Humalog

Generic name: insulin lispro
Drug class: Insulin

Medically reviewed by  A Ras MD.

What is Humalog?

Humalog is a man-made fast-acting insulin used to control high blood sugar in adults and children with diabetes mellitus. It is not known if Humalog is safe and effective in children younger than 3 years of age or when used to treat children with type 2 diabetes mellitus.

Description

HUMALOG Mix50/50 (insulin lispro protamine and insulin lispro injectable suspension) is a mixture of 50% insulin lispro protamine, an intermediate-acting human insulin analog, and 50% insulin lispro, a rapid-acting human insulin analog. Insulin lispro is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Chemically, it is Lys(B28), Pro(B29) human insulin analog and has the empirical formula C257H383N65O77S6 and a molecular weight of 5808, both identical to that of human insulin. Insulin lispro protamine suspension is a suspension of crystals produced from combining insulin lispro and protamine sulfate under appropriate conditions for crystal formation.

Insulin lispro has the following primary structure:

Primary Structure

HUMALOG Mix50/50 vials and KwikPens contain a white and cloudy, sterile suspension of insulin lispro protamine suspension mixed with soluble insulin lispro for use as an injection.

Each milliliter of HUMALOG Mix50/50 injection contains insulin lispro 100 units, 0.19 mg protamine sulfate, 16 mg glycerin, 3.78 mg dibasic sodium phosphate, 2.20 mg Metacresol, zinc oxide content adjusted to provide 0.0305 mg zinc ion, 0.89 mg phenol, and Water for Injection. The pH is 7.0 to 7.8. Sodium hydroxide and/or hydrochloric acid may be added during manufacture to adjust the pH.

Mechanism of Action

The primary activity of insulin including HUMALOG Mix50/50 is the regulation of glucose metabolism. Insulins lower blood glucose by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulins inhibit lipolysis and proteolysis, and enhance protein synthesis.

What is the most important information I should know about Humalog?

Do not share your Humalog prefilled pens, cartridges, reusable pen compatible with Lilly 3mL cartridges, 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.

Who should not take Humalog?

Do not take Humalog if you:

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

What should I tell my healthcare provider before taking Humalog?

Before taking Humalog, 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 Humalog.
  • 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.

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

How should I take Humalog?

  • Read the Instructions for Use that comes with your Humalog.
  • Take Humalog exactly as your healthcare provider tells you to. Your healthcare provider should tell you how much Humalog to take and when to take it.
  • Humalog starts acting fast. Inject Humalog 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 Humalog 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.

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,
  • because of other medicines you take.

What should I avoid while taking Humalog?

While taking Humalog do not:

  • drive or operate heavy machinery, until you know how Humalog affects you.
  • drink alcohol or take prescription or 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 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 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.

  • 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 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 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 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. 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

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not take 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. 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 health professionals.

How should I store Humalog?

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 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.
  • Do not use after the expiration date.
  • 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 vials, syringes, needles and all medicines out of the reach of children.

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

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. 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.

What are the ingredients in Humalog?

Active ingredient: insulin lispro

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

Instructions for Use

HUMALOG KwikPen®
insulin lispro injection (rDNA origin)
100 units/mL, 3 mL pen

 

 

HUMALOG KwikPen - Illustration

 

Read the Instructions for Use before you start taking HUMALOG® 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 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 KwikPen (“Pen”) is a disposable prefilled pen containing 300 units of HUMALOG. 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 than60 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.

This Pen is not recommended for use by the blind or visually impaired without the help ofsomeone trained to use the Pen.

 

 

Kwik Pen Parts and Pen Needle Parts - Illustration

 

How to recognize your HUMALOG KwikPen

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

Supplies you will need to give your injection

  • HUMALOG 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 otherpeople 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.

 

 

Pull the Pen Cap straight off - Illustration

 

Step 2:

  • Check the liquid in the Pen.
    HUMALOG 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.

 

 

Pull off the Paper Tab from the Outer Needle Shield - Illustration

 

Step 4:

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

 

 

Push the capped Needle straight onto the Pen - Illustration

 

Step 5:

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

 

 

Pull off the Outer Needle Shield & Inner Needle Shield - Illustration

 

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.

 

 

Turn the Dose Knob to select 2 units - Illustration

 

Step 7:

  • Hold your Pen with the Needle pointing up. Tap the Cartridge Holder gently to collect air bubbles at the top.

 

 

Tap the Cartridge Holder gently to collect air bubbles at the top - Illustration

 

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.

 

 

Continue holding your Pen with Needle pointing up - Illustration

 

 

 

Push the Dose Knob in until it stops, and “0” is seen in the Dose Window - Illustration

 

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.

 

 

Turn the Dose Knob to select the number of units you need to inject - Illustration

 

 

 

12 units shown in the Dose Window - Illustration

 

 

 

25 units shown in the Dose Window - Illustration

 

  • 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 10:

  • Choose your injection site. HUMALOG 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.

