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Oral Transmucosal Fentanyl

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Author: [Abdullah Naji](/content/point-of-care/26285#/ ""/index.html)Editor: [Davinder Ramsingh](/content/point-of-care/26285#/ ""/index.html)Updated: 5/1/2023 7:26:51 PM

Indications

Many medical situations require knowledge about pain management, especially when dealing with the tormenting chronic pain associated with cancer. Physicians have to provide patients with relief from agonizing pain, along with investigating the underlying cause. Opioids are a recognized class of analgesia for pain management with established therapeutic outcomes and side effects. Fentanyl is a strong synthetic short-acting opioid that acts on mu-receptors with greater than 50 to 100-fold potency than morphine, and its primary use is for analgesia and sedation. Opioids have numerous routes of administration; however, the oral route is a preferred method of delivery due to its noninvasive nature. Oral transmucosal fentanyl citrate (OTFC) incorporates fentanyl citrate into lozenges, which slowly dissolve in the mouth and undergo rapid absorption via the oral mucosa. Breakthrough pain (BTP) is a severe episodic flare-up of pain in cancer patients with long-term opioid-controlled baseline pain. BTP is a severe, paroxysmal, and brief episode of pain that peaks in intensity in 3 to 52 minutes. BTP results in daily functional impairment, psychological disturbance, and increased utilization of medical resources. The duration, intensity, and pathophysiology of BTP make it difficult to manage.

OTFC has received approval from the Food and Drug Administration (FDA) and indicated specifically for the management of BTP in cancer patients due to its rapid onset and short duration of analgesia, which mimic the characteristics of BTP episodes. Two randomized, double-blinded studies demonstrated that OTFC had superior analgesic effects, greater global satisfaction, and faster onset of action in managing BTP than the usual BTP medications. A study evaluating the efficacy of OTFC for the management of severe pain crises in cancer patients reported OTFC treatment resulted in reducing the mean pain intensity of patients from 9.0 to 3.0. This study demonstrated that OTFC prevented the need for hospitalization or parenteral opioids administration for the management of BTP., suggesting that OTFC is an ideal alternative to intravenous opioids for the management of BTP episodes in cancer patients. OTFC's rapid onset, coupled with its short duration of analgesia and its noninvasive delivery (oral), makes it ideal to be used for the management of paroxysmal, severe, and brief episodes of BTP. [[1]](/content/point-of-care/26285#ref_8424569 ""/index.html) [[2]](/content/point-of-care/26285#ref_10068176 ""/index.html) [[3]](/content/point-of-care/26285#ref_19810977 ""/index.html) [[4]](/content/point-of-care/26285#ref_17315410 ""/index.html) [[5]](/content/point-of-care/26285#ref_16766468 ""/index.html) [[6]](/content/point-of-care/26285#ref_16518441 ""/index.html) [[7]](/content/point-of-care/26285#ref_9769620 ""/index.html) [[8]](/content/point-of-care/26285#ref_10353500 ""/index.html) [[9]](/content/point-of-care/26285#ref_9779697 ""/index.html) [[10]](/content/point-of-care/26285#ref_15100597 ""/index.html)

OTFC can also have a role in non-FDA-approved indications in non-cancerous patients as a treatment of moderate to severe postoperative pain. A randomized, double-blinded study investigated potency, pain relief, and pain intensity in 133 postoperative patients assigned to one of four treatment groups: high- or low-dose OTFC (800 micrograms vs. 200 micrograms), or high- or low-dose intravenous (IV) morphine (10 milligrams or 2 milligrams). It demonstrated that the higher dosage groups of OTFC and morphine provided superior analgesia than the lower dosage groups of OTFC and morphine. Higher dosage groups of OTFC and morphine produced pain relief with the duration of analgesia lasting 3.5 hours, while lower dosage groups of OTFC and morphine provided pain relief for approximately 2.5 hours. There was no significant difference in pain relief outcomes when comparing similar dosage groups between the two medications. The study demonstrated that the relative potency of OTFC to morphine was between 8 and 14 to 1. [[11]](/content/point-of-care/26285#ref_10475315 ""/index.html)

