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Get a hold of the chance for fewer daily injections.*

Study conducted with U-100 insulin syringes and Humulin R U-500 vials.

Proven to lower A1C with the potential for fewer daily injections.*

Learn more about U-500

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.†

*Compared to U-100 insulin. Most patients will require 2 or 3 daily injections of U-500.1

†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.

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

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.

Select Important Safety Information for Humulin R U-500
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 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.

Pay as little as $25* for your prescription

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Governmental beneficiaries excluded, terms and conditions apply.

*For eligible, commercially insured patients. Patient's responsibility may exceed $25 depending on the pharmacy provider.

Click here to see Eligibility Requirements.

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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.

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Humulin® and KwikPen® are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

Humulin® R U-500 is available by prescription only.

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