Insulin Lispro (Humalog): Uses, Side Effects and Dosage

What is Insulin Lispro?

• Insulin Lispro is a man-made fast-acting insulin used to control high blood sugar in adults and children with diabetes mellitus.

Who should not take Insulin Lispro?

Do not take Insulin Lispro if you:

• are having an episode of low blood sugar (hypoglycemia).
• have an allergy to Insulin Lispro or any of the ingredients in Insulin Lispro. See the end of this Patient Information leaflet for a complete list of ingredients in Insulin Lispro.

What should I tell my healthcare provider before taking Insulin Lispro?

Before taking Insulin Lispro, tell your healthcare provider about all of your medical conditions, including if you:

• have kidney or liver 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 Insulin Lispro.

• 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 Insulin Lispro.

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 Insulin Lispro, talk to your healthcare provider about low blood sugar and how to manage it.

How should I take Insulin Lispro?

• Read the Instructions for Use that comes with your Insulin Lispro.
• Take Insulin Lispro exactly as your healthcare provider tells you to. Your healthcare provider should tell you how much Insulin Lispro to take and when to take it.
• Insulin Lispro starts acting fast. Inject Insulin Lispro within 15 minutes before or right after 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 Insulin Lispro under the skin (subcutaneously) of your stomach area, buttocks, upper legs or upper arms, or by continuous infusion under the skin (subcutaneously) through an insulin pump into an area of your body recommended in the instructions that come with your insulin pump.

• Change (rotate) your injection sites within the 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 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.
• 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.
• 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 Insulin Lispro and all medicines out of the reach of children.

Your dose of Insulin Lispro 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 Insulin Lispro?

While taking Insulin Lispro do not:

• drive or operate heavy machinery, until you know how Insulin Lispro affects you.
• drink alcohol or take prescription or over-the-counter medicines that contain alcohol.

What are the possible side effects of Insulin Lispro?

Insulin Lispro 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
• confusion
• headache
• blurred vision

• slurred speech
• shakiness
• fast heartbeat
• anxiety, irritability or mood changes
• hunger

Your healthcare provider may prescribe a glucagon product for emergency use 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.

• serious allergic reactions (whole body allergic 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
• feel faint

• low potassium in your blood (hypokalemia).
• heart failure. Taking certain diabetes pills called thiazolidinediones or “TZDs” with Insulin Lispro 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 Insulin Lispro. Your healthcare provider should monitor you closely while you are taking TZDs with Insulin Lispro. 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 Insulin Lispro 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 Insulin Lispro 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 Insulin Lispro. 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 Insulin Lispro.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not take Insulin Lispro for a condition for which it was not prescribed. Do not give Insulin Lispro 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 Insulin Lispro. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Insulin Lispro that is written for health professionals.

What are the ingredients in Insulin Lispro?

Active ingredient: insulin lispro

Inactive ingredients: dibasic sodium phosphate, glycerin, hydrochloric acid, metacresol, trace amounts of phenol, sodium hydroxide, zinc oxide (zinc ion), and Water for Injection, USP.

Humalog^® is a registered trademark of Eli Lilly and Company.

Manufactured by: Eli Lilly and Company, Indianapolis, IN 46285, USA, US License Number 1891

Copyright © 1996, 2023, Eli Lilly and Company. All rights reserved.

For more information, call 1-800-545-5979.

LIS-0007-PPI-20230721

Vial Instructions for Use

INSTRUCTIONS FOR USE

Insulin Lispro [IHN-soo-lihn LIYS-proh]

injection, for subcutaneous use

10 mL multiple-dose vial (100 units per mL, U-100)

This product is HUMALOG^® (insulin lispro).

Read this Instructions for Use before you start taking Insulin Lispro 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 multiple-dose Insulin Lispro 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.

Vial	Syringe

Preparing your Insulin Lispro dose

• Wash your hands with soap and water.
• Check the Insulin Lispro 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.
• Insulin Lispro should look clear and colorless. Do not use Insulin Lispro if it is thick, cloudy, or colored, or if you see lumps or particles in it.
• Do not use Insulin Lispro past the expiration date printed on the label or 28 days after you first use it.
• Always use a new syringe and needle for each injection to 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: If you are using a new vial, pull off the plastic Protective Cap, but do not remove the Rubber Stopper.
Step 2: Wipe the Rubber Stopper with an alcohol swab.
Step 3: 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.	(Example Dose: 20 units shown)
Step 4: Push the needle through the Rubber Stopper of the vial.
Step 5: Push the Plunger all the way in. This puts air into the vial.
Step 6: 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.	(Example Dose: 20 units Plunger is shown at 24 units)
If there are air bubbles, tap the syringe gently a few times to let any air bubbles rise to the top.
Step 7: 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.	(Example Dose: 20 units shown)
Step 8: Pull the syringe out of the Rubber Stopper of the vial.

