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.

Full Prescribing Information Important Safety Information
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OPVEE®—the first and only nasal rescue medicine specifically indicated for synthetic opioids1

OPNT003-OOD-001 study design1-3

This experimental model evaluated pharmacodynamic effects of OPVEE® compared with intranasal naloxone to reverse remifentanil-induced suppression of carbon dioxide (CO2)–induced increases in minute ventilation (MV). Healthy volunteers (N=69) were given the hypercapnic gas mixture for 10 minutes to elevate MV, followed by remifentanil for 15 minutes to suppress MV. OPVEE® was given and the subjects were monitored for changes in MV.

OPVEE® is fast1

In the pharmacodynamic study, OPVEE® reversed respiratory depression by an average of 98.9% at 5 minutes.1,2

Full recovery of respiratory drive was noted as early as 5 minutes (between 5 and 15 minutes).1

OPVEE® has a long half-life1

In the pharmacokinetic studies, the mean half-life of OPVEE® was 11.4 hours.1

The half-life of fentanyl varies greatly due to many factors, including the route of administration, dose, and formulation. The half-life of illicit fentanyl has not been studied; however, the half-life of fentanyl (when used as anesthesia) has been shown to be about 7.5 hours.4-6

The clinical relevance of these findings to a real-world overdose is unknown.

If the patient does not respond or responds and then relapses into respiratory depression, readminister OPVEE® using a new nasal spray, in the nose, every 2 to 5 minutes.1

Learn to administer OPVEE®

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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®.
2. Fratantonio J, Hutton E, Skolnick P. A pharmacodynamic study comparing IN nalmefene to IN naloxone in healthy volunteers. Poster presented at: Annual Meeting of the American Association of Psychiatric Pharmacists; April 16-19, 2023; Atlanta, GA.
3. Data on file. Indivior Inc.; 2022.
4. Skolnick P. Treatment of overdose in the synthetic opioid era. Pharmacol Ther. 2022;233:108019.
5. Moss RB, Carlo DJ. Higher doses of naloxone are needed in the synthetic opioid era. Subst Abuse Treat Prev Policy. 2019;14(1):6.
6. Ahonen J, Olkkola KT, Hynynen M, et al. Comparison of alfentanil, fentanyl and sufentanil for total intravenous anaesthesia with propofol in patients undergoing coronary artery bypass surgery. Br J Anaesth. 2000;85(4):533-540.