Narcotic analgesics:

Indications for: FENTORA

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.

Adult Dosage:

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 Dosage:

<18yrs: not established.

FENTORA 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.

Boxed Warning:

Life-threatening respiratory depression. Accidental ingestion. CYP450 3A4 interaction. Risks from concomitant use with benzodiazepines or other CNS depressants. Risk of medication errors. Addiction, abuse, and misuse. REMS program. Neonatal opioid withdrawal syndrome.

FENTORA 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). Life-threatening respiratory depression; monitor within first 24–72hrs of initiating therapy and following dose increases. 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. Abuse potential (monitor). 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.

FENTORA Classification:

Opioid agonist.

FENTORA 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.

Adverse Reactions:

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

Note:

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.

REMS:

YES

How Supplied:

Tabs—28 (4 tabs x 7 cards)

Pricing for FENTORA

400mcg buccal tablet (Qty: 150)
Appx. price $17580
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