Patient portrayal.
Humulin R U-500 is an insulin that is used to control high blood sugar in adults and children with diabetes mellitus who need more than 200 units of insulin in a day.
Patient portrayal.
Humulin R U-500 contains 5 times as much insulin in the same volume (500 units/mL) as Humulin R U-100 (100 units/mL).
It is not known if Humulin R U-500 is safe and effective when used in combination with other insulins or when used in an insulin pump.
Proven to lower A1C with the potential for fewer daily injections.1*
SELECT SAFETY INFORMATION
Humulin R U-500 is highly concentrated and contains 5 times as much insulin in 1 mL as standard U-100 (100 units/mL) insulin.
Do not share your Humulin R U-500 KwikPen or U-500 insulin 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.
Patient portrayal.
Meaningful results, simpler regimen*†
In a clinical study, U-500 was shown to lower A1C by an average of 1.1% in people who were not well controlled when taking more than 200 units of standard U-100 insulin a day.‡
U-500 is an insulin that is taken 2 or 3 times per day. Because it can be prescribed without other insulins, you may be able to reduce the number of insulins you take.
*Compared to standard U-100 insulin. Most patients will require 2 to 3 daily injections of U-500. U-500 KwikPen dials and doses the units you need, up to 300 units at a time.
†With U-500, you can inject up to 80% less liquid and still get the dose you need.
‡The purpose of the study was to compare the efficacy and safety of 2 dosing treatments (2 or 3 injections per day) of U-500 in adults with type 2 diabetes who were uncontrolled with high doses of standard U-100 insulin. The results between the 2 treatments were similar.
24-week, open-label, randomized trial to compare the efficacy and safety of 2 dosing regimens (TID, n=162 vs BID, n=163) for U-500 insulin replacing high dose U-100 insulin (>200 units per day) with or without oral antihyperglycemic drugs in adult patients with uncontrolled type 2 diabetes. These regimens were found to be equivalent for A1C reduction over 24 weeks, and both were efficacious.1
Study conducted with U-100 insulin syringes and Humulin R U-500 vials.
SELECT SAFETY INFORMATION
Humulin R U-500 is a concentrated insulin
U-500 is 5 times more concentrated than standard U-100 insulin. When insulin is concentrated, it takes less liquid per dose than standard U-100 insulin to help reduce your blood sugar levels.
With U-500, you can inject up to 80% less liquid and still get the dose you need. Reducing the amount of liquid may also reduce the number of times you have to inject in a day.* And because U-500 can be prescribed by itself, you may be able to reduce the number of insulins you take.
* Compared to U-100 insulin. Most patients will require 2 or 3 daily injections of U-500.
Here's one way to think about it
Same number of units, 80% less liquid per dose.*
*Compared to standard U-100 insulin. Most patients will require 2 or 3 daily injections of U-500.
Please see Instructions for Use included with your pen or read the instructions online.
Visual comparison of volume for illustrative purposes only.
There are 2 different delivery options for Humulin R U-500:
Be sure to check that you received Humulin R U-500 and that your medication has not expired. If you still have questions, call The Lilly Answers Center at 1-800-LillyRx (1-800-545-5979).
About the U-500 KwikPen®
With the U-500 KwikPen, you may notice some differences:
*Please see the Instructions for Use included with your pen.
SELECT SAFETY INFORMATION
Tell your healthcare provider:
Pharmacy Tips
To save yourself from unnecessary trips, call ahead to your pharmacy to confirm they have U-500 KwikPen® or U-500 insulin vial and BD™ U-500 Insulin Syringes (in the quantity you need) in stock. If not, they can order them for you. Once ordered, it typically takes 1 to 2 business days for the pharmacy to receive the medication and syringes.
If you are using the vial and syringe, be sure to bring all the necessary prescriptions with you to the pharmacy.
Two ways to take Humulin R U-500
For a handy reference, please have your doctor write down your daily dosing schedule.
Watch this video for step-by-step instructions.
00:00-00:04
[Humulin logo symbol appears in the center of the screen and opens up to reveal the full logo and text]
Caption: How to use your U-500 KwikPen
Caption: PP-HM-US-2135 ©Lilly USA, LLC 2023. All rights reserved.
00:06-00:10
[A timeline for this video appears, sharing the timestamps for parts of the video]
Narrator: Welcome to a demonstration of Humulin R U-500 KwikPen.
Caption: 0:00
Caption: 1:45 - Preparing your Humulin® R U-500 KwikPen®
Caption: 3:04 - Priming your Humulin R U-500 KwikPen
Caption: 4:18 - Selecting your dose
Caption: 6:19 - Giving your injection
Caption: 8:10 - After your injection
Caption: 8:37 - Disposing of your Pens and needles
Caption: 10:11 - Storing your Pen
Caption: 10:58 - General information
Caption: 13:10 - Important Safety Information
00:16-00:26
[An animation of the Humulin R U-500 KwikPen spinning appears on screen]
Narrator: Humulin® R U-500 is used to treat people with diabetes who need more than 200 units of insulin a day for the control of high blood sugar. Let’s get to know your pen.
Caption: Humulin® R U-500 is an insulin that is used to control high blood sugar in adults and children with diabetes mellitus who need more than 200 units of insulin a day.
Caption: Humulin R U-500 contains 5 times as much insulin in the same volume (500 units/mL) as Humulin R U-100 (100 units/mL).
00:26-00:34
[The camera zooms in on the Humulin R U-500 KwikPen]
Narrator: Humulin R U-500 KwikPen is a disposable pen. Dial your dose as instructed by your doctor.
Caption: It is not known if Humulin R U-500 is safe and effective when used in combination with other insulins or when used in an insulin pump.
Caption: Refer to the Instructions for Use included with your Pen before you start taking Humulin® R U-500 and each time you get another Pen.
00:34-00:53
[A 2D graphic of the pen and cap appears on screen with text]
Narrator: It's important to know your dose of Humulin R U-500. The Humulin R U-500 KwikPen delivers your dose in insulin units. Insulin units may not be the same as syringe markings. Ask your doctor what your dose should be for your pen.
Caption: IMPORTANT
Caption: Know your dose of Humulin® R U-500 insulin. The Pen delivers your dose in insulin units. Insulin units may not be the same as syringe markings. Ask your doctor what your dose should be for your Pen.
00:53-01:10
[A graphic appears on screen that looks like a KwikPen dose knob shows the number 5 selected]
Narrator: The Humulin R U-500 KwikPen is different from other pens you may have used. It dials 5 insulin units with each click. Do not count clicks of the dose knob to select your dose. You may not get enough insulin, or you may get too much insulin.
Caption: IMPORTANT
Caption: Your Humulin® R U-500 KwikPen® (Pen) works differently from other pens. It dials 5 insulin units with each click. Do not count clicks of the dose knob to select your dose. You may get too much insulin or you may not get enough insulin.
01:10-01:24
[An image appears on screen, showing an arrow pointing from the Humulin R U-500 KwikPen to an image of a syringe, and the arrow is crossed out, indicating to not transfer insulin from the Pen to a syringe.]
