Important Safety Information  | Full Prescribing Information  |  Medication Guide  
FENTORA is indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving
and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.
Limitations of Use:
FENTORA may be dispensed only to patients enrolled in the TIRF REMS Access program.

Important Safety Information

WARNING: RISK OF RESPIRATORY DEPRESSION, MEDICATION ERRORS, ABUSE POTENTIAL

RESPIRATORY DEPRESSION

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.

Due to the risk of respiratory depression, FENTORA is contraindicated in the management of acute or postoperative pain including headache/migraine and in opioid non-tolerant patients.

FENTORA must be kept out of reach of children.

The concomitant use of FENTORA with CYP3A4 inhibitors may result in an increase in fentanyl plasma concentrations, and may cause potentially fatal respiratory depression.

MEDICATION ERRORS

Substantial differences exist in the pharmacokinetic profile of FENTORA compared to other fentanyl products that result in clinically important differences in the extent of absorption of fentanyl that could result in fatal overdose.

  • -When prescribing, do not convert patients on a mcg per mcg basis from any other fentanyl products to FENTORA.
  • -When dispensing, do not substitute a FENTORA prescription for other fentanyl products.

ABUSE POTENTIAL

FENTORA contains fentanyl, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. FENTORA can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing FENTORA in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion.

Because of the risk for misuse, abuse, addiction, and overdose, FENTORA is available only through a restricted program required by the Food and Drug Administration, called a Risk Evaluation and Mitigation Strategy (REMS). Under the Transmucosal Immediate Release Fentanyl (TIRF) REMS Access program, outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors must enroll in the program. Further information is available at www.TIRFREMSAccess.com or by calling 1-866-822-1483.

Indication: FENTORA is indicated for the management of breakthrough pain in cancer patients 18 years of age and older who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.
Limitations of Use:
FENTORA may be dispensed only to patients enrolled in the TIRF REMS Access program.The following is not a complete list; please see full prescribing information.

Contraindications:

  • FENTORA is contraindicated in opioid non-tolerant patients. Life-threatening respiratory depression and death can occur at any dose in opioid
    non-tolerant patients
  • FENTORA is contraindicated in the management of acute or postoperative pain including headache/migraine and dental pain
  • FENTORA is contraindicated in patients with known intolerance or hypersensitivity to any of its components or the drug fentanyl

Warnings and Precautions:

  • Clinically significant respiratory and CNS depression can occur. Monitor patients accordingly
  • FENTORA is not bioequivalent to other fentanyl products. Do not convert patients on a mcg per mcg basis from other fentanyl products
  • FENTORA contains a medicine in an amount which can be fatal to a child
  • Use with other CNS depressants and cytochrome P450 3A4 inhibitors may increase depressant effects including hypoventilation, hypotension, and profound sedation. Consider dosage adjustments if warranted
  • FENTORA may impair the ability to drive a car or perform other potentially dangerous tasks. Counsel patients accordingly
  • Titrate FENTORA cautiously in patients with chronic obstructive pulmonary disease or preexisting medical conditions predisposing them to respiratory depression and in patients susceptible to intracranial effects of CO2 retention
  • Application site reactions occurred in 10% of patients in clinical trials and ranged from paresthesia to ulceration and bleeding
  • Use FENTORA with caution in patients with bradyarrhythmias

Adverse Reactions:

  • Most common (frequency ≥ 10%): nausea, dizziness, vomiting, fatigue, anemia, constipation, edema peripheral, asthenia, dehydration, and headache

Drug Interactions:

  • The concomitant use of FENTORA with CYP 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, and may cause potentially fatal respiratory depression
  • FENTORA is not recommended for use in patients who have received MAO inhibitors within 14 days, because severe and unpredictable potentiation by MAO inhibitors has been reported with opioid analgesics

Use in Specific Populations:

  • Administer FENTORA with caution to patients with severe hepatic or renal impairment

Please see accompanying full prescribing information, including boxed warning.

FEN-2406