If you use Insulin Lispro with NPH insulin:

• NPH insulin is the only type of insulin that can be mixed with Insulin Lispro. Do not mix Insulin Lispro with any other type of insulin.
• Insulin Lispro should be drawn up into the syringe first, before you draw up your NPH insulin. Talk to your healthcare provider if you are not sure about the right way to mix Insulin Lispro and NPH insulin.
• Give your injection right away.

Giving your Insulin Lispro with a syringe

• 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.
• Insulin Lispro starts acting fast, so give your injection within 15 minutes before or right after you eat a meal.
• 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 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.

Step 9: Choose your injection site. Insulin Lispro 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 10: Insert the needle into your skin.
Step 11: 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 12: 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.

Giving your Insulin Lispro using an insulin pump

• Insulin Lispro should be given into an area of your body recommended in the instructions that come with your insulin pump.
• Change your infusion set and rotate the infusion set insertion site according to the manufacturer's user manual.
• Change (rotate) your insertion sites within the area you choose for each insertion to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the insertion sites. Do not insert into the exact same spot for each insertion. Do not insert where the skin has pits, is thickened, or has lumps. Do not insert where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.
• This Insulin Lispro product can be used with the continuous subcutaneous insulin infusion pumps labeled for use with Humalog (insulin lispro) – refer to the insulin pump user manual to see if Humalog can be used.
• Change the insulin in the reservoir at least every 7 days or according to the pump user manual, whichever is shorter, even if you have not used all of the insulin.
• Do not dilute or mix Insulin Lispro with any other type of insulin in your insulin pump.
• See your insulin pump manual for instructions or talk to your healthcare provider.

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: 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 Insulin Lispro?

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 Insulin Lispro 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 up to 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.

Insulin Lispro in an insulin pump:

• Throw away Insulin Lispro in the pump reservoir if it has been exposed to temperatures higher than 98.6°F (37°C).

Keep Insulin Lispro vials, syringes, needles and all medicines out of the reach of children.

If you have any questions or problems with your Insulin Lispro, contact Lilly at 1-800-Lilly-Rx (1-800-545-5979) or call your healthcare provider for help.

Manufactured by:

Eli Lilly and Company

Indianapolis, IN 46285, USA

US License Number 1891

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Humalog^® is a registered trademark of Eli Lilly and Company.

Instructions for Use revised: July/2023

Copyright © 1996, 2023, Eli Lilly and Company. All rights reserved.

LISVL-0006-IFU-20230721

KwikPen (U-100) Instructions for Use

INSTRUCTIONS FOR USE

Insulin Lispro [IHN-soo-lihn LIYS-proh]

KwikPen ^®

injection, for subcutaneous use

3 mL single-patient-use pen (100 units per mL)

This product is HUMALOG^® (insulin lispro).

Read the Instructions for Use before you start taking Insulin Lispro 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 Insulin Lispro 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.

Insulin Lispro KwikPen (“Pen”) is a disposable single-patient-use prefilled pen containing 300 units of insulin lispro. You can give yourself more than 1 dose from the Pen. Each turn (click) of the Dose Knob dials 1 unit of insulin. 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 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 the Pen without help from a person trained to use the Pen.

How to recognize your Insulin Lispro KwikPen

• Pen color: Dark blue
• Dose Knob: Dark blue
• Labels: White label with burgundy stripe

Supplies you will need to give your injection

• Insulin Lispro 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.
• Do not use your Pen past the expiration date printed on the Label or for more than 28 days after you first start using the Pen.
• 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. Step 2: Check the liquid in the Pen. Insulin Lispro should look clear and colorless. Do not use if it is cloudy, colored, or has particles or clumps in it.
Step 3: Select a new Needle. Pull off the Paper Tab from the Outer Needle Shield.
Step 4: Push the capped Needle straight onto the Pen and twist the Needle on until it is tight.
Step 5: 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 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 6: To prime your Pen, turn the Dose Knob to select 2 units.
Step 7: Hold your Pen with the Needle pointing up. Tap the Cartridge Holder gently to collect air bubbles at the top.
Step 8: 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 6 to 8, no more than 4 times. If you still do not see insulin, change the Needle and repeat priming steps 6 to 8. 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 1 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 step.

Step 9: 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.

(Example: 12 units shown in the Dose Window) (Example: 25 units shown in the Dose Window)

• 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 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 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.
• Do not try to change your dose while injecting.

Step 10: Choose your injection site. Insulin Lispro 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 11: 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 12: 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 13: Carefully replace the Outer Needle Shield.
Step 14: 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 15: Replace the Pen Cap by lining up the Cap Clip with the Dose Indicator and pushing straight on.

