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Subsys
fentanyl transmucosal
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 pts requiring tx
Addiction, Abuse, and Misuse
opioid agonist Schedule II controlled substance w/ 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 pts for misuse, abuse, and addiction
Respiratory Depression
serious, life-threatening, or fatal cases have occurred, incl. after use in opioid non-tolerant pts and w/ improper dosing; monitor for resp. depression esp. 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 resp. depression risk, contraindicated in management of acute or postop pain incl. headache/migraine and in opioid non-tolerant pts
Accidental Ingestion
accidental ingestion of even one dose, esp. 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 w/ Benzodiazepines, CNS Depressants
concomitant opioid use w/ benzodiazepines or other CNS depressants, incl. alcohol, may result in profound sedation, resp. depression, coma, and death; reserve concomitant use for pts w/ 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 pts 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
extended use in pregnant pts can lead to potentially life-threatening neonatal opioid withdrawal syndrome; advise pregnant pts of risks and ensure tx by neonatology experts avail. at delivery if extended opioid use required
CYP450 3A4 Interaction
concomitant use w/ CYP450 3A4 inhibitors or D/C of concomitant CYP450 3A4 inducers may incr. fentanyl conc. which may incr. or prolong adverse effects incl. potentially fatal resp. depression; monitor pts receiving any concomitant CYP450 3A4 inhibitor or inducer
Adult Dosing .
Dosage forms: SPRAY: 100 mcg per actuation, 200 mcg per actuation, 400 mcg per actuation, 600 mcg per actuation, 800 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 naloxone if risk of opioid overdose or accidental ingestion.
- [formulation clarification]
- Info: transmucosal fentanyl products not bioequivalent, caution advised if switching between products; see pkg insert for conversion from other transmucosal forms; not interchangeable w/ other fentanyl products, do not substitute on a mcg to mcg basis
breakthrough cancer pain, opioid-tolerant pts
- [individualize dose SL x1 prn]
- Start: 100 mcg SL x1, may repeat x1 after 30min; Max: 2 doses/episode; 4 doses/24h once pain control achieved; Info: use lowest effective dose, shortest effective tx duration; must wait at least 4h before treating another episode; may titrate prn w/ each subsequent episode to 200 mcg dose, then 400 mcg dose, then 600 mcg dose, then 800 mcg dose, then 1200 mcg dose, then 1600 mcg dose; taper dose gradually to D/C if no longer require opioid tx
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.