 

 

Choose your injection site - Illustration

 

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.

 

 

Insert the Needle into your skin - Illustration

 

 

 

Continue to hold the Dose Knob in and slowly count to 5 before removing the Needle - Illustration

 

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.

 

 

Dose counter showing 0 - Illustration

 

After your injection

Step 13:

  • Carefully replace the Outer Needle Shield.

 

 

Carefully replace the Outer Needle Shield - Illustration

 

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.

 

 

Unscrew the capped Needle and throw it away - Illustration

 

Step 15:

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

 

 

Replace the Pen Cap by lining up the Cap Clip with the Dose Indicator - Illustration

 

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,
    • eak-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.
  • 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 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 HUMALOG 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 HUMALOG KwikPen, contact Lilly at 1-800LillyRx (1-800-545-5979) or call your healthcare provider for help. For more information on HUMALOG KwikPen and insulin, go to www.humalog.com.

Instructions for Use

HUMALOG®
(HU-ma-log)
(insulin lispro injection, USP [rDNA origin])
10mL Vial (100 Units/mL, U-100)

Read the Instructions for Use before you start taking HUMALOG and each time you get a new HUMALOG 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 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 vial
  • a U-100 insulin syringe and needle
  • 2 alcohol swabs
  • 1 sharps container for throwing away used needles and syringes. See “Disposing of used needles and syringes” at the end of these instructions.

 

 

Supplies needed - Illustration

 

 

 

Supplies needed - Illustration

 

Preparing your HUMALOG dose

  • Wash your hands with soap and water.
  • Check the HUMALOG 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 should look clear and colorless. Do not use HUMALOG if it is thick, cloudy, or colored, or if you see lumps or particles in it.
  • Do not use HUMALOG past the expiration date printed on the label or 28 days after you first use it.
  • Always use a new syringe or needle for each injection to help ensure sterility and prevent 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 fromthem.

Step 1: If you are using a new vial, pull off the plastic Protective Cap, but do not remove the Rubber Stopper.

 

 

Pull off the plastic Protective Cap - Illustration

 

Step 2: Wipe the Rubber Stopper with an alcohol swab.

 

 

Wipe the Rubber Stopper with an alcohol swab - Illustration

 

Step 3: Hold the syringe with the needle pointing up. Pull down on the Plunger until the tip of the Plunger reaches the line for the number of units for your prescribed dose.

 

 

Hold the syringe with the needle pointing up - Illustration

 

 

(Example Dose: 20 units shown)
 

Step 4: Push the needle through the Rubber Stopper of the vial.

 

 

Push the needle through the Rubber Stopper of the vial - Illustration

 

Step 5: Push the Plunger all the way in. This puts air into the vial.

 

 

Push the Plunger all the way in. This puts air into the vial - Illustration

 

Step 6: Turn the vial and syringe upside down and slowly pull the plunger down until the tip is a few units past the line for your prescribed dose.

 

 

Turn the vial and syringe upside down and slowly pull the plunger down - Illustration

 

 

(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.

 

 

Tap the syringe gently a few times to let any air bubbles rise to the top - Illustration

 

Step 7: Slowly push the Plunger up until the tip reaches the line for your prescribed dose. Check the syringe to make sure that you have the right dose.

 

 

Slowly push the Plunger up until the tip reaches the line - Illustration

 

 

(Example Dose: 20 units shown)
 

Step 8: Pull the syringe out of the vial’s Rubber Stopper.

 

 

Pull the syringe out of the vial’s Rubber Stopper - Illustration

 

If you use HUMALOG with NPH insulin:

  • NPH insulin is the only type of insulin that can be mixed with HUMALOG. Do not mix HUMALOG with any other type of insulin.
  • HUMALOG 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 HUMALOG and NPH insulin.
  • Give your injection right away.

Giving your HUMALOG Injection with a syringe

  • Inject your insulin exactly as your healthcare provider has shown you.
  • HUMALOG starts acting fast, so give your injection within 15 minutes before or right after you eat a meal.
  • Change (rotate) your injection site for each injection.

Step 9: Choose your injection site.

HUMALOG 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.

 

 

Choose your injection site - Illustration

 

Step 10: Insert the needle into your skin.

 

 

Insert the needle into your skin - Illustration

 

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.

 

 

Push down on the Plunger to inject your dose - Illustration

 

Step 12: Pull the needle out of your skin.

  • You may see a drop of insulin at the needle tip. This is normal and does not affect the dose you just received.
  • 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.

 

 

Pull the needle out of your skin - Illustration

 

Giving your HUMALOG using an insulin pump

  • Change your insertion site every 3 days.
  • Change the insulin in the reservoir at least every 7 days, even if you have not used all of the insulin.
  • Do not dilute or mix HUMALOG 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 HUMALOG?

