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Lazanda
fentanyl nasal
Black Box Warnings .
Appropriate Use
transmucosal immediate-release fentanyl restricted distribution program (TIRF REMS) due to accidental exposure, misuse, abuse, addiction, and overdose risks; enroll outpatients, outpatient prescribers, pharmacies, and distributors at 1-866-822-1483 or www.TIRFREMSAccess.com; develop inpatient pharmacy policies and procedures to verify opioid tolerance in hospitalized patients requiring tx
Addiction, Abuse, and Misuse
opioid agonist Schedule II controlled substance with risk of addiction, abuse, and misuse, which can lead to overdose and death; assess opioid abuse or addiction risk prior to prescribing; regularly reassess all patients for misuse, abuse, and addiction
Respiratory Depression
serious, life-threatening, or fatal cases have occurred, including after use in opioid non-tolerant patients and with improper dosing; monitor for respiratory depression especially during tx start or after dose incr; to decr. risk, initiate and titrate dose appropriately; substitution for any other fentanyl product may result in fatal overdose; due to respiratory depression risk, contraindicated in management of acute or postop pain including headache/migraine and in opioid non-tolerant patients
Accidental Ingestion
accidental ingestion of even one dose, especially by children, can result in fatal fentanyl overdose; death has been reported in children who have accidentally ingested transmucosal IR fentanyl; must keep out of reach of children
Risks from Concomitant Use with Benzodiazepines, CNS Depressants
concomitant opioid use with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death; reserve concomitant use for patients with inadequate alternative tx options
Medication Error Risk
substantial pharmacokinetic differences across fentanyl products result in clinically important differences in fentanyl absorption that could result in fatal overdose; when prescribing, do not convert patients on a mcg per mcg basis from any other fentanyl product; when dispensing, do not substitute prescription for other fentanyl products
Neonatal Opioid Withdrawal Syndrome
advise pregnant patients with extended opioid use of risk of potentially life-threatening neonatal opioid withdrawal syndrome; ensure tx by neonatology experts available at delivery
CYP450 3A4 Interaction
concomitant use with CYP450 3A4 inhibitors or D/C of concomitant CYP450 3A4 inducers may incr. fentanyl concentration which may incr. or prolong adverse effects including potentially fatal respiratory depression; monitor patients receiving any concomitant CYP450 3A4 inhibitor or inducer
Adult Dosing .
Dosage forms: SPRAY: 100 mcg per actuation, 300 mcg per actuation, 400 mcg per actuation
Restricted Distribution in US
- [1-866-822-1483 or www.TIRFREMSaccess.com for more info]
Special Note
- [prescribing info]
- Info: all transmucosal immediate-release fentanyl (TIRF) medicines discontinued on September 30, 2024; certified prescribers may continue to prescribe for currently enrolled patients until supplies are depleted; no new enrollments will be accepted; consider prescribing opioid overdose reversal agent (e.g., naloxone, nalmefene), especially if risk of opioid overdose or accidental ingestion
- [equivalency or interchangeability info]
- Info: fentanyl nasal not interchangeable with other fentanyl products; do not substitute on a mcg to mcg basis
breakthrough cancer pain, opioid-tolerant patients
- [individualize dose intranasally x1 prn]
- Start: 100 mcg intranasally x1; Max: 800 mcg/dose, 1 dose/episode, 4 doses/24h; Info: use lowest effective dose, shortest effective tx duration; must wait at least 2h before treating another episode; may titrate prn with each subsequent episode to 200 mcg dose, then 300 mcg dose, then 400 mcg dose, then 600 mcg dose, then 800 mcg dose; maintenance dose reached after adequate analgesia obtained within 30min x2 episodes
renal dosing
- [see below]
- renal impairment: not defined, caution advised
- HD/PD: not defined
hepatic dosing
- [see below]
- hepatic impairment: not defined, caution advised
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.