Nalmefene Intranasal

Nalmefene Intranasal is a prescription medication used for emergency treatment of known or suspected opioid (natural or synthetic) overdose as manifested by respiratory and/or central nervous system depression.

• Nalmefene Intranasal is available under the following different brand names: Opvee

Common side effects of Nalmefene Intranasal include:

• precipitation of severe opioid withdrawal
• increased blood pressure
• musculoskeletal pain
• headache
• nasal dryness
• nasal swelling
• nasal congestion
• nasal inflammation

Serious side effects of Nalmefene Intranasal include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat
• fast heart rate
• low or high blood pressure
• dizziness
• fever
• chills
• headache
• flushing, or feeling of warmth

Rare side effects of Nalmefene Intranasal include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Intranasal solution

• 2.7 mg/0.1 mL; each unit-dose nasal spray delivers a single 2.7 mg dose

Opioid overdose

Adult dosage

• Administer 1 spray (2.7 mg) Intranasally into the nose as soon as possible
• Administer additional doses, using a new nasal spray with each dose, if a patient is nonresponsive or relapses into respiratory depression after the response
• May readminister dose every 2-5 min until emergency medical assistance arrives
• Consider additional supportive and/or resuscitative measures

Pediatric dosage

• Children aged 12 years: Safety and efficacy not established
• Children aged 12 years and above
  • For Intranasal use only
  • Seek emergency care immediately after use
  • Administer 1 spray (2.7 mg) Intranasally into the nose as soon as possible
  • Administer additional doses, using a new nasal spray with each dose, if the patient is nonresponsive or relapses into respiratory depression after the response
  • May readminister dose every 2-5 min until emergency medical assistance arrives
  • Consider additional supportive and/or resuscitative measures

Dosage Considerations – Should be Given as Follows:

• See “Dosages”