects of HUMALOG
Mix75/25. 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 HUMALOG Mix75/25.
Medicines are sometimes prescribed for purposes other
than those listed in a Patient Information leaflet. Do not take HUMALOG
Mix75/25 for a condition for which it was not prescribed. Do not give HUMALOG
Mix75/25 to other people, even if they have the same symptoms that you have. It
may harm them.
This Patient Information leaflet summarizes the most
important information about HUMALOG Mix75/25. If you would like more information,
talk with your healthcare provider. You can ask your pharmacist or healthcare
provider for information about HUMALOG Mix75/25 that is written for health
professionals.
What are the ingredients in HUMALOG Mix75/25?
Active ingredients: insulin lispro
Inactive ingredients: protamine sulfate, glycerin,
dibasic sodium phosphate, metacresol, zinc oxide (zinc ion), phenol and water
for injection.
Instructions for Use
HUMALOG® (HU-ma-log) Mix75/25™
(insulin lispro protamine and insulin lispro injectable suspension) for
subcutaneous use 10 mL vial (100 units/mL)
Read this Instructions for Use before you start taking
HUMALOG Mix75/25 and each time you get a new vial. 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.
Do not share your needles or syringes 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.
Supplies needed to give your injection
- a HUMALOG Mix75/25 vial
- a U-100 insulin syringe and needle
- 2 alcohol swabs
- gauze
- 1 sharps container for throwing away used needles and
syringes. See “Disposing of used needles and syringes” at the end of
these instructions.
Preparing your HUMALOG Mix75/25 dose
- Wash your hands with soap and water.
- Check the HUMALOG Mix75/25 label to make sure you are
taking the right type of insulin. This is especially important if you use more
than 1 type of insulin.
- HUMALOG Mix75/25 is easier to mix when it is at room
temperature.
- After mixing HUMALOG Mix75/25, inject your dose right
away. If you wait to inject your dose, the insulin will need to be mixed again.
- Always use a new syringe and needle for each injection
to help prevent infections and blocked needles. Do not reuse or share your
syringes or needles with other people. You may give other people a serious
infection or get a serious infection from them.
Step 1:
Gently roll the vial between the palms of your hands at
least 10 times.
Step 2:
Gently move the vial up and down (invert) at least 10
times.
Mixing is important to make sure you get the right
dose. Humalog Mix75/25 should look white and cloudy after mixing. Do not use it
if it looks clear or contains any lumps or particles.
Step 3:
If you are using a new vial, pull off the plastic Protective
Cap, but do not remove the Rubber Stopper.
Step 4:
Wipe the Rubber Stopper with an alcohol swab.
Step 5:
Remove the Needle Shield from the syringe by pulling the
Needle Shield straight off. Hold the syringe with the needle pointing up. Pull
down on the Plunger until the Plunger Tip reaches the line for the number of
units for your prescribed dose.
Step 6:
Push the needle through the Rubber Stopper of the vial.
Step 7:
Push the Plunger all the way in. This puts air into the
vial.
Step 8:
Turn the vial and syringe upside down and slowly pull the
Plunger down until the Plunger
Tip is a few units past the line for your prescribed
dose.
If there are air bubbles, tap the syringe gently a few
times to let any air bubbles rise to the top.
Step 9:
Slowly push the Plunger up until the Plunger Tip reaches
the line for your prescribed dose.
Check the syringe to make sure that you have the right
dose.
Step 10:
Pull the syringe out of the Rubber Stopper of the vial.
Giving your HUMALOG Mix75/25 Injection
- Inject your insulin exactly as your healthcare provider
has shown you. Your healthcare provider should tell you if you should pinch the
skin before injecting.
- Change (rotate) your injection site for each injection.
Step 11:
Choose your injection site.
HUMALOG Mix75/25 is injected under the skin (subcutaneously)
of your stomach area (abdomen), buttocks, upper legs or upper arms.
Wipe the skin with an alcohol swab. Let the injection
site dry before you inject your dose.
Step 12:
Insert the needle into your skin.
Step 13:
Push down on the Plunger to inject your dose.
The needle should stay in your skin for at least 5 seconds
to make sure you have injected all of your insulin dose.
Step 14:
Pull the needle out of your skin.
- If you see blood after you take the needle out of your
skin, press the injection site with a piece of gauze or an alcohol swab. Do not
rub the area.
- Do not recap the needle. Recapping the needle can
lead to a needle stick injury.
Disposing of used needles and syringes
- Put your 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 safe
sharps disposal, and for specific information about sharps disposal in the
state that you live in, go to the FDA's website at: https://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 HUMALOG Mix75/25?
All unopened vials:
- Store all unopened vials in the refrigerator at 36°F to
46°F (2°C to 8°C).
