Two ways to take Humulin R U-500

Confirm your dose with your doctor

For a handy reference, please have your doctor write down your daily dosing schedule.

Using the U-500 KwikPen^®

Watch this video for step-by-step instructions.

About the U-500 KwikPen^®

You may notice that the U-500 KwikPen has some similarities and differences from what you’re used to:

Same size as other KwikPens
It dials and doses in 5-unit increments (standard U-100 pens dial and dose in single-unit increments)^*
It holds 1500 units per pen (standard U-100 pens only hold 300 units)
You'll receive 2 pens per pack
Distinctive aqua color

^*Please see the Instructions for Use included with your pen.

You’ll need to use a pen needle with your U-500 KwikPen. Your doctor may prescribe BD needles, which are recommended for use with your KwikPen. Pens and pen 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 any syringe. You may need a separate prescription for your pen needles.

Using a U-500 vial and syringe

Watch this video for step-by-step instructions.

About the U-500 Syringe

The U-500 syringe is made just for U-500 concentrated insulin:

With the U-500 syringe, you can draw up and take your prescribed dose of U-500 insulin in units. No extra math or conversion required.
Each line of the syringe measures 5 units of insulin
Each syringe doses up to 250 units of insulin
It's very important that your pharmacist gives you only the U-500 syringe for use with your U-500 insulin vial
To be sure that you have the U-500 syringe, look for the green needle cover and U-500 symbol

A few reminders for using the U-500 syringe at home:

Remember to inject U-500 approximately 30 minutes before eating a meal to reduce the risk of low blood sugar (hypoglycemia)
Learn how to use your syringe. Read the Instructions for Use (include hyperlink to IFU) for more information. If you have any additional questions, be sure to talk to your doctor.
Be sure to use only the U-500 syringe. Using other syringes could result in severe low blood sugar
Make sure you NEVER run out of U-500 syringes. Call your doctor or pharmacy if you’re close to running out

Note: The U-500 vial contains 10,000 units (20 mL at 500 units)

^*Please see the Instructions for Use included with your pen.

Dosing and storing Humulin R U-500

Where to inject U-500 insulin.Injection sites include the stomach area, buttocks, upper legs, and upper arms.

Injection Sites Whether you use the U-500 KwikPen or a U-500 vial and syringe, you’ll want to rotate the site each time you inject. Always be sure to wipe your skin with an alcohol swab and let the area dry first.
Confirm your dose with your doctor For a handy reference, please have your doctor write down your daily dosing schedule.
Administer Humulin R U-500 subcutaneously two or three times daily 30 minutes before a meal into the thigh, upper arm, abdomen, or buttocks.
Be sure to refer to the Instructions for Use that came with your U-500 KwikPen or vial . Of course, if you have any questions, please be sure to talk to your doctor.

How should I store Humulin R U-500? Keep Humulin R U-500 away from heat and direct sunlight and out of the reach of children. An unopened pen or vial should be kept in the refrigerator and discarded after the expiration date stamped on the label.
Storing the Humulin R U-500 KwikPen Once opened, do not refrigerate the Humulin R U-500 KwikPen. Throw away the pen you are using after 28 days, even if there is still insulin left.^*
Storing the Humulin R U-500 vial Do not use if it has been frozen. An unopened vial should be kept in the refrigerator until the expiration date. An open vial can be stored at room temperature and must be thrown away within 40 days of opening even if insulin remains.^**

^*Please see the Instructions for Use included with your pen. Do not freeze or use insulin that has been previously frozen. Do NOT withdraw insulin from the pen using any syringe.

^**Please see the Instructions for Use included with your vial. Do not freeze or use insulin that has been previously frozen.

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.

What are the potential side effects of Humulin R U-500?

Side effects of Humulin R U-500 may include low blood sugar that is severe and that can last a long time. Symptoms of low blood sugar may happen suddenly and may include:

sweating
dizziness
drowsiness
headache
or other symptoms

Severe low blood sugar can cause you to:

become confused
pass out (become unconscious)
have seizures or coma
and could cause death

Talk with your doctor about how to tell if you have low blood sugar and what to do if this happens while taking Humulin R U-500. Follow your doctor's instructions for treating your low blood sugar. Tell your doctor if low blood sugar from insulin use is a problem for you. Your doctor may need to change the amount of Humulin R U-500 that you take, or change your meal plans or your exercise program to help you avoid low blood sugar.

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:

severe low blood sugar
trouble breathing
shortness of breath
fast heartbeat
swelling of your face, tongue or throat
extreme drowsiness
dizziness
or confusion

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.

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.