Adult Dosing
Breakthrough cancer pain; opioid-tolerant patients
SL TABS (Abstral)
- Start 100 mcg PO x 1
- Titration: Increase dose to provide adequate analgesia
- Max: 200 mcg/episode; 8 units/day after pain control is achieved
- When treating another episode, wait at least 2 hrs
- Allow to completely dissolve (sublingually [alt method] or buccally?)
LOZENGE [fentanyl (generic)/Actiq]
- Start 200 mcg PO x 1 dissolved buccally over 15 mins, may repeat 15 mins after first unit is completed
- Max: 2 units/episode; 4 units/day after pain control is achieved
- If treatment of several consecutive breakthrough cancer pain episodes requires more than 1 unit per episode, consider increasing to the next higher dose strength
- Do not chew/swallow
Buccal tabs (Fentora)
- Start 100 mcg buccally x 1 if not taking oral transmucosal form (Actiq)
- For patients switching from oral transmucosal form (Actiq), the dose should be as follows
- If Actiq 200 or 400 mcg: Give 100 mcg buccal tabs
- If Actiq 600 or 800 mcg: Give 200 mcg buccal tabs
- If Actiq 1200 or 1600 mcg: Give 400 mcg buccal tabs
- May repeat dose x 1 after 30 mins. Max: 2 doses/episode
- When treating another episode, wait at least 4 hrs
- Titration: Increase dose by 100 mcg/episode PRN; titrate by 200 mcg if dose >400 mcg
- Maintenance: Consider increasing dose after several consecutive episodes require 2 doses. Once an effective dose is determined using the titration scheme as mentioned above, an alternate route to buccal administration is sublingual
- If the therapy needs to be discontinued, titrate gradually to lower dose
- Do not cut/chew/swallow/split
Films (Onsolis)
- Start 200 mcg PO x 1
- Titration: Increase dose by 200 mcg/episode PRN
- Max: 200 mcg/episode; 4 units/day once pain control is acheived
- When treating another episode, wait at least 2 hrs
Breakthrough cancer pain; opioid-tolerant patients
SL SPRAY (Subsys)
- Start 100 mcg SL, may repeat x 1 after 30 mins
- Titration: Increase dose to provide adequate analgesia
- Max: 200 mcg/episode; 4 units/day once pain control is achieved
- When treating another episode, wait at least 4 hrs
- May titrate if necessary with each subsequent episode to 200, 600, 800, 1200, and 1600 mcg dose
Pediatric Dosing
- Safety and efficacy in pediatric patients have not been established
[Outline]
Black Box Warning for fentanyl (generic)
- Fentanyl is an opioid agonist Schedule II controlled substance which has a strong abuse potential. This should be considered when prescribing or dispensing if concern about increased risk of misuse, abuse, or diversion
- Fentanyl transmucosal is indicated only for management of breakthrough pain in patients with cancer already receiving and tolerant to opioids. Patients are considered opioid tolerant if taking >60 mg/day morphine, >25 mcg/hr transdermal fentanyl, >30 mg/day oral oxycodone, >8 mg/day oral hydromorphone, or >25 mg/day oral oxymorphone or equianalgesic dose of other opioid for >1wk
- It should be prescribed only by oncologists and pain specialists in care of cancer pts
- It is contraindicated for acute or post-op pain; life-threatening hypoventilation may occur at any dose in patients not taking chronic opiates, do not use in opioid-nontolerant patients
- Instruct patients/caregivers that the amount of medicine in the product can be fatal to child; keep out of children's reach and discard open units properly
- Concomitant use with moderate or strong CYP3A4 inhibitors is contraindicated
- Fentanyl buccal form has increased bioavailability vs. oral transmucosal form. Do not substitute on a mcg per mcg basis while converting; adjust dose as appropriate
Black Box Warning for Abstral, Actiq, Fentora, Onsolis, Subsys
- Fatal respiratory depression has reported in patients treated with transmucosal immediate-release fentanyl products, including use in opioid non-tolerant patients and improper dosing. Substitution with any other fentanyl products; may result in fatal overdose
- Contraindicated in the treatment of acute or postoperative pain such as headache/migraine and in opioid-nontolerant patients
- Concomitant use with moderate or strong CYP3A4 may cause potentially fatal respiratory depression
