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U-500 KwikPen

The U-500 KwikPen

See video of how it's designed for high-dose insulin needs1

1. Data on file, Lilly USA, LLC. HM20151210a.

Efficacy Results

Review U-500 trial results in patients whose A1C was uncontrolled2

2. Hood RC et al. Endocr Pract. 2015;21(7):782-793.

Dosing and Titrating U-500

Review an algorithm for starting and titrating U-5002

2. Hood RC et al. Endocr Pract. 2015;21(7):782-793.

Rx Savings for Patients

Eligible patients* pay as little as $25 per prescription with U-500 Savings Card

What Your Peers Say

See what leading endocrinologists have to say about U-500

References

  1. Data on file, Lilly USA, LLC. HM20151210a.
  2. 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.

Indication for Humulin R U-500

  • Humulin R U-500 is a man-made 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 (500 units/mL) in 1 mL as standard insulin (100 units/mL).
  • There are no studies of Humulin R U-500 in children.

Indication for Humulin® R U-500

  • Humulin R U-500 is a concentrated human insulin indicated to improve glycemic control in adults and children with diabetes mellitus requiring more than 200 units of insulin per day.
  • Limitation of Use: The safety and efficacy of Humulin R U-500 used in combination with other insulins has not been determined. The safety and efficacy of Humulin R U-500 delivered by continuous subcutaneous infusion has not been determined.
VIEW ALL > VIEW ALL >

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.
  • Humulin R U-500 should not be mixed with other insulins.
  • Do not use Humulin R U-500 in an insulin pump.
  • You should never share needles or syringes with other people, even if the needle is changed. You may give other people a serious infection or get a serious infection from them.
  • DO NOT withdraw insulin from the Humulin R U-500 KwikPen using a syringe. The markings on the syringe will not measure the dose correctly. It could result in an overdose causing severe low blood sugar putting your life in danger.
  • Make sure you know the strength, dose in number of units of insulin, and type of insulin prescribed for you. Do not change the strength, dose, or type of insulin you use unless told to do so by your healthcare provider.
  • It is important that you take the right dose of Humulin R U-500. Taking too much can cause life-threatening low blood sugar (hypoglycemia) or death. Taking too little can cause high blood sugar (hyperglycemia).
    • Treat mild low blood sugar (hypoglycemia) by drinking or eating something sugary right away.
    • Your healthcare provider may prescribe a glucagon emergency kit so that others can give you an injection if your blood sugar becomes too low and you are unable to take sugar by mouth.
  • Always check the insulin label to be sure that you are using the correct insulin, including the correct type and strength.
  • The Humulin R U-500 KwikPen contains 3 mL and is aqua colored.
  • The Humulin R U-500 vial contains 20 mL and is marked with a band of diagonal brown stripes. “U-500” is also highlighted in red on the label.

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.

How should I take Humulin R U-500?

  • Take Humulin R U-500 exactly as prescribed. Your healthcare provider should show you how to prepare and inject Humulin R U-500 before you start taking it.
  • Check the label carefully before each injection to make sure you have the right type and strength of insulin prescribed.
  • Humulin R U-500 should look clear and colorless. Do not use Humulin R U-500 if it does not look clear, colorless, or has particles in it. Do not use Humulin R U-500 after the printed expiration date.
  • Follow your healthcare provider’s instructions about how often you should check your blood sugar level.
  • Humulin R U-500 starts working about 30 minutes after injection. The effects of Humulin R U-500 may last up to 24 hours. You should eat a meal 30 minutes after injecting Humulin R U-500.
  • Inject Humulin R U-500 under your skin (subcutaneously). Never inject into a vein or muscle. Change injection sites with each dose.
  • Do not re-use needles. Always use a new needle for each injection. Re-use of needles can result in infection.
  • Your healthcare provider should regularly check your diabetes with blood tests, including blood sugar levels and A1C.
  • To measure Humulin R U-500 using a vial and syringe, you should use either a U-100 insulin syringe or volumetric (tuberculin) syringe as instructed. Your healthcare provider should explain how to use the syringe to give the prescribed dose with the markings on the syringe. 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 blood sugar that is too low or blood sugar that is too high.
  • Use the Humulin R U-500 KwikPen as instructed. Your healthcare provider should explain how to use the U-500 KwikPen to dial and inject the prescribed dose.
  • Make sure you dispose of your used needles and syringes as your healthcare provider instructs.
  • If you are hospitalized or go to an emergency room, make sure to tell the hospital staff the dose of Humulin R U-500 in units of insulin that your healthcare provider has prescribed for you.

