A dedicated device1,2,3 for the unique dosing needs of high-dose patients (>200 units per day)
- Data on file, Lilly USA, LLC. HM20151210d.
- Data on file, Lilly USA, LLC. HM20151210a.
- Data on file, Lilly USA, LLC. HM20151210e.
Select Safety Information for Humulin R U-500
- DO NOT transfer Humulin R U-500 from the KwikPen into any syringe for administration. Overdose and severe hypoglycemia can occur.
- Never share a KwikPen or U-500 syringe between patients, even if the needle is changed, to avoid risk of transmission of blood-borne pathogens.
When prescribing for your patients…
For a U-500 KwikPen prescription, be sure to:
- Specify the full product name: Humulin R U-500 KwikPen
- Indicate the administration schedule as TID dosing or BID dosing
- Record the required number of units of U-500 insulin per dose and specify at which meals the doses are to be taken to ensure the appropriate supply is dispensed at the pharmacy.
- Prescribe pen needles with the KwikPen. BD pen needles recommended.
- Write “Do Not Substitute” on the prescription
For a U-500 syringe and vial prescriptions, be sure to:
- Specify the full product name: Humulin R U-500 vial
- Indicate the administration schedule as TID dosing or BID dosing
- Record the required number of units of U-500 insulin per dose and specify at which meals the doses are to be taken to ensure the appropriate supply is dispensed at the pharmacy.
- Prescribe BD U-500 syringes with the vial.
- Write or specify “Do Not Substitute” on the prescription
Provide this important information to your patients:
- Explain how many times a day the patient should inject and the dose at each injection
- Advise patients to inject U-500 approximately 30 minutes before eating a meal to reduce the risk of hypoglycemia
- Demonstrate how to dial the U-500 KwikPen or draw up the prescribed dose with the U-500 syringe to deliver the insulin dose
- For patients using the U-500 KwikPen, instruct patients not to withdraw insulin from the U-500 KwikPen using any syringe because overdose and severe hypoglycemia may occur
- Patients should call their pharmacy to check availability. Some pharmacies may not stock U-500 insulin or U-500 syringes, but it should be available within 24 to 48 hours
- Tell your eligible patients about the U-500 Savings Card to help with the cost of their prescription
Here's how to help anyone who brings a U-500 prescription to your pharmacy
NDC 0002-8824-27
NDC 0002-8501-01
*Example prescription. The prescription details should be individualized and determined, by the prescriber, in accordance with the needs of the patient.
For patients new to Humulin R U-500:
- New dosing regimen: High dose* insulin patients may welcome a regimen of 2 or 3 injections a day† with the U-500 KwikPen.
- Patient education: The patient needs to understand how this insulin is similar or different compared to insulins they used in the past
The makers of U-500 want you to be ready to counsel these patients, tell them what they need to know, and still have time to help all the other people you see each day. We hope the enclosed tools can make it a little easier for you to inform, educate, and support these high-dose insulin patients.
If you have any questions, please don’t hesitate to call The Lilly Answers Center at 1-800-LillyRx (1-800-545-5979).
*>200 units of insulin per day
†Compared to U-100 insulin therapy. Most patients will require 2 or 3 daily injections of U-500.
Select Important Safety Information
Hyperglycemia or Hypoglycemia With Changes in Insulin Regimen
- Changes in insulin strength, manufacturer, type, injection site, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Any changes in insulin regimen should be made cautiously and only under close medical supervision, and the frequency of blood glucose monitoring should be increased. Due to reports of hypoglycemia and hyperglycemia, advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to the unaffected areas and to closely monitor blood glucose. For patients with type 2 diabetes, dosage adjustments of concomitant anti-diabetic products may be needed.
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.
- Increase monitoring with changes to insulin dosage, co-administered glucose-lowering medications, meal patterns, physical activity, and in patients with renal or hepatic impairment or hypoglycemia unawareness. To minimize risk of hypoglycemia, do not administer Humulin R U-500 intravenously, intramuscularly, or in an insulin pump or dilute or mix with other products, including other insulins.
- 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.
Please click to access Important Safety Information and Full Prescribing Information for Humulin R U-500.
Help patients get started with U-500
Although each patient who is prescribed U-500 has injected insulin previously, you still play an important role in helping them to understand their medication and to get off to a good start.
Here is a checklist for how you can help:
Double-check their daily insulin regimen
☐ Confirm whether U-500 is replacing other insulins. If it’s not clear from the prescription, check with the doctor’s office
☐ Confirm dose in units with patient
☐ Confirm timing of dose with patient. U-500 is taken approximately 30 minutes before a meal. You may need to confirm dosing and how many times a day the patient is expected to inject
Demonstrate the device
☐ Confirm the patient knows how to measure the dose prescribed, either by dialing the KwikPen or by drawing insulin from the vial. For example, if you prescribe 100 units of U-500 using the BD U-500 syringe, a patient will draw the syringe to 100 units to measure the dose prescribed
☐ Ensure the patient has a prescription for pen needles or a BD™ U-500 Insulin Syringe. The U-500 KwikPen is designed to be used with all versions of BD pen needles. The U-500 vial should be used only with the U-500 insulin syringe
☐ Remind patients not to withdraw insulin from the U-500 KwikPen using a syringe because overdose and severe hypoglycemia may occur
Please click to access Important Safety Information and Full Prescribing Information for Humulin R U-500.
