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Nalmefene HCl offers an additional opioid overdose reversal option1

High binding affinity to
                  opioid receptors
High binding affinity to
opioid receptors2,3
10.8-hour mean terminal elimination half-life icon
10.8-hour mean terminal
elimination half-life1,*
Reverses opioid effects icon
Reverses opioid effects, including
respiratory depression, sedation,
and hypotension1
Safety and tolerability
                  icon
Safety and tolerability
similar to naloxone1
Duration of action
               as long as most opioid analgesics icon
Duration of action
as long as most
opioid analgesics1
While Nalmefene Hydrochloride injection has a longer duration of action than naloxone in fully reversing doses, the physician should be aware that a recurrence of respiratory depression is possible, even after an apparently adequate initial response to Nalmefene Hydrochloride injection treatment. Patients treated with Nalmefene Hydrochloride injection should be observed until, in the opinion of the physician, there is no reasonable risk of recurrent respiratory depression.1
High binding affinity to
               opioid receptors
High binding affinity
to opioid receptors2,3

Reverses opioid effects icon
Reverses opioid effects, including respiratory depression, sedation, and

hypotension1


Safety and tolerability icon
10.8-hour mean
terminal elimination half-life1,*

10.8-hour mean terminal elimination half-life icon
Safety and tolerability
similar to naloxone1

duration of action icon
Duration of action as long as most opioidanalgesics1
While Nalmefene Hydrochloride injection has a longer duration of action than naloxone in fully reversing doses, the physician should be aware that a recurrence of respiratory depression is possible, even after an apparently adequate initial response to Nalmefene Hydrochloride injection treatment. Patients treated with Nalmefene Hydrochloride injection should be observed until, in the opinion of the physician, there is no reasonable risk of recurrent respiratory depression.
*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

Demonstrated reversal of respiratory depression1

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 overdose
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
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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 mg1

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%
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 post operative 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.

WARNINGS AND PRECAUTIONS

Use of Nalmefene Hydrochloride injection in Emergencies
Nalmefene Hydrochloride injection, like all drugs in this class, is not the primary treatment for ventilatory failure. In most emergency settings, treatment with Nalmefene Hydrochloride injection should follow, not precede, the establishment of a patent airway, ventilatory assistance, administration of oxygen, and establishment of circulatory access.

Risk of Recurrent Respiratory Depression
Accidental overdose with long acting opioids [such as methadone and levo-alpha-acetylmethadol (LAAM)] may result in prolonged respiratory depression. Respiratory depression in both the postoperative and overdose setting may be complex and involve the effects of anesthetic agents, neuromuscular blockers, and other drugs. While Nalmefene Hydrochloride injection has a longer duration of action than naloxone in fully reversing doses, the physician should be aware that a recurrence of respiratory depression is possible, even after an apparently adequate initial response to Nalmefene Hydrochloride injection treatment.

Patients treated with Nalmefene Hydrochloride injection should be observed until, in the opinion of the physician, there is no reasonable risk of recurrent respiratory depression.

Cardiovascular Risks with Narcotic Antagonists
Pulmonary edema, cardiovascular instability, hypotension, hypertension, ventricular tachycardia, and ventricular fibrillation have been reported in connection with opioid reversal in both postoperative and emergency department settings. In many cases, these effects appear to be the result of abrupt reversal of opioid effects.

Although Nalmefene Hydrochloride injection has been used safely in patients with pre-existing cardiac disease, all drugs of this class should be used with caution in patients at high cardiovascular risk or who have received potentially cardiotoxic drugs

Risk of Precipitated Withdrawal
Nalmefene Hydrochloride injection, like other opioid antagonists, is known to produce acute withdrawal symptoms and, therefore, should be used with extreme caution in patients with known physical dependence on opioids or following surgery involving high doses of opioids. Imprudent use or excessive doses of opioid antagonists in the postoperative setting has been associated with hypertension, tachycardia, and excessive mortality in patients at high risk for cardiovascular complications.

Incomplete Reversal of Buprenorphine
Preclinical studies have shown that nalmefene at doses up to 10 mg/kg (437 times the maximum recommended human dose) produced incomplete reversal of buprenorphine-induced analgesia in animal models. This appears to be a consequence of a high affinity and slow displacement of buprenorphine from the opioid receptors. Hence, Nalmefene Hydrochloride injection may not completely reverse buprenorphine-induced respiratory depression.

Use in Pediatric Patients
Safety and effectiveness of nalmefene hydrochloride injection in pediatric patients have not been established.

ADVERSE REACTIONS
The most common adverse reactions (>1%) reported in clinical trials with nalmefene injection were nausea (18%), vomiting (9%), tachycardia (5%), hypertension (5%), postoperative pain (4%), fever (3%), and dizziness (3%).

INDICATIONS AND USAGE
Nalmefene Hydrochloride Injection is indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids. Nalmefene Hydrochloride Injection is indicated in the management of known or suspected opioid overdose.
To report SUSPECTED ADVERSE REACTIONS, contact Purdue Pharma L.P. at 1-888-726-7535 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please read Full Prescribing Information available here.

References. 1. Nalmefene HCl Injection Full Prescribing Information. Purdue Pharma L.P.; 2022. 2. Cassel JA, Daubert JD, DeHaven RN. [3H]Alvimopan binding to the μ opioid receptor: comparative binding kinetics of opioid antagonists. Eur J Pharmacol. 2005;520(1-3):29-36. doi:10.1016/j.ejphar.2005.08.008 3. Emmerson PJ, Liu M-R, Woods JH, Medzihradsky F. Binding affinity and selectivity of opioids at mu, delta and kappa receptors in monkey brain membranes. J Pharmacol Exp Ther. 1994;271(3):1630-1637. 4. US Food and Drug Administration. Determination that REVEX (nalmefene hydrochloride injection), 0.1 milligram base/milliliter and 1.0 milligram base/milliliter, was not withdrawn from sale for reasons of safety or effectiveness. Accessed June 30, 2022. https://www.federalregister.gov/ documents/2017/11/03/2017-23952/determination-that-revex-nalmefene-hydrochloride-injection-01-milligram-basemilliliter-and-10 5. Kaplan JL, Marx JA, Calabro JJ, et al. Double-blind, randomized study of nalmefene and naloxone in emergency department patients with suspected narcotic overdose. Ann Emerg Med. 1999;34(1):42-50. doi:10.1016/s0196-0644(99)70270-2
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IMPORTANT SAFETY INFORMATION AND INDICATION

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