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

  • Humulin R U-500 can cause 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 to your healthcare provider 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 healthcare provider’s instructions for treating your low blood sugar. Tell your healthcare provider if low blood sugar is a problem for you. Your healthcare provider 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.
  • If you forget to take your dose of Humulin R U-500, your blood sugar may go too high. Contact your healthcare provider if you miss a dose.
  • Get medical help right away if you have any of these symptoms of a severe allergic reaction: rash all over your body, shortness of breath, trouble breathing (wheezing), fast heartbeat, sweating, feeling faint.
  • You may develop low potassium (hypokalemia). Your healthcare provider may do a blood test to check your potassium level.
  • Additional side effects of Humulin R U-500 include:
    • Skin thickening or pits at the injection site (lipodystrophy). Do not inject insulin into this type of skin.
    • Injection site reactions (local allergic reaction). Symptoms may include: redness, swelling, and itching at the injection site. Tell your healthcare provider if you have skin reactions that do not go away.
    • Weight gain.
  • Serious side effects can include:
    • Swelling of your hands and feet.
    • Heart failure when taking certain pills called thiazolidinediones or “TZDs” with Humulin R U-500. This may occur in some people even if they have not had heart problems before. Tell your healthcare provider if you have shortness of breath, swelling of your ankles or feet, or sudden weight gain, which may be symptoms of heart failure. Your healthcare provider may need to adjust or stop your treatment with TZDs or Humulin R U-500.
  • Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of Humulin R U-500. For more information, ask your healthcare provider or pharmacist.
  • Call your healthcare provider for medical advice about side effects.
  • You are encouraged to report negative side effects of prescription drugs to the Food and Drug Administration (FDA). Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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

  • Drinking alcohol may affect your blood sugar when you take Humulin R U-500.
  • You may have trouble paying attention or reacting if you have low blood sugar. Be careful when you drive a car or operate machinery. Ask your healthcare provider if it is all right for you to drive if you have low blood sugar or decreased or no warning signs of low blood sugar.

How should I store Humulin R U-500?

  • Protect from heat and light. Do not freeze. Do not use Humulin R U-500 after the expiration date stamped on the label
  • Humulin R U-500 Vials: Unopened vials of Humulin R U-500 should be kept in a refrigerator. Opened (in-use) vials of Humulin R U-500 should be kept in the refrigerator or at room temperature and used within 40 days of opening. Throw away any opened vial after 40 days of use, even if there is insulin left in the vial.
  • Humulin R U-500 KwikPen: Unopened Humulin R U-500 KwikPens should be kept in a refrigerator. Opened (in-use) Humulin R U-500 KwikPens should be kept at room temperature and used within 28 days of opening. Do not refrigerate opened KwikPens. Throw away any opened KwikPen after 28 days of use, even if there is insulin left in the pen.

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

Humulin R U-500 is available by prescription only.

For additional information, talk to your healthcare provider and please click to access Full Prescribing Information, Patient Information, and Instructions for Use for vial and pen.

HI U500 CON ISI 12JAN2016

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

Important Safety Information for Humulin R U-500

Contraindications

  • Humulin R U-500 is contraindicated during episodes of hypoglycemia and in patients hypersensitive to Humulin R U-500 or any of its excipients.

Warnings and Precautions

  • Dosing Errors: Extreme caution must be observed in measuring the dose of Humulin R U-500 because inadvertent overdose may result in serious adverse reaction or life-threatening hypoglycemia.

Medication errors associated with the Humulin R U-500 vial have occurred and resulted in patients experiencing hyperglycemia, hypoglycemia, or death.

Dispensing

  • Instruct patients to always inspect insulin vials to confirm that the correct insulin is dispensed including the correct brand and concentration.
  • The Humulin R U-500 vial, which contains 20 mL, has a band of diagonal brown stripes. “U-500” is also highlighted in red on the Humulin R U-500 vial label.

