Zurnai

Zurnai (nalmefene) is an opioid antagonist autoinjector that may be used for the treatment of an opioidemergency such as an overdose or a possible opioid overdose with signs of breathing problems and severe sleepiness or not being able to respond, in adults and children aged 12 years and older.

• Zurnai should be given right away and does not replace emergency medical care. Get emergency medical help immediately after giving the first dose of Zurnai, even if the person wakes up.
• Zurnai can be used to reverse symptoms such as breathing problems, severe sleepiness, or unresponsiveness induced by natural or synthetic opioids.
• It is not known if Zurnai is safe and effective in children younger than 12 years of age for the emergency treatment of known or suspected opioid overdose.

Zurnai works by occupying the same receptors in the brain as opioids, preventing opioids from binding and producing their effects. This reverses the dangerous effects of opioids and improves breathing, alertness, and blood pressure.

Zurnai gained FDA approval on 7 August 2024, as the first nalmefene autoinjector. Nalmefene was first approved as an injection formulation in 1995 under the brand name Revex (now discontinued) and in a nasal spray formulation under the brand name Opvee in 2023.

Zurnai temporarily reverses the effects of opioid medicines. The medicine in Zurnai is not expected to affect people who are not taking opioid medicines. Always carry Zurnai with you in case of an opioid emergency.

Use Zurnai right away 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 by 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.

Family members, caregivers, or other people who may have to use Zurnai in an opioid emergency should know where Zurnai is stored and how to give Zurnai before an opioid emergency happens. Make sure everyone reads the information contained in the carton as soon as you receive Zurnai.

• Call 911 or get emergency medical help right away after giving the first dose of Zurnai. 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 Zurnai is given. If this happens, give additional doses of Zurnai every 2 to 5 minutes using a new Zurnai auto-injector for each dose and watch the person closely until emergency help arrives.

Do not use Zurnai if you are allergic to nalmefene hydrochloride or any of the ingredients in Zurnai (see the end of this guide for a list of ingredients).

Before using Zurnai, tell your healthcare provider about all of your medical conditions, including if you:

• have heart problems
• are pregnant or plan to become pregnant. It is not known if Zurnai will harm your unborn baby
• are breastfeeding or plan to breastfeed. It is not known if Zurnai passes into your breast milk.

Common side effects

The most common side effects of Zurnai include:

• feeling hot
• nausea
• headache
• dizziness
• chills
• vomiting
• feeling pain from things that are not usually painful (allodynia)
• irregular heartbeat (palpitations)
• ringing in the ear
• ear discomfort
• feeling abnormal
• burning sensation
• hot flush
• irritability.

Serious side effects and warnings

Zurnai may cause the following serious side effects:

• Sudden opioid withdrawal symptoms. In someone who has been using opioids regularly, opioid withdrawal symptoms can happen suddenly after receiving Zurnai and may include: body aches diarrhea increased heart rate fever runny nose sneezing goosebumps sweating yawning nausea or vomiting nervousness restlessness or irritability shivering or trembling stomach cramping weakness increased blood pressure.
• Risk of opioid overdose. Zurnai blocks the effects of opioids and may cause opioid withdrawal in someone who has been using opioids regularly. Do not take large amounts of opioids to try to overcome the opioid-blocking effects of Zurnai. This could lead to an opioid overdose and death. Call 911 or get emergency medical help right away after using Zurnai.

It is not known if Zurnai is safe and effective in children younger than 12 years of age for the emergency treatment of known or suspected opioid overdose.

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

Read the “Instructions for Use” in the Zurnai Package Insert for detailed information about the right way to use Zurnai. Use Zurnai exactly as prescribed by your healthcare provider.

• Each Zurnai auto-injector contains only 1 dose of medicine and cannot be reused.
• The Zurnai auto-injector is ready to use. Do not test or prime it before use.

Zurnai should be injected into the muscle (intramuscular) or underneath the skin (subcutaneous) of the outer thigh. It can be injected through your clothing if needed.

• Administer additional doses of Zurnai, using a new autoinjector for each dose. If the patient does not respond or responds and then relapses into respiratory depression, additional doses of Zurnai may be given every 2 to 5 minutes until emergency medical assistance arrives.

Seek emergency medical care immediately after use.

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

Tell your healthcare provider about the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Zurnai may not fully reverse an overdose caused by certain opioids, such as buprenorphine or pentazocine, because of the way these medicines work. If this happens, more than one dose may be needed. Give another dose using a new Zurnai auto-injector, and get emergency medical help right away.

Store Zurnai at room temperature between 68°F and 77°F (20°C and 25°C), with excursions permitted between 59°F and 86°F (15°C and 30°C).

• Do not freeze or refrigerate.
• Store in a clean, dry place. Protect from light.
• Keep in the carton until use.
• During storage, check Zurnai through the viewing window of the auto-injector every 30 days. The liquid should be clear, colorless to light yellow. If the liquid is discolored, cloudy, or contains solid particles, replace it with a new Zurnai.
• Check the expiration date. Replace Zurnai before the expiration date.

Keep Zurnai and all medicines out of the reach of children

Active ingredients: nalmefene 1.5 mg/ 0.5 mL

Inactive ingredients: hydrochloric acid to adjust pH, magnesium chloride 4.7 mg, and water for injection.

Each Zurnai auto-injector delivers 1.5 mg nalmefene (equivalent to 1.7 mg nalmefene hydrochloride) in 0.5 mL solution. The pH range is 3.5 to 4.5.

Zurnai (nalmefene) is manufactured for Knoa Pharma LLC, Stamford, CT 06901-3431.