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News

March 4, 2022

FDA Approves 10-mg Naloxone Injection to Treat Exposure to Ultra-Potent Weaponized Opioids

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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.