Naloxone Auto-Injector 10mg Logo

Rapid Opioid Countermeasure System “ROCS”

Designed for Military Personnel &
Chemical Incident Responders

COMPACT
DURABLE
RELIABLE

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 mission
  • Approved by the U.S. Food and Drug Administration (FDA) in February 2022
  • Highest FDA-approved dosage as 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  • First to meet FDA draft guidance standard for 99.999% device reliability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.
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Designed in Partnership with U.S. Department of Defense

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

– COL Ryan R. Eckmeier, U.S. Army

A Market Leader In Emergency Use Auto-Injectors

Specifications

Protection for Military, Police & Emergency Responders

Use Cases

Featured In

August 2023 | JPEO-CBRND

DOD-Supported Lifesaving Autoinjector to Combat Ultra-Potent Opioid Exposure Available through DLA
September 2022 | Globe Newswire

Kaléo Announces First U.S. Department of Defense Supply Contract for the Rapid Opioid Countermeasure System (ROCS) Antidote for Ultra-Potent Weaponized Opioids
September 2022 | Health.Mil

MHSRS 2022 Award Winner Video: Rapid Opioid Countermeasure System

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INDICATION and IMPORTANT SAFETY INFORMATION

INDICATION

Naloxone Auto-Injector 10 mg 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 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 10 mg is contraindicated in individuals with hypersensitivity to naloxone hydrochloride or to any of the other ingredients in NAI 10 mg.
  • Use 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 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.

Please see full Prescribing Information.

To report suspected adverse reactions, contact the FDA at 1-800-FDA-1088 or fda.gov/medwatch.