Fentora

— THERAPEUTIC CATEGORIES —
  • Narcotic analgesics
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Fentora Generic Name & Formulations

    Legal Class

    CII

    General Description

    Fentanyl (as citrate) 100mcg, 200mcg, 400mcg, 600mcg, 800mcg; buccal tabs.

    Pharmacological Class

    Opioid agonist.

    How Supplied

    Tabs—28 (4 tabs x 7 cards)

    Manufacturer

    Teva Pharmaceuticals

    Generic Availability

    NO

    Mechanism of Action

    Fentanyl is an opioid agonist whose principal therapeutic action is analgesia. The precise mechanism of the analgesic action is unknown although fentanyl is known to be a mu opioid receptor agonist. Specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and play a role in the analgesic effects of this drug.

    Fentora Indications

    Indications

    Breakthrough pain, in opioid-tolerant patients already receiving and who are tolerant to continuous opioid therapy for underlying persistent cancer pain. Opioid-tolerant patients are those taking oral morphine ≥60mg/day, transdermal fentanyl ≥25mcg/hr, oral oxycodone ≥30mg/day, oral hydromorphone ≥8mg/day, oral oxymorphone ≥25mg/day, oral hydrocodone ≥60mg/day, or equianalgesic dose of another opioid for ≥1 week.

    Fentora Dosage and Administration

    Adult

    Do not substitute with other fentanyl products; not equivalent to other fentanyl products on a mcg to mcg basis. Use lowest effective dose for shortest duration. ≥18yrs: Place tablet in buccal cavity (above a rear molar, between upper cheek and gum); alternate sides of the mouth for subsequent doses. Do not swallow whole, split, suck, or chew. Individualize. Initially 100mcg/dose; if pain unrelieved after 30mins, take only 1 additional dose; max 2 doses per episode. Must wait at least 4hrs before treating another episode. Reevaluate maintenance pain therapy if >4 doses/24hrs is needed. Conversion from Actiq: see full labeling. Concomitant use or discontinuation of CYP3A4 inhibitors or inducers: monitor closely and consider dose adjustments (see full labeling).

    Children

    <18yrs: not established.

    Fentora Contraindications

    Contraindications

    Opioid non-tolerant patients. Significant respiratory depression. Acute or post-op pain (including headache/migraine, dental pain, or ER). Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment. Known or suspected GI obstruction, including paralytic ileus.

    Fentora Boxed Warnings

    Boxed Warning

    Serious and life-threatening risks from use of Fentora: Addiction, abuse, and misuse; Life-threatening respiratory depression; Accidental ingestion; Risks from concomitant use with benzodiazepines or other CNS depressants; Risk of medication errors; CYP450 3A4 interaction; Risk evaluation and mitigation strategy (REMS); Neonatal opioid withdrawal syndrome.

    Fentora Warnings/Precautions

    Warnings/Precautions

    Assess the potential need for access to naloxone when initiating and renewing therapy. Consider prescribing naloxone based on risk factors for overdose (eg, history of opioid use disorder, prior opioid overdose, household members or other close contacts at risk for accidental ingestion or overdose). Abuse potential (monitor). Life-threatening respiratory depression; monitor during initiation or following a dose increase. Accidental exposure may cause fatal overdose (esp. in children). Sleep-related breathing disorders (including central sleep apnea (CSA), sleep-related hypoxemia); consider dose reduction if CSA develops. COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor and consider non-opioid analgesics. Opioid-induced hyperalgesia (OIH) and allodynia; consider decreasing dose of current opioid or opioid rotation if OIH is suspected. Monitor for signs of hypotension when initiating or titrating dose. Adrenal insufficiency. Head injury. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. CNS depression. Impaired consciousness, coma, shock; avoid. Biliary tract disease. Acute pancreatitis. Bradyarrhythmias. Drug abusers. Renal or hepatic impairment. Reevaluate periodically. Avoid abrupt cessation. Elderly. Cachectic. Debilitated. Pregnancy; potential neonatal opioid withdrawal syndrome during prolonged use. Labor & delivery, nursing mothers: not recommended.

    REMS

    YES

    Fentora Pharmacokinetics

    Absorption

    Absolute bioavailability: 65%. Time to maximum plasma concentration: 46.8 minutes. Maximum plasma concentration: 1.02 ± 0.42 ng/mL.

    Distribution

    Volume of distribution at steady state: 25.4 L/kg. Plasma protein bound: 80–85%.

    Metabolism

    Hepatic (CYP3A4).

    Elimination

    Primarily (>90%) eliminated by biotransformation; renal (<7%), fecal (~1%).

    Half-life: ~2.63 hours (100mcg); ~4.43 hours (200mcg); ~11.09 hours (400mcg); ~11.70 hours (800mcg).

    Fentora Interactions

    Interactions

    Increased risk of hypotension, respiratory depression, sedation with benzodiazepines or other CNS depressants (eg, non-benzodiazepine sedatives/hypnotics, anxiolytics, general anesthetics, phenothiazines, tranquilizers, muscle relaxants, antipsychotics, alcohol, other opioids); reserve concomitant use in those for whom alternative options are inadequate; limit dosages/durations to minimum required; monitor closely; consider prescribing naloxone if concomitant use is warranted. During or within 14 days of MAOIs: not recommended. Risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, 5-HT3 antagonists, mirtazapine, trazodone, tramadol, cyclobenzaprine, metaxalone, MAOIs, linezolid, IV methylene blue); monitor and discontinue if suspected. Avoid concomitant mixed agonist/antagonist opioids (eg, butorphanol, nalbuphine, pentazocine) or partial agonist (eg, buprenorphine); may reduce effects and/or precipitate withdrawal symptoms. Potentiated by CYP3A4 inhibitors (eg, macrolides, azole antifungals, protease inhibitors, grapefruit juice). Antagonized by CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin). May antagonize diuretics; monitor. Paralytic ileus may occur with anticholinergics.

    Fentora Adverse Reactions

    Adverse Reactions

    Nausea, dizziness, vomiting, fatigue, anemia, constipation, peripheral edema, asthenia, dehydration, headache; respiratory depression, orthostatic hypotension, syncope, local reactions, OIH and allodynia.

    Fentora Clinical Trials

    See Literature

    Fentora Note

    Notes

    Available by restricted distribution program. Call (866) 822-1483 or visit www.tirfremsaccess.com to enroll. Caution patients and caregivers in proper handling and disposal; may be fatal to children.

    Fentora Patient Counseling

    See Literature

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