FDA

Rezenopy

Approved 19 Apr 2024NasalSpray

Indications

REZENOPY nasal spray is indicated 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. REZENOPY nasal spray is intended for immediate administration as emergency therapy in settings where opioids may be present. REZENOPY nasal spray is not a substitute for emergency medical care. REZENOPY nasal spray is an opioid antagonist 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.

( 1 ) REZENOPY nasal spray is intended for immediate administration as emergency therapy in settings where opioids may be present. ( 1 ) REZENOPY nasal spray is not a substitute for emergency medical care. ( 1 )

Contraindications

REZENOPY nasal spray is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients. Hypersensitivity to naloxone hydrochloride. ( 4 )

Warnings and precautions

Risk of Recurrent Respiratory and CNS Depression : Due to the duration of action of naloxone relative to the opioid, keep patient under continued surveillance and administer additional doses of REZENOPY nasal spray, as necessary, using a new nasal spray device while awaiting emergency medical assistance. ( 5.1 ) Risk of Limited Efficacy with Partial Agonists or Mixed Agonists/Antagonists : Reversal of respiratory depression caused by partial agonists or mixed agonists/antagonists, such as buprenorphine and pentazocine, may be incomplete.

Larger or repeat doses may be required. ( 5.2 ) Precipitation of Severe Opioid Withdrawa l: Use in patients who are opioid dependent may precipitate opioid withdrawal. In neonates, opioid withdrawal may be life- threatening if not recognized and properly treated. Monitor for the development of opioid withdrawal. ( 5.3 ) Risk of Cardiovascular (CV) Effects : Abrupt postoperative reversal of opioid depression may result in adverse CV effects.

These events have primarily occurred in patients who had pre-existing CV disorders or received other drugs that may have similar adverse CV effects. Monitor these patients closely in an appropriate healthcare setting after use of naloxone hydrochloride. ( 5.3 )

5.1Risk of Recurrent Respiratory and Central Nervous System Depression

At a glance

Brand name: Rezenopy
Active substance: naloxone hydrochloride
Route: Nasal
Dosage form: Spray
Applicant: Scienture
Status: Prescription
FDA approval: 19 Apr 2024
Application: NDA215487-001

Indications

Warnings and precautions

5.1Risk of Recurrent Respiratory and Central Nervous System Depression

Adverse reactions

The following serious adverse reactions are discussed elsewhere in the labeling: Precipitation of Severe Opioid Withdrawal [see Warnings and Precautions (5.3) ]. Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical studies of another drug and may not reflect the rates observed in practice.

The following adverse reactions were observed in a REZENOPY nasal spray clinical study. In a pharmacokinetic study of 30 healthy adult volunteers exposed to one spray of REZENOPY nasal spray, adverse reactions of abdominal pain upper, nasopharyngitis and dysgeusia were observed. The following adverse reactions have been identified primarily during post-approval use of naloxone hydrochloride in the post-operative setting.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Hypotension, hypertension, ventricular tachycardia and fibrillation, dyspnea, pulmonary edema, and cardiac arrest. Death, coma, and encephalopathy have been reported as sequelae of these events. Excessive doses of naloxone hydrochloride in post-operative patients have resulted in significant reversal of analgesia, and have caused agitation.

Abrupt reversal of opioid effects in persons who were physically dependent on opioids has precipitated an acute withdrawal syndrome. Signs and symptoms have included: body aches, fever, sweating, runny nose, sneezing, piloerection, yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, abdominal cramps, increased blood pressure, tachycardia. In some patients, there may be aggressive behavior upon abrupt reversal of an opioid overdose.

In the neonate, opioid withdrawal signs and symptoms also included convulsions, excessive crying, and hyperactive reflexes. The following adverse reactions were observed in a REZENOPY nasal spray clinical study: abdominal pain upper, nasopharyngitis, and dysgeusia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Scienture, LLC at 1-833-754-4917 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Rezenopy

Indications

Contraindications

Warnings and precautions

5.1Risk of Recurrent Respiratory and Central Nervous System Depression

At a glance

Two medicines in one question?

Rezenopy

Indications

Contraindications

Warnings and precautions

5.1Risk of Recurrent Respiratory and Central Nervous System Depression

At a glance

Two medicines in one question?

5.2Risk of Limited Efficacy with Partial Agonists or Mixed Agonist/Antagonists Reversal

5.3Precipitation of Severe Opioid Withdrawal

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

Composition

Official product information