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”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Nalmefene Intranasal has severe interactions with no other drugs.
• Nalmefene Intranasal has serious interactions with no other drugs.
• Nalmefene Intranasal has moderate interactions with no other drugs.
• Nalmefene Intranasal has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity to Nalmefene or any of the other ingredients

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Nalmefene Intranasal?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Nalmefene Intranasal?”

Cautions

• Reversal of respiratory depression by partial agonists or mixed agonists/antagonists (e.g., buprenorphine, pentazocine) may be incomplete; repeated doses of Nalmefene Intranasal may be necessary to antagonize buprenorphine owing to the long duration of action due to its slow rate of binding and subsequent slow dissociation from the opioid receptor
• Risk for recurrent respiratory and CNS depression
• Recurrence of respiratory depression is possible, even after adequate initial response to Nalmefene Intranasal
• Always seek out emergency medical assistance immediately after administering the first dose and continue to monitor the patient
• Additional doses may be necessary if symptoms of opioid overdose recur
• Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance
• Precipitation of severe opioid withdrawal
• May precipitate opioid withdrawal in patients who are opioid dependent
• Signs and symptoms include body aches, diarrhea, tachycardia, fever, runny nose, sneezing, piloerection, sweating, yawning, nausea or vomiting, nervousness, restlessness, or irritability, shivering or trembling, abdominal cramps, weakness, increased blood pressure
• Abrupt postoperative reversal of opioid depression after use may result in nausea, vomiting, sweating, tremulousness, tachycardia, hypotension, hypertension, seizures, ventricular tachycardia and fibrillation, pulmonary edema, and cardiac arrest
• After use, monitor patients with preexisting cardiac disease or patients who have received medications associated with cardiovascular effects, such as hypotension, ventricular tachycardia or fibrillation, and pulmonary edema, in an appropriate healthcare setting
• In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated and may include the following signs and symptoms: convulsions, excessive crying, and hyperactive reflexes
• Monitor for developing signs and symptoms of opioid withdrawal
• Use an alternative opioid antagonist product that can be titrated to effect and, where applicable, dosed according to weight
• Risk for opioid overdose from attempts to overcome the blockade
• Unlikely to produce acute withdrawal symptoms in nonopioid-dependent patients
• Use in patients who are opioid dependent may precipitate opioid withdrawal
• Attempting to overcome opioid withdrawal symptoms caused by opioid antagonists with high or repeated doses of exogenous opioids could lead to opioid intoxication and death
• Inform patients of the potential consequences of trying to overcome the opioid blockade
• Get emergency medical assistance as soon as possible after using nalmefene nasal spray regardless of withdrawal symptoms

Pregnancy and Lactation

• Do not withhold life-sustaining therapy for opioid overdose
• There are no available data on nalmefene use in pregnant women to evaluate for a drug-associated risk for major birth defects or miscarriage
• Clinical considerations
  • An opioid overdose is a medical emergency and can be fatal for the pregnant woman and fetus if left untreated
• Lactation
  • There are no data on the presence of nalmefene and its metabolites in human milk, effects on breastfed children, or on milk production
  • Nalmefene and its metabolites are present in rat milk
  • When a drug is present in animal milk, the drug is likely to be present in human milk