The FDA has approved Rextovy (naloxone hydrochloride) nasal spray for the emergency treatment of known or suspected opioid overdose. This includes cases where a person has slowed breathing or is not responding due to opioids. The spray is approved for use in both adults and children. It is designed to be given by someone other than the patient, such as a family member or bystander, in community settings where opioids may be present. Rextovy is not a substitute for emergency medical care. After giving the first dose, you must call 911 or get emergency help right away. The effects of naloxone wear off faster than many opioids, so the person may need another dose every 2 to 3 minutes until help arrives. This approval gives people another intranasal naloxone option to have on hand. If you or someone you know is at risk of opioid overdose, talk to your doctor about whether having Rextovy available is right for you. Your doctor can also teach you how to use it properly and when to seek emergency care.
FDA approved Rextovy (naloxone) Nasal Spray for Opioid Overdose Emergency TreatmentFDA approved Rextovy nasal spray for emergency opioid overdose treatment.
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The FDA has approved Rextovy (naloxone hydrochloride) nasal spray for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, in adult and pediatric patients. The approval provides another intranasal naloxone option for use in community settings where opioids may be present. Rextovy is intended for immediate administration by someone other than the patient and is not a substitute for emergency medical care. Clinicians should emphasize to patients and caregivers that the duration of action of most opioids exceeds that of naloxone, necessitating immediate emergency medical assistance after the first dose and continued surveillance with possible repeat dosing every 2 to 3 minutes until help arrives.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Naloxone hydrochloride is an opioid antagonist that reverses the effects of opioids by competitively binding to opioid receptors, thereby blocking the action of opioids.
Rextovy Nasal Spray is indicated for emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult and pediatric patients. It is intended for immediate administration as emergency therapy in settings where opioids may be present.
Rextovy is for intranasal use only. The recommended initial dose in adults and pediatric patients is one spray (4 mg naloxone hydrochloride) into one nostril. Additional doses using a new device may be given every 2 to 3 minutes if the patient does not respond or relapses into respiratory depression. Administer in alternate nostrils with each dose. Seek emergency medical care immediately after first use. Do not prime or test the device prior to administration.
Trial data not available in label.
Rextovy is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or any ingredients. Warnings include: risk of recurrent respiratory depression due to short duration of naloxone relative to opioids; need for immediate emergency medical care; incomplete reversal with partial agonists (e.g., buprenorphine) may require higher or repeated doses.
Rextovy provides a ready-to-use intranasal formulation of naloxone for opioid overdose reversal in community settings. It is not a substitute for emergency medical care and should be used as part of a comprehensive response including activation of emergency services.
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