Nalmefene (NAL-me-feen)

Treats opioid overdose in an emergency situation. Must be given as soon as possible.

Brand Name(s):

Opvee

When This Medicine Should Not Be Used:

How to Use This Medicine:

Spray

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• This medicine must be given to you (the patient) by someone else. Talk with people close to you so they know what to do in case of an emergency.
• This medicine is for use only in the nose. Do not get any of it in your eyes or on your skin. If it does get on these areas, rinse it off right away.
• To use:
  • Each nasal spray contains only one dose of nalmefene. Do not prime or test the nasal spray.
  • Hold the nasal spray with your thumb on the white plunger and your fingers on either side of the nozzle.
  • Lay the patient on his or her back. Support the patient's neck with your hand and let the head tilt back.
  • 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 patient's nose.
  • Press the plunger firmly to give the dose. Remove the nasal spray from the patient's nose.
  • Move the patient on his or her side (recovery position). Get emergency medical help right away.
  • Watch the patient closely. If needed, you may give more doses every 2 to 5 minutes until the patient responds or emergency medical assistance becomes available. Use a new nasal spray for each dose and spray the medicine into the other nostril each time.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have heart or blood vessel disease.
• This medicine should be given right away after a suspected or known overdose of an opioid (narcotic) medicine. This will help prevent serious breathing problems and severe sleepiness that can lead to death.
• The effects of the opioid medicine may last longer than the effects of the nalmefene. This means the breathing problems and sleepiness could come back. Always call for emergency help after the first dose of nalmefene.
• This medicine could cause withdrawal symptoms from the opioid medicine.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Diarrhea, nausea, vomiting, stomach cramps or pain
• Fast, pounding, or uneven heartbeat
• Fever, runny nose, sneezing, sweating, yawning, discomfort in the nose
• Lightheadedness, dizziness, fainting
• Seizures, shaking, or feeling restless, nervous, or irritable
• Unusual tiredness or weakness

If you notice these less serious side effects, talk with your doctor:

• Change or loss of taste
• Headache
• Increased sweating
• Warmth or redness in your face, neck, arms, or upper chest

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088