- Do not freeze. Do not use if HUMALOG Mix75/25 has been
frozen.
- Keep away from heat and out of direct light.
- Unopened vials can be used until the expiration date on
the carton and 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:
- Store opened vials in the refrigerator or at room
temperature below 86°F (30°C) for up to 28 days.
- Keep vials away from heat and out of direct light.
- Throw away all opened vials after 28 days of use, even if
there is insulin left in the vial.
Keep HUMALOG Mix75/25 vials, syringes, needles, and
all medicines out of the reach of children.
If you have any questions or problems with your HUMALOG,
contact Lilly at 1-800-Lilly-Rx (1-800-545-5979) or call your healthcare
provider for help. For more information on HUMALOG and insulin, go to www.humalog.com.Scan
this code to launch the humalog.com website
Instructions for Use
HUMALOG® (HU-ma-log) Mix75/25™ KwikPen®
(insulin lispro protamine and insulin lispro injectable suspension) for
subcutaneous use 3 mL pen (100 units/mL)
Read this Instructions for Use before you start taking
HUMALOG Mix75/25 and each time you get another KwikPen. 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.
Do not share your HUMALOG Mix75/25 KwikPen 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.
HUMALOG Mix75/25 KwikPen (“Pen”) is a disposable
prefilled pen containing 300 units of HUMALOG Mix75/25.
- You can give yourself more than 1 dose from the Pen.
- By turning the Dose Knob, you can dial doses from 1 to 60
units in 1 unit increments.
- If your dose is more than 60 units, you will need to
give yourself more than 1 injection.
- The Plunger only moves a little with each injection, and
you may not notice that it moves. The Plunger will only reach the end of the cartridge when
you have used all 300 units in the Pen.
People who are blind or have vision problems should
not use this Pen without help from a person trained to use the Pen.
Pen Needle Parts (Needles Not Included)
How to recognize your HUMALOG Mix75/25 KwikPen
- Pen color: Dark blue
- Dose Knob: Dark blue
- Labels: White label with yellow stripe
Supplies you will need to give your injection
- HUMALOG Mix75/25 KwikPen
- KwikPen compatible Needle (Becton, Dickinson and Company
Pen Needles recommended)
- Alcohol swab
- Gauze
Preparing your Pen
- Wash your hands with soap and water.
- Check your Pen to make sure you are taking the right type
of insulin. This is especially important if you use more than 1 type of
insulin.
- Always use a new needle for each injection to help
prevent infections and 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.
Step 1:
- Pull the Pen Cap straight off.
- Do not remove the Pen Label.
- Wipe the Rubber Seal with an alcohol swab.
- Do not attach the Needle before mixing.
Step 2:
- Gently roll the Pen between your hands at least 10 times.
Step 3:
- Move the Pen up and down (invert) at least 10 times. Mixing by rolling and inverting the Pen is important
to make sure you get the right dose. After mixing HUMALOG Mix75/25, inject your dose right
away. If you wait to inject your dose, the insulin will need to be mixed again.
Step 4:
- Check the liquid in the Pen. HUMALOG Mix75/25 should look white and cloudy after
mixing. Do not use if it looks clear or has any lumps or particles in it.
Step 5:
- Select a new Needle.
- Pull off the Paper Tab from the Outer Needle Shield.
Step 6:
- Push the capped Needle straight onto the Pen and twist
the Needle on until it is tight.
Step 7:
- Pull off the Outer Needle Shield. Do not throw it away.
- Pull off the Inner Needle Shield and throw it away.
Priming your Pen
Prime your Pen before each injection.
- Priming your Pen means removing the air from the Needle
and Cartridge that may collect during normal use and ensures that the Pen is
working correctly.
- If you do not prime before each injection, you may get
too much or too little insulin.
Step 8:
- To prime your Pen, turn the Dose Knob to select 2 units.
Step 9:
- Hold your Pen with the Needle pointing up. Tap the
Cartridge Holder gently to collect air bubbles at the top.
Step 10:
- Continue holding your Pen with Needle pointing up. Push
the Dose Knob in until it stops, and “0” is seen in the Dose Window. Hold the
Dose Knob in and count to 5 slowly.
- You should see insulin at the tip of the Needle.
- If you do not see insulin, repeat priming steps 8 to 10,
no more than 4 times.
- If you still do not see insulin, change the Needle and
repeat priming steps 8 to 10.
Small air bubbles are normal and will not affect your
dose.
Selecting your dose
- You can give from 1 to 60 units in a single injection.
- If your dose is more than 60 units, you will need to give
more than one injection.
- If you need help with dividing up your dose the right
way, ask your healthcare provider.
