Label Changes for:
Humulin R U-500 (insulin human injection)
Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
WARNINGS AND PRECAUTIONS
Hyperglycemia, Hypoglycemia or Death due to Dosing Errors with the Vial Presentation
Dispensing Errors (new information is added below)
- The HUMULIN R U-500 vial, which contains 20 mL, has a band of aqua coloring, a 500 units/mL concentration statement consisting of white lettering on a green rectangular background, and a green “U-500” statement prominently displayed next to the trade name. Additionally, the vial has a green flip top and a red warning on the front panel describing the highly concentrated dose and a statement advising use with only U-500 insulin syringes.
Prescribing Errors (new information is added below)
- Dosing errors have occurred when the HUMULIN R U-500 dose was administered with syringes other than a U-500 insulin syringe. Patients should be prescribed U-500 syringes for use with the HUMULIN R U-500 vials. The prescribed dose of HUMULIN R U-500 should always be expressed in units of insulin.
- Use only a U-500 insulin syringe with HUMULIN R U-500 to avoid administration errors. Do not use any other type of syringe to administer Humulin R U-500. Adhere to administration instructions replaces A majority of the medication errors with HUMULIN R U-500 vial presentation occurred due to dosing confusion when the HUMULIN R U-500 dose was prescribed in units or volume corresponding to a U-100 syringe or tuberculin syringe markings, respectively, or the prescribed dose was administered without recognizing that the markings on the syringe used do not directly correspond to U-500 dose. Adhere to administration and conversion instructions.
Never Share a HUMULIN R U-500 KwikPen or U-500 Insulin Syringe Between Patients (subheading updated to include U-500 insulin syringe)
- Patients using HUMULIN R U-500 vials should never share needles or U-500 insulin syringes with another person. (addition of U-500 insuling syringes).
PATIENT COUNSELING INFORMATION
- When using HUMULIN R U-500 from a vial, patients should be counseled to use only a U-500 insulin syringe and be informed that no dose conversion is required replaces patients should be counseled to calculate the conversion and measure the amount of delivered insulin using the unit of measurement that corresponds to the type of syringe being used.
- Do not share your Humulin R U-500 KwikPen or U-500 insulin syringes… (addition of U-500 insulin syringes)
What is Humulin R U-500?
Addition of the following bullets:
- It is not known if Humulin R U-500 is safe and effective when used in combination with other insulins.
- It is not known if Humulin R U-500 is safe and effective when given by continuous subcutaneous infusion.
How should I use Humulin R U-500?
- When using the Humulin R U-500 vial: There is a special U-500 insulin syringe to measure Humulin R U-500.
- Use only a U-500 insulin syringe to draw up and inject your Humulin R U-500 replaces There are no special syringes to measure Humulin R U-500. Use a U-100 insulin syringe or tuberculin syringe as instructed by your healthcare provider.
Dosing Confusion/Dosing Errors
- Medication errors associated with Humulin R U-500 have occurred and resulted in patients experiencing hyperglycemia, hypoglycemia or death. The majority of errors occurred due to errors in dispensing, prescribing or administration. Attention to the following details may prevent:
- The prescribed dose of Humulin R U-500 should always be expressed in actual units of Humulin R U-500 along with corresponding markings on the syringe the patient is using (i.e., a U-100 insulin syringe or tuberculin syringe).
- A majority of these errors occurred due to dosing confusion when the Humulin R U-500 dose was prescribed in units or volume corresponding to a U-100 syringe or tuberculin syringe markings, respectively, or the prescribed dose was administered without recognizing that the markings on the syringe used do not directly correspond to U-500 dose. Instructions for use should always be read and followed before use.
- A conversion chart is provided and should always be used when administering Humulin R U-500 doses with U-100 insulin syringes or tuberculin syringes.