
STEP 1
Firmly pull the auto-injector from the outer case.
Kaléo intends this device to be useful in protecting civilians and government employees who may come in contact with ultra-potent opioids in the fulfillment of their duties or during a mass casualty event.
Naloxone Auto-Injector 10 mg can be administered through clothing, including personal protective equipment such as MOPP4. Removal of personal protective equipment is not required.
Firmly pull the auto-injector from the outer case.
Pull off the red safety guard.
Place the black end of the auto-injector against the outer thigh, through clothing or personal protective equipment equipment (including MOPP4 PPE), if needed. Press firmly until you hear a click and hiss and hold in place for 5 seconds.
NOTE: After administering the first dose of Naloxone Auto-Injector 10 mg, get emergency medical help right away.2
Two human factor validation studies were conducted to validate the user interface of Naloxone Auto-Injector 10 mg for law enforcement officers, emergency medical services personnel, and military personnel using simulated use scenarios and post-simulation interviews. Overall, all seventy-five participants were able to successfully deliver a simulated Naloxone Auto-Injector 10 mg dose to either a victim or themselves and answered all critical knowledge task questions correctly.
Untrained participants – half of whom where experienced with a trainer for a similar auto-injector – were instructed to administer Naloxone Auto-Injector 10 mg to an opioid overdose victim (manikin) in a simulated sports bar/recreational area.
The testing environment included variables aimed at inducing stress (e.g., low lighting, flashing disco lights, loud music, beeping that increased in frequency and loudness, live patron bystanders).
A week after instructor-led training on Naloxone Auto-Injector 10 mg use, participants were asked to don MOPP4 and administer Naloxone Auto-Injector 10 mg to an unconscious soldier (manakin also wearing personal protective equipment) and themselves (due to a breach in personal protective equipment) in a simulated scenario where a high-potency opioid had been released in a populated area.
In addition to the challenges inherent with MOPP Level 4 (e.g., impaired dexterity, tactility, visibility), environmental challenges included emergency sirens/alarms, fog, darkness, flashing emergency lights, crowded space, multiple casualties, and beeping that increased in frequency/loudness.
IMPORTANT SAFETY INFORMATION
Contraindications, Warnings, Precautions, and Adverse Events