Company:
Cephalon
Pharmacologic class:
Opioid analgesic
Active ingredient:
Fentanyl (as citrate) 100 µg, 200 µg, 400 µg, 600 µg, 800 µg; buccal tablets.
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Indication:
Management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Opioid-tolerant patients are those taking oral morphine ≥60 mg/day, transdermal fentanyl ≥25 µg/hr, oxycodone ≥30 mg/day, oral hydromorphone ≥8 mg/day; or equivalent, for one week or longer.
Pharmacology:
Fentora is a buccal tablet formulation of the opioid analgesic fentanyl. Following buccal administration of Fentora, fentanyl is absorbed with an absolute bioavailability of 65%. When comparing the bioavailability of Fentora with oral transmucosal fentanyl citrate, the rate and extent of fentanyl absorption were considerably different (approximately 30%-50% greater exposure with Fentora).
Clinical trials:
The efficacy of Fentora was evaluated in a double-blind placebo-controlled cross-over study involving opioid-tolerant patients with cancer and breakthrough pain. Sixty-five percent of patients who entered the study achieved a successful dose (adequate analgesia with tolerable side effects). The primary efficacy measure was the sum of differences in pain intensity scores at 15 and 30 minutes from baseline (SPID30). The least-squares mean SPID30 for Fentora-treated episodes was 3, while for placebo-treated episodes it was 1.8.
Adults:
Place tablet in buccal cavity (above a rear molar, between upper cheek and gum). Do not swallow whole, split, suck, or chew. Individualize; not interchangeable on a µg/µg basis with other oral fentanyl products. Initially 100 µg/dose; if pain unrelieved, may repeat in 30 minutes. Previously on oral fentanyl: see literature. Re-evaluate maintenance pain therapy if more than four doses per 24 hours are needed.
Children:
<18 years: not recommended.
Contraindications:
Notfor opioid-intolerant patients. Not for treating acute or postoperative pain. During or within 14 days of monoamine oxidase inhibitors.
Precautions:
Respiratory depression. Higher than grade 1 mucositis. Head injury. Central nervous system (CNS) depression. Increased intracranial pressure. Impaired cardiovascular (e.g., bradyarrhythmias), pulmonary, hepatic, renal, thyroid function. Avoid abrupt cessation. Re-evaluate periodically. Elderly. Debilitated. Pregnancy (Cat. C). Labor & delivery, nursing mothers: not recommended.
Interactions:
See Contraindications. Potentiates CNS depression with benzodiazepines, barbiturates, alcohol, other CNS depressants, other psychoactive substances. Potentiated by CYP3A4 inhibitors (e.g., erythromycin, clarithromycin, fluconazole, ketoconazole, itraconazole, troleandomycin, ritonavir, nelfinavir, amprenavir, fosamprenavir, aprepitant, nefazodone, verapamil, diltiazem, grapefruit juice); monitor for extended period of time. Antagonized by CYP3A4 inducers.
Adverse reactions:
GI upset, constipation, local reactions, fatigue, anemia, dizziness, peripheral edema, dehydration, headache.
Note:
For use only by clinicians trained to use CII opioids for cancer pain. Caution patients and caregivers in proper handling and disposal; may be fatal to children.
How supplied:
Tabs—28 (4 tabs 2 x 7 cards).
For more information call 800-896-5855 or visit www.Fentora.com.
