fentanyl transmucosal (Rx)

Brand and Other Names:Actiq, Fentora, more...Abstral, Onsolis, Subsys
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

troche/lozenge (Actiq): Schedule II

  • 200mcg
  • 400mcg
  • 600mcg
  • 800mcg
  • 1200mcg
  • 1600mcg

tablet, sublingual (Abstral): Schedule II

  • 100mcg
  • 200mcg
  • 300mcg
  • 400mcg
  • 600mcg
  • 800mcg

buccal tablet (Fentora): Schedule II

  • 100mcg
  • 200mcg
  • 400mcg
  • 600mcg
  • 800mcg

soluble film (Onsolis): Schedule II

  • 200mcg
  • 400mcg
  • 600mcg
  • 800mcg
  • 1200mcg

sublingual spray (Subsys): Schedule II

  • 100mcg/spray
  • 200mcg/spray
  • 400mcg/spray
  • 600mcg/spray
  • 800mcg/spray
more...

Breakthrough Cancer Pain

Only for patient already receiving and tolerant to opioid analgesics (ie, >60 mg morphine equivalent/day or 50 mcg transdermal fentanyl/hr)

Abstral

Initial dose: 100 mcg SL

Individually titrate to tolerable dose that provides adequeate analgeisa for breakthrough pain

Not to exceed 2 doses/breakthrough pain episode

Wait at least 2 hr before treating another episode of breakthrough pain

Limit consumption to 4 or fewer breakthrough pain episodes/24 hr

Administer on floor of mouth directly under tongue and allow to completely dissolve

Dose titration

  • If adequate analgesia was not obtained with the first 100 mcg dose, continue dose escalation in a stepwise manner over consecutive breakthrough episodes until adequate analgesia with tolerable side effects achieved
  • Increase the dose by 100 mcg multiples up to 400 mcg as needed If adequate analgesia is not obtained with a 400 mcg dose, the next titration step is 600 mcg
  • If adequate analgesia is not obtained with a 600 mcg dose, the next titration step is 800 mcg
  • During titration, patients can be instructed to use multiples of 100 mcg tablets and/or 200 mcg tablets for any single dose
  • Instruct patients not to use more than 4 tablets at one time
  • If adequate analgesia is not obtained 30 minutes after the use, may repeat the same dose
  • Maintenance: Once an appropriate dose for pain management has been established, instruct patients to use only 1 tablet of the appropriate strength per dose

Dose conversion from Actiq

  • The initial dose of Abstral is always 100 mcg with the only exception being patients already using Actiq
  • For patients being converted from Actiq, instruct patient to stop use of Actiq and dispose of any remaining units
  • Initial dose for Abstral when converting from patients taking Actiq:
  • -Current Actiq dose = 200 mcg, initial Abstral dose = 100 mcg
  • -Current Actiq dose = 400, 600, 800, or 1200 mcg, initial Abstral dose = 200 mcg
  • -Current Actiq dose = 1600 mcg, initial Abstral dose = 400 mcg
  • Titrating Abstral after converting from Actiq:
  • -Converting from Actiq doses ≤400 mcg, initiate titration with 100 mcg Abstral and proceed using multiples of this strength
  • -Converting from Actiq doses of 600, 800, or 1200 mcg, initiate titration with 200 mcg Abstral and proceed using multiples of this strength
  • -Converting from Actiq doses of 1600 mcg, initiate titration with 400 mcg Abstral and proceed using multiples of this strength

Actiq

200 mcg dissolve in mouth over 15 min period, PRN; wait 15 min before taking next dose

Titrate up to 1600 mcg; limit consumption to <4 units/day

Gradual downward titration for discontinuation

Product substitution

  • Substitution of Actiq for any other fentanyl product may result in fatal overdose
  • Do not convert on a mcg per mcg basis to Actiq from other fentanyl products
  • Do not substitute Actiq prescription for other fentanyl products; pharmacokinetic profile differs substantially and may result in fatal overdose

Fentora

Initial 100 mcg, may redose once after 30 min (place tab between upper cheek and gum till dissolves, any remnant after 30 min may be drunk with water); must wait at least 4 hours before treating another episode of breakthrough pain

Titrate PRN

Dose conversion from Actiq

  • Initial 100 mcg if switching from 200-400 mcg Actiq
  • Initial 200 mcg if switching from 600-800 mcg Actiq
  • Initial 400 mcg if switching from 1200-1600 mcg Actiq

Maintenance dosing

  • Once titrated to an effective dose, patients should generally use only 1 tablet of the appropriate strength per breakthrough pain episode
  • On occasion when the breakthrough pain episode is not relieved after 30 minutes, patients may take ONLY ONE additional dose using the same strength for that episode
  • Must wait at least 4 hours before treating another episode of breakthrough pain
  • Once an effective dose is determined using the titration scheme outlined above, an alternate route to buccal administration is sublingual

