Important Administration Instructions

• OPVEE is for intranasal use only.
• The device is ready to use. No device assembly is required.
• Do not prime or test prior to administration. OPVEE nasal spray delivers its entire contents automatically, upon activation.
• Do not attempt to reuse OPVEE. Each unit-dose device contains a single dose of nalmefene and cannot be reused.
• No device assembly is required.
• 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 OPVEE 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 OPVEE nasal spray. Emphasize the following instructions to the patient or caregiver:
• Administer OPVEE nasal spray as quickly as possible because prolonged respiratory depression may result in damage to the central nervous system or death.
• Always seek emergency medical assistance after administration of the first dose of OPVEE nasal spray in the event of a suspected, potentially life-threatening opioid emergency. Keep the patient under continued surveillance until emergency personnel arrive.
• Additional doses of OPVEE nasal spray may be required until emergency medical assistance becomes available.
• Re-administer OPVEE nasal spray, using a new nasal spray, in the nose, every 2 to 5 minutes if the patient does not respond or responds and then relapses into respiratory depression.
• Administer OPVEE nasal spray according to the printed instructions on the Quick Start Guide and the Instructions for Use.

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  Place the patient in the supine position. Prior to administration, be sure the device nozzle is inserted in the nose of the patient and provide support to the back of the neck to allow the head to tilt back. Do not prime or test the device prior to administration.

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  To administer the dose, press firmly on the device plunger and remove the device nozzle from the nose after use.

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  If the patient responds by waking up to the voice or touch or starts breathing normally, place the patient on their side (recovery position) as shown in the Instructions for Use and call for emergency medical assistance immediately after administration of the first dose of OPVEE nasal spray.

Dosing in Adults and Pediatric Patients aged 12 years and older

Dosing Modifications due to Partial Agonists or Mixed Agonists/Antagonists

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