Narrator: Humulin R U-500 is a concentrated insulin. Do not transfer Humulin R U-500 insulin from your pen into a syringe. A severe overdose can happen, causing very low blood sugar which may put your life in danger.
Caption: IMPORTANT
Caption: Humulin® R U-500 is a concentrated insulin. DO NOT transfer Humulin R U-500 insulin from your Pen into a syringe. A severe overdose can happen, causing very low blood sugar which may put your life in danger.
Caption: DO NOT TRANSFER TO A SYRINGE SEVERE OVERDOSE CAN RESULT
01:24-01:38
[An image appears on screen with one hand giving the pen to another hand, and both hands and the pen are crossed out, indicating that a pen should not be shared with another person.]
Narrator: Do not share your pen with other people, even if the needle has been changed. Do not reuse or share your needles with other people. You may give an infection to them, or get an infection from them.
Caption: IMPORTANT
Caption: Do not share your Humulin® R U-500 KwikPen® or U-500 insulin 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.
01:38-01:50
[An image of the pen is crossed out, indicating it should not be used by the blind or visually-impaired]
Narrator: This pen is not recommended for use by the blind or visually-impaired, without the help of someone trained to use the pen. Now, let’s get started.
Caption: IMPORTANT
Caption: People who are blind or have vision problems should not use the Pen without help from a person trained to use the Pen.
01:51-01:58
Narrator: Step 1. Preparing your Humulin R U-500 KwikPen. You will need the following supplies:
Caption: Step 1: Preparing your Humulin® R U-500 KwikPen®
01:58-2:04
[An image of the Humulin R U-500 KwikPen, the pen needle and an alcohol swab appear on screen]
Narrator: Your pen, compatible pen needle, and an alcohol swab.
Caption: BD™ Pen Needles Recommended
2:04-2:09
[An image of two hands washing with soap appears on screen]
Narrator: Before you begin, wash your hands with soap and water first.
Caption: Wash your hands with soap and water
2:09-2:30
[An image of the Humulin R U-500 KwikPen appears on screen, with a line pointing to the Insulin type on the label. The pen label expands to show the expiration area on the label]
Narrator: 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. And check the expiration date. 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.
Caption: Wash your hands with soap and water
Caption: Check the Pen and type of insulin
Caption: Insulin type
Caption: Do not use your Pen past the expiration date printed on the label
Caption: Expiration
2:30-2:48
[An animation shows the cap being removed from the Humulin R U-500 KwikPen, and an alcohol swab wiping the rubber seal on the pen]
Narrator: When you’re ready, pull the Pen cap straight off. Do not remove the Pen label. Wipe the rubber seal with an alcohol swab. The insulin should be clear and colorless. Do not use if it is cloudy, colored, or has particles or clumps in it.
2:48-3:09
[An animation showing a paper tab being removed from a new needle, and the new needle being pushed securely onto the Pen, and the outer needle shield being removed and thrown away.]
Narrator: If everything looks good, 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 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.
Caption: Always use a new needle for each injection to help prevent infections and blocked needles.
3:09-3:20
Narrator: Step 2: Priming your Humulin R U-500 KwikPen. It’s important to prime your Pen before each injection
Caption: Step 2: Priming your Humulin® R U-500 KwikPen®
3:20-3:36
[The Humulin R U-500 KwikPen appears on screen]
Narrator: 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.
Caption: Removes air from the needle and cartridge
Caption: If you do not prime, you may get too much or too little insulin.
3:36-3:50
[An animation of the Humulin R U-500 KwikPen appears on screen, showing the pen dose knob turning to 5 units, holding the pen with the needle pointing up and a hand tapping the pen on the side; The 3D pen disappears to show a 2D graphic of someone tapping a Pen near the needle]
Narrator: To prime your Pen, turn the dose knob to select 5 units. Hold your Pen with the needle pointing up. Then, tap the cartridge holder gently to collect air bubbles at the top.
Caption: Turn the dose knob to select 5 units.
Caption: Hold your Pen with the needle pointing up.
Caption: Tap the cartridge holder gently to collect air bubbles at the top.
3:50-4:24
[An animation of the Humulin R U-500 KwikPen appears on screen, indicating how to hold the pen upright, pushing the dose knob and seeing insulin at the tip of the needle]
Narrator: Continue holding your pen with the needle pointing up. Push the dose knob in until it stops, and zero 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, but not more than 8 times. If you still do not see insulin, change the needle and repeat the priming steps. Small air bubbles are normal and will not affect your dose.
Caption: If you do not see insulin, repeat the priming steps, but not more than 8 times.
Caption: If you still do not see insulin, change the needle and repeat the priming steps.
4:24-4:27
Narrator: Step 3: Selecting your dose.
Caption: Step 3: Selecting your dose
4:27-5:00
[The Humulin R U-500 KwikPen appears on screen, with a close up of the dose window on the pen.]
Narrator: Humulin R U-500 KwikPen has been designed to deliver the dose in insulin units that is shown in the dose window. Ask your doctor what your dose should be for this Pen. You can give from 5 to 300 units in a single injection. If your dose is more than 300 units, you will need to give more than one injection. If you need help deciding how to divide up your dose, ask your doctor. You must use a new needle for each injection and repeat the priming step.
Caption: Dose window
5:00-5:59
[A 3D up-close animation of the Humulin R U-500 KwikPen appears on screen, with a close up of the dose window moving between higher and lower dose amounts]
Narrator: To select your dose, 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 knob clicks as you turn it. Each click of the dose knob dials 5 units at a time. Do not dial your dose by counting the clicks because 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, 10, 20, 30) are printed on the dial. The odd numbers (for example, 5, 15, 25) are shown as lines between the even numbers. Always check the number in the dose window to make sure you have dialed the correct dose. The Pen will not let you dial more than the number of units left in the Pen.
Caption: 5 units at a time
5:59-6:15
[The Humulin R U-500 KwikPen appears on screen, with a graphic of a hand injecting the pen into their body next to the 3D model of the KwikPen]
Narrator: 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.
Caption: Inject the amount left in your Pen and then use a new Pen to give the rest of your dose
Caption: OR
Caption: Get a new Pen and inject the full dose.
6:15-6:25
[An arrow pointing from the Humulin R U-500 KwikPen to a syringe is crossed out, indicating to NOT transfer insulin to a syringe.]
Narrator: 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.
6:25-6:29
Narrator: Step 4: Giving your injection.
Caption: Step 4: Giving your injection
6:29-6:43
[The 3D Humulin R U-500 KwikPen appears on screen]
Narrator: You are now ready to inject your insulin as your doctor has shown you. Be sure to change or rotate your injection site for each injection. And do not try to change your dose while injecting.
Caption: Inject as your doctor has shown you.
Caption: Change the injection site for each injection.
Caption: 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.
Caption: Do not try to change your dose while injecting.
6:43-6:57
[An image of a person appears on screen, with their stomach area, buttocks, upper legs and upper arms highlighted as possible injection sites]
Narrator: Choose an injection site. Humulin R U-500 can be injected under the skin of the stomach area, in the buttocks, upper legs, or in the upper arms.
