Nalmefene Nasal Spray

Nalmefene nasal spray is used along with emergency medical treatment to reverse the life-threatening effects of a known or suspected opiate (narcotic) overdose in adults and children 12 years of age and older. Nalmefene nasal spray is in a class of medications called opiate antagonists. It works by blocking the effects of opiates to relieve dangerous symptoms caused by high levels of opiates in the blood.

Nalmefene comes as a solution (liquid) to spray into the nose. It is usually given as needed to treat opiate overdoses. Each nalmefene nasal spray contains a single dose of nalmefene and should be used only once.

You will probably be unable to treat yourself if you experience an opiate overdose. You should make sure that your family members, caregivers, or the people who spend time with you know how to tell if you are experiencing an overdose, how to use nalmefene nasal spray, and what to do until emergency medical help arrives. Your doctor or pharmacist will show you and your family members how to use the medication. You and anyone who may need to give the medication should read the instructions that come with the nasal spray. Ask your pharmacist for the instructions or visit the manufacturer's website to get the instructions.

You should keep the nasal spray available at all times in case you experience an opioid overdose. Be aware of the expiration date on your device and replace the spray when this date passes.

Nalmefene nasal spray may not reverse the effects of certain opiates such as buprenorphine (Belbuca, Buprenex, Butrans, Sublocade) and pentazocine (Talwin) and may require additional nalmefene doses with a new nasal spray each time.

Symptoms of an opioid overdose include excessive sleepiness, not awakening when spoken to in a loud voice or when the middle of your chest is rubbed firmly, shallow or stopped breathing, or small pupils (black circles in the center of the eyes). If someone sees that you are experiencing these symptoms, he or she should give you your first nalmefene dose and then call 911 immediately. After receiving the nalmefene nasal spray, a person should stay with you and watch you closely until emergency medical help arrives.

To give the inhaler, follow these steps:

1. Lay the person on their back to give the medication.
2. Remove the nalmefene nasal spray from the box. Peel back the tab to open the spray.
3. Do not prime the nasal spray before using it.
4. Hold the nalmefene nasal spray with your thumb on the bottom of the plunger and your first and middle fingers on either side of the nozzle.
5. Gently insert the tip of the nozzle into one nostril, until your fingers on either side of the nozzle are against the bottom of the person's nose. Provide support to the back of the person's neck with your hand to allow the head to tilt back.
6. Press the plunger firmly to release the medication.
7. Remove the nasal spray nozzle from the nostril after giving the medication.
8. Turn the person on their side (recovery position) and call for emergency medical assistance immediately after giving the first nalmefene dose.
9. If the person does not respond by waking up, to voice or touch, or breathing normally or responds and then relapses, give another dose. If needed, give additional doses (repeating steps 2 through 7) every 2 to 5 minutes in alternate nostrils with a new nasal spray each time until emergency medical assistance arrives.
10. Put the used nasal spray(s) back in the container and out of reach of children until you can safely dispose of it.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving nalmefene nasal spray,

• tell your doctor and pharmacist if you are allergic to nalmefene, any other medications, or any of the ingredients in nalmefene nasal spray. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• tell your doctor if you have or have ever had heart disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you receive naloxone nasal spray during pregnancy, your doctor may need to monitor your unborn baby carefully after you receive the medication.

Nalmefene nasal spray may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• nasal congestion, discomfort, or pain
• throat irritation
• dizziness
• hot flushes
• red skin
• feeling anxious
• tiredness
• decreased appetite
• change in sense of taste

Some side effects can be serious. If you experience any of these symptoms, get emergency medical treatment:

• signs of opiate withdrawal such as body aches; diarrhea; fast, pounding, or irregular heartbeat; fever; runny nose; sneezing; sweating; yawning; nausea; vomiting; nervousness; restlessness; irritability; shivering or trembling; stomach cramps; weakness; and the appearance of hair on the skin standing on end
• seizures
• loss of consciousness

Nalmefene nasal spray may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom). Do not freeze the nalmefene nasal spray.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location — one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Opvee^®