- Use a new Needle for each injection and repeat the
priming steps.
Step 11:
- Turn the Dose Knob to select the number of units you need
to inject. The Dose Indicator should line up with your dose.
- The Pen dials 1 unit at a time.
- The Dose Knob clicks as you turn it.
- Do not dial your dose by counting the clicks. You may
dial the wrong dose. This may lead to you getting too much insulin or not
enough insulin.
- The dose can be corrected by turning the Dose Knob in
either direction until the correct dose lines up with the Dose Indicator.
- The even numbers (for example, 12) are printed on the
dial.
- The odd numbers, (for example, 25) after the number 1,
are shown as full lines.
- Always check the number in the Dose Window to make
sure you have dialed the correct dose.
 |
- The Pen will not let you dial more than the number of
units left in the Pen.
- If you need to inject more than the number of units left
in the Pen, you may either:
- inject the amount left in your Pen and then use a new Pen
to give the rest of your dose, or
- get a new Pen and inject the full dose.
- It is normal to see a small amount of insulin left in the
Pen that you can not inject.
Giving your injection
- Inject your insulin as your healthcare provider has shown
you.
- Change (rotate) your injection site for each injection.
- Do not try to change your dose while injecting.
Step 12:
- Choose your injection site. HUMALOG Mix75/25 is injected under the skin
(subcutaneously) of your stomach area, buttocks, upper legs or upper arms.
- Wipe your skin with an alcohol swab, and let your skin
dry before you inject your dose.
Step 13:
- Insert the Needle into your skin.
- Push the Dose Knob all the way in.
- Continue to hold the Dose Knob in and slowly count to 5
before removing the Needle.
Do not try to inject your insulin by turning the Dose
Knob. You will not receive your insulin by turning the Dose Knob.
Step 14:
- Pull the Needle out of your skin. A drop of insulin at
the Needle tip is normal. It will not affect your dose.
- Check the number in the Dose Window.
- If you see “0” in the Dose Window, you have received the
full amount you dialed.
- If you do not see “0” in the Dose Window, do not redial.
Insert the Needle into your skin and finish your injection.
- If you still do not think you received the full amount
you dialed for your injection, do not start over or repeat the injection.
Monitor your blood glucose as instructed by your healthcare provider.
- If you normally need to give 2 injections for your full
dose, be sure to give your second injection.
The Plunger only moves a little with each injection, and
you may not notice that it moves.
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
Step 15:
- Carefully replace the Outer Needle Shield.
Step 16:
- Unscrew the capped Needle and throw it away (see
Disposing of Pens and Needles section).
- Do not store the Pen with the Needle attached to prevent
leaking, blocking the Needle, and air from entering the Pen.
Step 17:
- Replace the Pen Cap by lining up the Cap Clip with the
Dose Indicator and pushing straight on.
Disposing of Pens and Needles
- 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, 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 safe
sharps disposal, and for specific information about sharps disposal in the
state that you live in, go to the FDA's website at:
https://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.
The used Pen may be discarded in your household trash
after you have removed the needle.
Storing your Pen
Unused Pens
- Store unused Pens in the refrigerator at 36°F to 46°F
(2°C to 8°C).
- Do not freeze your insulin. Do not use if HUMALOG
Mix75/25 has been frozen.
- Unused Pens may be used until the expiration date printed
on the Label, if the Pen has been kept in the refrigerator.
- Unused Pens stored at room temperature, below 86°F
(30°C), should be thrown away after 10 days.
In-use Pen
- Store the Pen you are currently using at room temperature
[up to 86°F (30°C)]. Keep away from heat and light.
- Throw away the HUMALOG Mix75/25 Pen you are using after
10 days, even if it still has insulin left in it.
General information about the safe and effective use
of your Pen
- Keep your Pen and needles out of the reach of
children.
- Do not use your Pen if any part looks broken or
damaged.
- Always carry an extra Pen in case yours is lost or
damaged.
Troubleshooting
- If you can not remove the Pen Cap, gently twist the cap
back and forth, and then pull the cap straight off.
- If the Dose Knob is hard to push:
- Pushing the Dose Knob more slowly will make it easier to
inject.
- Your Needle may be blocked. Put on a new Needle and prime
the Pen.
- You may have dust, food, or liquid inside the Pen. Throw
the Pen away and get a new Pen.
If you have any questions or problems with your HUMALOG
Mix75/25 KwikPen, contact Lilly at 1- 800-LillyRx (1-800-545-5979) or call your
healthcare provider for help. For more information on HUMALOG Mix75/25 KwikPen
and insulin, go to www.humalog.com. Scan this code to launch www.humalog.com
This Instructions for Use has been approved by the U.S.
Food and Drug Administration.