Caption: Choose an Injection Site
Caption: Stomach area
Caption: Buttocks
Caption: Upper legs
Caption: Upper arms
6:57-7:28
[An animation of a person wiping their stomach area with an alcohol swab (70% isopropyl alcohol) and then using the KwikPen to give themselves an injection in their stomach area. A timer appears on screen, counting from one to five]
Narrator: First, wipe the skin with an alcohol swab and let the injection site dry before injecting. Then, insert the needle into your skin. Push the dose knob until it stops. Hold the dose knob in and slowly count to 5. The plunger only moves a little with each injection, and you may not notice that it moves. Do not try to inject your insulin by turning the dose knob. You will not receive your insulin by turning the dose knob.
Caption: Alcohol Swab 70% Isopropyl Alcohol
7:28-7:51
[A close-up image of the pen and dose window appears showing zero]
Narrator: After counting to 5, pull the needle out of your skin. A drop of insulin at the needle tip is normal. It will not affect your dose. If you see zero in the dose window, you have received your full dose. If you do not see zero in the dose window, you did not receive your full dose. Do not redial. Insert the needle into your skin and finish your injection.
7:51-8:03
Narrator: If you still do not think you received the full amount you dialed for your injection, do not start over or repeat your injection. Monitor your blood glucose as instructed by your doctor.
Caption: If you still do not think you received your full dose, DO NOT take another dose. If you have questions, contact your doctor.
8:03-8:14
[An animation of a person holding gauze and moving it over a drop of blood on their stomach area injection site appears on screen]
Narrator: If you see blood after you take the need out of your skin, press the injection site lightly with a piece of gauze or an alcohol swab. Do not rub the area.
8:14-8:19
Narrator: Step 5: After your injection.
Caption: Step 5: After your injection
8:19-8:42
[An animation of the Humulin R U-500 KwikPen appears on screen, showing the capped needle being unscrewed and discarded, and showing the pen cap being replaced]
Narrator: Carefully replace the outer needle shield. 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. Replace the Pen cap by lining up the cap clip with the dose indicator and pushing it straight on.
8:42-8:47
Narrator: Step 6: Disposing of your pens and needles.
Caption: Step 6: Disposing of your Pens and needles
8:47-10:17
[An animation of a needle disposal container appears on screen, with a recycle symbol crossed out, indicating to NOT throw away or dispose of loose needles in household trash]
[A question mark and a hazardous waste warning image appear on screen, indicating specifications to use a household container for safe needle storage and disposal]
[The needle disposal container with the hazardous waste warning image inside it appears on screen, indicating to follow your local guidelines for safe and proper needle disposal]
Narrator: Put your used needles in an FDA-cleared sharps disposal container right away after use. Do not throw away or dispose of loose needles in your household trash. If you do not have an FDA-cleared sharps disposal container, you may use a household container that:
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: 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.
Caption: Place used needle in a sharps container,
Caption: or use an appropriate household container.
Caption: Follow local guidelines for proper sharps disposal.
www.fda.gov/safesharpsdisposal
10:17-10:27
Narrator: Step 7: Storing your Pen.
Caption: Step 7: Storing your pen
10:28-10:30
[The Humulin R U-500 KwikPen appears on screen, with the words “below 86°F,” and a flame image crossed out, indicating that the pen should be stored at room temperature and away from heat and light]
Narrator: The Pen you are currently using should be stored at room temperature (below 86 degrees Fahrenheit) and away from heat and light.
10:30-10:37
[An image appears with a person throwing a needle into a trash can, and on the image of a calendar tear page, the number 28 appears, indicating the pen should be thrown away after 28 days]
Narrator: After 28 days, throw the Pen away, even if it still has insulin left in it.
10:37-10:54
[The Humulin R U-500 KwikPen appears on screen, with the degrees 36°F to 46°F displayed, and a picture of a snowflake crossed out, indicating that unused pens should be stored in the refrigerator at 36 degrees Fahrenheit to 46 degrees Fahrenheit, and should not be frozen]
Narrator: Store unused Pens in the refrigerator at 36 degrees Fahrenheit to 46 degrees Fahrenheit (2 degrees Celsius to 8 degrees Celsius). Do not freeze Humulin R U-500 and do not use if it has been frozen.
Caption: Keep refrigerated
Caption: Do not freeze
10:54-11:03
[The Humulin R U-500 KwikPen appears on screen, zooms in on the pen’s label, and shows where to look for the expiration date]
Narrator: Unused Pens may be used until the expiration date printed on the label, if the Pen has been kept in the refrigerator.
Caption: Expiration
11:03-11:11
Narrator: Additionally, there is some general information to keep in mind when using your Humulin R U-500 KwikPen.
Caption: General information about the safe and effective use of your Pen
11:11-11:26
Narrator: Here are a few things you should know if you are switching to Humulin R U-500 KwikPen: Ask your doctor what your dose should be for your Pen in insulin units. Always follow your doctor’s dosing instructions.
Caption: What you should know if you are switching to Humulin® R U-500 KwikPen®: Ask your doctor what your dose should be for your Pen in insulin units. Always follow your doctor's dosing instructions.
11:26-11:38
Narrator: If you are switching from Humulin R U-500 vial (and syringe): Your Pen may measure your dose differently. Ask your doctor what your dose should be for your Pen in insulin units.
Caption: If you are switching from Humulin® R U-500 vial (and syringe): Your Pen may measure your dose differently. The markings on the dose window may not be the same as the markings on the syringe you used in the past. Ask your doctor what your dose should be for your Pen in units of insulin.
11:38-11:59
Narrator: If you are switching from another type of insulin device or pen: The Humulin R U-500 KwikPen is different from other pens. It dials 5 units with each click of the dose knob. Do not select your dose by counting clicks. You may not get enough insulin or you may get too much insulin.
Caption: If you are switching from another type of insulin device or pen: The Humulin® R U-500 KwikPen® is different from other pens. It dials 5 units with each click of the dose knob. Do not select your dose by counting clicks. You may not get enough insulin or you may get too much insulin.
11:59-12:08
[An image of a child reaching for the pen is circled. This is replaced by an image of a broken pen which is crossed out. Both images together indicate the pen should be kept out of the reach of children and should not be used if any part looks broken or damaged]
Narrator: 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.
Caption: Keep out of sight and reach of children.
Caption: Do not use if damaged.
12:08-12:14
[Two pens appear side-by-side on screen]
Narrator: And always carry an extra Pen in case yours is lost or damaged.
Caption: Carry an extra Pen.
12:14-12:21
[An animation of the pen displays on screen, with the pen cap twisting back and forth, indicating that the cap should be gently twisted and pulled off if there is difficulty initially removing the Pen cap]
Narrator: If you cannot remove the Pen cap, gently twist the cap back and forth, and then pull the cap straight off.