All unopened HUMALOG vials:

  • Store all unopened vials in the refrigerator.
  • Do not freeze. Do not use if it 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 HUMALOG 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.

General information about the safe and effective use of HUMALOG

  • Keep HUMALOG vials, syringes, needles, and all medicines out of the reach of children.
  • Always use a new syringe or needle for each injection.
  • 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.

If you have any questions or problems with your HUMALOG, contact Lilly at 1-800-Lilly-Rx (1800-545-5979) or call your healthcare provider for help. For more information on HUMALOG and insulin, go to www.humalog.com.

Instructions for Use

HUMALOG®
Junior KwikPen®
insulin lispro injection
100 units/mL, 3 mL pen

 

 

Junior KwikPen - Illustration

 

Read the Instructions for Use before you start taking HUMALOG and each time you get another HUMALOG® 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 HUMALOG 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.

HUMALOG Junior KwikPen (“Pen”) is a disposable prefilled pen containing 300 units of HUMALOG.

  • 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.

This Pen is not recommended for use by the blind or visually impaired without the help of someone trained to use the Pen.

HUMALOG Junior KwikPen Parts

 

 

Junior KwikPen Parts - Illustration

 

How to recognize your HUMALOG 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:

  • HUMALOG 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 notreuse or share your needles with other people. You may give other people a serious infection or geta 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. HUMALOG should look clear and colorless. Do not use if it is cloudy, colored, or has particles or clumps in it.

 

 

Pull the Pen Cap straight off - Illustration

 

Step 3:

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

 

 

Pull off the Paper Tab from the Outer Needle Shield - Illustration

 

Step 4:

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

 

 

Push the capped Needle straight onto the Pen and twist the Needle - Illustration

 

Step 5:

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

 

 

Pull off the Outer Needle Shield and Inner Needle Shield - Illustration

 

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.

 

 

Turn the Dose Knob to select 2 units - Illustration

 

Step 7:

  • Hold your Pen with the Needle pointing up. Tap the Cartridge Holder gently to collect air bubbles at the top.

 

 

Tap the Cartridge Holder gently - Illustration

 

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.

 

 

Continue holding your Pen with the Needle pointing up - Illustration

 

 

 

Push the Dose Knob in until it stops, and “0” is seen in the Dose Window - Illustration

 

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.

 

 

Turn the Dose Knob to select the number of units you need to inject - Illustration

 

 

 

4 units shown in the Dose Window - Illustration

 

 

 

10.5 (10 ½) units shown in the Dose Window - Illustration

 

  • 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 10:

    • Choose your injection site.

HUMALOG 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.

 

 

Choose your injection site - Illustration

 

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.

 

 

Insert the Needle into your skin - Illustration

 

 

 

Continue to hold the Dose Knob in and slowly count to 5 before removing the Needle - Illustration

 

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.

 

 

Pull the Needle out of your skin - Illustration

 

After your injection

Step 13:

  • Carefully replace the Outer Needle Shield.

 

 

Carefully replace the Outer Needle Shield - Illustration

 

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.

 

 

Unscrew the capped Needle and throw it away - Illustration

 

Step 15:

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

 

 

Replace the Pen Cap by lining up the Cap Clip with the Dose Indicator and pushing straight on - Illustration

 

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. 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.

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 HUMALOG 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 HUMALOG Junior KwikPen, contact Lilly at 1-800-LillyRx (1800-545-5979) or call your healthcare provider for help. For more information on HUMALOG Junior KwikPen and insulin, go to www.humalog.com.

Label

PACKAGE CARTON – HUMALOG Mix50/50 10 mL vial 1ct

  • NDC 0002-7512-01
  • 10 mL
  • 100 units per mL
  • Humalog® Mix50/50™
  • insulin lispro protamine
  • and insulin lispro injectable suspension
  • For subcutaneous use only.
  • Rx only
  • U-100
  • www.humalog.com
  • Lilly
PACKAGE CARTON – HUMALOG Mix50/50 10 mL vial 1ct

 

PACKAGE CARTON – HUMALOG Mix50/50 KwikPen 5ct

  • NDC 0002-8798-59
  • Humalog® Mix50/50™
  • KwikPen®
  • insulin lispro protamine and insulin lispro injectable suspension
  • For Single Patient Use Only
  • Dispense in this sealed carton.
  • U-100
  • 100 units per mL
  • Needles not included
  • This device is recommended for use with Becton, Dickinson and Company’s insulin pen needles
  • For subcutaneous use only.
  • prefilled insulin delivery device
  • Rx only
  • 5 x 3 mL Prefilled Pens
  • Read Insulin Delivery Device Instructions for Use
PACKAGE CARTON – HUMALOG Mix50/50 KwikPen 5ct

SRC: NLM .