Zurnai (Nalmefene hydrochloride): Uses, Side Effects and Dosage

What is the most important information I should know about ZURNAI?

ZURNAI is used to temporarily reverse the effects of opioid medicines. The medicine in ZURNAI is not expected to have an effect in people who are not taking opioid medicines. Always carry ZURNAI with you in case of an opioid emergency.

1. 1.

   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.
2. 2. 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.
3. 3. 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.
4. 4. 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.

What is ZURNAI?

• ZURNAI is a prescription medicine used in adults and children 12 years of age and older for the treatment of an opioid emergency such as an overdose or a possible opioid overdose with signs of breathing problems and severe sleepiness or not being able to respond.
• ZURNAI is to be given right away and does not take the place of emergency medical care. Get emergency medical help right away after giving the first dose of ZURNAI, even if the person wakes up.

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.

Do not use ZURNAI if you are allergic to nalmefene hydrochloride or any of the ingredients in ZURNAI. See the end of this Patient Information leaflet for a complete list of ingredients in ZURNAI.

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.

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

How should I use ZURNAI?

Read the "Instructions for Use" at the end of this Patient Information leaflet 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 ZURNAI 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.

What are the possible side effects of ZURNAI?

ZURNAI 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 ZURNAI and may include:

• body aches
• diarrhea
• increased heart rate
• fever
• runny nose
• sneezing

• goose bumps
• 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.

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

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 FDA at 1-800-FDA-1088.

How should I store ZURNAI?

• Store ZURNAI at room temperature between 68°F to 77°F (20°C to 25°C).
• Do not freeze or refrigerate.
• Store ZURNAI in a clean dry place. Protect from light.
• Keep ZURNAI 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 ZURNAI 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.

General information about the safe and effective use of ZURNAI.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ZURNAI for a condition for which it was not prescribed. You can ask your pharmacist or healthcare provider for information about ZURNAI that is written for health professionals.

What are the ingredients in ZURNAI?

Active ingredient: nalmefene

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

ZURNAI is not made with natural rubber latex.

Manufactured for: Knoa Pharma LLC, Stamford, CT 06901-3431.

For more information, go to www.ZURNAI.com or call 1-888-726-7535.

INSTRUCTIONS FOR USE

ZURNAI™ (zur nye)

(nalmefene injection)

The Instructions for Use contains information on how to give ZURNAI in response to a known or suspected opioid overdose in adults and children 12 years of age and older. You and your family members or caregivers should read the Instructions for Use that comes with ZURNAI before using it. Talk to your healthcare provider if you and your family members or caregivers have any questions about the use of ZURNAI.

ZURNAI auto-injector parts:

Important information you need to know before injecting ZURNAI

• The ZURNAI auto-injector is ready to use. Do not test or prime ZURNAI before use.
• Each ZURNAI auto-injector contains 1 dose of medicine and cannot be reused.
• Inject ZURNAI into the muscle (intramuscular) or underneath the skin (subcutaneous) of the outer thigh. Do not inject into any other area of the body.

Preparing to inject ZURNAI

• Check person for signs of a suspected overdose:

  • will not wake to voice or touch
  • very sleepy
  • not breathing well
• Check the auto-injector label to make sure you are injecting ZURNAI.
• Check for any visible damage to the auto-injector before using.
• Check the auto-injector to make sure the safety seal is not broken and the blue cap is secure and not missing.
• Check the liquid through the viewing window before using. It should be clear, colorless to light-yellow and free of particles. You may see air bubbles. This is normal.

Injecting ZURNAI

1. Remove the blue cap
Twist the blue cap counterclockwise to break the safety seal and pull straight off to remove the cap. After the blue cap is removed, a few drops of liquid may appear on the needle end. This is normal. ZURNAI must be used right away after the safety seal is broken and blue cap is removed. Do not replace the blue cap after it has been removed. If you do not use ZURNAI right away, see Step 5 for instructions on how to throw away ZURNAI. Do not touch the needle end of the auto-injector after the blue cap is removed to prevent injury or accidental activation.
2. Position and inject
Place the needle guard of the auto-injector against the outer thigh. The needle will inject through clothing. Push the auto-injector firmly down against the outer thigh until you hear a "click" (the click indicates the start of the injection). Hold in place for 3 seconds.
3. Inspect the viewing window
After holding in place for 3 seconds, the viewing window should turn completely orange. A fully blocked (completely orange) window confirms the injection is complete. Remove the auto-injector from the outer thigh. Do not replace the blue cap after the injection. If the viewing window is not fully blocked after injecting, repeat Steps 1 to 3 using a new ZURNAI auto-injector.
4. Call 911 and watch the person
Call 911 or get emergency medical help right away after the injection. Move the person on their side (recovery position). Hand is supporting their head. Bend their knee. Turn their face to the side. Watch the person for response. Wait for 2 to 5 minutes to see if the person wakes up. If no response, repeat Steps 1 to 3 using a new ZURNAI auto-injector to give another dose. If more ZURNAI auto-injectors are available, Steps 1 to 3 may be repeated every 2 to 5 minutes until the person responds or emergency medical help arrives. Stay with the person until medical help arrives, even if the person wakes up.
5. Throw away (dispose of) the used ZURNAI auto-injector
Disposing of (throwing away) ZURNAI Put your used ZURNAI auto-injector in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) ZURNAI in your household trash. If you do not have an FDA-cleared sharps disposal container, you may use a household container that is: made of a heavy-duty plastic, can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, upright and stable during use, leak resistant, and properly labeled to warn of hazardous waste inside the container. When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal. Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
Important: Always keep the sharps disposal container out of the reach of children.