TABLE 1.

Required Pen Demonstration Steps: Evaluation Criteria

AlbiglutideDulaglutideExenatide XR
Preparation1. Take out of refrigerator1. Take out of refrigerator1. Take out of refrigerator
2. Wash hands2. Wash hands2. Keep at room temperature for 15 minutes
3. Remove gray base cap3. Wash hands
4. Press against skin and turn towards green button to unlock4. Look at liquid in the window and make sure it’s clear
Attaching needle and reconstitution3. Make sure pen has #1 in the window, and don’t use if there isn’tNA5. Keep pen upright and attach needle by twisting and pushing down until tight
4. Hold pen up and twist clockwise until you feel and hear a click6. Don’t remove the plastic cap
5. You will see #2 in the window7. Twist the bottom until you hear a click and the green label disappears
6. Rock pen side to side five times in a windshield motion8. Tap 80 times
7. Keep upright in a cup for 15 minutes9. Rotate every 10 taps
8. Wash hands again10. Make sure the solution is uniformly cloudy with no clumps
9. Rock side to side five times again11. If it’s not, tap longer and firmer
10. Inspect liquid to make sure it’s clear and doesn’t have particles
11. Inspect liquid, since it will look yellow and have large air bubbles
12. Peel tab off needle and push needle until you hear click and feel it in place
13. Don’t twist
14. Tap cartridge two to three times to bring air bubbles to the top
15. Keep pen upright
Administration16. Twist clockwise and feel and hear click5. Push green button until you hear a click12. Once mixed, twist until orange label disappears and pull cap off needle
17. You will see #36. Wait for a second click, which means drug is delivered, and dispose of pen into FDA-approved sharps container13. Inject needle into skin at 90-degree angle
18. Injection button will also pop out14. Push button down until you hear click
19. Remove outer cap15. Hold 10 seconds to get full dose and then remove
20. Remove inner cap16. Dispose of needle in FDA-approved sharps container
21. Push needle slowly into abdomen and push until you hear click
22. Hold thumb down for 5 seconds
23. Pull needle out and put right away into FDA-approved sharps container
Total number of required demonstration steps23616
  • FDA, U.S. Food and Drug Administration.