12:21-12:43
[An image of the top half of the pen appears on screen, with an arrow animation pointing down to the dose knob, indicating what to do if the needle may be blocked]
Narrator: If it is hard to push the dose knob or if the Pen is not working the right way, your needle may be blocked. Put on a new needle and prime the Pen. It may help to push the dose knob more slowly during your injection. You may have dust, food, or liquid inside the Pen. Throw the Pen away and get a new Pen.
Caption: Your needle may be blocked.
Caption: It may help to push the dose knob more slowly during your injection.
Caption: You may have dust, food, or liquid inside the Pen.
12:43-12:49
[An image appears on screen, showing an arrow pointing from the Humulin R U-500 KwikPen to an image of a syringe, and the arrow is crossed out, indicating to not transfer insulin from the Pen to a syringe]
Narrator: Do not transfer insulin from the Pen to a syringe. Severe overdose can result.
12:49-13:14
Narrator: If you have any questions or problems with your Humulin R U-500 KwikPen, contact Lilly at 1-800-LillyRx, that’s 1-800-545-5979, or call your doctor for help. For more information on Humulin R U-500 KwikPen and insulin, go to www.humulin.com.
Caption: If you have any questions or problems with your Humulin® R U-500 KwikPen®, contact Lilly at 1-800-LillyRX (1-800-545-5979) or call your doctor for help. For more information on Humulin R U-500 KwikPen and insulin, go to www.humulin.com.
13:14-21:22
[Indication and Safety Summary for Humulin R U-500 is scrolling on the screen]
Caption:
INDICATION AND SAFETY SUMMARY
Humulin® (HUE-mu-lin) R U-500 (500 units/mL) is for adults and children who need more than 200 units of insulin in a day to control high blood sugar for their diabetes mellitus. It is more concentrated than Humulin R U-100. It has 5 times as much insulin in each mL as Humulin R U-100 (100 units/mL).
It is not known if Humulin R U-500 is safe and effective when used with other insulins or when used in an insulin pump.
Warnings: Humulin R U-500 may cause serious side effects, including:
Severe low blood sugar, which can lead to seizures, unconsciousness, and death.
Severe allergic reactions. Get medical help right away if you develop a rash over your whole body, have trouble breathing, have a fast heartbeat, or are sweating.
Swelling of your hands and feet. Tell your doctor if you are short of breath, have swelling in your ankles, or have gained weight suddenly.
Heart failure when taking a medication from a class of drugs called thiazolidinediones (TZDs) with Humulin R U-500. This may occur in some people even if they have not had heart problems before.
Low potassium in your blood (hypokalemia). This can lead to severe breathing problems, irregular heartbeat, and death.
Do not share your Humulin R U-500 KwikPen® or U-500 syringe with anyone. Even if you have changed the needle, you or the other person can get a serious infection.
When using the Humulin R U-500 KwikPen: The Humulin R U-500 KwikPen is made to dial and deliver the correct dose of Humulin R U-500 insulin. Do not remove Humulin R U-500 from the KwikPen to inject with any syringe. This could cause severe overdose and may lead to death.
When using the Humulin R U-500 vial: There is a special syringe to measure Humulin R U-500 called the “U-500 insulin syringe.” Only use the U-500 insulin syringe to inject Humulin R U-500. If you do not use the right syringe, you may take the wrong dose of Humulin R U-500. This could cause severe overdose and may lead to death.
Do NOT perform dose conversion when using the Humulin R U-500 KwikPen or U-500 insulin syringe.
Do not use Humulin R U-500 in an insulin pump or inject it into your vein.
Do not take this medicine if you have low blood sugar.
Do not change the insulin you use without talking to your doctor. Changing insulin may lead to low or high blood sugar.
Do not drive or use heavy machinery until you know how Humulin R U-500 affects you. Do not drink alcohol while using Humulin R U-500.
Common side effects
The most common side effects of Humulin R U-500 include:
Low blood sugar (hypoglycemia). Talk to your doctor about low blood sugar symptoms and treatment. Symptoms may be different for each person.
Allergic reactions, such as redness and swelling at the site where you inject.
Skin thickening or pits at the injection site (lipodystrophy).
Itching and rash.
These are not all the possible side effects of Humulin R U-500.
Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.
Before using
Tell your doctor if you are pregnant or plan to become pregnant. Also tell your doctor about:
Any allergies you have. Your doctor can check if the medicine has ingredients that may cause a reaction.
Any medical conditions, including problems with your liver, kidney, or heart.
All the medicines you take, especially a class of drugs called thiazolidinediones, or TZDs. Be sure to include the over-the-counter medicines, vitamins, and herbal supplements you take.
How to take
Read the instructions that come with your Humulin R U-500 carefully. Take it exactly the way your doctor tells you.
Know how much Humulin R U-500 you are supposed to take. Do not change your dose unless your doctor tells you to.
Check the label of your insulin each time you use it. This will help you make sure you are using the right one.
Test your blood sugar before you take Humulin R U-500. Do not take it if your blood sugar is too low.
Do not mix Humulin R U-500 with any other insulin.
Always use a new needle when injecting Humulin R U-500. This will help you avoid infection.
Inject Humulin R U-500 under your skin. Change (rotate) where you inject your insulin with each dose. Do not inject your insulin into the exact same spot. Avoid injecting your insulin into areas where the skin has pits or lumps, or is thickened, tender, bruised, scaly, hard, scarred, or damaged. This will help reduce your chance of getting pits, lumps, or thickened skin where you inject your insulin.
Learn more
Humulin R U-500 is a prescription medicine. For more information, call 1-800-545-5979 or go to humulin.com.
This summary provides basic information about Humulin R U-500 but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Humulin R U-500 and how to take it. Your doctor is the best person to help you decide if Humulin R U-500 is right for you.
Humulin® and KwikPen® are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates. BD™ is a trademark of Becton Dickinson and Co.
HM CON BS 02FEB2023
PP-HM-US-2135 06/2023 ©Lilly USA, LLC 2023. All rights reserved.
21:36-21:42
[The Humulin logo appears on a white alongside text reading “How to use your U-500 KwikPen”]
Caption: How to use your U-500 KwikPen
Watch this video for step-by-step instructions.
00:00-00:09
[The Humulin logo alongside blue text on a white background]
Narrator: Welcome to a demonstration of how to use the BD U-500 insulin syringe with Humulin R U-500.
Caption: How to use your BD™ U-500 Insulin Syringe
Caption: Humulin® R U-500 insulin human injection 500 units/mL
00:09-00:23
[A timeline on a light blue background to show when information will be discussed in the video]
Narrator: This video will show how to prepare and give an injection, how to dispose of syringes, and how to store and handle U-500 vials. These instructions will begin after the following important information.
Caption: 2:29-Before you start
Caption: 3:57-Preparing to give your injection
Caption: 5:25-Giving your injection
Caption: 6:37-Disposal of used syringes
Caption: 7:49-Storage and handling of U-500 vials
Caption: 8:38-General information
Caption: 10:04-Important Safety Information
00:23-00:54
[White text on a blue background to the right and a Humulin vial on a white background to the left of the text]
Narrator: Humulin R U-500 is an insulin that is used to control high blood sugar in adults and children with diabetes mellitus who need more than 200 units of insulin in a day. Humulin R U-500 contains 5 times as much insulin in the same volume (500 units/mL) as standard insulin (100 units/mL). It is not known if Humulin R U-500 is safe and effective when used with other insulins or when used in an insulin pump.