Onsolis

Initial dose: 200-mcg film placed buccally with breakthrough pain episode

If pain relief not achieved, titrate using multiples of the 200-mcg film (ie, increase dose by 200 mcg in each subsequent episode until adequate pain relief); not to exceed 4 of the 200-mcg films per breakthrough pain episode; do not place films on top of one another, but may place on both sides of mouth

Once pain relief achieved: Treat subsequent breakthrough pain using the determined dose within range of 200-800 mcg

If pain relief not achieved with 800 mcg

  • Treat next episode using 1 film containing 1200 mcg; not to exceed 1200 mcg per pain episode
  • Separate each dose by at least 2 h, use only once per breakthrough pain episode (do not redose), and limit to 4 or fewer doses daily; if experiencing >4 breakthrough pain episodes per day, consider increasing dose of around-the-clock opioid medication for persistent pain
  • Rescue pain medication may be used as directed after 30 min following Onsolis if adequate pain relief not achieved

Administration

  • Use tongue to wet inside of cheek or rinse mouth with water to wet area before film placement
  • Place pink side of film against inside of cheek and hold in place for 5 seconds
  • Avoid consuming liquids for 5 min after film placement
  • Do not eat until film dissolves

Subsys

Initial dose is always 100 mcg SL

Individually titrate after initial dose to provide adequate analgesia and minimize side effects

When prescribing, do not switch patients on a mcg per mcg basis from any other oral transmucosal fentanyl product (not equivalent on mcg per mcg with other fentanyl products)

Dose titration

  • From the 100 mcg initial dose, closely follow patients and change the dosage level until the patient reaches a dose that provides adequate analgesia using a single dosage per breakthrough cancer pain episode with tolerable side effects; patients should record their use of Subsys over several episodes of breakthrough cancer pain and review their experience with their physicians to determine if a dosage adjustment is warranted
  • For each breakthrough pain episode treated, if pain is not relieved after 30 minutes, patients may take only 1 additional dose of the same strength for that episode; thus patients should take a maximum of 2 doses of Subsys for any breakthrough pain episode
  • Patients must wait at least 4 hours before treating another episode of breakthrough pain
  • If there is a need to titrate to a 200 mcg dose, prescribe 200 mcg Subsys units
  • Subsequent titration steps are 400 mcg, 600 mcg, 800 mcg, 1200 mcg and 1600 mcg (see prescribing information)
  • To reduce the risk of overdose during titration, patients should have only one strength of Subsys available at any time

Other information

Not equivalent on a mcg-per-mcg basis to any other oral transmucosal fentanyl product

Individually titrate to dose providing adequate analgesia with tolerable adverse effects

Only available via special access program

Actiq <16 years: Safety and efficacy not established

Abstral; Fentora; Onslis; Subsys <18 years: Safety and efficacy not established

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Interactions

Interaction Checker

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            Adverse Effects

            >10%

            Asthenia

            Confusion

            Constipation

            Dry mouth

            Nausea

            Somnolence

            Sweating

            Vomiting

            1-10%

            Abdominal pain

            Anorexia

            Anxiety

            Apnea

            Depression

            Diarrhea

            Dizziness

            Dyspepsia

            Dyspnea

            Euphoria

            Fatigue

            Hallucinations

            Headache

            Hemoptysis

            Hypoventilation

            Influenza-like symptoms

            Nervousness

            Pharyngitis

            Pruritus

            Urinary retention

            Upper respiratory tract infection

            Frequency Not Defined

            Abnormal coordination, thinking, gait, dreams

            Amnesia

            Agitation

            Application site reaction

            Back pain

            Bronchitis

            Fever

            Flatulence

            Hiccups

            Accidental injury

            Micturition disorder

            Mucosal inflammation

            Paranoid reaction

            Paresthesia

            Rash

            Rhinitis, sinusitis

            Speech disorder

            Syncope

            Tremor

            Bradycardia

            QT-interval prolongation

            Severe cardiac arrhythmias

            Cardiac arrest

            ST segment elevation

            Ventricular tachycardia

            MI

            Angina pectoris

            Respiratory/circulatory depression

            Respiratory arrest

            Shock

            Visual disturbances

            Mental clouding

            Sedation

            Coma

            Dysphoria

            Weakness

            Faintness

            Seizures

            Urinary retention

            Oliguria

            Sweating

            Flushing

            Warmness of face/neck/upper thorax

            Urticaria

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            Warnings

            Black Box Warnings

            Reports of serious adverse events, including deaths, in patients treated with Fentora have been reported. Deaths occurred as a result of improper patient selection (eg, use in patients not opioid tolerant) and/or improper dosing. The substitution of Fentora (buccal table formulation) for any other fentanyl product may result in fatal overdose

