Patient Information
HUMALOG KwikPen**®**
insulin lispro injection
U-200 (200 units per mL)

Do not share your HUMALOG 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.
What is HUMALOG?

• HUMALOG is a rapid-acting man-made insulin used to control high blood sugar in adults and children with diabetes mellitus.
• This HUMALOG KwikPen (“Pen”) contains2 times as much insulin (200U/mL) in 1 mL as standard insulin (100U/mL).
• It is not known if HUMALOG is safe and effective in children less than 3 years of age.
• It is not known if HUMALOG is safe and effective in children with type 2 diabetes.

Who should not take HUMALOG?
Do not take HUMALOG if you:

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

What should I tell my healthcare provider before using HUMALOG?
Before using HUMALOG, tell your healthcare provider about all your medical conditions, including if you:

• have liver or kidney problems
• take 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.
• are pregnant, planning to become pregnant, or breastfeeding. It is not known if HUMALOG may harm your unborn or breastfeeding baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Before you start using HUMALOG, talk to your healthcare provider about low blood sugar and how to manage it.

How should I use HUMALOG KwikPen?

• Read the detailedInstructions for Use that come with your HUMALOG KwikPen.
• Use HUMALOG KwikPen exactly as your healthcare provider tells you to. Your healthcare provider should tell you how much HUMALOG to use and when to use it.
• Know the amount of HUMALOG you use.Do not change the amount of HUMALOG you use unless your healthcare provider tells you to.
• Check your insulin label each time you give your injection to make sure you are using the correct insulin.
• HUMALOG comes in a KwikPen which is a disposable prefilled pen that you must use to give your HUMALOG. The dose window on your pen shows your dose of HUMALOG.Do not make any dose changes unless your healthcare provider tells you to. Do not use a syringe to remove HUMALOG from your KwikPen disposable prefilled pen. Do not re-use needles. Always use a new needle for each injection. Re-use of needles increases your risk of having blocked needles, which may cause you to get the wrong dose of HUMALOG. Using a new needle for each injection also lowers your risk of getting an infection. If your needle is blocked, follow the instructions in the“General information about the safe and effective use of your Pen”** section of the Instructions for Use.
• HUMALOG is a rapid-acting insulin. Take HUMALOGwithin 15 minutes before eating or right after eating a meal.
• Inject HUMALOG under your skin (subcutaneously).Do not use HUMALOG KwikPen (“Pen”) in an insulin pump or inject HUMALOG KwikPen into your vein (intravenously).
• Change (rotate) your injection site with each dose. *Do not mix the HUMALOG in the HUMALOG KwikPen with any other type of insulin or liquid medicine. *Check your blood sugar levels. Ask your healthcare provider what your blood sugar should be and when you should check your blood sugar levels.

Keep HUMALOG KwikPen and all medicines out of reach of children.

Your dose of HUMALOG 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 using HUMALOG KwikPen?
While using HUMALOG KwikPen do not:

• drive or operate heavy machinery, until you know how HUMALOG KwikPen affects you
• drink alcohol or use over-the-counter medicines that contain alcohol

What are the possible side effects of HUMALOG?
HUMALOG 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 lightheadedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability or mood changes, hunger. *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, have trouble breathing, a fast heartbeat, or sweating. *low potassium in your blood (hypokalemia). *heart failure. Taking certain diabetes pills called TZDs (thiazolidinediones) with HUMALOG 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. Your healthcare provider should monitor you closely while you are taking TZDs with HUMALOG. 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 may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.
Get emergency 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 include:

• low blood sugar (hypoglycemia), allergic reactions, including reactions at your injection site, skin thickening or pits at the injection site (lipodystrophy), itching, and rash.

These are not all of the possible side effects from HUMALOG. 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 KwikPen.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.Do not use HUMALOG for a condition for which it was not prescribed.Do not give HUMALOG 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 KwikPen. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about HUMALOG that is written for healthcare providers. For more information go to www.humalog.com or call 1-800-LillyRx (1-800-545-5979).

What are the ingredients in HUMALOG U-200?
Active ingredient: insulin lispro.
Inactive ingredient: glycerin, tromethamine, metacresol, zinc oxide (zinc ion), trace amounts of phenol and water for injection.

Humalog ® and Humalog KwikPen ® are registered trademarks of Eli Lilly and Company.
Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA

For more information, go to www.humalog.com.
Patient Information issued: May 26, 2015
Copyright © 2015, Eli Lilly and Company. All rights reserved.

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. 

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      * Choose your injection site.   

      * Wipe your skin with an alcohol swab, and let your skin dry before you inject your dose.

      * 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.   

      * 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.   

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

          * 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. 

            * 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 Pen you are using after 28 days, even if it still has insulin left in it. 

              ***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. 
                * 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.
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      * Carefully replace the Outer Needle Shield.

      * 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.

      * Replace the Pen Cap by lining up the Cap Clip with the Dose Indicator and pushing straight on.

      * 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. 
        * 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: 

Giving your injection

          * 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. 
            * 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.   

      * 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.**

      * 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.**
        * 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.   

      * 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.   

      * Select a new Needle.
      * Pull off the Paper Tab from the Outer Needle Shield.

      * Push the capped Needle straight onto the Pen and twist the Needle on until it is tight.

      * Pull off the Outer Needle Shield.**Do not** throw it away. 
      * Pull off the Inner Needle Shield and throw it away.