Caption: Humulin® R U-500 is an insulin that is used to control high blood sugar in adults and children with diabetes mellitus who need more than 200 units of insulin in a day.
Caption: Humulin® R U-500 contains 5 times as much insulin in the same volume (500 units/mL) as Humulin R U-100 (100 units/mL).
Caption: It is not known if Humulin® R U-500 is safe and effective when used with other insulins or when used in an insulin pump.
00:54-01:13
[A photo of the Humulin R U-500 vial and syringe]
Narrator: The BD U-500 syringe is for Humulin R U-500 insulin. You should only use a U-500 syringe to inject Humulin R U-500 insulin. If you use the wrong syringe, you can give yourself a severe overdose.
01:13-1:23
Narrator: Humulin R U-500 is a concentrated insulin. It's important to know your dose. Your doctor will tell you how many units of insulin you should take.
Caption: IMPORTANT
Caption: Humulin® R U-500 is a concentrated insulin
Caption: Know your dose in units
01:23-01:33
Narrator: Always inject Humulin R U-500 insulin with a green U-500 syringe. Other syringes will not measure your dose correctly.
Caption: IMPORTANT
Caption: Always inject Humulin® R U-500 insulin with a green U-500 syringe
01:33-01:55
Narrator: If you use the wrong syringe, you can give yourself a severe overdose. This can cause very low blood sugar, which may put your life in danger. For example, using a U-100 syringe can give you a five times overdose. If you do not have a U-500 syringe, you should contact your doctor or pharmacist.
Caption: IMPORTANT
Caption: If you use the wrong syringe, you can give yourself a severe overdose. This can cause very low blood sugar, which may put your life in danger.
01:55-02:16
[A close-up of five units on the syringe, then zoomed out to show the full 250 units on the syringe]
Narrator: Each line of the syringe measures five units of insulin. You can give from 5 to 250 units of insulin in one injection. If your dose is more than 250 units, you will need to give more than one injection. Make sure you know how to draw up your dose with a U-500 syringe.
Caption: IMPORTANT
Caption: Each line on the U-500 syringe measures 5 units of U-500 insulin
Caption: 5 UNITS
Caption: 250 UNITS
02:16- 02:28
[Blue text on a white background]
Narrator: If you have any questions, call the Lilly Answers Center at 1-800-LILLYRX. That's 1-800-545-5979.
Caption: The Lilly Answers Center
Caption: 1-800-LillyRx (1-800-545-5979)
02:28-02:46
[Images of supplies: a Humulin vial, a syringe, two alcohol swabs, and a sharps container]
Narrator: Step 1: Before you start
Narrator: In order to give yourself your injection of insulin, you will need the following supplies: Humulin R U-500 vial, U-500 syringe, two alcohol swabs, and one sharps container.
Caption: Step 1: Before you start
Caption: Supplies:
Caption: Humulin® R U-500 vial
Caption: BD U-500 syringe
Caption: 2 alcohol swabs
Caption: 1 sharps container
02:46-03:07
[Image of vial showing brand name; vial is turned on its side to show the expiration date; the back of the vial appears on screen, and the insulin in the vial is clear]
Narrator: Before you begin, check your vial to be sure it says Humulin R U-500 and it has not expired. Now, look at the back of the vial. The insulin should be clear. Do not use it if it is thick, cloudy, or colored, or has solid particles.
Caption: Do not use it if it is expired. Throw away the opened vial after 40 days of use, even if there is still insulin left in the vial.
Caption: Expiration Date
Caption: The insulin should be clear.
Caption: Do not use if it is thick, cloudy, or colored, or has solid particles.
03:07-03:37
[Image of green BD U-500 syringe; U-500 symbol at the bottom of the syringe is circled; green needle shield is circled]
Narrator: Do not mix with other insulins in the same syringe. Next, make sure you have a new U-500 syringe and that it has the green U-500 symbol and green needle shield. Do not reuse or share the U-500 syringes. Use only a U-500 syringe to inject Humulin R U-500 insulin.
Caption: Do not mix with other insulins in the same syringe.
Caption: The BD U-500 syringe.
Caption: You should never share needles or syringes with other people, even if the needle is changed.
Caption: You may give other people a serious infection or get a serious infection from them.
Caption: Use only a U-500 syringe to inject Humulin R U-500 insulin.
03:37-03:56
[An image of a checkmark shows on screen next to a Humulin R U-500 vial and three green U-500 syringes; an image of a question mark shows on screen]
Narrator: This is a good time to check your supply of U-500 insulin and syringes. Make sure you have enough Humulin R U-500 insulin and U-500 syringes for several injections. Always reorder before you run out. Check with your healthcare provider if you have any questions.
Caption: Check your supply of U-500 insulin and syringes.
Caption: Remember to reorder before you run out.
Caption: Check with your healthcare provider if you have any questions.
03:56-04:12
[An illustration shows two hands lathered with soap, washing; image of a green U-500 syringe]
Narrator: Step 2: Preparing to give your injection
Narrator: Now you are ready to give yourself an injection. Before you do, wash your hands with soap and water. And always be sure to use a new syringe to help prevent infections and block needles.
Caption: Step 2: Preparing to give your injection
Caption: Wash your hands with soap and water.
Caption: Always use a new syringe.
04:12-04:23
[An illustration shows someone removing the cap off the vial and wiping the stopper with an alcohol swab]
Narrator: If you are using a new vial, pull off the plastic protective cap. Do not remove the rubber stopper. Wipe the rubber stopper with an alcohol swab.
Caption: Pull off the green protective cap.
Caption: Do not remove the rubber stopper. Wipe the rubber stopper with an alcohol swab.
04:23-04:34
[A graphic of the syringe showing dosing from a line marked 25 to a line marked 175; an arrow scrolls up and down the syringe before stopping at the 85-unit line]
Narrator: Find the line on the syringe that matches your prescribed dose. This is called the dose line. Each line represents five units. In this demonstration, we will show an 85-unit dose.
Caption: Find your dose line.
Caption: 85 UNITS
Caption: This is just a demonstration dose.
04:34-04:53
[An illustration shows two hands holding the U-500 syringe; the hands pull the plunger rod down while a close-up graphic shows the plunger move down the chamber of the syringe; in another illustration, two hands push the needle through the rubber stopper of the vial, and push the plunger all the way in]
Narrator: With the syringe needle pointing up, pull down on the plunger rod until the plunger tip reaches your dose line. Push the needle through the rubber stopper of the vial, and push the plunger all the way in. This puts air into the vial.
Caption: Pull plunger until tip reaches your dose line.
Caption: Push needle through stopper and push plunger all the way in.
