Nalmefene
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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 ZURNAI 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 ZURNAI dosage is not required.
Preparation and administration
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Important Administration Instructions All approved nalmefene products achieve plasma concentrations that have been shown to be efficacious in reversing the effects of opioid overdose. Comparing different products on a nominal mg-for-mg basis may be misleading. ZURNAI is for intramuscular and subcutaneous use only. The device is ready to use.
No device assembly is required. Do not prime or test prior to administration. ZURNAI delivers its entire contents automatically, upon injection. Inject ZURNAI into the anterolateral aspect of the thigh. ZURNAI can be administered through clothing if necessary. Do not reuse ZURNAI. Each ZURNAI device contains a single dose of nalmefene and cannot be reused.
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 ZURNAI and the Instructions for Use . Instruct the patient or caregiver to read the Instructions for Use at the time they receive a prescription for ZURNAI.
Emphasize the following instructions to the patient or caregiver: – Administer ZURNAI 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 ZURNAI in the event of a suspected, potentially life-threatening opioid emergency.
Keep the patient under continued surveillance until emergency personnel arrive. – Additional doses of ZURNAI may be required until emergency medical assistance becomes available. – If available, re-administer ZURNAI using a new auto-injector, every 2 to 5 minutes if the patient does not respond or responds and then relapses into respiratory depression. – Once the safety seal is broken and blue cap is removed, ZURNAI must be used immediately or disposed of properly.
Do not attempt to replace the blue cap once it is removed. – Visually inspect ZURNAI through the viewing window for particulate matter and discoloration prior to administration. Do not administer unless the solution is clear, free of particulates, and the glass container is undamaged. – Administer ZURNAI according to the printed instructions on the device label, carton, and the Instructions for Use. ⮚ Place the needle guard of ZURNAI against the outer thigh.
Press the needle end firmly into the injection site until you hear a click and then hold for 3 seconds. After 3 seconds, the viewing window should turn completely orange, signaling that ZURNAI has delivered the intended dose of nalmefene. ⮚ Remove ZURNAI from the outer thigh. ⮚ Call for emergency medical assistance immediately after administration of the first dose of ZURNAI. ⮚ Move the patient on their side (recovery position).
Remain with the patient until emergency medical assistance arrives, even if the patient wakes up.
Contraindications
4 CONTRAINDICATIONS ZURNAI is contraindicated in patients known to be hypersensitive to nalmefene hydrochloride or to any other ingredients in the product. Hypersensitivity to nalmefene hydrochloride or to any other ingredients in ZURNAI. ( 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 effects on embryo-fetal development were observed in rats and rabbits treated with nalmefene [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 ZURNAI for opioid overdose should not be withheld because of potential concerns regarding the effects of ZURNAI on the fetus. Data Animal Data Reproduction studies have been performed in rats and rabbits by oral administration and in rabbits by intravenous administration of nalmefene.
No effects on embryo-fetal development were observed at rat oral doses up to 1200 mg/m 2 /day and rabbit oral doses up to 2400 mg/m 2 /day, and intravenous dose up to 96 mg/m 2 /day, which is 52 times the human dose of 3.0 mg (two ZURNAI administrations) based on body surface area comparison. 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.