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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.

PURPOSE and SAFETY SUMMARY

Important Facts About Humulin® (HUE-mu-lin) R U-500. It is also known as insulin human injection (500 units/mL).


Humulin R U-500 is a prescription insulin used in adults and children who need more than 200 units of insulin a day to control high blood sugar for their diabetes mellitus. It is more concentrated than standard insulin. It has 5 times as much insulin in each mL as standard insulin.


It is not known if Humulin R U-500 is safe and effective when used with other insulins, when used in an insulin pump, or in children. There were no studies done in children, so your doctor will give you special instructions for use in children.

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 or muscle.


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

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.


HM CON BS 15NOV2019

Please see accompanying Full Prescribing Information and Patient Information.


Please see Instructions for Use included with the pen.


Please see Instructions for Use included with the vial.

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