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  • CNS - Adult-Gerontology Clinical Nurse Specialist (ACCNS-AG® or AGCNS-BC™)
  • CNS - Advanced Diabetes Management (BC-ADM®)
  • Colon and Rectal Surgery / Colorectal
  • Colorado State CME CE Requirements
  • COMLEX-USA® Level 1
  • COMLEX-USA® Level 2
  • COMLEX-USA® Level 3
  • Community Health - Nursing Student
  • Complex General Surgical Oncology (CGSO®)
  • COMVEX®
  • Connecticut State CME CE Requirements
  • Correctional Medicine
  • Cosmetic Surgery (ABCS®)
  • Critical Care and Basic Rhythms - Nursing Student
  • Critical Care Medicine
  • Delaware State CME CE Requirements
  • Dental Licensure Objective Structured Clinical Examination (DLOSCE™)
  • Dermatology - Applied
  • Dermatology - Basic
  • Dermatology - Core
  • Dermatology - Micrographic Dermatologic Surgery (Mohs)
  • Dermatology - Pediatric
  • Dermatopathology
  • Disaster Medicine
  • District of Columbia CME CE Requirements
  • Egyptian Medical Licensing Exam (EMLE)
  • Elder Adult Care - Nursing Student
  • Emergency Medicine
  • Emergency Medicine - Emergency Medical Services (ABEM® EMS®)
  • Emergency Medicine - FRCEM SBA
  • Emergency Medicine - MRCEM Primary
  • Emergency Medicine - MRCEM SBA-FRCEM Intermediate
  • Emirates Medical Residency Entrance Examination (EMREE)
  • EMS - Advanced Emergency Medical Technician (NREMT® AEMT®)
  • EMS - Certified Flight Paramedic (IBSC FP-C®)
  • EMS - Community Paramedic (IBSC CP-C®)
  • EMS - Critical Care Paramedic (IBSC CCP-C®)
  • EMS - Emergency Medical Responder (NREMT® EMR®)
  • EMS - Emergency Medical Technician (NREMT® EMT®)
  • EMS - Paramedic (NREMT®)
  • EMS - Tactical Paramedic Certification (IBSC TP-C®)
  • EMS - Wilderness Paramedic (IBSC WP-C®)
  • ENARM Mexico
  • Endocrinology
  • Endovascular Medicine
  • Facial Cosmetic Surgery
  • Facial Plastic and Reconstructive Surgery
  • Family Medicine
  • Family Medicine - MRCGP-Applied Knowledge Test
  • Florida State CME CE Requirements
  • Fundamentals - Nursing Student
  • Gastroenterology
  • General Surgery
  • General Surgery - In-Training ABSITE®
  • General Surgery Review (All Subspecialties) - MRCS Part A
  • Genetics and Genomics - Clinical
  • Genetics and Genomics - General
  • Georgia State CME CE Requirements
  • Geriatrics
  • Guam State CME CE Requirements
  • Hand Surgery
  • Hawaii State CME CE Requirements
  • Health Assessment - Nursing Student
  • Healthcare Administration, Leadership, and Management (HALM®)
  • Healthcare Ethics Consultant Exam (HEC-C)
  • Hematology
  • Hospice And Palliative Medicine
  • Idaho State CME CE Requirements
  • Illinois State CME CE Requirements
  • Indian PG Entrance (NEET-PG)
  • Indiana State CME CE Requirements
  • Infectious Disease
  • Integrated National Board Dental Examination (INBDE®)
  • Internal Medicine
  • Internal Medicine - Focused Practice In Hospital Medicine
  • Internal Medicine - MRCP UK and Ireland Part 1
  • Internal Medicine - MRCP UK and Ireland Part 2
  • International Trauma Life Support® (ITLS®)
  • Iowa State CME CE Requirements
  • Kansas State CME CE Requirements
  • Kentucky State CME CE Requirements
  • Lab - Medical Laboratory Scientist MLS(ASCP®)
  • Lab - Medical Laboratory Technician MLT(ASCP®)
  • Lab - Phlebotomy Technician PBT(ASCP®) or (NPS CPT®)
  • Lab - Technologist in Blood Banking BB(ASCP®)
  • Lab - Technologist in Chemistry C(ASCP®)
  • Lab - Technologist in Hematology H(ASCP®)
  • Lab - Technologist in Microbiology M(ASCP®)
  • Lab and Diagnostic Testing - Nursing Student
  • Lifestyle Medicine
  • Louisiana State CME CE Requirements
  • Maine State CME CE Requirements
  • Maryland State CME CE Requirements
  • Massachusetts State CME CE Requirements
  • Maternal Newborn PN - Nursing Student
  • Maternal Newborn RN - Nursing Student
  • MCCQE Part I (Medical Council of Canada Qualifying Examination)
  • Medical Council Nigeria (MDCN)
  • Medical Student Elective - Allergy
  • Medical Student Elective - Anesthesiology
  • Medical Student Elective - Biostatistics and Economics
  • Medical Student Elective - Cardiothoracic Surgery
  • Medical Student Elective - Cardiovascular Disease
  • Medical Student Elective - Critical Care
