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.

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EVERY SECOND MATTERS1,2

During an opioid overdose, impaired breathing reduces the amount of oxygen in the blood, which may lead to decreased oxygen in the brain and other organs. This can be dangerous and even deadly. Synthetic opioids, like fentanyl, can induce overdose more rapidly than nonsynthetic opioids.3,4

Every overdose is unique and unpredictable, and there’s a wide range of symptoms associated with opioid overdose2,5:

Impaired 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 we look beyond overdose deaths.

For each opioid-induced fatality,
it was estimated that there are between

6.4 and 8.4

nonfatal overdoses,
which takes a toll on overdose victims and society.2

Not actual size.

With the cause of overdose often unknown, OPVEE® may help in the event of an accidental opioid overdose or illicit fentanyl poisoning.3,7

Synthetic opioids, like fentanyl, are added to drugs like marijuana, cocaine, counterfeit prescription pills, and benzodiazepines, leaving unsuspecting users at risk.3,7

Not actual size.

In 2022, 6 out of 10 pills
seized by the DEA contained a potentially deadly amount of fentanyl.8

Abbreviation: DEA, Drug Enforcement Administration.

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. Somerville NJ, O’Donnell J, Gladden RM, et al. Characteristics of fentanyl overdose — Massachusetts, 2014–2016. MMWR Morb Mortal Wkly Rep. 2017;66(14):382-386.
2. Skolnick P. Treatment of overdose in the synthetic opioid era. Pharmacol Ther. 2022;233:108019.
3. Burns SM, Cunningham CW, Mercer SL. DARK classics in chemical neuroscience: fentanyl. ACS Chem Neurosci. 2018;9(10):2428-2437.
4. 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. Accessed March 8, 2023. https://aspe.hhs.gov/reports/non-fatal-opioid-overdose-associated-health-outcomes-final-summary-report
5. Boyer EW. Management of opioid analgesic overdose. N Engl J Med. 2012;367(2):146-155.
6. Prescribing Information for OPVEE®.
7. 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.
8. DEA laboratory testing reveals that 6 out of 10 fentanyl-laced fake prescription pills now contain a potentially lethal dose of fentanyl. News release. US Drug Enforcement Agency; November 22, 2022. Accessed March 7, 2023. https://www.dea.gov/alert/dea-laboratory-testing-reveals-6-out-10-fentanyl-laced-fake-prescription-pills-now-contain