04:53-05:09
[A graphic shows two hands holding the vial and syringe upside down, pulling insulin from the vial; a close-up graphic to the right of the main graphic shows the placement of the syringe inside the vial; while the syringe and vial are upside down, the graphic shows the hands tapping the syringe to remove air bubbles]
Narrator: Holding the vial and syringe upside down, slowly pull the plunger down until the plunger tip is past the dose line. If there are air bubbles, tap the syringe gently a few times. This lets the air bubbles rise to the top.
Caption: With the vial upside down, slowly pull the plunger down so the plunger tip is past the dose line.
Caption: Tap the syringe gently to collect air bubbles at the top.
05:09-05:25
[A graphic shows insulin being pulled from the vial using the syringe; a close-up graphic to the right of the main graphic shows insulin entering the chamber; two hands remove the syringe from the vial while the vial is upright; an arrow shows the direction to remove the syringe from the vial]
Narrator: To get to your dose, slowly push the plunger up until the plunger tip reaches your dose line. Check the syringe to make sure that you have the right dose. Pull the syringe out of the vial’s rubber stopper.
Caption: Push the plunger until the tip reaches your dose line.
Caption: Remove the syringe.
05:25-05:38
[A graphic of a human body on screen with areas circled, with them being highlighted one at a time to show where to rotate your injection site]
Narrator: Step 3: Giving your injection
Narrator: You are now ready to inject your insulin exactly as your doctor has shown you. Be sure to change or rotate your injection site for each injection.
Caption: Step 3: Giving your injection
05:38-05:52
[On the graphic of the human body, the possible areas for injection are highlighted while the narrator speaks about each one]
Narrator: First, choose your injection site. Humulin R U-500 can be injected under the skin of the stomach area, in the buttocks, upper legs, or in the upper arms.
Caption: Do not inject where the skin has pits, is thickened, or has lumps.
Caption: Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.
Caption: Choose an Injection Site
Caption: Stomach area
Caption: Buttocks
Caption: Upper legs
Caption: Upper arms
05:52-06:18
[A 2D character wiping their stomach area with an alcohol swab, then injecting the needle into their stomach area]
Narrator: Then, wipe the skin with an alcohol swab and let the injection site dry before you inject your dose. Next, insert the needle into your skin. Push down on the plunger to inject your dose and keep the needle in your skin for at least 5 seconds to make sure that you have injected all of your dose. Once you have delivered the complete dose, pull the needle out of your skin.
Caption: Wipe skin with an alcohol swab.
Caption: Insert needle into skin.
Caption: Push down plunger.
Caption: Keep needle in at least 5 seconds.
Caption: Once you have delivered the complete dose, pull the needle out of your skin.
06:18-06:36
[The 2D character wipes blood from injection site; a graphic with a red “X” over it, showing someone placing the needle shield back on the needle]
Narrator: If you see blood after you take out the needle, this is normal. Just press the injection site lightly with a piece of gauze or an alcohol swab. Do not rub the area. To avoid a needle stick injury, do not put the needle shield back on the needle.
Caption: If there is blood, use a piece of gauze or an alcohol swab. Do not rub.
Caption: Do not put the needle shield back on the needle.
06:36-06:52
[An image of a sharps disposal container with a hazard symbol]
Narrator: Step 4: Disposal of used syringes
Narrator: Put your used syringes in an FDA-cleared sharps disposal container right away after use. Do not throw away syringes in your household trash.
Caption: Step 4: Disposal of used syringes
Caption: Use an FDA-cleared sharps disposal container.
06:52-07:18
[An image of a household container labeled “Sharps”]
Narrator: If you do not have an 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, stands upright and is stable during use, is leak resistant, and is properly labeled to warn of hazardous waste inside the container.
Caption: Or you can use an appropriate household container
Caption: heavy-duty plastic
Caption: secure, puncture-proof lid
Caption: upright and stable
Caption: leak-resistant
Caption: labeled as hazardous waste
07:18-07:49
[Image of sharps disposal container that has many used needles and syringes inside]
Narrator: When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of the 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 www.fda.gov/safesharpsdisposal.
Caption: Follow community guidelines to properly dispose of your sharps container.
Caption: For more information, go to the FDA’s website at
www.fda.gov/safesharpsdisposal
07:49-08:15
[Graphics of a sun with a red “X” through it, a vial with a red “X” through it, a refrigerator, and snowflakes with a red “X” through them]
Narrator: Step 5: Storage and handling of U-500 vials
Narrator: The Humulin R U-500 vials should be kept away from heat and light. Do not shake the vial. Unopened vials should be stored in the refrigerator. In addition, do not freeze Humulin R U-500. If it has been frozen, do not use.
Caption: Step 5: Storage and handling of U-500 vials
Caption: Keep the vial away from heat and light.
Caption: Do not shake the vial.
Caption: Unopened vials should be stored in the refrigerator.
Caption: Do not freeze Humulin® R U-500.
08:15-08:38
[Graphics of a calendar with days crossed out, a thermometer with the ideal temperature range highlighted, and a trash can]
Narrator: If unopened vials have been stored in the refrigerator, you may use them until the expiration date. Store opened vials in the refrigerator or at room temperature below 86 degrees Fahrenheit for up to 40 days. Throw away opened vials after 40 days, even if there is still insulin left in the vial.
Caption: Check the expiration date.
Caption: Store opened vials in the refrigerator or at room temperature.
Caption: Below 86°F
Caption: Dispose of opened vials after 40 days.
08:38-08:48
[Images of the syringe and vial]
Narrator: As a reminder, here is some general information to keep in mind when injecting Humulin R U-500 insulin with a U-500 syringe.
Caption: General Information
08:48-09:02
[An image of the U-500 syringe]
Narrator: Always use a green U-500 syringe to inject Humulin R U-500 insulin. Never use other syringes. The lines and numbers on other syringes will not measure your dose correctly.
Caption: Always use a green U-500 syringe to inject Humulin® R U-500 insulin.
09:02-09:24
Narrator: You can give yourself the wrong dose if you use any other syringe such as a U-100, tuberculin, or allergy syringe. For example, a U-100 syringe is made to measure U-100 insulin. If you use a U-100 syringe for your U-500 dose, you can give yourself a five times overdose.
Caption: You can give yourself the wrong dose if you use any other syringe.
09:24-09:38
[An image of a prescription pad filled in with BD U-500 syringe prescribing information, a graphic of a hand]
Narrator: Do not make any changes to your dose or the type of insulin you use unless you are told to do so by your doctor. Keep your vials and syringes out of the sight and reach of children.
Caption: Do not make any changes to your dose or the type of insulin you use unless you are told to do so by your doctor.
Caption: Keep out of reach of children
09:38-10:02
Narrator: If you have any questions about Humulin® R U-500 insulin or U-500 syringes, contact Lilly at 1-800-LillyRX. That's 1-800-545-5979. You can also call your healthcare provider or pharmacist. For more information on Humulin R U-500 insulin, go to www.humulin.com.