Disposing of Pens and Needles

• The used Pen may be discarded in your household trash after you have removed the needle.
• 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: 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.

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 it 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.

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 Insulin Lispro Pen you are using after 28 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 Insulin Lispro KwikPen, contact Lilly at 1-800-LillyRx (1-800-545-5979) or call your healthcare provider for help.

Manufactured by:

Eli Lilly and Company

Indianapolis, IN 46285, USA

US License Number 1891

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised: July/2023

Humalog^® and KwikPen^® are registered trademarks of Eli Lilly and Company.

Copyright © 2007, 2023, Eli Lilly and Company. All rights reserved.

LISKP-0006-IFU-20230721

Junior KwikPen (U-100) Instructions for Use

INSTRUCTIONS FOR USE

Insulin Lispro [IHN-soo-lihn LIYS-proh]

Junior KwikPen ^®

injection, for subcutaneous use

3 mL single-patient-use pen (100 units per mL)

This product is HUMALOG^® (insulin lispro).

Read the Instructions for Use before you start taking Insulin Lispro and each time you get another Insulin Lispro Junior 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 Insulin Lispro Junior 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.

Insulin Lispro Junior KwikPen (“Pen”) is a disposable single-patient-use prefilled pen containing 300 units of Insulin Lispro.

• You can give yourself more than 1 dose from the Pen.
• Each turn of the Dose Knob dials 0.5 (½) unit of insulin. You can give from 0.5 (½) to 30 units in a single injection.
• If your dose is more than 30 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 the Pen without help from a person trained to use the Pen.

How to recognize your Insulin Lispro Junior KwikPen:

• Pen color: Blue
• Dose Knob: Blue, with raised ridges on end and side
• Label: White with an orange color bar and orange-to-yellow color band

Supplies needed to give your injection:

• Insulin Lispro Junior KwikPen
• KwikPen compatible Needle (BD [Becton, Dickinson and Company] Pen Needles recommended)
• Alcohol swab
• Gauze

Preparing your Pen

• Wash your hands with soap and water.
• Check the 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.
• Do not use your Pen past the expiration date printed on the Label or for more than 28 days after you first start using the Pen.
• 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. Step 2: Check the liquid in the Pen. Insulin Lispro should look clear and colorless. Do not use if it is cloudy, colored, or has particles or clumps in it.
Step 3: Select a new Needle. Pull off the Paper Tab from the Outer Needle Shield.
Step 4: Push the capped Needle straight onto the Pen and twist the Needle on until it is tight.
Step 5: 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 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 6: To prime your Pen, turn the Dose Knob to select 2 units.
Step 7: Hold your Pen with the Needle pointing up. Tap the Cartridge Holder gently to collect air bubbles at the top.
Step 8: Continue holding your Pen with the 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 the priming steps 6 to 8, but not more than 4 times. If you still do not see insulin, change the Needle and repeat the priming steps 6 to 8. Small air bubbles are normal and will not affect your dose.

Selecting your dose

• You can give from 0.5 (½) to 30 units in a single injection.

• If your dose is more than 30 units, you will need to give more than 1 injection.

  • If you need help with dividing up your dose the right way, ask your healthcare provider.
  • You must use a new Needle for each injection and repeat the priming step.

Step 9: 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 0.5 (½) 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 whole unit numbers (for example, 4) are printed on the dial. The half units are shown as lines between the whole unit numbers. Always check the number in the Dose Window to make sure you have dialed the correct dose.

Example: 4 units shown in the Dose Window Example: 10.5 (10 ½) units shown in the Dose Window

• 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 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 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.
• Do not try to change your dose while injecting.

Step 10: Choose your injection site. Insulin Lispro 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 11: 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 12: 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 that 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 13: Carefully replace the Outer Needle Shield.
Step 14: 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 15: Replace the Pen Cap by lining up the Cap Clip with the Dose Indicator and pushing straight on.

Disposing of Pens and Needles

• The used Pen may be discarded in your household trash after you have removed the needle.
• 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. 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 the container.

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 it 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.

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 Insulin Lispro Pen you are using after 28 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 sight and 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 Insulin Lispro Junior KwikPen, contact Lilly at 1-800-LillyRx (1-800-545-5979) or call your healthcare provider for help.

Manufactured by:

Eli Lilly and Company

Indianapolis, IN 46285, USA

US License Number 1891

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised: July/2023

Humalog^® and KwikPen^® are registered trademarks of Eli Lilly and Company.

Copyright © 2017, 2023, Eli Lilly and Company. All rights reserved.

LIS-JRKP-0002-IFU-20230721