REZENOPY Nasal spray Ref.[109668] Active ingredients: Naloxone

2.1 Important Administration Instructions

REZENOPY nasal spray is for intranasal use only.

All approved naloxone hydrochloride products achieve plasma concentrations that have been shown to be efficacious in reversing the effects of opioid overdose. Comparing different products on a nominal mg-for-mg basis may be misleading [see Clinical Pharmacology (12.3)].

Because treatment of suspected opioid overdose must be performed by someone other than the patient, instruct the prescription recipient to inform those around them about the presence of REZENOPY nasal spray and the Instructions for Use.

Instruct the patient or caregiver to read the Instructions for Use at the time they receive a prescription for REZENOPY nasal spray.

Emphasize the following instructions to the patient or caregiver:

• Seek medical care immediately after use. Since the duration of action of most opioids exceeds that of naloxone hydrochloride and the suspected opioid overdose may occur outside of supervised medical settings, seek immediate emergency medical assistance, keep the patient under continued surveillance until emergency personnel arrive, and administer additional doses of REZENOPY nasal spray, as necessary. Always seek emergency medical assistance in the event of a suspected, potentially life-threatening opioid emergency after administration of the first dose of REZENOPY nasal spray.
• Additional doses of REZENOPY nasal spray may be required before emergency medical assistance becomes available.
• Do not attempt to reuse REZENOPY nasal spray. Each REZENOPY nasal spray contains a single dose of naloxone.
• Re-administer REZENOPY nasal spray, using a new nasal spray, if the patient does not respond within 2 to 3 minutes or responds and then relapses into respiratory depression.
• Administer REZENOPY nasal spray in alternate nostrils with each dose.
• Administer REZENOPY nasal spray according to the printed instructions on the device label and the Instructions for Use.
• Place the patient in the supine position on their back. Prior to administration, be sure the device nozzle is inserted in either nostril of the patient, support the back of the neck and tilt the patient’s head back. Do not prime or test the device prior to administration.
• To administer the dose firmly press the bottom of the device plunger.
• Remove the device nozzle from the nostril after use.
• Turn patient on their side as shown in the Instructions for Use and call for emergency medical assistance immediately after administration of the first dose of REZENOPY nasal spray.

2.2 Dosing in Adult and Pediatric Patients

Initial Dosing

The recommended initial dose of REZENOPY nasal spray in adults and pediatric patients is one spray delivered by intranasal administration. Administer REZENOPY nasal spray as quickly as possible because prolonged respiratory depression may result in damage to the central nervous system or death.

Repeat Dosing

Seek emergency medical assistance as soon as possible after administering the first dose of REZENOPY nasal spray.

The requirement for repeat doses of REZENOPY nasal spray depends upon the amount, type, and route of administration of the opioid being antagonized.

Administer REZENOPY nasal spray in alternate nostrils with each dose.

If the desired response is not obtained after 2 to 3 minutes, administer a second dose of REZENOPY nasal spray using a new REZENOPY nasal spray device. If there is still no response and additional doses are available, administer additional doses of REZENOPY every 2 to 3 minutes, alternating nostrils and using a new REZENOPY, until emergency medical assistance arrives. Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance.

If the patient responds to REZENOPY nasal spray and relapses back into respiratory depression before emergency assistance arrives, administer an additional dose of REZENOPY nasal spray using a new REZENOPY nasal spray device and continue surveillance of the patient.

2.3 Dosing Modifications due to Partial Agonists or Mixed Agonist/Antagonists

Reversal of respiratory depression by partial agonists or mixed agonist/antagonists, such as buprenorphine and pentazocine, may be incomplete and require higher doses of naloxone hydrochloride or repeat administration of REZENOPY nasal spray using a new nasal spray device [see Warnings and Precautions (5.2)].

Store REZENOPY nasal spray in the blister and cartons provided.

Store between 2°C to 25°C (36°F to 77°F). Excursions permitted up to 40°C (104°F). Do not freeze or expose to excessive heat above 40°C (104°F). Protect from light.

REZENOPY nasal spray may freeze at cold temperatures. If this happens, the device will not spray. If REZENOPY nasal spray is frozen and is needed in an emergency, do NOT wait for REZENOPY nasal spray to thaw. Get emergency medical help right away.