NALMEFENE SOLN,NASAL
Clinical Criteria Summary
Indications
- Emergency treatment of known or suspected overdose induced by natural or synthetic opioids in adults and pediatric patients aged 12 years and older.
Contraindications
- Known hypersensitivity to nalmefene or excipients.
Warnings & Precautions
- Risk of recurrent respiratory or central nervous system depression, especially in poly-drug overdose settings.
- Risk of limited efficacy with partial agonists or mixed agonists/antagonists (e.g., buprenorphine, pentazocine).
- Risk of severe, precipitated opioid withdrawal.
- Risk of overdose from attempts by an OPVEE-rescued patient to overcome the blockade.
Adverse Effects
- Nasal discomfort, dizziness, fatigue, headache, nausea, hot flush, anxiety, and vomiting.
- Adverse effects are common and expected with abrupt reversal of opioid agonism.
Dosage, Administration & Patient Population
- Single-use nasal administration device containing 2.7 mg nalmefene (3 mg nalmefene HCl) in 0.1 mL total volume; two dose units per package.
- Formulated with dodecylmaltoside (DDM), an absorption enhancer.
- Intended for bystander administration.
Clinical Limitations & Place in Therapy
- Based on Phase I pharmacokinetic and pharmacodynamic studies only.
- Claims of higher potency than naloxone for reversing illicit fentanyl and fentanyl analogues are overstated without real-world experience.
- Post-marketing published study found no difference in recovery rates between nalmefene and naloxone in an emergency department setting for suspected opioid overdose.