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Dedicated syringe for Humulin insulin receives FDA approval

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The FDA approved a dedicated syringe for the administration of Humulin R U-500 insulin, eliminating the need for dose conversions for patients who used U-100 or tuberculin syringes.

The dedicated syringe is now the only device approved for use with U-500 insulin vial since it became available in 1994. The vial label will be updated to remove dose conversation information for U-100 and tuberculin (volumetric) syringes, as dose conversations are no longer needed.

The approved syringes will be available only with a prescription and should be prescribed with U-500 insulin. If patients are hospitalized or transitioning care, their dose of Humulin R U-500 should be clearly communicated to hospital staff, according to the FDA.

The FDA noted that patients prescribed Humulin R U-500 insulin should be aware of the following:

• Use the U-500 insulin syringe only with the U-500 insulin vial.
• Do not switch between types of syringes because switching may increase the risk for dosing errors.
• Maintain an adequate supply of U-500 insulin syringes. Patients should not attempt to dose with another type of syringe if their supply of U-500 insulin syringes runs out, but instead call their pharmacist or health care provider immediately for further instruction.

Humulin R U-500 is also available in a prefilled pen device. For patients who do not use the pen, the vial can be used as an alternative.