Opvee (nalmefene) is a nasal spray used for the emergency treatment of opioid overdose for patients 12 years and older. Opvee works by rapidly reversing the effects of opioid overdose, including respiratory depression, sedation and low blood pressure (hypotension). Opvee should be given as soon as possible when an opioid overdose is suspected, the patient should also receive emergency medical care immediately, even if they wake up.

Opvee it is an opioid antagonist that blocks the opioid receptors. Opvee competes for the opiate receptors in the brain and other areas of the body to help reverse the dangerous effects of the opioid so that the patient's breathing improves and they become more awake, and their blood pressure normalizes.

Examples of opioids are codeine, oxycodone (Oxycontin), heroin morphine, hydrocodone (Vicodin, Lortab), fentanyl, methadone, oxymorphone, meperidine, tramadol, buprenorphine, and hydromorphone.

Opvee Nasal Spray is a prescription medicine that delivers 2.7mg nalmefene. Each unit-dose nasal spray device sprays one (1) time and cannot be re-used. Each carton containis two unit-dose nasal spray devices.

Opvee Nasal Spray was FDA approved on May 22, 2023.

Use Opvee nasal spray as soon as possible if you or your caregiver think there are signs or symptoms of an opioid emergency, even if you are not sure, because an opioid emergency can cause severe injury or death. 

How to recognize opioid overdose

Signs and symptoms of an opioid overdose may include:

• unusual sleepiness and you are not able to wake the person up with a loud voice or by by rubbing firmly on the middle of their chest 
• problems with breathing such as slow or shallow breathing when a person who is difficult to wake up or who looks like they are not breathing
• the pupil (black circle in the center of the colored part of the eye) is very small, sometimes called "pinpoint pupils," in someone difficult to awaken.

Know where Opvee is kept and how to use it: It is important that family members and other people have access to Opvee nasal spray and know where it is and how to use it before there is an opioid overdose.

Call emergency services: It is important to call 911 or get emergency help immediately after giving the first dose. Rescue breathing or CPR (cardiopulmonary resuscitation) may be given while waiting for emergency medical help to arrive.

Risk of overdose symptoms returning: After the first dose of Opvee, even if the patient has had a good response, there may be a return of the symptoms of overdose, and another dose with a new Opvee nasal spray may be necessary every 2 to 5 minutes.

May not work with partial agonists or mixed agonists/antagonists: Reversal of opioid overdose symptoms may not be fully reversed or may need a second dose if the overdose is caused by partial agonists or mixed agonists/antagonists, such as buprenorphine and pentazocine.

May cause severe opioid withdrawal: In people who are opioid-dependent Opvee use may result in opioid withdrawal with signs and symptoms including body aches, diarrhea, fast heart rate (tachycardia), fever, runny nose, sneezing, goosebumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure.

Risk of Opioid Overdose from Attempts to Overcome the Blockade: If you try to overcome opioid withdrawal symptoms caused by opioid antagonists by using high or repeated doses of exogenous opioids may lead to opioid intoxication and death.

Before you need to use Opvee read the “Instructions for Use” for detailed information about how to use Opvee nasal spray.  Use Opvee exactly as prescribed by your doctor. 

• Each Opvee nasal spray only contains 1 dose of medicine and cannot be reused.
• Do NOT test or prime the nasal spray before use.
• Lay the person on their back with their neck supported with your hand and allow the head to tilt back before giving the nasal spray.
• Use one single nasal spray into nostril. 
• Call 911 or seek emergency care immediately after use.
• If the patient does not respond or responds and then relapses into respiratory depression, use another dose of nasal spray in the other nostril, using a new nasal spray with each dose. Additional doses of Opvee nasal spray may be given every 2 to 5 minutes until emergency medical assistance arrives. 
• Additional supportive and/or resuscitative measures may be helpful when waiting for emergency medical assistance to arrive. 

Opvee Dosing in Adults and Pediatric Patients aged 12 years and older: 

Initial Dosing: one spray given into nostril.

Repeat Dosing: Needing repeat doses of nasal spray depends on the amount, type, and or how the opioid has been used. 

• If the patient responds when the nasal spray is used and then overdose symptoms return, an additional dose may be used in the opposite nostril using a new Opvee nasal spray.
• If the patient has not responded after 2 to 5 minutes, an additional dose of nasal spray may be given using a new nasal spray. If there is still no response and additional doses are available, administer additional doses of nasal spray every 2 to 5 minutes using a new Opvee nasal spray device with each dose until emergency medical assistance arrives.
• If the patient has used buprenorphine and pentazocine, or other partial agonists or mixed agonists/antagonists then reversal of overdose symptoms may be incomplete, and repeated dose of nasal spray may be needed using a new nasal spray each time.

While waiting for emergency services to arrive, rescue breathing or CPR (cardiopulmonary resuscitation) may be given.

You should not use this medicine if you are allergic to nalmefene or any of the inactive ingredients in Opvee. Click here for a full list Opvee ingredients.

It is important to tell your healthcare professional if you have any

• Heart problems

Pregnancy

Tell your healthcare provider if you are pregnant or plan to become pregnant as Opvee nasal spray may cause withdrawal symptoms in your unborn baby. Your unborn baby should be examined by a healthcare provider right away after you use Opvee nasal spray. 

Breastfeeding

Tell your healthcare provider if you are breastfeeding or plan to breastfeed as it is not known if Opvee passes into your breastmilk.

Avoid leaving a person alone after giving him or her a Opvee nasal spray.

Get emergency medical help if you have signs of an allergic reaction symptoms include: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

The most common Opvee side effects (incidence at least 2%) may include nasal discomfort,headache, nausea, dizziness, hot flush, vomiting, anxiety, tiredness, nasal congestion, throat irritation, painful nose, decreased appetite, change in taste, skin redness, and increase in sweating.

Because this medicine reverses opioid effects, its use may cause sudden opioid withdrawal symptoms such as:

• nausea, vomiting, diarrhea, stomach pain;
• fever, sweating, body aches, weakness;
• tremors or shivering, fast heart rate, pounding heartbeats, increased blood pressure;
• goose bumps, shivering;
• runny nose, yawning; or
• feeling nervous, restless, or irritable.

Sudden withdrawal symptoms in a baby younger than 4 weeks old may be life-threatening if not treated the right way. Symptoms include crying, stiffness, overactive reflexes, and seizures. Call your doctor or get emergency medical help if you are not sure how to properly give this medicine to a baby.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with Opvee, including prescription and over-the-counter medicines, vitamins, recreational drugs and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.