INDICATION: OPVEE® is for emergency treatment of known or suspected overdose induced by natural or synthetic opioids in patients 12 years and older, as manifested by respiratory and/or central nervous system depression. OPVEE® is for immediate administration as emergency therapy in settings where opioids may be present and is not a substitute for emergency medical care.

Header Image

OPVEE® (nalmefene) Nasal Spray

is an overdose rescue medicine specifically indicated for the emergency treatment of known or suspected overdose from synthetic opioids, like fentanyl, as well as nonsynthetic opioids1

If you suspect that someone is overdosing, administer OPVEE® as quickly as possible because prolonged respiratory depression may result in damage to the central nervous system or death.1
After the first dose, call 911 right away and stay with the person until medical help arrives. If they do not return to normal breathing, or if their breathing returns but they relapse, an additional dose of OPVEE can be administered as needed every 2 to 5 minutes.1

Key Steps for Using OPVEE®1

PLACE

Holding the device with your fingers on both sides of the nozzle and your thumb on the plunger, place the tip of the OPVEE® nozzle into one nostril until your fingers are against the bottom of the person's nose.


PRESS

Press the plunger firmly, which delivers one dose of OPVEE® automatically when the plunger stops moving.


PAUSE

Call 911 immediately and wait with the person. Move the person on their side, with their hand supporting their head, bend their knee, and turn their face to the side. If the person does not wake up or start breathing normally after 2 to 5 minutes, another dose may be given.


Not actual size.

OPVEE® is ready to use1,*

Includes 2 devices per box

Delivers its entire contents automatically upon activation. Each unit-dose device contains a single dose of nalmefene and cannot be reused.

Can be readministered with a new device every 2 to 5 minutes as needed

*Administer in accordance with the Instructions for Use.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION: Do not use in patients who are allergic to nalmefene or any of the other ingredients.

WARNINGS AND PRECAUTIONS: Risk of Recurrent Respiratory and Central Nervous System Depression: While the duration of action of nalmefene is as long as most opioids, a recurrence of slowed breathing (respiratory depression) is possible after treatment with OPVEE®. Watch patients and give repeat doses of OPVEE® using a new device, as necessary, while awaiting emergency medical assistance.


IMPORTANT SAFETY INFORMATION

CONTRAINDICATION: Do not use in patients who are allergic to nalmefene or any of the other ingredients.

WARNINGS AND PRECAUTIONS

Risk of Recurrent Respiratory and Central Nervous System Depression: While the duration of action of nalmefene is as long as most opioids, a recurrence of slowed breathing (respiratory depression) is possible after treatment with OPVEE®. Watch patients and give repeat doses of OPVEE® using a new device, as necessary, while awaiting emergency medical assistance.

Risk of Limited Efficacy with Partial Agonists or Mixed Agonist/Antagonists: Improvement in respiratory depression caused by medicines such as buprenorphine and pentazocine may not be complete. Repeat doses of OPVEE® may be required.

Precipitation of Severe Opioid Withdrawal: Use in patients who are opioid dependent may cause symptoms of opioid withdrawal like body aches, fever, sweating, runny nose, sneezing, goose bumps, yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, abdominal cramps, increased blood pressure, and rapid heart rate. Some patients may become aggressive when an opioid overdose is treated.

Abrupt postoperative reversal of opioid depression may result in adverse cardiovascular (CV) effects. These events have primarily occurred in patients with preexisting CV disorders or who received other drugs with similar adverse CV effects. Monitor these patients closely in an appropriate healthcare setting.

In newborns, opioid withdrawal may be life-threatening if not recognized and properly treated and may also include convulsions, excessive crying, and hyperactive reflexes. Monitor for symptoms of opioid withdrawal.

Risk of Opioid Overdose from Attempts to Overcome the Blockade: Taking large or repeated doses of opioids, such as heroin or prescription pain pills to overcome blockade, may lead to opioid intoxication and death.

ADVERSE REACTIONS: Most common adverse reactions (incidence at least 2%) are nasal discomfort, headache, nausea, dizziness, hot flush, vomiting, anxiety, fatigue, nasal congestion, throat irritation, pain in the nose, decreased appetite, changes in sense of taste, skin redness, and increased sweating.

To report a pregnancy or side effects associated with taking OPVEE® or any safety related information, product complaint, request for medical information, or product query, please contact or 1-877-782-6966. You are encouraged to report negative side effects of drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information.


1. Prescribing Information for OPVEE®.