Three ways for your patients to save on high-dose** insulin
**>200 units of insulin per day
1. Lowest branded co-pay for most patients
88%* of commercially insured patients have unrestricted access† to Humulin R U-500 at the lowest branded co-pay.
* Represents Commercial formulary data. Access was 84% for the Humulin R U-500 vial and 80% for the Humulin R U-500 KwikPen. Calculation determined through total commercial lives in the USA as of July 2018. Plan types: Employer, HMO, Medical Group, Other Insurers, PBM Offering, POS, PPO. Includes plans/patients with appropriate restrictions. Calculation does not include uninsured lives.
†Without prior authorization.
Source: Managed Markets Insight & Technology (MMIT), LLC as of 07/2018, and is subject to change without notice by a health plan or state. Please contact the plan or state for the most current information.
2. With the U-500 Savings Card, eligible patients with commercial insurance can pay as little as $25 per prescription‡
‡Eligible commercially insured patients. For full terms and conditions please click here .
3. One co-pay§ for insulin monotherapy
U-500 can be administered as insulin monotherapy, so transitioning from an analog basal/bolus regimen will lower the number of prescription co-pays each month.
§ As compared with basal-bolus therapy. Assumes Humulin R U-500 KwikPen insulin monotherapy
- Underlying enrollment values developed by Managed Markets Insight & Technology (MMIT), LLC using a combination of third party and public sources as well as a proprietary allocation methodology. The values may not be representative of an individual physician’s patient population.
- This information is not a guarantee of coverage or payment (partial or full). Actual benefits are determined by each plan administrator in accordance with its respective policy and procedures.
- Employers and employer groups may also offer additional benefit designs which may be different than described.
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.
Limitations of Use: The safety and efficacy of Humulin R U-500 used in combination with other insulins, or when delivered by continuous subcutaneous infusion, has not been determined.
IMPORTANT SAFETY INFORMATION
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.
Hyperglycemia, Hypoglycemia, Or Death Due To Dosing Errors With Vial Presentation
- Can be life-threatening. Overdose has occurred as a result of dispensing, prescribing, or administration errors. Attention to details at all levels is required to prevent these errors.
- Patients should be prescribed U-500 syringes for use with Humulin R U-500 vials. Do not use any other type of syringe to administer Humulin R U-500.
- If using the Humulin R U-500 KwikPen®, patients should be counseled to dial and dose the prescribed number of units of insulin.
- Do NOT perform dose conversion when using the Humulin R U-500 KwikPen or U-500 insulin syringe.
DO NOT transfer Humulin R U-500 from the KwikPen into any syringe for administration. Overdose and severe hypoglycemia can occur.
Never share a KwikPen or U-500 syringe between patients, even if the needle is changed, to avoid risk of transmission of blood-borne pathogens.
Hyperglycemia Or Hypoglycemia With Changes In Insulin Regimen
- Changes in insulin strength, manufacturer, type, injection site, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Any changes in insulin regimen should be made cautiously and only under close medical supervision, and the frequency of blood glucose monitoring should be increased. Due to reports of hypoglycemia and hyperglycemia, advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to the unaffected areas and to closely monitor blood glucose. For patients with type 2 diabetes, dosage adjustments of concomitant anti-diabetic products may be needed.
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.
- Increase monitoring with changes to insulin dosage, co-administered glucose-lowering medications, meal patterns, physical activity, and in patients with renal or hepatic impairment or hypoglycemia unawareness. To minimize risk of hypoglycemia, do not administer Humulin R U-500 intravenously, intramuscularly, or in an insulin pump or dilute or mix with other products, including other insulins.
- 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
- May be life-threatening. Monitor potassium levels in patients at risk for hypokalemia and treat if indicated.
Fluid Retention And Heart Failure With Concomitant Use Of Thiazolidinediones (TZDs)
- Thiazolidinediones (TZDs) can cause dose-related fluid retention, particularly when used in combination with insulin. Observe for signs and symptoms of heart failure and consider reduction or discontinuation if heart failure occurs.
Adverse Reactions
- Other adverse reactions include allergic reactions, lipodystrophy, injection site reactions, pruritus, and rash.
Drug Interactions
- Some medications may alter glucose metabolism and may necessitate insulin dose adjustment.
- Particularly close glucose monitoring may be required when Humulin R U-500 is co-administered with drugs such as antiadrenergic agents that can alter the signs of hypoglycemia.
HM U500 HCP ISI 15NOV2019
For more information, see Prescribing Information , including Patient Information and Instructions for Use for the KwikPen and vial .