Humulin R U-500 human insulin monotherapy delivers a dual action, providing the properties of both basal and mealtime coverage when dosed as directed
Select Safety Information for Humulin R U-500
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 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.
U-500 insulin monotherapy may reduce the injection burden*3,4
In patients who need more than 200 units a day, U-500 is usually injected 2 or 3 times per day, compared with a median of 5‡ times for other insulin regimens.§1
Lower the daily insulin volume
80% less liquid volume than U-100 insulin delivers the same number of daily units.
Demonstrated in the Humulin R U-500 Initiation Trial
A clinical framework for transitioning patients from U-100 insulin to U-5001
How starting doses were determined in the U-500 Initiation Trial:
• If A1C was >8% at Week -4 and mean self-monitored plasma glucose (SMPG) ≥183 mg/dL in the 7 days before Week 0, then the starting total daily dose (TDD) of U-500 was 100% of the final U-100 TDD
• If A1C was ≤8% at Week -4 or mean SMPG <183 mg/dL in the 7 days before Week 0, then the starting TDD of U-500 was 80% of the final U-100 TDD (20% reduction)
24-week, open-label, randomized trial to compare the efficacy and safety of 2 dosing regimens (TID, n=162 vs BID, n=163) for U-500 insulin replacing high-dose U-100 insulin (>200 units per day) with or without oral antihyperglycemic drugs in adult patients with uncontrolled type 2 diabetes. These regimens were found to be equivalent for A1C reduction over 24 weeks, and both were found to be efficacious1.
• Treat-to-target dosing algorithms titrated TID or BID regimens to achieve fasting and pre-meal SMPG 71-130 mg/dL
• Both doses of the BID regimen were titrated; only 2 of 3 TID doses were titrated (those most needing adjustment)
• Dose reductions were prioritized over dose increases for hypoglycemia
• U-500 dosing was recommended 30 minutes before meals using a U-100 insulin syringe
• Patients checked their blood glucose before each meal and at bedtime daily, and at 3 AM if they had increased their dose in the last 48 hours
Select Important Safety Information for Humulin R U-500
- 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.