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FENTORA is a brand name for Fentanyl, supplied as a tablet (effervescent). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: FENTORA (fentanyl buccal/sublingual effervescent tablets) is indicated only for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to continuous opioid therapy for their persistent baseline cancer pain. Patients considered opioid tolerant are…
Verbatim from this product's HC label. Tap a section to expand.
). This product must not be used in opioid non-tolerant patients because life-threatening respiratory depression and death could occur at any dose in patients not on a chronic regimen of opioids. For this reason, FENTORA is contraindicated in the management of acute or post- operative pain, including headache/migraine, dental pain or use in the emergency room.
Note:
FENTORA is contraindicated in all post-operative pain, including post-operative cancer pain if the patient is not already opioid tolerant. The addition of the qualifier “non cancer” may be confusing as it could be interpreted to mean that FENTORA can be used for post- operative pain after surgery for cancer or post-operatively for cancer pain, both of which can occur in opioid non-tolerant patients.
The term “post-operative” already implies that the pain is due to surgery and not to cancer. FENTORA is intended to be used only in the care of opioid tolerant cancer patients and only by healthcare professionals who are knowledgeable of and skilled in the use of opioids to treat cancer pain.
3 Pediatrics). 4 Geriatrics). Patients over the age of 65 years tended to titrate to slightly lower doses than younger patients. Patients over the age of 65 years reported a slightly higher frequency for some adverse events specifically vomiting, constipation, and abdominal pain.
Therefore, caution should be exercised in individually titrating FENTORA in elderly patients to provide adequate efficacy while minimizing risk. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, concomitant disease or other drug therapy (see 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions, Geriatrics).
2 CONTRAINDICATIONS • Opioid non-tolerant patients (use in acute or post-operative pain, including headache/migraine, dental pain or use in the emergency room). • Patients who are hypersensitive to the active substance, fentanyl citrate, or other opioid analgesics or to any ingredient in the formulation.
For a complete listing, see
2 DOSAGE AND ADMINISTRATION, Adjustment or Reduction of Dosage). The administration of FENTORA should be guided by the response of the patient. Physical dependence, per se, is not ordinarily a concern when one is treating a patient with cancer and chronic pain, and fear of tolerance and physical dependence should not deter using doses that adequately relieve the pain.
FENTORA is an opioid with no approved use in the management of addictive disorders. Its proper usage in individuals with drug or alcohol dependence, either active or in remission, is for the management of breakthrough cancer pain requiring opioid analgesia.
Patients with a history of addiction to drugs or alcohol may be at higher risk of becoming addicted to FENTORA; extreme caution and awareness is warranted to mitigate the risk. Driving and Operating Machinery FENTORA may impair the mental and/or physical abilities needed for certain potentially hazardous activities such as driving a car or operating machinery.
Patients should be cautioned, accordingly. Patients should also be cautioned about the combined effects of fentanyl with other CNS depressants, including other opioids, phenothiazine, sedative/hypnotics, and alcohol or gabapentinioids (gabapentin or pregabalin).
Endocrine Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure.
If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible. If adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids. Wean the patient off of the opioid to allow adrenal Product Monograph FENTORA fentanyl Page 20 of 69 Internal Use Only function to recover and continue corticosteroid treatment until adrenal function recovers.
). All patients starting treatment with FENTORA must begin with titration from the 100 mcg dose (see 4 DOSAGE AND ADMINISTRATION). This product must not be used in opioid non-tolerant patients because life-threatening respiratory depression and death could occur at any dose in patients not on a chronic regimen of opioids.
For this reason, FENTORA is contraindicated in the management of acute or post- operative pain, including headache/migraine, dental pain or use in the emergency room.
Note:
FENTORA is contraindicated in all post-operative pain, including post-operative cancer pain if the patient is not already opioid tolerant. The addition of the qualifier “non cancer” may be confusing as it could be interpreted to mean that FENTORA can be used for post- operative pain after surgery for cancer or post-operatively for cancer pain, both of which can occur in opioid non-tolerant patients.
The term “post-operative” already implies that the pain is due to surgery and not to cancer. FENTORA is intended to be used only in the care of opioid tolerant cancer patients and only by healthcare professionals who are knowledgeable of and skilled in the use of opioids to treat cancer pain.
3 Pediatrics). 4 Geriatrics). Patients over the age of 65 years tended to titrate to slightly lower doses than younger patients. Patients over the age of 65 years reported a slightly higher frequency for some adverse events specifically vomiting, constipation, and abdominal pain.
