The United States Food and Drug Administration (USFDA) has approved Humulin R U-500 Kwikpen (human insulin injection), pre-filled device (500 units/mL) for type-1 and type-2 diabetes management. The device is indicated for diabetics who are in need over 200 units of insulin per day.
Diabetics with severe insulin resistance are poor respondents to insulin effects, and they need much higher insulin doses.
The device is to be manufactured by Eli Lilly. The safety and efficacy of the device as a combined therapy with insulin infusion pump or other insulin formulations has not been determined.
Humulin R U-500 is contraindicated in certain diabetics who are hypersensitive to Humulin R U-500 and/or with episodes of hypoglycemia.