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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Quick Start Guide

Simple instructions for administering OPVEE®.

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OPVEE® Frequently Asked Questions

OPVEE® is a prefilled, single-dose intranasal spray.1

OPVEE® is the first and only nasal opioid overdose rescue medicine specifically indicated for synthetic opioids, like fentanyl, as well as nonsynthetic opioids. OPVEE® is for patients 12 years or older and is not a substitute for medical care.1

Use OPVEE® right away if you think signs or symptoms of an opioid emergency are present, even if you are not sure, because an opioid emergency can cause severe injury or death.1

If the person does not return to normal breathing, or if their breathing returns but they relapse, an additional dose of OPVEE® can be administered as needed every 2 to 5 minutes.1

OPVEE® is indicated in the emergency treatment of known or suspected opioid overdose.1

OPVEE® is not a substitute for emergency medical care.1

If you suspect that someone is overdosing, administer OPVEE® as quickly as possible according to the Quick Start Guide and Instructions for Use, which can be found in the Full Prescribing Information.1

While the duration of action of nalmefene is as long as most opioids, seek immediate emergency medical assistance after administration of the first dose of OPVEE®. Keep the person under continued surveillance, even after an apparently adequate initial response to OPVEE® nasal spray treatment. A second dose may be necessary if there is recurrence of symptoms of opioid overdose.1

No, nalmefene is not addictive, and it has no activity in the absence of opioids.1

The most common adverse effects include1:

  • Nose (nasal) discomfort
  • Headache
  • Nausea
  • Dizziness
  • Hot flush
  • Vomiting
  • Anxiety
  • Tiredness
  • Nasal congestion
  • Throat irritation
  • Pain in the nose
  • Decreased appetite
  • Changes in the sense of taste
  • Skin redness
  • Increased sweating

These are not all of the possible side effects of OPVEE®.1

The safety of OPVEE® is supported by safety and pharmacokinetic studies of OPVEE® in healthy subjects.1

People who use opioids regularly may experience precipitated withdrawal (opioid withdrawal symptoms) after administration.

Symptoms can happen suddenly after receiving OPVEE® and may include 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.1

The active ingredient in OPVEE® is nalmefene 2.7 mg (equivalent to nalmefene HCl 3.0 mg) in 0.1 mL solution.1

Inactive ingredients include benzalkonium chloride, disodium ethylenediaminetetraacetate, dodecyl maltoside, sodium chloride, and purified water.1

The active ingredient of OPVEE® is nalmefene, whereas the active ingredient of NARCAN® is naloxone. OPVEE® is the first nasal rescue medicine to utilize nalmefene.1-3

Store OPVEE® in the blister and cartons provided.1

Store OPVEE® at controlled room temperature 15 °C to 25 °C (59 °F to 77 °F). Short-term excursions permitted between 4 °C to 40 °C (39 °F to 104 °F). Do not freeze. Protect from light.1

Do not open individual blister packs or test nasal spray devices before use.1

Each unit-dose nasal spray device sprays one (1) time and cannot be reused.1

OPVEE® has a 28-month shelf life from the date of manufacture.4

Learn how to order OPVEE® at OPVEEdirect.com.

Qualified direct purchasers may be eligible for public interest pricing. Product updates and additional product information are available from your representative. Reach out here to be connected to an Indivior representative today.

Qualifying direct purchasers, such as departments of health, emergency medical services, law enforcement, schools/universities, and community organizations, may be eligible to purchase OPVEE® at the public interest price, which is $37.50/dose or $75/2-pack (as of October 2, 2023). For other orders, the Wholesale Acquisition Cost (WAC)* of OPVEE® is $49/dose or $98/2-pack (as of October 2, 2023).

*The WAC price represents the manufacturer’s published catalog or list price for a drug product to wholesalers as reported to third-party drug price publishers. WAC does not represent actual transaction prices and does not include discounts, rebates, or reductions in price. Pricing information listed above does not imply safety or efficacy of the product, and no comparisons should be made.

Learn to administer OPVEE®

How to Use

WHAT IS OPVEE®

Learn more about the first and only overdose rescue medicine approved to reverse overdoses caused by synthetic opioids.

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Visit OPVEEdirect.com for a rescue medicine specifically designed to fight synthetic opioids, like fentanyl.

OVERDOSE EMERGENCIES

Gain a better understanding of why every
second matters during an overdose.

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. Prescribing Information for NARCAN®.
3. Prescribing Information for KLOXXADO®.
4. Roca R. NDA 217470 approval letter: Opvee (nalmefene) nasal spray. US Food and Drug Administration; May 22, 2023. Accessed June 8, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217470Orig1s000ltr.pdf