Generic Name and Formulations:
Fentanyl (as citrate) 100mcg, 200mcg, 400mcg, 600mcg, 800mcg; buccal tabs.
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.
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). 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).
<18yrs: not established.
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.
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). 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.
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. 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, 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 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.
Nausea, dizziness, vomiting, fatigue, anemia, constipation, peripheral edema, asthenia, dehydration, headache; respiratory depression, severe hypotension, syncope, local reactions.
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.
Tabs—28 (4 tabs x 7 cards)