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Management of known or suspected opioid overdose

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.1

RECOMMENDED DOSING FOR NALMEFENE HCI INJECTION ADMINISTRATION1,*

Patients without
opioid dependency

Initial dose
0.5 mg / 70 kg
Second dose
1.0 mg / 70 kg
2 to 5 minutes later, if needed
In both cases, if a total dose of 1.5 mg/70 kg has been administered without clinical response, additional Nalmefene injection is unlikely to have an effect. Patients should not be given more Nalmefene HCl Injection than is required to restore the respiratory rate to normal, thus minimizing the likelihood of cardiovascular stress and precipitated withdrawal syndrome.1

Patients with known or
suspected opioid dependency

Challenge dose
0.1 mg / 70 kg
If there is no evidence of
withdrawal in 2 minutes, proceed with the initial dose below
Initial dose
0.5 mg / 70 kg
Second dose
1.0 mg / 70 kg
2 to 5 minutes later, if needed
*While the Nalmefene Full Prescribing Information references dosing based on 70 kg body weight, clinical efficacy and safety studies conducted with Revex administered doses of Nalmefene without regard to body weight.2
In both cases, if a total dose of 1.5 mg/70 kg has been administered without clinical response, additional Nalmefene injection is unlikely to have an effect. Patients should not be given more Nalmefene HCl Injection than is required to restore the respiratory rate to normal, thus minimizing the likelihood of cardiovascular stress and precipitated withdrawal syndrome.1

Further information on Nalmefene HCl administration

  • The primary administration route of Nalmefene is intravenous (IV)
  • Nalmefene can also be given intramuscularly (IM) or subcutaneously (SC) if venous access cannot be established1
  • Nalmefene is intended for parenteral use only. It is not intended or indicated for intranasal use with a nasal atomizer3

Important considerations for Nalmefene HCl administration

FOLLOWING ADMINISTRATION RECOMMENDATIONS CAN
HELP AVOID PRECIPITATED WITHDRAWAL


The recommended doses of Nalmefene were selected with the goal of achieving a prompt opioid reversal in a controlled manner.1
  • Using higher doses or shorter intervals between incremental doses is likely to increase the incidence and severity of acute withdrawal symptoms1

Nalmefene, like other opioid antagonists, is known to produce acute withdrawal symptoms that may require medical attention and, therefore, should be used with extreme caution in patients with known physical dependence on opioids.1

The recommended doses of Nalmefene were selected with the goal of achieving a prompt opioid reversal in a controlled manner.1

  • Using higher doses or shorter intervals between incremental doses is likely to increase the incidence and severity of acute withdrawal symptoms1

Nalmefene, like other opioid antagonists, is known to produce acute withdrawal symptoms that may require medical attention and, therefore, should be used with extreme caution in patients with known physical dependence on opioids1

DURATION OF ACTION AND POTENTIAL FOR RECURRENCE
OF RESPIRATORY DEPRESSION1



Although Nalmefene has a long duration of action, the recurrence of respiratory depression can occur, even after an apparently adequate initial response to Nalmefene1

Patients treated with Nalmefene should be observed until, in the physician’s opinion, there is no reasonable risk of recurrent respiratory depression1

The duration of action of Nalmefene can vary depending on1:

  • The half-life and plasma concentration of the narcotic being reversed
  • The presence of other drugs affecting the brain or respiratory muscles
  • The dose of Nalmefene administered

Although Nalmefene has a long duration of action, the recurrence of respiratory depression can occur, even after an apparently adequate initial response to Nalmefene.1

Patients treated with Nalmefene should be observed until, in the physician’s opinion, there is no reasonable risk of recurrent respiratory depression1

The duration of action of Nalmefene can vary depending on1:

  • The half-life and plasma concentration of the narcotic being reversed
  • The presence of other drugs affecting the brain or respiratory muscles
  • The dose of Nalmefene administered
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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. 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.