Humulin R U-500

HUMULIN R U-500 is a concentrated human insulin indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus requiring more than 200 units of insulin per day.

• Adhere to administration instructions to reduce the risk of dosing errors.
• HUMULIN R U-500 is available as a single-patient-use KwikPen or multiple-dose vial. Patients using the vial must be prescribed the U-500 insulin syringe to avoid medication 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 30 minutes before a meal into the thigh, upper arm, abdomen, or buttocks. Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis.
• Do NOT mix HUMULIN R U-500 with other insulins.
• Do NOT administer HUMULIN R U-500 intravenously
• Do NOT perform dose conversion when using the HUMULIN R U-500 KwikPen. The dose window of the HUMULIN R U-500 KwikPen shows the number of units of HUMULIN R U-500 to be injected.
• Do NOT transfer HUMULIN R U-500 from the HUMULIN R U-500 KwikPen into any syringe.
• Do NOT perform dose conversion when using a U-500 insulin syringe. Use only a U-500 insulin syringe with the HUMULIN R U-500 vial.

Injection: 500 units/mL (U-500) clear, colorless solution available as:

• 3 mL single-patient-use HUMULIN R U-500 KwikPen prefilled pen (containing 1,500 units of insulin)
• 20 mL multiple-dose vial (containing 10,000 units of insulin)

Available data from published studies over decades have not established an association with human insulin use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes (

The estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a HbA1c >7% and has been reported to be as high as 20-25% in women with a HbA1c >10%. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

• 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.
• Never share a HUMULIN R U-500 KwikPen or U-500 insulin syringe between patients, even if the needle is changed.
• Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen:
  Make changes to a patient's insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) under close medical supervision with increased frequency of blood glucose monitoring.
• Hypoglycemia:
  May be life-threatening. Increase monitoring with changes to: insulin dosage, co-administered glucose lowering medications, meal pattern, physical activity; and in patients with renal impairment or hepatic impairment or hypoglycemia unawareness.
• Hypersensitivity Reactions:
  Severe, life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue HUMULIN R U-500, monitor, and treat if indicated.
• 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):
  Observe for signs and symptoms of heart failure; consider dosage reduction or discontinuation if heart failure occurs.