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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The opioid epidemic continues to evolve

Synthetic opioids, like fentanyl, have changed the landscape.

There were over 106,000 total drug overdose deaths in 2021. Of these, 66% involved synthetic opioids.1

Provisional data from 2022 reports that synthetic opioids, like fentanyl, caused about 90% of all opioid overdose deaths.2

bottle pill pill pill pill
pills pill
In the US, synthetic opioids are a leading cause of death for people aged 18 to 45.3-5

Fentanyl and other synthetic opioids are fast, long-lasting, and strong.6-9

Synthetic opioids can induce an overdose in minutes, and fentanyl has a quick effect but stays in the body a long time.6-8


Fentanyl is up to
50x stronger than heroin and
100x stronger than morphine.9
Fentanyl is up to 50x stronger than heroin and
100x stronger than morphine.9

From January to June 2021, illicit fentanyl and synthetics were identified in 77% of adolescent overdose deaths.10

[D]rug traffickers are harnessing social media because it is accessible, they’re able to access millions of Americans and it is anonymous and they’re able to sell these fake pills that are not what they say they are.

–Anne Milgram, DEA Administrator11

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. Spencer MR, Miniño AM, Warner M. Drug overdose deaths in the United States, 2001-2021. NCHS Data Brief. 2022;(457):1-8. https://www.cdc.gov/nchs/data/databriefs/db457-tables.pdf
2. Ahmad FB, Cisewski JA, Rossen LM, Sutton P. National Vital Statistics System. Provisional drug overdose death counts: 12 month-ending provisional number of drug overdose deaths by drug or drug class. National Center for Health Statistics. Updated May 7, 2023. Accessed June 2, 2023. https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm
3. Cotton T, Trone DJ, Markey E, et al. Commission on Combating Synthetic Opioid Trafficking: Final Report. RAND Corporation; February 8, 2022. Accessed March 8, 2023. https://www.rand.org/content/dam/rand/pubs/external_publications/EP60000/EP68838/RAND_EP68838.pdf
4. WISQARS Injury Database. 20 leading causes of death, United States: 2020, all races, both sexes, ages: 18-45. Centers for Disease Control and Prevention. Updated February 20, 2020. Accessed March 8, 2023. https://wisqars.cdc.gov/fatal-leading
5. CDC WONDER Online Database. Multiple cause of death, 2018-2020, single race results: deaths occurring through 2020. Centers for Disease Control and Prevention. Updated 2021. Accessed May 11, 2022. https://wonder.cdc.gov/controller/datarequest/D157;jsessionid=C003973203296DC9773978C0CF93
6. 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.
7. Skolnick P. Treatment of overdose in the synthetic opioid era. Pharmacol Ther. 2022;233:108019.
8. Burns SM, Cunningham CW, Mercer SL. DARK classics in chemical neuroscience: fentanyl. ACS Chem Neurosci. 2018;9(10):2428-2437.
9. Volkow ND. The epidemic of fentanyl misuse and overdoses: challenges and strategies. World Psychiatry. 2021;20(2):195-196.
10. 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.
11. Full transcript: DEA Administrator Anne Milgram on “Face the Nation,” December 19, 2021. CBS News. December 19, 2021. Accessed March 8, 2023. https://www.cbsnews.com/news/transcript-dea-administrator-anne-milgram-face-the-nation-12-19-2021