FDA Approves Dedicated Syringe for Humulin R U-500 Insulin

Humulin R U-500 has been approved since 1994 for the treatment of diabetes, but a dedicated syringe did not previously exist.

The FDA last week approved the first dedicated syringe for use with Humulin R U-500 insulin in the treatment of diabetes.

Since 1994, there has been no dedicated syringe for delivery. Instead, healthcare providers and patients were required to make dose conversions for delivery using a U-100 insulin syringe for a volumetric syringe, according to a press release from the FDA.

The Humulin R U-500 insulin vial will be updated, and the U-100 and volumetric dose conversions will be removed. The syringes will be available by prescription only and should be co-prescribed with U-500 insulin.

The Humulin R U-500 is currently available as a prefilled pen device and a vial. The vial should be used with the U-500 insulin syringe.

The FDA suggests maintaining an adequate supply of U-500 syringes and should not switch between different syringes to prevent dosing errors.