Prescribing

  • When using a U-100 insulin syringe or tuberculin syringe, express the prescribed dose of Humulin R U-500 in units of insulin along with the appropriate corresponding markings on the syringe the patient is using.

Administration

  • Instruct patients to always check the insulin label before each injection.
  • A majority of the medication errors with Humulin R U-500 vial occurred due to dosing confusion when the dose was prescribed in units or volume corresponding to a U-100 syringe or tuberculin syringe markings, respectively, or the prescribed dose was administered without recognizing that the markings on the syringe used do not directly correspond to the U-500 dose. Instructions for use should always be read and followed before use.
  • Instruct the patient to inform hospital or emergency department staff of the dose of Humulin R U-500 prescribed.
  • A conversion chart should always be used when administering doses from the Humulin R U-500 vial with U-100 insulin syringes or 1 mL tuberculin syringes.

If using the Humulin R U-500 KwikPen, patients should be counseled to dial and dose the prescribed number of units of insulin (NO dose conversion is required).

DO NOT transfer Humulin R U-500 from the Humulin R U-500 KwikPen into a syringe for administration. Overdose and severe hypoglycemia can occur.

  • Patients Should Never Share KwikPens, Needles, or Syringes with Other People, even if the needle is changed. Sharing poses a risk for transmission of blood-borne pathogens.
  • Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Changes in insulin, manufacturer, type, or method of administration should be made cautiously and only under medical supervision and the frequency of blood glucose monitoring should be increased.
  • Hypoglycemia: Hypoglycemia is the most common adverse reaction associated with insulin, including Humulin R U-500. Severe hypoglycemia can cause seizures, may be life-threatening, or cause death. Severe hypoglycemia may develop as long as 18 to 24 hours after an injection of Humulin R U-500. Hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important, such as driving or operating other machinery.

Hypoglycemia can happen suddenly and symptoms may differ in each individual and change over time in the same individual.

Early warning symptoms of hypoglycemia may be less pronounced in patients with longstanding diabetes, in patients with diabetic nerve disease, in patients using medications that block the sympathetic nervous system, or in patients who experience recurrent hypoglycemia.

The timing of hypoglycemia usually reflects the time-action profile of the administered insulin formulation. As with all insulin preparations, the glucose lowering effect time course of Humulin R U-500 may vary in different individuals or at different times in the same individual and depends on many conditions.

Patients and caregivers must be educated to recognize and manage hypoglycemia. Self-monitoring of blood glucose plays an essential role in the prevention and management of hypoglycemia. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended.

  • Hypersensitivity and Allergic Reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including Humulin R U-500. If hypersensitivity reactions occur, discontinue Humulin R U-500; treat per standard of care and monitor until symptoms and signs resolve.
  • Hypokalemia: Insulin use can lead to hypokalemia that left untreated may cause respiratory paralysis, ventricular arrhythmia, and death. Use caution in patients who may be at risk for hypokalemia (e.g., patients using potassium-lowering medications, patients taking medications sensitive to serum potassium concentrations).
  • Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma Agonists: Thiazolidinediones (TZDs), which are PPAR-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure. Observe patients for signs and symptoms of heart failure. If heart failure develops, it should be managed according to current standards of care, and discontinuation or dose reduction of the PPAR-gamma agonist must be considered.

Adverse Reactions

  • Adverse reactions include hypoglycemia, allergic reactions, lipodystrophy, injection site reactions, weight gain, peripheral edema, and immunogenicity.

Drug Interactions

  • Some medications may alter glucose metabolism and may necessitate insulin dose adjustment. Signs of hypoglycemia may be reduced or absent in patients taking antiadrenergic drugs. Particularly close monitoring may be required.

Use in Specific Populations

  • Pregnancy Category B: While there are no adequate and well-controlled studies in pregnant women, evidence from published literature suggests that good glycemic control in patients with diabetes during pregnancy provides significant maternal and fetal benefits.
  • Pediatric Use: There are no well-controlled studies of use of Humulin R U-500 in children. Standard precautions as applied to use of Humulin R U-500 in adults are appropriate for use in children.
  • Geriatric Use: There are no well-controlled studies of use of Humulin R U-500 in geriatric patients. In elderly patients with diabetes, the initial dosing, dose increments, and maintenance dosage should be conservative to avoid hypoglycemia.
  • Renal or Hepatic Impairment: Frequent glucose monitoring and insulin dose reduction may be required in patients with renal or hepatic impairment.

