August 31, 2015
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Humalog

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Humalog




PATIENT INFORMATION

HUMALOG®
(HU-ma-log)
(insulin lispro injection, USP [rDNA origin]) for injection

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.

Who should not use HUMALOG?

Do not use HUMALOG if you:

  • are having an episode of low blood sugar (hypoglycemia).
  • have an allergy to HUMALOG or any of the ingredients in HUMALOG.

Before using HUMALOG, tell your healthcare provider about all of your medicalconditions, including if you:

  • have kidney or liver problems.
  • take any other medicines, especially ones commonly 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.
  • have any other medical conditions. Some medical conditions can affect your insulin needs and your dose of HUMALOG.
  • are pregnant or plan to become pregnant. Talk to your healthcare provider if you are pregnant or plan to become pregnant. You and your healthcare provider should decide about the best way to manage your diabetes while you are pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if HUMALOG passes into your breast milk. You and your healthcare provider should decide if you will use HUMALOG while you breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription or overthe-counter medicines, vitamins, or 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?

  • Read the Instructions for Use that come with your HUMALOG.
  • Do not share your Humalog KwikPen, cartridges, reusable pen compatible with Lilly 3 mL cartridges, 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.
  • Use HUMALOG exactly as your healthcare provider tells you to.
  • HUMALOG starts acting fast, so inject it up to 15 minutes before or right after you eat a meal.
  • Know the type and strength of insulin you use. Do not change the type of insulin you use 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 a different type of insulin.
  • Check your blood sugar levels. Ask your healthcare provider what your blood sugars should be and when you should check your blood sugar level.

What should I avoid while using HUMALOG?

While using HUMALOG do not:

  • Drive or operate heavy machinery, until you know how HUMALOG affects you.
  • Drink alcohol or use prescription or over-the-counter medicines that contain alcohol.

What are the possible side effects of HUMALOG?

HUMALOG may cause serious side effects, including:

  • low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include:
    • dizziness or light-headedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, hunger, anxiety, irritability, or mood changes.

Your HUMALOG dose may need to change because of a:

    • change in level of physical activity or exercise, weight gain or loss, change in diet, illness.
  • serious allergic reactions (whole body allergic reaction). Get medical help right away,if you have any of these symptoms of an allergic reaction:
    • a rash over your whole body, trouble breathing, a fast heartbeat, sweating, feel faint.
  • 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.

The most common side effects of HUMALOG include:

  • low blood sugar (hypoglycemia), reactions at the injection site, skin thickening or pits at the injection site (lipodystrophy), itching (pruritis), 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 1800-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. You can ask your pharmacist or healthcare provider for information about HUMALOG that is written for health professionals.
  • Do not use HUMALOG for a condition for which it was not prescribed. Do not give or share HUMALOG with other people, even if they also have diabetes. It may harm them.

What are the ingredients in HUMALOG?

Active ingredient: insulin lispro

Inactive ingredients: glycerin, dibasic sodium phosphate, metacresol, zinc oxide (zinc ion), trace amounts of phenol and water for injection

Instructions for Use

HUMALOG KwikPen®
insulin lispro injection (rDNA origin)

HUMALOG KwikPen - Illustration

Read the Instructions for Use before you start taking HUMALOG and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

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 pen containing 3 mL (300 units) of U-100 HUMALOG® [insulin lispro injection (rDNA origin)] insulin. You can inject from 1 to 60 units in a single injection.

This Pen is not recommended for use by the blind or visually impaired without the assistance of a person trained in the proper use of the product.

Parts of the HUMALOG KwikPen - Illustration

Supplies you will need to give your HUMALOG injection:

  • HUMALOG KwikPen
  • HUMALOG KwikPen compatible needle (Becton, Dickinson and Company Pen Needles recommended)
  • Alcohol swab

Preparing HUMALOG KwikPen:

  • Wash your hands with soap and water.
  • Check the HUMALOG KwikPen 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.
  • Do not use HUMALOG past the expiration date printed on the Label.
  • Always use a new needle for each injection to help ensure sterility and prevent 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. Wipe the Rubber Seal with an alcohol swab.

  • Do not twist the cap.
  • Do not remove the KwikPen Label.

HUMALOG should look clear and colorless. Do not use HUMALOG if it is thick, cloudy, colored, has solid particles or clumps in it.

Pull the Pen Cap straight off - Illustration

Step 2: Pull off the Paper Tab from Outer Needle Shield.

Pull off the Paper Tab - Illustration

Step 3: Push the capped Needle straight onto the Pen and turn the Needle forward until it is tight.

