Nalmefene (nasal)
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
Renal Impairment Renal impairment substantially reduces the clearance of nalmefene [see Clinical Pharmacology ]. For single episodes of opioid antagonisms, adjustment of OPVEE nasal spray dosage is not required.
Dosing in liver impairment
Hepatic Impairment Hepatic impairment substantially reduces the clearance of nalmefene [see Clinical Pharmacology ]. For single episodes of opioid antagonism, adjustment of OPVEE nasal spray dosage is not required.
Preparation and administration
Important Administration Instructions OPVEE is for intranasal use only. The device is ready to use. No device assembly is required. Do not prime or test prior to administration. OPVEE nasal spray delivers its entire contents automatically, upon activation. Do not attempt to reuse OPVEE. Each unit-dose device contains a single dose of nalmefene and cannot be reused.
No device assembly is required. Because treatment of suspected opioid overdose must be performed by someone other than the patient, instruct the prescription recipient to inform those around them about the presence of OPVEE nasal spray and the Instructions for Use . Instruct the patient or caregiver to read the Instructions for Use at the time they receive a prescription for OPVEE nasal spray.
Emphasize the following instructions to the patient or caregiver: Administer OPVEE nasal spray as quickly as possible because prolonged respiratory depression may result in damage to the central nervous system or death. Always seek emergency medical assistance after administration of the first dose of OPVEE nasal spray in the event of a suspected, potentially life-threatening opioid emergency.
Keep the patient under continued surveillance until emergency personnel arrive. Additional doses of OPVEE nasal spray may be required until emergency medical assistance becomes available. Re-administer OPVEE nasal spray, using a new nasal spray, in the nose, every 2 to 5 minutes if the patient does not respond or responds and then relapses into respiratory depression.
Administer OPVEE nasal spray according to the printed instructions on the Quick Start Guide and the Instructions for Use . Place the patient in the supine position. Prior to administration, be sure the device nozzle is inserted in the nose of the patient and provide support to the back of the neck to allow the head to tilt back.
Do not prime or test the device prior to administration. To administer the dose, press firmly on the device plunger and remove the device nozzle from the nose after use. If the patient responds by waking up to the voice or touch or starts breathing normally, place the patient on their side (recovery position) as shown in the Instructions for Use and call for emergency medical assistance immediately after administration of the first dose of OPVEE nasal spray.
Contraindications
4 CONTRAINDICATIONS OPVEE nasal spray is contraindicated in patients known to be hypersensitive to nalmefene or to any of the other ingredients. Hypersensitivity to nalmefene or to any of the other ingredients. ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Life-sustaining therapy for opioid overdose should not be withheld (see Clinical Considerations ). There are no available data on nalmefene use in pregnant women to evaluate for a drug-associated risk of major birth defects or miscarriage. In animal reproduction studies, no embryotoxic effects on embryo-fetal development were observed in rats and rabbits treated with nalmefene at exposures at least 6 times (rats) and up to 20 times (rabbits) the exposure at two human nasal doses of 5.4 mg (see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk An opioid overdose is a medical emergency and can be fatal for the pregnant woman and fetus if left untreated. Treatment with OPVEE for opioid overdose should not be withheld because of potential concerns regarding the effects of OPVEE on the fetus.
Data Animal Data Reproduction studies have been performed in rats (up to 1200 mg/m 2 /day) and rabbits (up to 2400 mg/m 2 /day) by oral administration of nalmefene and in rabbits by intravenous administration up to 96 mg/m 2 /day. No effects on embryo-fetal development were observed at exposures at least 6 times (rats) and up to 20 times (rabbits) the exposure corresponding to a human dose of 5.4 mg (two nalmefene nasal sprays) on an AUC basis. The treatment in rats did not affect offspring survival.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.