Rapid Opioid Countermeasure System “ROCS”

Designed for Military Personnel, First Responders, & Chemical Incident Responders

Product Highlights

Temporary prophylaxis of respiratory and/or central nervous system depression in military personnel and chemical incident responders entering an area contaminated with high-potency opioids such as fentanyl analogues.

  • Only naloxone product with two indications – post-exposure and temporary prophylactic use ahead of the mission
  • Approved by the U.S. Food and Drug Administration (FDA) in February 2022
  • Highest FDA-approved dosage as a countermeasure against high-potency opioids
  • Issued NATO Stock Number #6505-01-699-8878
  • Naloxone Auto-Injector (NAI) 10 mg passes U.S. Department of Defense military standard durability tests3
  • First to meet FDA draft guidance standard for 99.999% device reliability
  • For those outside the U.S.;  the product is available to allied foreign military services through the U.S. Department of Defense (FMS) or through direct sales via expanded access approval exclusively for government or military use.

Instructions for Use

Step One

Firmly pull the auto-injector from the outer case.


Step Two

Pull off the red safety guard.


Step Three

Place the black end of the auto-injector against the outer thigh, through clothing or personal protective equipment. Press firmly until you hear a click and hiss and hold in place for 5 seconds.


If symptoms return, administer an additional dose of Naloxone Auto-Injector 10mg.

Device Configuration

DESIGNED IN PARTNERSHIP WITH THE U.S. DEPARTMENT OF DEFENSE

“Access to a point-of-injury countermeasure such as the 10mg naloxone autoinjector is a major step forward to protect and maintain the readiness of the Joint Force”

-Col Ryan R. Eckmeier, U.S. Army

Specifications

Strength10 mg
SizeApprox. 2” wide x 3.4” height x 0.54” depth, Approx. 5.08cm wide x 8.636cm height x 1.3716cm depth
WeightApprox. 58 grams
Mechanism of ActionOpioid receptor antagonist
Route of AdministrationIntramuscularly or subcutaneously into the anterolateral aspect of the thigh (can be administered through clothing)
NATO Stock Number (NSN)6505-01-699-8878
NDC Code60842-002-02
SterileYes
GradeUSP
Storage RequirementsDo not freeze. Protect from heat. Store at controlled room temperature 59F-77F (15C-25C); excursions permitted between 39F and 104F (4C and 40C).
Container TypeCarton containing ten (10) Naloxone Hydrochloride Injection, USP Auto-Injector 10mg
BrandNaloxone Auto-Injector 10mg
Active IngredientNaloxone HCI
Dosage FormInjection
INDICATION

Naloxone hydrochloride injection (USP, 10 mg Auto-Injector) is an opioid antagonist indicated for use by military personnel and chemical incident responders for:

  • Emergency treatment of patients 12 years of age and older where the use of high-potency opioids, such as fentanyl analogues as a chemical weapon, is suspected.
  • Temporary prophylaxis of respiratory and/or central nervous system depression in military personnel and chemical incident responders entering an area contaminated with high-potency opioids, such as fentanyl analogues.

Training Device

Practice With A Trainer

For additional information on the injection technique for Naloxone Auto-Injector 10 mg, please select the Instructions For Use.

Kaléo is a market leader in emergency-use auto-injectors committed to protecting military, police, and emergency responders. Our gas-powered auto-injector is durable, reliable, and compact, designed to preserve and make a difference in people’s lives.

A countermeasure to the threat of Synthetic Opioids

“ROCS” is a device designed to be useful in protecting military personnel and first responders who may come in contact with ultra-potent opioids in the fulfillment of their duties or during a mass casualty event. Naloxone Auto-Injector 10mg can be administered through clothing, including personal protective equipment such as MOPP4. Removal of personal protective equipment is not required.

Weaponized opioids deployed in a threat-based dynamic environment

Illicit drug production facilities with aerosolized opioids

Domestic terrorist attack using weaponized opioids

Land-based or maritime drug interdiction for mass quantity opioid exposure

Usability and Simulated Real-World Use Scenarios

Study One:

Sixty Law Enforcement & Emergency Medical Services Personnel

Untrained participants – half of whom were experienced with a trainer for a similar autoinjector – were instructed to administer NAI 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, and live patron bystanders).

100% Completed a Simulation

Study Two:

Fifteen Military Personnel

A week after instructor-led training on NAI 10 mg use, participants were asked to don MOPP4 and administer NAI 10 mg to an unconscious soldier (manakin also wearing PPE) and themselves (due to a breach in PPE) 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.

100% Completed a Simulation

Limitations: These studies were sponsored by Kaléo. As this was a simulated use scenario, participants may not have experienced the same level of stress that they might experience during an actual event.

CONTACT US FOR MORE INFORMATION

INDICATION and IMPORTANT SAFETY INFORMATION

INDICATION

Naloxone Auto-Injector 10mg is an opioid antagonist indicated for use by military personnel and chemical incident responders for:
– Temporary prophylaxis of respiratory and/or central nervous system depression in military personnel and chemical incident responders entering an area contaminated with high-potency opioids such as fentanyl analogues.
– Emergency treatment of patients 12 years of age and older where the use of high-potency opioids such as fentanyl analogues as a chemical weapon is suspected.

IMPORTANT SAFETY INFORMATION

Contraindications, Warnings, Precautions, and Adverse Events
– NAI 10mg is contraindicated in individuals with hypersensitivity to naloxone hydrochloride or to any of the other ingredients in NAI 10mg.
– Uses in patients who are opioid dependent may cause abrupt opioid withdrawal. Use of a product that delivers a dose lower than 10 mg of naloxone HCl may be preferable in the treatment of a patient with known opioid dependence.
– Due to the duration of action of naloxone HCl relative to the opioid, keep the patient under continued surveillance and administer additional naloxone HCl, as necessary, while awaiting emergency medical assistance.
– The following adverse reactions were observed in more than one subject in clinical studies evaluating NAI: dizziness, feeling hot, headache, and injection site erythema.

PRESCRIBING INFORMATION (STANDING ORDERS)

Please see the full Prescribing Information.
By State:
ArizonaFloridaGeorgiaIllinois
New JerseyPennsylvaniaVirginia
To report suspected adverse reactions, contact the FDA at 1-800-FDA-1088 or fda.gov/medwatch.

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