Push the capped Needle straight onto the Pen - Illustration

Step 4: 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 - Illustration

Priming your HUMALOG KwikPen:

Prime before each injection. Priming ensures the Pen is ready to dose and removes air that may collect in the cartridge during normal use. If you do not prime before each injection, you may get too much or too little insulin.

Step 5: Turn the Dose Knob to select 2 units.

Turn the Dose Knob to select 2 units - Illustration

Step 6: 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 7: Hold 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.

  • A stream of insulin should be seen from the needle.
    • If you do not see a stream of insulin, repeat steps 5 to 7, no more than 4 times.
    • If you still do not see a stream of insulin, change the needle and repeat steps 5 to 7.

A stream of insulin - Illustration

Selecting your dose:

Step 8: Turn the Dose Knob to select the number of units you need to inject. The Dose Indicator should line up with your dose.

  • 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 are printed on the dial. The odd numbers, after the number 1, are shown as full lines.

Selecting your dose - Illustration

  • The HUMALOG KwikPen will not let you dial more than the number of units left in the Pen.
  • If your dose is 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.
  • The Pen is designed to deliver a total of 300 units of insulin. The cartridge contains an additional small amount of insulin that can’t be delivered.

Giving your HUMALOG injection:

  • Inject your HUMALOG as your healthcare provider has shown you.
  • Change (rotate) your injection site for each injection.
  • Do not try to change your dose while injecting HUMALOG.

Step 9: Choose your injection site.

HUMALOG is injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs or upper arms.

Wipe the skin with an alcohol swab, and 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: Put your thumb on the Dose Knob and push the Dose Knob in until it stops. Hold the Dose Knob in and slowly count to 5.

Hold the Dose Knob in and slowly count to 5 - Illustration

Step 12: Pull the Needle out of your skin.

You should see “0” in the Dose Window. If you do not see “0” in the Dose Window, you did not receive your full dose.

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.

A drop of insulin at the needle tip is normal. It will not affect your dose.

If you do not think you received your full dose, do not take another dose. Call Lilly or your healthcare provider for assistance.

“0” in the Dose Window - Illustration

Step 13: Carefully replace the Outer Needle Shield.

Replace the Outer Needle Shield - Illustration

Step 14: Unscrew the capped Needle and throw it away. Do not store the Pen with the Needle attached to prevent leaking, blocking of the Needle, and air from entering the Pen.

Unscrew the capped Needle - 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 - Illustration

After your injection:

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

How should I store my HUMALOG KwikPen?

  • Store unused HUMALOG Pens in the refrigerator at 36°F to 46°F (2°C to 8°C). The Pen you are currently using can be stored out of the refrigerator below 86°F (30°C).
  • Do not freeze HUMALOG. Do not use HUMALOG if it has been frozen.
  • Unused HUMALOG Pens may be used until the expiration date printed on the Label, if kept in the refrigerator.
  • The HUMALOG Pen you are using should be thrown away after 28 days, even if it still has insulin left in it.
  • Keep HUMALOG away from heat and out of the light.

General information about the safe and effective use of HUMALOG KwikPen

  • Keep HUMALOG KwikPen and needles out of the reach of children.
  • Always use a new needle for each injection.
  • Do not share your Pen or needles with other people. You may give other people a serious infection or get a serious infection from them.
  • 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 Pen Cap back and forth, and then pull the Pen Cap straight off.
  • If it is hard to push the Dose Knob or the Pen is not working the right way:
    • 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 one.
    • It may help to push the Dose Knob more slowly during your injection.
  • Use the space below to keep track of how long you should use each HUMALOG KwikPen.
    • Write down the date you start using your HUMALOG KwikPen. Count forward 28 days.
    • Write down the date you should throw it away.

Example:

Pen 1 - First used on (Date) _______ + 28 days = Throw out on (Date) ______

Pen 1 - First used on(Date) _______ Throw out on (Date) _______

Pen 2 - First used on (Date) _______ Throw out on (Date) _______

Pen 3 - First used on (Date) _______ Throw out on (Date) _______

Pen 4 - First used on (Date) _______ Throw out on (Date) _______

Pen 5 - First used on (Date) _______ Throw out on (Date) _______

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

These Instructions for Use have been approved by the U.S. Food and Drug Administration.

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 to give injection - 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 - 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.

Pull down on the Plunger - 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 - Illustration

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

Push the Plunger all the way in - 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 - 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 - 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 - 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 - 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 - 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 - 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.

Code to scan to launch website - Illustration

Scan this code to launch the humalog.com website

Last reviewed on RxList: 6/30/2015
This monograph has been modified to include the generic and brand name in many instances.

Humalog - User Reviews

Humalog User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Humalog sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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