            Buccal tablets contain an opioid agonist and a Schedule II controlled substance with an abuse liability potential similar to other opioid analgesics. This should be considered when prescribing or dispensing fentanyl buccal tablets in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion

            Fentanyl buccal tablets is indicated only for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to around the clock opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking >60 mg of oral morphine/day, >25 mcg of transdermal fentanyl/hour, >30 mg of oxycodone daily, >8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid for a week or longer

            Special care must be used when dosing this drug in buccal form. If the breakthrough pain episode is not relieved after 30 minutes, patients may take only one additional dose using the same strength and must wait at least 4 hours before taking another dose

            Because life-threatening respiratory depression could occur at any dose in patients not opioid tolerant, fentanyl buccal tablets are contraindicated in the management of acute or postoperative pain, including headache/migraine. Deaths have occurred in patients not opioid tolerant. Patients and their caregivers must be instructed that fentanyl buccal tablets contain a medicine in an amount that can be fatal to a child

            Patients and their caregivers must be instructed to keep all tablets out of the reach of children (See Information for Patients and Caregivers for disposal instructions)

            When prescribing, do not convert patients on a microgram per microgram basis from Actiq (transmucosal) to Fentora (buccal tablet). Carefully consult the Initial Dosing Recommendations table

            When dispensing, do not substitute a Fentora (buccal tablet) prescription for other products. The substitution of Fentora for any other fentanyl products may result in fatal overdose because of differences that exist in the pharmacokinetic profile of buccal tablet

            Fentanyl buccal tablets are intended for use only in the care of opioid-tolerant cancer patients and only by healthcare professional who are knowledgeable of and skilled in the use of Schedule II opioids to treat cancer pain

            The concomitant use of this drug with strong and moderate cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations and may cause potentially fatal respiratory depression

            Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death; reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to minimum required; follow patients for signs and symptoms of respiratory depression and sedation

            Contraindications

            Hypersensitivity to drug or components of the formulation

            Acute or postoperative pain

            Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment

            Diarrhea from toxicity (until toxins cleared)

            Known or suspected gastrointestinal obstruction, including paralytic ileus

            Within 2 wk of MAO inhibitors

            Significant respiratory depression

            Cautions

            Acute pancreatitis, Addison's disease, BPH, cardiac arrhythmias, CNS depression, drug abuse/dependence, emotional lability, gallbladder disease, GI disorder, pseudomembranous colitis, GI surgery, head injury, hypothyroidism/untreated myxedema, intracranial HTN, brain tumor, toxic psychosis, urethral stricture, urinary tract surgery, seizures, acute alcoholism, delirium tremens, shock, cor pulmonale, chronic pulmonary disease, emphysema, hypercapnia, kyphoscoliosis, severe obesity, renal/hepatic impairment, elderly/debilitated patients

            To dispose, flush drug matrix down toilet

            Addiction can occur at recommended dosages and if drug is misused or abused

            Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing opioid and monitor; risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression); potential for these risks should not prevent proper management of pain in any given patient; patients at increased risk may be prescribed opioids, but use in such patients necessitates intensive counseling about risks and proper use of opioid sulfate along with intensive monitoring for signs of addiction, abuse, and misuse; prescribe the drug in smallest appropriate quantity and advise patient on proper disposal of unused drug

            Cases of serotonin syndrome, a potentially life-threatening condition, reported with concomitant use of serotonergic drugs; this may occur within the recommended dosage range; the onset of symptoms generally occur within several hours to a few days of concomitant use, but may occur later than that; discontinue therapy immediately if serotonin syndrome is suspected

            Therapy may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients; there is increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e.g., phenothiazines or general anesthetics); monitor patients for signs of hypotension after initiating or titrating dosage; in patients with circulatory shock, therapy may cause vasodilation that can further reduce cardiac output and blood pressure; avoid therapy in patients with circulatory shock

            In patients who may be susceptible to intracranial effects of CO2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors), therapy may reduce respiratory drive, and resultant CO2 retention can further increase intracranial pressure; monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy; opioids may obscure clinical course in a patient with a head injury; avoid the use in patients with impaired consciousness or coma

            Contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus; may cause spasm of sphincter of Oddi; opioids may cause increases in serum amylase; monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms

            Therapy may increase frequency of seizures in patients with seizure disorders and in other clinical settings associated with seizures; monitor patients for worsened seizure control during therapy

            Avoid use of mixed agonist/antagonist (e.g., pentazocine, nalbuphine, and butorphanol) or partial agonist (e.g., buprenorphine) analgesics in patients who are receiving a full opioid agonist analgesic; mixed agonist/antagonist and partial agonist analgesics may reduce analgesic effect and/or precipitate withdrawal symptoms; when discontinuing therapy in physically-dependent patient, gradually taper dosage; do not abruptly discontinue therapy in these patients

            Warn patients not to drive or operate dangerous machinery unless they are tolerant to effects of drug and know how they will react to medication