Dosage and Administration

  • Prescribe Humulin R U-500 ONLY to patients who require more than 200 units of insulin per day.
  • Adhere to administration instructions to reduce the risk of dosing errors.
  • Individualize dose of Humulin R U-500 based on metabolic needs, blood glucose monitoring results, and glycemic control goal.
  • Administer Humulin R U-500 subcutaneously two or three times daily approximately 30 minutes before a meal. Rotate injection sites to reduce the risk of lipodystrophy.
  • Do NOT mix Humulin R U-500 with other insulins.
  • Do NOT administer Humulin R U-500 intravenously or intramuscularly.
  • Do NOT perform dose conversion when using the Humulin R U-500 KwikPen. The dose window of the KwikPen shows the number of units of Humulin R U-500 to be injected and NO dose conversion is required.
  • Do NOT transfer Humulin R U-500 from the KwikPen into a syringe.
  • CONVERT the prescribed dose of Humulin R U-500 into a “unit” or “volume” mark when using the vial and a U-100 or a tuberculin syringe device to deliver Humulin R U-500.

Storage

  • Protect from heat and light. Do not freeze. Do not use Humulin R U-500 after the expiration date stamped on the label.
  • Humulin R U-500 Vials: Unopened vials of Humulin R U-500 should be kept in a refrigerator. Opened (in-use) vials of Humulin R U-500 should be kept in the refrigerator or at room temperature and used within 40 days of opening. Throw away any opened vial after 40 days of use, even if there is insulin left in the vial.
  • Humulin R U-500 KwikPen: Unopened Humulin R U-500 KwikPens should be kept in a refrigerator. Opened (in-use) Humulin R U-500 KwikPens should be kept at room temperature and used within 28 days of opening. Do not refrigerate opened KwikPens. Throw away any opened KwikPen after 28 days of use, even if there is insulin left in the pen.

For more safety information, please click to access Patient Information, Full Prescribing Information, and Instructions for Use for the pen and vial.

HI U500 HCP ISI 04JAN2016

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.

VIEW ALL > VIEW ALL >
Tap to view Important Safety Information

Indication for Humulin R U-500

  • Humulin R U-500 is a man-made 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 (500 units/mL) in 1 mL as standard insulin (100 units/mL).
  • There are no studies of Humulin R U-500 in children.
Tap to view Important Safety Information

Indication for Humulin® R U-500

  • Humulin R U-500 is a concentrated human insulin indicated to improve glycemic control in adults and children with diabetes mellitus requiring more than 200 units of insulin per day.
  • Limitation of Use: The safety and efficacy of Humulin R U-500 used in combination with other insulins has not been determined. The safety and efficacy of Humulin R U-500 delivered by continuous subcutaneous infusion has not been determined.

PP-HM-US-0283  03/2016.  ©Lilly USA, LLC 2016. All rights reserved. This site is intended for US residents ages 18 and over. Models used for illustrative purposes only. Not actual patients or healthcare providers.

PP-HM-US-0283  03/2016.  ©Lilly USA, LLC 2016. All rights reserved. This site is intended for US healthcare professionals only. Models used for illustrative purposes only. Not actual patients.

For Healthcare Professionals

The information contained in Humulin.com for healthcare professionals is technical in nature and intended for healthcare professionals in the United States only. If you are a US healthcare professional, click the “Continue” button below.

Yes, I am a US healthcare professional and would like to continue.

You are now leaving the Humulin.com website

The link you clicked on will take you to a site maintained by a third party, which is solely responsible for its content. Lilly USA, LLC, does not control, influence, or endorse this site, and the opinions, claims, or comments expressed on this site should not be attributed to Lilly USA, LLC. Lilly USA, LLC, is not responsible for the privacy policy of any third-party websites. We encourage you to read the privacy policy of every website you visit.

Click "Continue" to proceed or "Cancel" to return to Humulin.com