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Nalmefene HCl offers an additional overdose reversal option1

High binding affinity to opioid receptors2,3
Reverses opioid effects, including respiratory depression, sedation, and hypotension1
Duration of action as long as most opioid analgesics1
10.8-hour mean terminal elimination half-life1,*
Safety and tolerability similar to naloxone1
 
In 1995, Nalmefene HCl Injection was approved by the FDA for use as an opioid overdose reversal medication under the brand name Revex®. It was withdrawn from the US market in 2008 by its manufacturer for reasons other than safety or effectiveness. The trials are based on studies conducted with Revex.4
Nalmefene was studied in 284 patients presumed to have taken an opioid overdose1
  • One of the 4 trials was a randomized, double-blind, phase 3 trial (N=176)5
Nalmefene injection doses of 0.5 mg to 1 mg effectively reversed respiratory depression within 2 to 5 minutes in most patients1
  • Dose range in clinical trials: 0.5 mg to 2 mg5
 
*Nalmefene elimination half-life is based on pharmacokinetic data. The mean terminal elimination half-life is 10.8 hours and 9.4 hours in younger (19 to 32 years) and elderly (62 to 80 years) healthy male subjects, respectively, following a Nalmefene 1 mg IV dose.1

Nalmefene HCl safety and tolerability

RELATIVE FREQUENCIES OF COMMON ADVERSE REACTIONS (INCIDENCE >1%, ALL CLINICAL SETTINGS)1

ADVERSE EVENT NALMEFENE (n=1127) NALOXONE (n=369) PLACEBO (n=77)
Nausea 18% 18% 6%
Vomiting 9% 7% 4%
Tachycardia 5% 8%
Hypertension 5% 7%
Postoperative pain 4% 4% N/A
Fever 3% 4%
Dizziness 3% 4% 1%
Headache 1% 1% 4%
Chills 1% 1%
Hypotension 1% 1%
Vasodilation 1% 1%
Nalmefene safety and tolerability profile in adult patients:
  • Adverse events were evaluated in both 152 healthy volunteers and 1127 patients who were treated for opioid overdose or for postoperative opioid reversal1
  • Nalmefene was well tolerated and no serious toxicity was observed during administration in healthy individuals when given at high doses (15x the highest recommended dose)1
  • At doses exceeding the recommended dose, Nalmefene produced symptoms suggestive of reversal of endogenous opioids, such as have been reported for other narcotic antagonist drugs. These symptoms (nausea, chills, myalgia, dysphoria, abdominal cramps, and joint pain) were usually transient and occurred at very low frequency1
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IMPORTANT SAFETY INFORMATION AND INDICATION

CONTRAINDICATION
Nalmefene Hydrochloride injection is contraindicated in patients with a known hypersensitivity to the product.