Instructions for Use
HUMULIN® R U-500 KwikPen®
(insulin human)
injection, for subcutaneous use
3 mL single-patient-use pen (500 units/mL, U-500)
Read the Instructions for Use before you start taking HUMULINR U-500 and each time you get another Pen. 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 HUMULINR U-500 Pen 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.
HUMULINR U-500 KwikPen (“Pen”) is a disposable single-patient-use prefilled pen containing 1500units of HUMULINR. You can give yourself more than 1 dose from the Pen. Each turn (click) of the Dose Knob dials 5units of insulin. You can give from 5 to 300units in a single 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 1500units in the Pen.
Inject HUMULINR U-500 only with your Pen. Do not transfer insulin from your Pen to a syringe.
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 HUMULINR U-500 KwikPen
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Supplies needed to give your injection
- HUMULINR U-500 KwikPen
- KwikPen compatible Needle (Becton, Dickinson and Company Pen Needles recommended)
- Alcohol swab
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.
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.
Selecting your dose
This Pen has been made to deliver the dose in insulin units that is shown in the Dose Window. Ask your healthcare provider what your dose should be for this Pen.
- You can give from 5 to 300units in a single injection.
- If your dose is more than 300units, you will need to give more than 1 injection.
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- If you need help with dividing up your dose the right way, ask your healthcare provider.
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- 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 your dose is more than the number of units left in the Pen, you may either:
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- 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 your full dose.
- It is normal to see a small amount of insulin left in the Pen that you cannot inject. Do not transfer this to a syringe. Severe overdose can happen.
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.
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:
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- made of a heavy-duty plastic,
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- can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
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- upright and stable during use,
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- leak-resistant, and
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- 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 HUMULINR U-500. 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 Pen you are using after 28 days, even if it still has insulin left in it.
What you should know if you are switching to HUMULINR U-500 KwikPen
Ask your healthcare provider what your dose should be for your Pen in insulin units. Always follow your healthcare provider's instructions for dosing.
If you are: | It is important to know: |
Switching from HUMULINR U-500 vial (and syringe) | Your Pen may measure your dose differently. The markings in the Dose Window may not be the same as the markings on the syringe you used in the past. If you were using the U-500 syringe to administer your dose, the markings on the syringe may be the same as the markings in the Pen Dose Window. Ask your healthcare provider what dose in insulin units you should dial on your Pen. |
Switching from another type of insulin device or pen. | The HUMULINR U-500 KwikPen is different from other pens. It dials 5 insulin units with each click of the Dose Knob. Do not select your dose by counting clicks. You may get too much insulin or you may not get enough insulin. |
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 cannot remove the Pen Cap, gently twist the cap back and forth, and then pull the cap straight off.
- If it is hard to push the Dose Knob:
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- Pushing the Dose Knob more slowly will make it easier to inject.
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- Your Needle may be blocked. Put on a new Needle and prime the Pen.
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- 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 HUMULINR U-500 KwikPen, contact Lilly at 1-800-LillyRx (1-800-545-5979) or call your healthcare provider for help. For more information on HUMULINR U-500 KwikPen and insulin, go to www.humulin.com.
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These Instructions for Use have been approved by the U.S. Food and Drug Administration.
HUMULIN® and HUMULIN®KwikPen® are trademarks of Eli Lilly and Company.
Manufactured by:
Eli Lilly and Company
Indianapolis, IN 46285, USA
US License Number 1891
Copyright © 2015, 2022, Eli Lilly and Company. All rights reserved.
HUMULINR U-500 KwikPen meets the current dose accuracy and functional requirements of ISO 11608-1.
Document revision date: June 2022
LINR500KP-0005-IFU-20220627