RiVive nasal spray (Naloxone 3 mg) is used for the emergency treatment of opioid overdose to help prevent deaths. RiVive nasal spray will be available over-the-counter (OTC) and is expected to be free or low-cost as the company, Harm Reduction Therapeutics (HRT), Inc., is a nonprofit pharmaceutical company. 

RiVive nasal spray is not a controlled substance, according to the US Drug Enforcement Administration (DEA).

RiVive nasal spray works by rapidly reversing the opioid's effects as it is an opioid antagonist. RiVive 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.

RiVive should be given as soon as possible when an opioid overdose is suspected if there are signs of slowed breathing, severe sleepiness, or the person is not able to respond (loss of consciousness). Once RiVive nasal spray has been given, the patient must receive emergency medical care straight away, even if they wake up.

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

When will RiVive be available?

It is expected that RiVive nasal spray will be available in early 2024. RiVive nasal spray received FDA approval on July 28, 2023.

RiVive is a medication that can temporarily reverse the effects of opioid medicines. It is effective only for those taking opioids. Remember to keep RiVive with you for opioid overdose emergencies.

Use the 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. Signs and symptoms of an opioid emergency may include:

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

You should know where your nasal spray is stored and how to give RiVive before an opioid emergency happens if you have family members, caregivers, or other people who are at risk of opioid overdose and may need to have a naloxone nasal spray administered in an opioid emergency.

After giving the first dose of RiVive, you need to get emergency medical help right away, even if the person wakes up. Rescue breathing or CPR (cardiopulmonary resuscitation) may be given while waiting for emergency medical help

The signs and symptoms of an opioid emergency can return after the nasal spray is given. If this happens, give another dose after 2 to 3 minutes using a new RiVive nasal spray and watch the person closely until emergency help is received.

Use RiVive exactly as instructed, follow all directions on the label, and read all medication guides or instruction sheets.

If you are a caregiver or family member, read all instructions when you first get this medicine so you will know how to use it in an emergency. Ask your doctor, pharmacist, or other healthcare provider if you have any questions.

• One RiVive nasal spray device contains one dose of medicine and cannot be reused.
• Do NOT test RiVive nasal spray before use.
• Hold the nasal spray device with your thumb plunger and a finger on each side of the nozzle.
• Insert the nozzle into one nostril and press the plunger firmly.
• You must get emergency help immediately. Call 911.
• After giving RiVive wait 2 to 3 minutes after the first dose to give time for the medicine to work. If they wake up but then become sleepy again, give the person another dose.  
• Stay with the person until the ambulance arrives, even if the person wakes up.
• If the person does not wake up 2 to 3 minutes after the first dose, give a second RiVive dose using a new nasal spray device.  
• It is safe to keep giving doses every 2 to 3 minutes until the person wakes up.
• Do not assume that an overdose episode has ended if symptoms improve. You may need to perform CPR (cardiopulmonary resuscitation) on the person while you are waiting for emergency help to arrive.

Usual RiVive nasal spray dose for opioid overdose:

Administer 1 RiVive spray intranasally into 1 nostril

If the desired response is not achieved after 2 or 3 minutes, give a second dose from a new RiVIve nasal spray device. Additional doses may be administered every 2 to 3 minutes in alternating nostrils until emergency medical assistance arrives.

Comments:

The duration of action of some opioids exceeds that of this drug and therefore, repeat doses may be needed; the need for repeat doses will depend on the amount, type, and route of administration of the opioid being antagonized.

Patients should remain under continued surveillance; if a patient responds and relapses back into respiratory depression, additional doses should be given.

Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance.

You should not be treated with this nasal spray if you are allergic to naloxone or any ingredients this nasal spray click here for a full list of RiVive ingredients.

If possible, before you receive this medicine, tell your doctor if you have heart problems.

RiVive in Pregnancy and breastfeeding

Tell your healthcare provider are pregnant or breastfeeding. Using RiVIve while you are pregnant may cause opioid withdrawal effects in your unborn baby. However, having an opioid overdose can be fatal to both mother and baby. It is much more important to treat an overdose in the mother. You must get emergency medical help after using this medicine. Be sure all emergency medical caregivers know that you are pregnant.

If you use opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks.

In an emergency, you may not be able to tell caregivers if you are pregnant or breastfeeding. Make sure any doctor caring for your pregnancy or your baby knows you received naloxone.

Avoid leaving a person alone after giving them a nasal spray dose. An overdose of naloxone can impair a person's thinking or reactions.

Get emergency medical help if you have signs of an allergic reaction to RiVive including hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Because RiVive nasal spray reverses opioid effects, RiVive 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 give this medicine to a baby properly. Everyone who has been given a dose of RiVive nasal spray should receive medical help immediately.

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 this nasal spray, 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.