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Take charge with Humulin R U-500 (insulin human injection), proven to lower A1C with the potential for fewer 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 standard U-100 insulin. Most patients will require 2-3 daily injections of U-500.

†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.

Pay as little as $25* for your prescription

Download savings card

*For eligible, commercially insured patients. Patient's responsibility may exceed $25 depending on the pharmacy provider. Click here to see Eligibility Requirements.

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

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Eligibility Requirements

By using the Humulin R U-500 Savings Card ("Card"), you attest that you meet the eligibility criteria and will comply with the Terms and Conditions described below:

Offer void where prohibited by law. This offer is invalid for patients without commercial insurance coverage or those whose prescription claims for Humulin R U-500 are eligible to be reimbursed, in whole or in part, by any governmental program, including, without limitation, Medicaid, Medicare, Medicare Part D, Medigap, DOD, VA, TRICARE/CHAMPUS, or any State Patient or Pharmaceutical Assistance Program. If you live in Massachusetts, the Card expires on the earlier of: (i) the expiration date of this Card (December 31, 2019); (ii) the date an AB rated generic equivalent becomes available; or (iii) June 30, 2019, absent a change in Massachusetts state law. If you live in California, the card expires on the earlier of: (i) the expiration date of this card (12/31/2019) or (ii) the date an FDA approved therapeutic equivalent for Humulin R U-500 or over the counter product withthe same active ingredients becomes available. Available only in the US and Puerto Rico for residents of the US and Puerto Rico. By accepting this offer, you agree that if you are required to do so under the terms of your insurance coverage for this prescription or are otherwise required to do so by law, you should notify your insurance carrier of your redemption of this Card. This offer is not valid with any other program, discount, incentive, or similar offer involving Humulin R U-500. It is prohibited for any person to sell, purchase or trade; or to offer to sell, purchase or trade, or to counterfeit this Card.This offer may be terminated, rescinded, revoked, or amended by Lilly USA, LLC at any time without notice. This Card is not health insurance. This Card expires on 12/31/2019.

For government-sponsored insurance programs:

While you are not eligible for the savings card, your co-pay or out-of-pocket costs for Humulin R U-500 KwikPen will depend on your insurance plan. Keep in mind that the cost of Humulin R U-500 KwikPen is determined by several groups/organizations, including wholesalers and pharmacies.