Fentanyl Citrate

FENTANYL CITRATE- fentanyl citrate lozenge
Teva Pharmaceuticals USA, Inc.

WARNING: LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; RISKS FROM CYTOCHROME P450 3A4 INTERACTION; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, AND MISUSE; REMS; and NEONATAL OPIOID WITHDRAWAL SYNDROME

Life-Threatening Respiratory Depression

Serious, life-threatening and/or fatal respiratory depression has occurred in patients treated with Oral Transmucosal Fentanyl Citrate (OTFC), including following use in opioid non-tolerant patients and improper dosing. Monitor for respiratory depression, especially during initiation of OTFC or following a dose increase [see Warnings and Precautions (5.1)]. The substitution of OTFC for any other fentanyl product may result in fatal overdose [see Warnings and Precautions (5.1)].

Due to the risk of respiratory depression, OTFC is contraindicated in the management of acute or postoperative pain including headache/migraine and in opioid non-tolerant patients [see Contraindications (4)].

Accidental Ingestion

Accidental ingestion of even one dose of OTFC, especially by children, can result in a fatal overdose of fentanyl [see Warnings and Precautions ( 5.2)].

Death has been reported in children who have accidentally ingested OTFC. OTFC must be kept out of reach of children [see Patient Counseling Information and How Supplied/Storage and Handling (16)].

Cytochrome P450 3A4 Interaction

The concomitant use of OTFC with all cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in fentanyl plasma concentration. Monitor patients receiving OTFC and any CYP3A4 inhibitor or inducer [see Warnings and Precautions ( 5.3), Drug Interactions (7), Clinical Pharmacology (12.3)].

Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see Warnings and Precautions ( 5.4), Drug Interactions (7)].

  • Reserve concomitant prescribing of OTFC and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
  • Limit dosages and durations to the minimum required.
  • Follow patients for signs and symptoms of respiratory depression and sedation.

Risk of Medication Errors

Substantial differences exist in the pharmacokinetic profile of OTFC compared to other fentanyl products that result in clinically important differences in the extent of absorption of fentanyl and that could result in fatal overdose [see Dosage and Administration (2.1), Warnings and Precautions (5.5)].

  • When prescribing, do not convert patients on a mcg per mcg basis from any other fentanyl products to OTFC [see Dosage and Administration (2.1)].
  • When dispensing, do not substitute an OTFC prescription for other fentanyl products.

Addiction, Abuse, and Misuse

OTFC exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing OTFC, and monitor all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions ( 5.6)].

Risk Evaluation and Mitigation Strategy (REMS)

B ecause of the risk for accidental exposure, misuse, abuse, addiction, and overdose, OTFC 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, pharmacies, outpatients, and healthcare professionals who prescribe to outpatients must enroll in the program. Inpatient pharmacies must develop policies and procedures to verify opioid tolerance in inpatients who require OTFC while hospitalized [see Warnings and Precautions (5.7)]. Further information is available at www.TIRFREMSAccess.com or by calling 1-866-822-1483.

Neonatal Opioid Withdrawal Syndrome

Prolonged use of OTFC during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Warnings and Precautions ( 5.8)].

1 INDICATIONS AND USAGE

Oral Transmucosal Fentanyl Citrate (OTFC) is indicated for the management of breakthrough pain in cancer patients 16 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.

Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg of oral hydrocodone per day, or an equianalgesic dose of another opioid. Patients must remain on around-the-clock opioids when taking OTFC.

Limitations of Use:

  • Not for use in opioid non-tolerant patients.
  • Not for use in the management of acute or postoperative pain, including headache/migraine and dental pain [see Contraindications (4)].
  • As a part of the TIRF REMS, OTFC may be dispensed by outpatient pharmacies only to outpatients enrolled in the program [see Warnings and Precautions (5.7)]. For inpatient administration of OTFC, patient and prescriber enrollment are not required.

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Instructions

  • Healthcare professionals who prescribe Oral Transmucosal Fentanyl Citrate (OTFC) for outpatients must enroll in the TIRF REMS and comply with the requirements of the REMS to ensure safe use of OTFC [see Warnings and Precautions (5.7)].
  • Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions ( 5)].
  • It is important to minimize the number of strengths available to patients at any time to prevent confusion and possible overdose.
  • Initiate the dosing regimen for each patient individually, taking into account the patient’s severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see Warnings and Precautions ( 5.1)].
  • Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with OTFC and adjust the dosage accordingly [see Warnings and Precautions ( 5.1)].
  • Instruct patients and caregivers to take steps to store OTFC securely and to properly dispose of unused OTFC as soon as no longer needed [see Warnings and Precautions ( 5.1, 5.2), Patient Counseling Information (17)].
  • Other TIRF formulations and OTFC are not equivalent. DO NOT substitute an OTFC prescription for any other TIRF formulation under any circumstances. Do not convert patients on a mcg per mcg basis from any other fentanyl product to OTFC [see Warnings and Precautions ( 5.5)].

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