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.

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Made for the moment

Dangerously slow breathing during opioid overdose may cause low oxygen levels in tissues, which can be a primary driver of subsequent health complications if it goes on too long.1

Synthetic opioids, like fentanyl, can act fast, causing potentially life-threatening breathing problems within 2 minutes.1-3

Every overdose is unique and unpredictable, and there is a wide range of symptoms associated with opioid overdose4,5:

Slowed or shallow breathing

Sleepiness or unresponsiveness

Reduced pupil size

Slowed heartbeat

If you suspect that someone is overdosing, administer OPVEE® as quickly as possible and call 911.6

Overdoses have an even broader impact when looking beyond overdose deaths.

Data from a nationwide emergency department sample database from 2010-2020 estimated that for each opioid-induced fatality, there are

6 nonfatal
overdoses

and this takes a toll on overdose victims and society.

This estimate only includes opioid overdoses treated in emergency departments.

This ratio could underestimate the true burden of nonfatal overdoses in the community.7

The cause of an overdose is often unknown2,8

Synthetic opioids, like fentanyl, are added to drugs like marijuana, cocaine, counterfeit prescription pills, and benzodiazepines, leaving unsuspecting users at risk.2,8
OPVEE® is the first and only nasal opioid rescue medicine specifically indicated for synthetic opioids, like fentanyl, as well as nonsynthetic opioids.6

Not actual size.

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. Zibbell J, Howard J, Duhart Clarke S, Ferrell A, Karon SL; RTI International. Non-Fatal Opioid Overdose and Associated Health Outcomes: Final Summary Report. US Dept of Health and Human Services; September 2019.
2. Burns SM, Cunningham CW, Mercer SL. DARK classics in chemical neuroscience: fentanyl. ACS Chem Neurosci. 2018;9(10):2428-2437.
3. Fairbairn N, Coffin PO, Walley AY. Naloxone for heroin, prescription opioid, and illicitly made fentanyl overdoses: challenges and innovations responding to a dynamic epidemic. Int J Drug Policy. 2017;46:172-179.
4. Skolnick P. Treatment of overdose in the synthetic opioid era. Pharmacol Ther. 2022;233:108019.
5. Boyer EW. Management of opioid analgesic overdose. N Engl J Med. 2012;367(2):146-155.
6. OPVEE. Prescribing information. Indivior Inc; 2023.
7. Casillas SM, Pickens CM, Tanz LJ, Vivolo-Kantor AM. Estimating the ratio of fatal to non-fatal overdoses involving all drugs, all opioids, synthetic opioids, heroin or stimulants, USA, 2010-2020. Inj Prev. 2024;30(2):114-124.
8. Friedman J, Godvin M, Shover CL, Gone JP, Hansen H, Schriger DL. Trends in drug overdose deaths among US adolescents, January 2010 to June 2021. JAMA. 2022;327(14):1398-1400.