Caption: Where to get more information: If you have any questions about Humulin® R U-500 insulin or U-500 syringes, contact Lilly at 1-800-Lilly-Rx (1-800-545-5979)
Caption: You can also call your healthcare provider or pharmacist
Caption: For more information on Humulin R U-500 insulin, go to www.humulin.com
10:02-18:13
Caption: INDICATION and SAFETY SUMMARY
Caption: Humulin® (HUE-mu-lin) R U-500 (500 units/mL) is for adults and children who need more than 200 units of insulin in a day to control high blood sugar for their diabetes mellitus. It is more concentrated than Humulin R U-100. It has 5 times as much insulin in each mL as Humulin R U-100 (100 units/mL).
Caption: It is not known if Humulin R U-500 is safe and effective when used with other insulins or when used in an insulin pump.
Caption: Warnings: Humulin R U-500 may cause serious side effects, including:
Caption: Severe low blood sugar, which can lead to seizures, unconsciousness, and death.
Caption: Severe allergic reactions. Get medical help right away if you develop a rash over your whole body, have trouble breathing, have a fast heartbeat, or are sweating.
Caption: Swelling of your hands and feet. Tell your doctor if you are short of breath, have swelling in your ankles, or have gained weight suddenly.
Caption: Heart failure when taking a medication from a class of drugs called thiazolidinediones (TZDs) with Humulin R U-500. This may occur in some people even if they have not had heart problems before.
Caption: Low potassium in your blood (hypokalemia) This can lead to severe breathing problems, irregular heartbeat, and death.
Caption: Do not share your Humulin R U-500 KwikPen® or U-500 syringe with anyone. Even if you have changed the needle, you or the other person can get a serious infection.
Caption: When using the Humulin R U-500 KwikPen: The Humulin R U-500 KwikPen is made to dial and deliver the correct dose of Humulin R U-500 insulin. Do not remove Humulin R U-500 from the KwikPen to inject with any syringe. This could cause severe overdose and may lead to death.
Caption: When using the Humulin R U-500 vial: There is a special syringe to measure Humulin R U-500 called the "U-500 insulin syringe." Only use the U-500 insulin syringe to inject Humulin R U-500. If you do not use the right syringe, you may take the wrong dose of Humulin R U-500. This could cause severe overdose and may lead to death.
Caption: Do NOT perform dose conversion when using the Humulin R U-500 KwikPen or U-500 insulin syringe.
Caption: Do not use Humulin R U-500 in an insulin pump or inject it into your vein.
Caption: Do not take this medicine if you have low blood sugar.
Caption: Do not change the insulin you use without talking to your doctor. Changing insulin may lead to low or high blood sugar.
Caption: Do not drive or use heavy machinery until you know how Humulin R U-500 affects you. Do not drink alcohol while using Humulin R U-500.
Caption: Common side effects
Caption: The most common side effects of Humulin R U-500 include:
Caption: Low blood sugar (hypoglycemia). Talk to your doctor about low blood sugar symptoms and treatment. Symptoms may be different for each person.
Caption: Allergic reactions, such as redness and swelling at the site where you inject.
Caption: Skin thickening or pits at the injection site (lipodystrophy).
Caption: Itching and rash.
Caption: These are not all the possible side effects of Humulin R U-500.
Caption: Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.
Caption: Before using
Caption: Tell your doctor if you are pregnant or plan to become pregnant. Also tell your doctor about:
Caption: Any allergies you have. Your doctor can check if the medicine has ingredients that may cause a reaction.
Caption: Any medical conditions, including problems with your liver, kidney, or heart.
Caption: All the medicines you take, especially a class of drugs called thiazolidinediones, or TZDs. Be sure to include the over-the-counter medicines, vitamins, and herbal supplements you take.
Caption: How to take
Caption: Read the instructions that come with your Humulin R U-500 carefully. Take it exactly the way your doctor tells you.
Caption: Know how much Humulin R U-500 you are supposed to take. Do not change your dose unless your doctor tells you to.
Caption: Check the label of your insulin each time you use it This will help you make sure you are using the right one.
Caption: Test your blood sugar before you take Humulin R U-500. Do not take it if your blood sugar is too low.
Caption: Do not mix Humulin R U-500 with any other insulin.
Caption: Always use a new needle when injecting Humulin R U-500. This will help you avoid infection.
Caption: Inject Humulin R U-500 under your skin. Change (rotate) where you inject your insulin with each dose. Do not inject your insulin into the exact same spot. Avoid injecting your insulin into areas where the skin has pits or lumps, or is thickened, tender, bruised, scaly, hard, scarred, or damaged. This will help reduce your chance of getting pits, lumps, or thickened skin where you inject your insulin.
Caption: Learn more: Humulin R U-500 is a prescription medicine. For more information, call 1-800-545-5979 or go to humulin.com.
Caption: This summary provides basic information about Humulin R U-500 but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Humulin R U-500 and how to take it. Your doctor is the best person to help you decide if Humulin R U-500 is right for you.
Caption: Humulin® and KwikPen® are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.
Caption: HM CON BS 02FEB2023
Caption: PP-HM-US-2136 06/2023 ©Lilly USA, LLC 2023. All rights reserved.
18:13-18:22
[Humulin logo]
Caption: Humulin® R U-500 insulin human injection 500 units/mL
Dosing and storing Humulin R U-500
*Please see the Instructions for Use included with your pen. Do not freeze or use insulin that has been previously frozen.
**Please see the Instructions for Use included with your vial. Do not freeze or use insulin that has been previously frozen.
SELECT SAFETY INFORMATION
What to expect
To know if U-500 is helping to improve your glucose, check your blood sugar.
Low blood sugar is the most common side effect of U-500.
It's normal to want to understand possible side effects like low blood sugar when starting a new insulin. Be sure to talk to your doctor about the causes and how to identify and manage low blood sugar.
Take your dose 30 minutes before eating a meal as your doctor instructed. Timing is important to help reduce the risk of low blood sugar (hypoglycemia).
As with any insulin, there is potential to experience low blood sugar at any time, including in the first few weeks as you're getting used to your new medication or dose. Checking your blood sugar as directed by your doctor will help monitor for any highs or lows, as well as possible improvements in your blood sugar.
SELECT SAFETY INFORMATION
Humulin R U-500 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. Your healthcare provider may prescribe a glucagon emergency kit so that others can give you an injection if your blood sugar becomes too low and you are unable to take sugar by mouth.
What are the potential side effects of Humulin R U-500?
Common side effects
The most common side effects of Humulin R U-500 include:
These are not all the possible side effects of Humulin R U-500.
Experiencing side effects of insulin use?
If you are experiencing any side effects of taking insulin, please contact your doctor. Get emergency medical help if you have:
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Other Available Humulin Insulins
Introduced by Eli Lilly and Company in 1982, Humulin U-100 insulins are affordable choices that celebrate over 30 years of helping people manage type 1 and type 2 diabetes.
For the treatment of high blood sugar (glucose) levels, 3 types of Humulin U-100 insulin can help manage diabetes. Each insulin type varies in onset, peak time and duration. Keep in mind that insulin should only be used under a healthcare provider's advice and care.
