What is Humulin^® R U-100?

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 it appears cloudy, thickened, or slightly colored, or
If solid particles are visible

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.

INDICATION AND IMPORTANT SAFETY INFORMATION

Indication for Humulin^® R U-500

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 in combination with other insulins, when used in an insulin pump, or in children.

IMPORTANT SAFETY INFORMATION FOR HUMULIN R U-500

What is the most important information I should know about 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 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.

Who should not take Humulin R U-500?

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.

What should I tell my healthcare provider before taking Humulin R U-500?

Tell your healthcare provider:

If you have liver, kidney, or heart problems or any other medical conditions.
If you are pregnant, plan to become pregnant, or are breast-feeding.
About all the medicines you take, including prescription (especially ones commonly called TZDs [thiazolidinediones]) and over the counter medicines, vitamins, and herbal supplements.

Before you start using Humulin R U-500, talk to your healthcare provider about low blood sugar and how to manage it.

How should I use Humulin R U-500?

Read the detailed Instructions for Use that come with your Humulin R U-500.

Take Humulin R U-500 exactly as your healthcare provider tells you to. Your healthcare provider should show you how much Humulin R U-500 to use and when to use it.

Know the dose of Humulin R U-500 you use. Do not change your dose unless your healthcare provider tells you to.

Check your insulin label each time you give your injection to make sure you are using the correct insulin.

Humulin R U-500 KwikPen: The U-500 KwikPen is specially made to dial and deliver doses of Humulin R U-500 insulin. Do not use any syringe to remove Humulin R U-500 insulin from your U-500 KwikPen. The markings on certain syringes will not measure your dose correctly. A severe overdose can happen, causing low blood sugar, which may put your life in danger.

Humulin R U-500 vial: There is a special U-500 insulin syringe to measure Humulin R U-500. Use only a U-500 insulin syringe to draw up and inject your Humulin R U-500. If you do not use the right syringe type, you may take the wrong dose of Humulin R U-500. This can cause you to have too low blood sugar (hypoglycemia) or too high blood sugar (hyperglycemia). Your healthcare provider should show you how to draw up Humulin R U-500.

Use Humulin R U-500 30 minutes before eating a meal.

Inject Humulin R U-500 under your skin (subcutaneously). Do not use Humulin R U-500 in an insulin pump or inject Humulin R U-500 into your vein (intravenously) or your muscle (intramuscularly).

Do not mix Humulin R U-500 with any other type of insulin or liquid medicine.

Change your injection site with each dose.

Check your blood sugar levels. Ask your healthcare provider what your blood sugar level should be and when you should check your blood sugar.

Your dose of Humulin R U-500 may need to change because of changes in your level of exercise, weight, or diet, or because of increased stress, illness, or other medicines you take.

Keep Humulin R U-500 and all medicines out of the reach of children.

What should I avoid while taking Humulin R U-500?

Do not drive or operate heavy machinery until you know how Humulin R U-500 affects you. Do not drink alcohol or use over-the-counter medicines that contain alcohol.

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

Humulin R U-500 can cause serious side effects that can lead to death, including:

Low blood sugar. Signs of low blood sugar may include dizziness or lightheadedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability or mood changes, or 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 (hypoglycemic) and you are unable to take sugar by mouth.
Severe allergic reaction. Get medical help right away if you have a rash over your whole body, have trouble breathing, a fast heartbeat, or sweating. These are signs of a severe allergic reaction.
Low potassium in your blood.
Heart failure. Taking certain diabetes pills called thiazolidinediones or “TZDs” with Humulin R U-500 may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure, it may get worse while you take TZDs with Humulin R U-500. Your healthcare provider should monitor you closely while you are taking TZDs with Humulin R U-500. Tell your healthcare provider if you have any new or worse symptoms of heart failure, including shortness of breath, swelling of your ankles or feet, or sudden weight gain.

Treatment with TZDs and Humulin R U-500 may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.

Get emergency medical help if you have:

severe low blood sugar needing hospitalization or emergency room care. Be sure to tell the hospital staff the units of Humulin R U-500 that your healthcare provider has prescribed for you.
trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, confusion.

The most common side effects of Humulin R U-500 include low blood sugar, allergic reactions including reactions at your injection site, skin thickening or pits at the injection site, itching, and rash.

These are not all of the possible side effects of Humulin R U-500. Call your doctor for medical advice about side effects. 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.

How should I store Humulin R U-500?

Keep away from heat and out of direct light. Do not freeze. Do not use Humulin R U-500 after the expiration date stamped on the label. Do not shake the vial.

Humulin R U-500 Vials: Store unopened vials of Humulin R U-500 in a refrigerator. Store opened (in-use) vials of Humulin R U-500 in the refrigerator or at room temperature for up to 40 days. Throw away any opened vial after 40 days of use, even if there is insulin left in the vial.

Humulin R U-500 KwikPen: Store unopened Humulin R U-500 KwikPens in a refrigerator. Store opened (in-use) Humulin R U-500 KwikPens at room temperature for up to 28 days. Do not refrigerate opened KwikPens. Throw away any opened KwikPen after 28 days of use, even if there is insulin left in the pen.

General Information about the safe and effective use of Humulin R U-500

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Humulin R U-500 for a condition for which it was not prescribed. Do not give Humulin R U-500 to other people, even if they have the same symptoms you have. It may harm them.

The Patient Information leaflet summarizes the most important information about Humulin R U-500. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Humulin R U-500 that is written for healthcare professionals. For more information go to www.humulin.com or call 1-800-545-5979.

Additional Information

Humulin R U-500 is available by prescription only.

Please see Full Prescribing Information

Please see Instructions for Use included with the pen.

Please see Instructions for Use included with the vial.

HI U500 CON ISI 27SEP2016