Generic Name and Formulations:
Fentanyl (as citrate) 200mcg, 400mcg, 600mcg, 800mcg, 1200mcg, 1600mcg; units for oral transmucosal administration; berry-flavored.
Indications for ACTIQ:
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. ≥16yrs: Place unit between cheek and lower gum, occasionally switching sides. Suck (do not chew) over 15 mins; if excessive opioid effects occur, remove unit and reduce next dose. Initially one 200mcg unit. Titrate, evaluating dose over several episodes of pain, until a single unit provides adequate analgesia. If re-dosing for one pain episode is needed, start second unit 15 mins after first unit is finished; max 2 units/episode. Wait at least 4hrs before treating another episode. Prescribe 6 units during titration. After a successful dose is determined: max 4 units/day. Concomitant use or discontinuation of CYP3A4 inhibitors or inducers: monitor closely and consider dose adjustments (see full labeling).
<16yrs: 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.
Addiction, abuse, and misuse. Life threatening respiratory depression. Accidental ingestion (may be fatal). Risks from concomitant use of CYP3A4 inhibitors/inducers, benzodiazepines, or other CNS depressants. Risk of medication errors. REMS enrollment required. Neonatal opioid withdrawal syndrome.
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, somnolence, vomiting, asthenia, headache, dyspnea, constipation, anxiety, confusion, depression, rash, insomnia; respiratory depression, severe hypotension, syncope.
Available by restricted distribution program. Call (866) 822-1483 or visit www.tirfremsaccess.com to enroll.