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.

Prescribing Information Important Safety Information
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Made for the moment

you can help give her daughter another chance

Fight overdose from fentanyl and other synthetic opioids with OPVEE®1

OPVEE® is the first and only nasal opioid overdose rescue medicine specifically indicated for synthetic opioids, like fentanyl, as well as nonsynthetic opioids.1

OPVEE® is fast1

OPVEE® quickly reversed breathing effects in a simulated* opioid overdose.1,2

  • In a pharmacologic study, OPVEE® returned breathing to baseline levels by an average of 98.9% at 5 minutes1,3
  • Full recovery of normal breathing happened as soon as 5 minutes (between 5 and 15 minutes) after OPVEE®1

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

The signs and symptoms of an opioid emergency can return after OPVEE® is given. If this happens, give another dose every 2 to 5 minutes using a new OPVEE® nasal spray in the other nostril.1

*Study design

To study OPVEE®, researchers simulated slowed and shallow breathing (the main symptom of an opioid overdose) in 69 healthy and non-opioid dependent adult volunteers to measure the ability of OPVEE® compared with 4 mg intranasal naloxone to restore breathing.1,2

Participants were first given a carbon dioxide gas mixture to elevate their breathing. This elevated breathing was considered their baseline breathing rate.1,2

Once their breathing was elevated, participants were given remifentanil in the vein (intravenously), which lowered their breathing. One spray of OPVEE® was administered to each participant. At 5 minutes after administration, measurements were taken to determine if the study medication successfully restored breathing to baseline. Their breathing was then monitored for the next 2 hours.1

OPVEE® uses an absorption enhancer to help deliver the medication into the bloodstream.1,7,8

The addition of the absorption enhancer allows nalmefene to reach maximum concentration faster.

In pharmacology studies, the maximum level of medication in the blood was reached in 15 minutes with OPVEE® compared with 20 minutes for nalmefene injected into the muscle.

OPVEE® is long-lasting1

OPVEE® has a half-life of 11.4 hours, so it remains in the bloodstream for a long time.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.9-12

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

The signs and symptoms of an opioid emergency can return after OPVEE® is given. If this happens, give another dose every 2 to 5 minutes using a new OPVEE® nasal spray in the other nostril.1

Tools like OPVEE® give us the ability to reverse the effects of opioid overdose in critical moments, adding to our choice of resources as our nation continues to battle fentanyl-related overdoses.
–Sheriff Michael J. Bouchard, Oakland County Sheriff's Department

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OPVEE® is ready to use1,†

  • Includes 2 devices per box
  • Delivers its entire contents automatically upon activation; each device contains a single dose of nalmefene and cannot be reused
  • If signs and symptoms return, give another dose every 2 to 5 minutes using a new OPVEE® nasal spray in the other nostril as needed
OPVEE® is indicated in the emergency treatment of a known or suspected opioid overdose.1

Do not use OPVEE® if you are allergic to nalmefene or any of its ingredients.1

†Administer in accordance with the Instructions for Use.

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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. OPVEE. Prescribing information. Indivior Inc; 2023.
2. Ellison M, Hutton E, Webster L, Skolnick P. Reversal of opioid-induced respiratory depression in healthy volunteers: comparison of intranasal nalmefene and intranasal naloxone. J Clin Pharmacol. 2024;64(7):828-839.
3. 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.
4. Skolnick P. Treatment of overdose in the synthetic opioid era. Pharmacol Ther. 2022;233:108019.
5. Bird HE, Huhn AS, Dunn KE. Fentanyl absorption, distribution, metabolism, and excretion: narrative review and clinical significance related to illicitly manufactured fentanyl. J Addict Med. 2023;17(5):503-508.
6. Moss RB, Carlo DJ. Higher doses of naloxone are needed in the synthetic opioid era. Subst Abuse Treat Prev Policy. 2019;14(1):6.
7. 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.
8. Egan TD, Lemmens HJ, Fiset P, et al. The pharmacokinetics of the new short-acting opioid remifentanil (GI87084B) in healthy adult male volunteers. Anesthesiology. 1993;79(5):881-892.
9. Glass PSA, Gan TJ, Howell S. A review of the pharmacokinetics and pharmacodynamics of remifentanil. Anesth Analg. 1999;89(4)(suppl):7.
10. Shafi A, Berry AJ, Sumnall H, Wood DM, Tracy DK. Synthetic opioids: a review and clinical update. Ther Adv Psychopharmacol. 2022;12:20451253221139616.
11. FDA Approval Summary Opvee NDA 217470. Center for Drug Evaluation and Research, US Food and Drug Administration. May 22, 2023. Accessed December 9, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/217470Orig1s000MedR.pdf
12. Krieter P, Gyaw S, Crystal R, Skolnick P. Fighting fire with fire: development of intranasal nalmefene to treat synthetic opioid overdose. J Pharmacol Exp Ther. 2019;371(2):409-415.