HUMULIN® R U-500 (insulin human injection): Dosage Schedule

Detailed Information

In a euglycemic clamp study of 24 healthy obese subject with a BMI of 30 to 39 kg/m², single doses of SC U-500R at 50 units (0.4-0.6 units/kg) and 100 units (0.8-1.3 units/kg) resulted in a

• mean time of onset of action <15 minutes at both doses

• mean duration of action of 21 hours with a range of 13 to 24 hours, and

• median peak insulin concentration occurring between 4 (50-unit dose) and 8 hours (100-unit dose) with a range of 0.5 to 8 hours.¹

After administration of single doses of 50 and 100 units of SC U-500R to healthy obese subjects (N≥21), the mean apparent half-life was approximately 4.5 hours with a range of 1.9 to 10 hours.¹

The time action characteristics reflect both prandial and basal activity, consistent with clinical experience. This effect has been attributed to the high concentration of U-500R.¹

Given the time action characteristics of U-500R, it is usually administered 2 to 3 times daily approximately 30 minutes before meals. ¹

The dosage of U-500R should be individualized and titrated based on the

• patient’s metabolic needs

• BG monitoring results, and

• glycemic control goal.¹

Dosage adjustments may be needed to minimize the risk of hypoglycemia or hyperglycemia with changes in

• physical activity

• meal patterns (eg, macronutrient content or timing of food intake)

• renal or hepatic function

• medications, or

• health (i.e., during acute illness.)¹

Enclosed Prescribing Information

HUMULIN® R U-500 (insulin human injection), for subcutaneous use, Lilly

Reference

1. Humulin R U-500 [package insert]. Indianapolis, IN: Eli Lilly and Company; 2016.

Glossary

BG = blood glucose

BMI = body mass index

SC = subcutaneous

U-500R = Humulin® R U-500 (insulin human injection) 500 units/mL