Humulin R U-100 (regular insulin human injection) 100 units/mL
Humulin R U-100 (regular insulin human injection) 100 units/mL
Provides a short-acting insulin peak to cover blood sugar increases from meals eaten within 30 minutes
Humulin N (insulin human isophane suspension) 100 units/mL
Humulin N (insulin human isophane suspension) 100 units/mL
Provides an intermediate-acting insulin peak to cover blood sugar increases between meals and during the night
Humulin 70/30 (insulin human isophane suspension and insulin human injection) 100 units/mL
Humulin 70/30 (insulin human isophane suspension and insulin human injection) 100 units/mL
Short- and intermediate-acting insulin peaks combined to cover insulin needs after meals, throughout the day, and at night
Short-acting insulin to cover blood sugar increases from meals eaten within 30 minutes
Humulin R U-100 is a short-acting insulin, which means it can cover insulin needs for meals eaten within 30 minutes.
There are 2 types of Humulin R insulin: Humulin R U-100 and a more concentrated insulin, Humulin R U-500. U-100 insulins, including Humulin R, contain 100 units per mL. It's important to make sure you have the correct one.
Humulin R U-100 is for injection under the skin. It should not be injected into the muscle. Doses of insulin are measured in units. With Humulin R U-100, it is important to use a syringe that is marked for U-100 insulins.
Do not use Humulin R U-100:
If you notice your insulin requirements changing, talk to your doctor.
Be sure to read the Patient Information that comes with your Humulin R U-100 insulin.
Also be sure to read the Instructions for Use for your Humulin R U-100 vial.
To learn more about Humulin R U-100, call The Lilly Answers Center at 1-800-LillyRx (1-800-545-5979).
Pens and needles are for single-patient use only and should not be shared, even in healthcare facilities, as infection or disease can be spread from one person to another.
Do not withdraw insulin from the pen using a syringe.
Humulin R U-100 is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients with type 1 and type 2 diabetes mellitus.
For more safety information, please click to access Humulin R U-100 Patient Information and Humulin R U-100 Full Prescribing Information.
Intermediate-acting insulin to cover blood sugar increases between meals and during the night
Humulin N is an intermediate acting insulin that is slower to act and lasts longer than regular human insulin. Humulin N is available in the prefilled Humulin® N KwikPen® or in a Humulin N U-100 vial.
Humulin N is injected under the skin. It should not be injected into muscle or veins. Doses of insulin are measured in units. U-100 insulins, including Humulin N, contain 100 units/mL. With the Humulin N U-100 vial, it is important to use a syringe that is marked for U-100 insulin preparations.
Do not use Humulin N:
If you notice your insulin requirements changing, talk to your doctor.
Be sure to read the Patient Information that comes with your Humulin N insulin.
Also be sure to read the Instructions for Use for your Humulin N vial or KwikPen
To learn more about Humulin N KwikPen, call The Lilly Answers Center at 1-800-LillyRx (1-800-545-5979).
Pens and needles are for single-patient use only and should not be shared, even in healthcare facilities, as infection or disease can be spread from one person to another.
Do not withdraw insulin from the pen using a syringe.
Humulin N is used to treat people with diabetes for the control of high blood sugar.
Important Considerations for Use for Humulin R U-100, Humulin N, and Humulin 70/30:
For more safety information, please click to access Humulin N Patient Information and Humulin N Full Prescribing Information.
Please see the Instructions for Use included with your pen.
Short- and intermediate-acting insulins combined to cover insulin needs after meals, throughout the day, and at night
Humulin 70/30 is an insulin that combines the short action of regular human insulin (Humulin R U-100) and the intermediate action of Humulin N. Humulin 70/30 is available in the prefilled Humulin® 70/30 KwikPen® or in a Humulin 70/30 U-100 vial.
Humulin 70/30 is injected under the skin. It should not be injected into a vein or muscle. Doses of insulin are measured in units. U-100 insulins, including Humulin 70/30, contain 100 units/mL. With the Humulin 70/30 vial, it is important to use a syringe that is marked for U-100 insulins.
Do not use Humulin 70/30:
If you notice your insulin requirements changing, talk to your doctor.
Be sure to read the
Also be sure to read the
To learn more about Humulin 70/30 KwikPen, call The Lilly Answers Center at 1-800-LillyRx (1-800-545-5979).
Pens and needles are for single-patient use only and should not be shared, even in healthcare facilities, as infection or disease can be spread from one person to another.
Do not withdraw insulin from the pen using a syringe.
Humulin 70/30 is used to treat people with diabetes for the control of high blood sugar.
Important Considerations for Use for Humulin R U-100, Humulin N, and Humulin 70/30:
For more safety information, please click to access: Humulin R U-100 Patient Information, Humulin R U-100 Full Prescribing Information, Humulin N Patient Information, Humulin N Full Prescribing Information, Humulin 70/30 Patient Information, and Humulin 70/30 Full Prescribing Information. Please see Instructions for Use included with your Humulin N KwikPen or Humulin 70/30 KwikPen.
References
Humulin® (HUE-mu-lin) R U-500 (500 units/mL) is for adults and children who need more than 200 units of insulin in a day to control high blood sugar for their diabetes mellitus. It is more concentrated than Humulin R U-100. It has 5 times as much insulin in each mL as Humulin R U-100 (100 units/mL).
It is not known if Humulin R U-500 is safe and effective when used with other insulins or when used in an insulin pump.
Humulin R U-500 may cause serious side effects, including:
Do not share your Humulin R U-500 KwikPen® or U-500 syringe with anyone. Even if you have changed the needle, you or the other person can get a serious infection.
When using the Humulin R U-500 KwikPen: The Humulin R U-500 KwikPen is made to dial and deliver the correct dose of Humulin R U-500 insulin. Do not remove Humulin R U-500 from the KwikPen to inject with any syringe. This could cause severe overdose and may lead to death.
When using the Humulin R U-500 vial: There is a special syringe to measure Humulin R U-500 called the “U-500 insulin syringe.” Only use the U-500 insulin syringe to inject Humulin R U-500. If you do not use the right syringe, you may take the wrong dose of Humulin R U-500. This could cause severe overdose and may lead to death.
Do NOT perform dose conversion when using the Humulin R U-500 KwikPen or U-500 insulin syringe.
Do not use Humulin R U-500 in an insulin pump or inject it into your vein.
Do not take this medicine if you have low blood sugar.
Do not change the insulin you use without talking to your doctor. Changing insulin may lead to low or high blood sugar.
Do not drive or use heavy machinery until you know how Humulin R U-500 affects you. Do not drink alcohol while using Humulin R U-500.
The most common side effects of Humulin R U-500 include:
These are not all the possible side effects of Humulin R U-500.
Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.
Tell your doctor if you are pregnant or plan to become pregnant. Also tell your doctor about:
Humulin R U-500 is a prescription medicine. For more information, call 1-800-545-5979.
This summary provides basic information about Humulin R U-500 but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Humulin R U-500 and how to take it. Your doctor is the best person to help you decide if Humulin R U-500 is right for you.
HM CON BS 02FEB2023
Humulin® and KwikPen® are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.
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