- Death may occur upon accidental ingestion of fentanyl in children; keep out of reach of children
- Avoid dose conversions on a mcg per mcg basis and substitution of fentanyl transmucosal for another fentanyl product as substantial pharmacokinetic differences exist
- Fentanyl is an opioid agonist Schedule II controlled substance which has a strong abuse potential. This should be considered when prescribing or dispensing if concern about increased risk of misuse, abuse, or diversion
- Available only through restrictive distribution program called TIRF REMS Access program (Transmucosal Immediate Release Fentanyl Risk Evaluation Mitigation Strategy). Prescribing healthcare professionals, outpatients, pharmacies, and distributors must enroll in this program
- When prescribing or dispensing fentanyl consider that it is an opioid agonist Schedule II controlled substance which has a strong abuse potential [US Black Box Warning]
- Fentanyl transmucosal is indicated only for management of breakthrough pain in patients with cancer already receiving and tolerant to opioids [US Black Box Warning]
- Only oncologists and pain specialists in care of cancer pts should prescribe the therapy [US Black Box Warning]
- Life-threatening hypoventilation may occur at any dose in patients not taking chronic opiates therefore it is contraindicated for acute or post-operative pain. Do not use in opioid-nontolerant patients [US Black Box Warning]
- The amount of medicine in the product can be fatal to child; keep out of children's reach and discard open units properly [US Black Box Warning]
- Concomitant use with moderate or strong CYP3A4 inhibitors is contraindicated [US Black Box Warning]
- Fentanyl buccal form has increased bioavailability vs. oral transmucosal form. Do not substitute on a mcg per mcg basis while converting; adjust dose as appropriate [US Black Box Warning]
- Follow all patients for symptoms of respiratory depression as there is a risk of clinically significant hypoventilation in patients using oral fentanyl therapy alone or in conjunction with other agents that depress respiration
- Full/partially consumed lozenges contain medicine that can be fatal to a child; ensure proper disposal and storage
- Use with other CNS depressants/alcohol may increase depressants effects including hypoventilation, hypotension and profound sedation; consider dosage adjustments if warranted
- Fentanyl may impair the mental or physical abilities required for the performance of certain tasks such as driving and operating dangerous machinery
- Titrate cautiously in patients with COPD or preexisting medical conditions predisposing them to hypoventilation
- Caution advised when administering in patients with evidence of increased intracranial pressure or impaired consciousness or in patient with a head injury
- Severe and unpredictable potentiation by MAO inhibitors has been reported with opioid analgesics when used in patients who have received MAO inhibitors within 14 days. Avoid use in such patients
Cautions: Use cautiously in
- Renal impairment
- Hepatic impairment
- Hx of cardiac disease (may cause bradycardia)
- Bradyarrhythmias
- Hx of pancreatic/biliary tract disease
- Bladder &/or Bowel obstruction
- Head injury
- Intracranial tumor
- Increased ICP
- Alcohol or substance abuse
- CNS depressant use
- Asthma
- COPD
- Impaired pulmonary function
- Elderly population
Pregnancy Category:C
Breastfeeding: Fentanyl is excreted in breastmilk. According to manufacturer's data, use is not recommended due to the possibility of sedation and/or respiratory depression in the infants.
Pricing data from www.DrugStore.com in U.S.A.
- Actiq 600 MCG LPOP [Box] (CEPHALON)
20 mcg = $1436.93
30 mcg = $2155.39 - Actiq 800 MCG LPOP [Box] (CEPHALON)
20 mcg = $1671.84
30 mcg = $2507.77 - Actiq 400 MCG LPOP [Box] (CEPHALON)
20 mcg = $1194.94
30 mcg = $1792.41 - Actiq 1600 MCG LPOP [Box] (CEPHALON)
20 mcg = $2627.02
30 mcg = $3940.54 - Fentora 200 MCG TABS [Box] (CEPHALON)
28 mcg = $1006.04
56 mcg = $2012.07 - Actiq 200 MCG LPOP [Box] (CEPHALON)
20 mcg = $927.31
30 mcg = $1390.97
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
