*Compared to U-100 insulin. Most patients will require 2 or 3 daily injections of U-500.1
U-500 is specifically for people like you - people whose A1C levels are above their target even though they've been taking more than 200 units of insulin each day.
U-500 is a different kind of insulin compared to standard regular insulin (U-100), as it covers both long-acting and mealtime insulin needs, which could mean fewer daily injections.*
Ask your doctor about U-500.
1. Hood RC, Arakaki RF, Wysham C, et al. Two treatment approaches for human regular U-500 insulin in patients with type 2 diabetes not achieving adequate glycemic control on high-dose U-100 insulin therapy with or without oral agents: a randomized, titration-to-target clinical trial. Endocr Pract. 2015;21(7):782-793. Erratum, 2016;22(7):905
Study conducted with U-100 insulin syringes and Humulin R U-500 vials
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Meaningful results, simpler regimen*,†
In a clinical study, U-500 was shown to lower A1C by an average of 1.1% points in people who were not well controlled on more than 200 units of standard U-100 insulin a day.ǂ
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.
†With U-500, you can inject up to 80% less liquid and still get the dose you need.
ǂThe 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.
Actor portrayal. Not an actual patient.
Select Important 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.
- Do not take Humulin R U-500 if your blood sugar is too low (hypoglycemia) or you are allergic to any of the ingredients in Humulin R U-500.
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 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.Visual comparison of volume for illustrative purposes only.
†Please see Instructions for Use included with your pen or read the instructions online.
There are 2 different delivery options for Humulin R U-500:
U-500 KwikPen®
Using a U-500 KwikPen
U-500 Vial and BD™ U-500 Insulin Syringe
Using a U-500 Syringe and Vial
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).
SAFETY SUMMARY
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.
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.
INDICATION
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.
