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fentanyl transmucosal
generic
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: BUCCAL TAB: 100 mcg, 200 mcg, 400 mcg, 600 mcg, 800 mcg; LOZENGE: 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1200 mcg, 1600 mcg
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: transmucosal fentanyl products not bioequivalent, caution advised if switching between products; see pkg insert for conversion from other transmucosal forms; not interchangeable with other fentanyl products, do not substitute on a mcg to mcg basis
breakthrough cancer pain, opioid-tolerant patients
- [buccal tablet form]
- Dose: individualize dose buccally/SL x1 prn; Start: 100 mcg buccally x1, may repeat x1 after 30min; Max: 4 tabs/dose; 2 doses/episode; Info: use lowest effective dose, shortest effective tx duration; must wait at least 4h before treating another episode; for initial titration incr. dose by 100 mcg/episode prn; titrate by 200 mcg if dose >400 mcg; for maintenance dosing, consider incr. dose after several consecutive episodes require 2 doses; may give maintenance doses SL; do not cut/chew/swallow tab
- [lozenge form]
- Dose: individualize dose PO x1 prn; Start: 200 mcg PO x1, may repeat x1 after 30min; Max: 2 doses/episode; 4 doses/day once pain control achieved; Info: use lowest effective dose, shortest effective tx duration; must wait at least 4h before treating another episode; for maintenance dosing, consider dose incr. after several consecutive episodes require 2 doses; titrate slowly in patients 65 yo and older; do not chew/swallow lozenge
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 .
- Dosage forms: LOZENGE: 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1200 mcg, 1600 mcg
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: transmucosal fentanyl products not bioequivalent, caution advised if switching between products; not interchangeable with other fentanyl products, do not substitute on a mcg to mcg basis
breakthrough cancer pain, opioid-tolerant patients
- [16 yo and older]
- Dose: individualize dose PO x1 prn; Start: 200 mcg PO x1, may repeat x1 after 30min; Max: 2 doses/episode; 4 doses/day once pain control achieved; Info: use lowest effective dose, shortest effective tx duration; must wait at least 4h before treating another episode; for maintenance dosing, consider dose incr. after several consecutive episodes require 2 doses; do not chew/swallow lozenge
renal dosing
- [see below]
- renal impairment: not defined, caution advised
- HD/PD: not defined
hepatic dosing
- [see below]
- hepatic impairment: not defined, caution advised