Dedicated Syringe for Humulin R U-500 Gets FDA Nod

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

The syringe is now the sole device approved for use with U-500 insulin vial since it hit the market in 1994. Previously, health care professionals needed to make dose conversions using a U-100 insulin syringe or tuberculin syringe. The labeling for Humulin R U-500 insulin will be updated accordingly.

The approved syringe will only be available with a prescription. It can be used as an alternative by patients who typically utilize a prefilled pen, and the FDA is urging patients to only use the new dedicated syringe with the U-500 insulin vial and to avoid switching to reduce the risk of dosing errors.

Humulin R U-500 is only recommended for individuals who require more than 200 units of insulin per day. It is not designed to be administered intravenously or intramuscularly.

Humulin R U-500 is a concentrated human insulin indicated to improve glycemic control in individuals with diabetes. The most common adverse reactions associated with the product are hypoglycemia, allergic reactions, and injection site reactions, such as rash. The FDA encourages individuals to report suspected side effects to MedWatch, the Safety Information and Adverse Event Reporting Program.