Humulin R U-500

HUMULIN R U-500 — insulin human injection, solution
HUMULIN R U-500 KWIKPEN — insulin human injection, solution
Eli Lilly and Company

1 INDICATIONS AND USAGE

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.

1.1 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.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

  • Prescribe HUMULIN R U-500 ONLY to patients who require more than 200 units of insulin per day.
  • 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.
  • Instruct patients using the vial presentation to use only a U-500 insulin syringe and on how to correctly draw the prescribed dose of HUMULIN R U-500 into the U-500 insulin syringe. Confirm that the patient has understood these instructions and can correctly draw the prescribed dose of HUMULIN R U-500 with their syringe [see Dosage and Administration (2.4) and Warnings and Precautions (5.1)].
  • Instruct patients to always check the insulin label before administration to confirm the correct insulin product is being used [see Warnings and Precautions (5.1)].
  • Inspect HUMULIN R U-500 visually for particulate matter and discoloration. Only use HUMULIN R U-500 if the solution appears clear and colorless.
  • Instruct patients to inject HUMULIN R U-500 subcutaneously into the thigh, upper arm, abdomen, or buttocks.
  • Rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis [see Warnings and Precautions (5.3) and Adverse Reactions (6)].
  • During changes to a patient’s insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions (5.3)].
  • Use HUMULIN R U-500 KwikPen with caution in patients with visual impairment that may rely on audible clicks to dial their dose.
  • DO NOT administer HUMULIN R U-500 intravenously.
  • DO NOT dilute or mix HUMULIN R U-500 with any other insulin products or solutions.

2.2 Dosing Instructions

  • Instruct patients to inject HUMULIN R U-500 subcutaneously usually two or three times daily approximately 30 minutes before meals.
  • Individualize and titrate the dosage of HUMULIN R U-500 based on the patient’s metabolic needs, blood glucose monitoring results, and glycemic control goal.
  • Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (i.e., macronutrient content or timing of food intake), changes in renal or hepatic function, changes in medications or during acute illness to minimize the risk of hypoglycemia or hyperglycemia [see Warnings and Precautions (5.3)].

2.3 Delivery of HUMULIN R U-500 Using the HUMULIN R U-500 Disposable Prefilled KwikPen Device

  • The HUMULIN R U-500 KwikPen dials in 5 unit increments and delivers a maximum dose of 300 units per injection.
  • 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 and NO dose conversion is required.
  • DO NOT transfer HUMULIN R U-500 from the HUMULIN R U-500 KwikPen into any syringe for administration as overdose and severe hypoglycemia can occur [see Warnings and Precautions (5.4)].

2.4 Delivery of HUMULIN R U-500 Using the Vial Presentation and the U-500 Insulin Syringe

  • DO NOT perform dose conversion when using a U-500 insulin syringe. The markings on the U-500 insulin syringe show the number of units of HUMULIN R U-500 to be injected.
  • Each marking on the syringe represents 5 units of insulin.
  • Prescribe patients a U-500 insulin syringe to administer HUMULIN R U-500 from the vial to avoid administration errors. DO NOT use any other type of syringe [see Warnings and Precautions (5.1)].

3 DOSAGE FORMS AND STRENGTHS

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)

4 CONTRAINDICATIONS

HUMULIN R U-500 is contraindicated:

  • During episodes of hypoglycemia [see Warnings and Precautions (5.4)]
  • In patients who are hypersensitive to HUMULIN R U-500 or any of its excipients [see Warnings and Precautions (5.5)]

5 WARNINGS AND PRECAUTIONS

5.1 Hyperglycemia, Hypoglycemia or Death Due to Dosing Errors with the Vial Presentation

Medication errors associated with the HUMULIN R U-500 vial presentation resulting in patients experiencing hyperglycemia, hypoglycemia or death have been reported. The majority of errors occurred due to errors in dispensing, prescribing or administration. Attention to details at all levels may prevent these errors.

Dispensing Errors

Instruct patients to always inspect insulin vials to confirm that the correct insulin is dispensed including the correct insulin brand and concentration.

The HUMULIN R U-500 vial, which contains 20 mL, has a band of aqua coloring, a 500 units/mL concentration statement consisting of white lettering on a green rectangular background, and a green “U-500” statement prominently displayed next to the trade name. Additionally, the vial has a green flip top and a red warning on the front panel describing the highly concentrated dose and a statement advising use with only U-500 insulin syringes.

Prescribing Errors

Dosing errors have occurred when the HUMULIN R U-500 dose was administered with syringes other than a U-500 insulin syringe. Patients should be prescribed U-500 syringes for use with the HUMULIN R U-500 vials. The prescribed dose of HUMULIN R U-500 should always be expressed in units of insulin [see Dosage and Administration (2.4)].

Administration Errors

Instruct patients to always check the insulin label before each injection.

Use only a U-500 insulin syringe with HUMULIN R U-500 to avoid administration errors. Do not use any other type of syringe to administer Humulin R U-500. Adhere to administration instructions [see Dosage and Administration (2.1, 2.4)].

Instruct the patient to inform hospital or emergency department staff of the dose of HUMULIN R U-500 prescribed, in the event of a future hospitalization or visit to the emergency department.

5.2 Never Share a HUMULIN R U-500 KwikPen or U-500 Insulin Syringe Between Patients

HUMULIN R U-500 KwikPens should never be shared between patients, even if the needle is changed. Patients using HUMULIN R U-500 vials should never share needles or U-500 insulin syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.

5.3 Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen

Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) may affect glycemic control and predispose to hypoglycemia [see Warnings and Precautions (5.4)] or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia [see Adverse Reactions (6)].

Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. For patients with type 2 diabetes, adjustments in concomitant oral anti-diabetic treatment may be needed.

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