            While serious, life-threatening, or fatal respiratory depression can occur at any time during therapy, risk is greatest during initiation of therapy or following dosage increase; monitor patients closely for respiratory depression, especially within first 24 to 72 hr of initiating therapy with and following dosage increases; accidental ingestion of even one dose, especially by children, can result in respiratory depression and death due to overdose of opioid

            Concomitant use with a CYP3A4 inhibitor, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), may increase plasma concentrations of fentanyl and prolong opioid adverse reactions, which may cause potentially fatal respiratory depression, particularly when an inhibitor is added after a stable dose of fentanyl injection is achieved; similarly, discontinuation of a CYP3A4 inducer, such as rifampin, carbamazepine, and phenytoin, in fentanyl-injection treated patients may increase fentanyl plasma concentrations and prolong opioid adverse reactions; when using fentanyl Injection with CYP3A4 inhibitors or discontinuing CYP3A4 inducers in fentanyl-Injection treated patients, monitor patients closely at frequent intervals and consider dosage reduction of fentanyl injection until stable drug effects are achieved

            Concomitant use of fentanyl injection with CYP3A4 inducers or discontinuation of a CYP3A4 inhibitor could decrease fentanyl plasma concentrations, decrease opioid efficacy or, possibly, lead to a withdrawal syndrome in a patient who had developed physical dependence to fentanyl; when using fentanyl injection with CYP3A4 inducers or discontinuing CYP3A4 inhibitors, monitor patients closely at frequent intervals and consider increasing opioid dosage if needed to maintain adequate analgesia or if symptoms of opioid withdrawal occur

            Deaths have occurred in nursing infants exposed to high levels of opioid in breast milk because mothers were ultra-rapid metabolizers of opioid

            Profound sedation, respiratory depression, coma, and death may result from concomitant administration with benzodiazepines or other CNS depressants (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol); because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate

            Use in patients with acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment is contraindicated; patients with significant chronic obstructive pulmonary disease or cor pulmonale, and with substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of decreased respiratory drive including apnea, even at recommended dosages

            Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients because they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients; monitor closely

            Monoamine oxidase inhibitors (MAOIs) may potentiate effects of opioid, opioid’s active metabolite, including respiratory depression, coma, and confusion; therapy should not be administered within 14 days of initiating or stopping MAOIs

            Cases of adrenal insufficiency reported with opioid use, more often following greater than one month of use; symptoms may include nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure; if adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids; wean patient off of opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers; other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency

            Use caution when selecting dosage for an elderly patient, usually starting at low end of dosing range, reflecting greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy; because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and may be useful to monitor renal function

            Opioid pharmacokinetics may be altered in patients with renal failure; clearance may be decreased and metabolites may accumulate much higher plasma levels in patients with renal failure as compared to patients with normal renal function; start with a lower than normal dosage or with longer dosing intervals and titrate slowly while monitoring for signs of respiratory depression, sedation, and hypotension

            Actiq: prescribe 6 units of each new dose during titration period

            Mucositis (>Grade I)

            Fentora: do not break tab in mouth or swallow

            Onsolis: after buccal placement, do not drink for at least 5 min, do not eat until film dissolves (15-30 min)

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            Pregnancy & Lactation

            Pregnancy

            Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth; observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly; opioids cross placenta and may produce respiratory depression and psycho-physiologic effects in neonates; an opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate; opioid sulfate is not recommended for use in pregnant women during or immediately prior to labor, when other analgesic techniques are more appropriate; opioid analgesics can prolong labor through actions which temporarily reduce strength, duration, and frequency of uterine contractions

            Fertility

            • Due to effects of androgen deficiency, chronic use of opioids may cause reduced fertility in females and males of reproductive potential; it is not known whether effects on fertility are reversible

            Lactation

            Opioid is secreted into human milk; in women with normal opioid metabolism (normal CYP2D6 activity), the amount of opioid secreted into human milk is low and dose-dependent; some women are ultra-rapid metabolizers of opioid; these women achieve higher-than-expected serum levels of opioid's active metabolite, opioid, leading to higher-than-expected levels of opioid in breast milk and potentially dangerously high serum opioid levels in their breastfed infants that can potentially lead to serious adverse reactions, including death, in nursing infants

            Developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from therapy or from underlying maternal condition

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Narcotic agonist-analgesic of opiate receptors; inhibits ascending pain pathways, which causes alteration in response to pain; produces analgesia, respiratory depression, and sedation

            Pharmacokinetics

            Bioavailability: Onsolis 71%

            Duration: 1-2 hr

            Peak Plasma Time: 0.5-4 hr

            Metabolism: CYP3A4 (Predominantly)

            Metabolite: norfentanyl (inactive)

            Half-Life: 1.5-6 hr

            Excretion: urine, feces

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.