Rezenopy Nasal Spray

Rezenopy (naloxone hydrochloride) is a nasal spray that may be used to temporarily treat an opioid overdose or suspected opioid overdose in adults and children who have breathing problems and severe sleepiness or who are not able to respond.

• Rezenopy nasal spray should be given right away and should not take the place of emergency medical care.
• Follow up with emergency medical help right away after giving the first dose of Rezenopy nasal spray, even if the person wakes up.
• Rezenopy nasal spray does not affect people who are not taking opioid medicines. Always carry Rezenopy nasal spray with you in case of an opioid emergency.

Rezenopy (naloxone hydrochloride) works by antagonizing the effects of opioids by competing for the same receptor sites. This reverses the effects of opioids, such as breathing problems, sedation, and low blood pressure. It can also undo the mind-altering and unpleasant effects caused by drugs like pentazocine.

Rezenopy nasal spray is safe and effective in children for a known or suspected opioid overdose.

Rezenopy nasal spray was granted FDA approval on April 19, 2024. Naloxone has been FDA-approved since April 13, 1971.

Rezenopy nasal spray is for use inside your nose only.

• Always seek emergency medical care immediately after use.

To administer Rezenopy nasal spray, lie the person on their back. Support their neck with your hand and allow the head to tilt back before inserting the nozzle of the nasal spray into ONE nostril. Do not prime or test the device before administration.

• Administer the dose by firmly pressing the bottom of the device plunger.
• Remove the device from the nostril after giving the dose.
• Turn the person onto their side. Call 911 or get emergency medical help right away after giving the first dose of Rezenopy nasal spray.
• if the patient does not respond within 2 to 3 minutes or responds and then starts having breathing problems again while you are awaiting emergency help, administer another dose of Rezenopy nasal spray into the other nostril, using a new nasal spray,
• Do not administer more than 2 sprays of Rezenopy nasal spray per day.
• Provide additional first aid, such as rescue breathing or CPR (cardiopulmonary resuscitation) while awaiting emergency medical assistance if necessary.

Naloxone has a shorter duration of action relative to opioids which means additional doses of Rezenopy nasal spray may be required. A caregiver should stay with the person who has been administered Rezenopy nasal spray until emergency medical assistance is available and administer additional doses of Rezenopy as necessary, using a new nasal spray device.

Naloxone may not be as effective at reversing breathing problems caused by partial agonists or mixed agonists/antagonists, such as buprenorphine or pentazocine. Larger or repeat doses may be required.

The use of Rezenopy nasal spray in patients who are opioid dependent may precipitate severe opioid withdrawal. In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated. This is why it is important to seek emergency help.

Abruptly reversing breathing problems caused by opioid administration post-surgery may cause adverse cardiovascular events. These events have most commonly occurred in people with pre-existing cardiovascular disorders or who have received other drugs that may have similar adverse cardiovascular effects. When used in this setting the patient should be monitored closely in an appropriate healthcare setting.

You and your family members or caregivers should read the Patient Information leaflet provided with Rezenopy BEFORE an opioid emergency happens. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

Do not use or give to people who are hypersensitive to naloxone or any of the other ingredients in the nasal spray.

Tell your healthcare provider about all your medical conditions, including if you:

• have heart problems
• are pregnant or intending to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

Life-sustaining treatment for an opioid overdose, such as Rezenopy nasal spray, should not be withheld in someone who is pregnant. An untreated opioid overdose can be fatal for the pregnant woman and unborn baby.

Breastfeeding

It is not known if Rezenopy nasal spray passes into your breast milk.

Rezenopy nasal spray may cause serious side effects, including sudden opioid withdrawal symptoms.

In someone who has been using opioids regularly, opioid withdrawal symptoms can happen suddenly after receiving Rezenopy nasal spray and may include:

• body aches, restlessness, or irritability
• nervousness or goosebumps
• increased heart rate or increased blood pressure
• fever, sweating, shivering, or trembling
• stomach cramping or diarrhea
• runny nose or sneezing
• yawning, nausea, or vomiting
• weakness.

In infants under 4 weeks old who have been receiving opioids regularly, sudden opioid withdrawal may be life-threatening if not treated the right way. Signs and symptoms include seizures, crying more than usual, and increased reflexes.

The most common side effects of Rezenopy nasal spray are upper stomach-area (abdominal) pain, the common cold, and changes in sense of taste.

These are not all the possible side effects of Rezenopy nasal spray. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1 800-FDA-1088.

The usual dosage is 1 spray of Rezenopy nasal spray into 1 nostril for adults and children. Each Rezenopy nasal spray contains 1 dose of medicine and cannot be reused.

Administer as quickly as possible if you or your caregiver 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. Signs and symptoms of an opioid emergency may include:

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

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

• Naloxone may not be as effective at reversing breathing problems caused by partial agonists or mixed agonists/antagonists, such as buprenorphine or pentazocine. Larger or repeat doses may be required.
• Naloxone may interact with other medications, such as kinase inhibitors (such as biminetinib), and droperidol. However, an opioid overdose is a potentially fatal medical emergency and these types of interactions are not a reason not to give naloxone.

This is not a complete list of interactions. Tell your healthcare provider about all the medicines you take.

Store Rezenopy nasal spray either in the refrigerator or at room temperature between 2°C to 25°C (36°F to 77°F).

Do not freeze. Do not expose to excessive heat above 40°C (104°F). Keep it in its box until ready to use. Protect from light.

Replace the nasal spray before the expiration date on the box.

Keep out of the reach of children.

Active ingredients: naloxone hydrochloride 10mg in 0.11 mL.

Inactive ingredients: glycerin, trisodium citrate dihydrate, hydrochloric acid, and sodium hydroxide to adjust pH, and purified water.

Rezenopy nasal spray is not made with natural rubber latex.

Summit Biosciences Inc.