Therefore, caution should be exercised in individually titrating FENTORA in elderly patients to provide adequate efficacy while minimizing risk. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, concomitant disease or other drug therapy (see 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions, Geriatrics).
• Opioid non-tolerant patients (use in acute or post-operative pain, including headache/migraine, dental pain or use in the emergency room). • Patients who are hypersensitive to the active substance, fentanyl citrate, or other opioid analgesics or to any ingredient in the formulation.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. Anaphylaxis and hypersensitivity have been reported in association with the use of oral transmucosal fentanyl products. , ileus of any type). , acute appendicitis or pancreatitis).
• Patients with acute or severe bronchial asthma, chronic obstructive airway, or status asthmaticus. • Patients with acute respiratory depression, elevated carbon dioxide levels in the blood and cor pulmonale. • Patients with acute alcoholism, delirium tremens, and convulsive disorders.
• Patients with severe CNS depression, increased cerebrospinal or intracranial pressure, and head injury. • Patients taking monoamine oxidase (MAO) inhibitors (or within 14 days of such therapy). Product Monograph FENTORA fentanyl Page 6 of 69 Internal Use Only
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Fentanyl in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency. The information available does not identify any particular opioids as being more likely to be associated with adrenal insufficiency.
Gastrointestinal FENTORA and other morphine-like opioids have been shown to decrease bowel motility. Fentanyl may obscure the diagnosis or clinical course of patients with acute abdominal conditions (see 2 CONTRAINDICATIONS).
Neurologic • Serotonin toxicity / Serotonin syndrome:
Serotonin toxicity, also known as serotonin syndrome, is a potentially life-threatening condition and has been reported with opioids, including FENTORA, particularly during combined use with other serotonergic drugs. (See
2 CONTRAINDICATIONS • Opioid non-tolerant patients (use in acute or post-operative pain, including headache/migraine, dental pain or use in the emergency room). • Patients who are hypersensitive to the active substance, fentanyl citrate, or other opioid analgesics or to any ingredient in the formulation.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. Anaphylaxis and hypersensitivity have been reported in association with the use of oral transmucosal fentanyl products. , ileus of any type). , acute appendicitis or pancreatitis).
• Patients with acute or severe bronchial asthma, chronic obstructive airway, or status asthmaticus. • Patients with acute respiratory depression, elevated carbon dioxide levels in the blood and cor pulmonale. • Patients with acute alcoholism, delirium tremens, and convulsive disorders.
• Patients with severe CNS depression, increased cerebrospinal or intracranial pressure, and head injury. • Patients taking monoamine oxidase (MAO) inhibitors (or within 14 days of such therapy). Product Monograph FENTORA fentanyl Page 6 of 69 Internal Use Only 3 SERIOUS WARNINGS AND PRECAUTIONS Serious Warnings and Precautions Proper Patient Selection • FENTORA (fentanyl buccal/sublingual effervescent tablets) is intended to be used only in the care of opioid tolerant patients with cancer and only by healthcare professionals who are knowledgeable of, and skilled in, the use of opioids to treat cancer pain.
• FENTORA is an opioid analgesic indicated only for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to continuous opioid therapy for their persistent baseline cancer pain.
Patients considered opioid-tolerant are those who have taken at least 60 mg of oral morphine daily, at least 25 mcg/hr of transdermal fentanyl, at least 30 mg of oral oxycodone daily, at least 8 mg of oral hydromorphone daily, at least 25 mg oral oxymorphone daily, or an equianalgesic dose of another opioid daily for a week or longer.
• FENTORA is contraindicated for use in opioid non-tolerant patients including those using opioids intermittently, on an as needed basis (see 2 CONTRAINDICATIONS). 4 DRUG INTERACTIONS, Drug-Drug Interactions). Addiction, Abuse, and Misuse • FENTORA poses risks of opioid addiction, abuse, and misuse, which can lead to overdose and death.
Each patient's risk should be assessed prior to prescribing FENTORA, and all patients should be monitored regularly for the development of these behaviours or conditions (see 7 WARNINGS AND PRECAUTIONS). FENTORA should be stored securely to avoid theft or misuse.
Product Monograph FENTORA fentanyl Page 7 of 69 Internal Use Only Life-threatening Respiratory Depression: OVERDOSE • Fatal respiratory depression has occurred in patients treated with FENTORA, including following use in opioid non-tolerant patients and improper dosing.
The substitution of FENTORA for any other fentanyl product may result in fatal overdose. • Infants exposed in-utero or through breast milk are at risk of life-threatening respiratory depression upon […]