  • Medical Student Elective - Dermatology
  • Medical Student Elective - Diagnostic Radiology
  • Medical Student Elective - ECG and Rhythm Strip Review
  • Medical Student Elective - Endocrinology
  • Medical Student Elective - Gastroenterology
  • Medical Student Elective - Genetics
  • Medical Student Elective - Geriatrics
  • Medical Student Elective - Hand
  • Medical Student Elective - Hematology
  • Medical Student Elective - Infectious Disease
  • Medical Student Elective - Law, Medicine, and Ethics
  • Medical Student Elective - Neonatology
  • Medical Student Elective - Nephrology
  • Medical Student Elective - Neurosurgery
  • Medical Student Elective - Oncology
  • Medical Student Elective - Ophthalmology
  • Medical Student Elective - Orthopedic
  • Medical Student Elective - Otolaryngology
  • Medical Student Elective - Pathology, Clinical Laboratory
  • Medical Student Elective - Pediatric Cardiology
  • Medical Student Elective - Pediatric Critical Care
  • Medical Student Elective - Pediatric Endocrinology
  • Medical Student Elective - Pediatric Gastroenterology
  • Medical Student Elective - Pediatric Hematology & Oncology
  • Medical Student Elective - Pediatric Infectious Diseases
  • Medical Student Elective - Pediatric Nephrology
  • Medical Student Elective - Pediatric Neurology
  • Medical Student Elective - Pediatric Pulmonology
  • Medical Student Elective - Pediatric Surgery
  • Medical Student Elective - Physical Medicine and Rehabilitation
  • Medical Student Elective - Plastic Surgery
  • Medical Student Elective - Pulmonology
  • Medical Student Elective - Rheumatology
  • Medical Student Elective - Sports Medicine
  • Medical Student Elective - Urology
  • Medical Student Elective - Vascular Surgery
  • Mental Health PN - Nursing Student
  • Mental Health RN - Nursing Student
  • Metabolic and Bariatric Surgery (MBS FPD®)
  • Michigan State CME CE Requirements
  • Microbiology - Nursing Student
  • Minnesota State CME CE Requirements
  • Mississippi State CME CE Requirements
  • Missouri State CME CE Requirements
  • Montana State CME CE Requirements
  • Multistate Pharmacy Jurisprudence Examination® (MPJE®)
  • National Board Dental Hygienist Examination (NBDHE®)
  • NBME® Shelf - Ambulatory Care
  • NBME® Shelf - Anatomy
  • NBME® Shelf - Behavioral Science
  • NBME® Shelf - Biochemistry
  • NBME® Shelf - Clinical Neurology
  • NBME® Shelf - Comprehensive Basic Science (CBSE®)
  • NBME® Shelf - Comprehensive Clinical Science (CCC®)
  • NBME® Shelf - Embryology
  • NBME® Shelf - Emergency Medicine
  • NBME® Shelf - Family Medicine
  • NBME® Shelf - Health Systems Science
  • NBME® Shelf - Histology
  • NBME® Shelf - Internal Medicine (Advanced Clinical Exam)
  • NBME® Shelf - Introduction to Clinical Diagnosis
  • NBME® Shelf - Medicine
  • NBME® Shelf - Microbiology and Immunology
  • NBME® Shelf - Neuroscience
  • NBME® Shelf - Obstetrics and Gynecology
  • NBME® Shelf - Pathology
  • NBME® Shelf - Pediatrics
  • NBME® Shelf - Pharmacology
  • NBME® Shelf - Physiology
  • NBME® Shelf - Psychiatry
  • NBME® Shelf - Surgery
  • NBOME® Subject Exam / Shelf - Osteopathic Principles and Practice
  • NCLEX-PN® - Nursing Student
  • NCLEX-RN® - Nursing Student
  • Nebraska State CME CE Requirements
  • Nepal Medical Council Licensing Examination (NMCLE)
  • Nephrology
  • Neurology
  • Neurology - Behavioral Neurology and Neuropsychiatry
  • Neurology - Clinical Neurophysiology
  • Neurology - Epilepsy Medicine
  • Neurology - Headache
  • Neurology - Neurocritical Care
  • Neurology - Neurodevelopmental Disabilities
  • Neurology - Neuromuscular Medicine
  • Neurology - Vascular Neurology
  • Neurosurgery
  • Nevada State CME CE Requirements
  • New Hampshire State CME CE Requirements
  • New Jersey State CME CE Requirements
  • New Mexico State CME CE Requirements
  • New York State CME CE Requirements
  • North Carolina State CME CE Requirements
  • North Dakota State CME CE Requirements
  • NP - Adult-Gerontology Acute Care Nurse Practitioner (AGACNP® or ACNPC-AG®)
  • NP - Adult-Gerontology Primary Care Nurse Practitioner (AGPCNP® or AGNP®)
  • NP - Advanced Certified Hospice and Palliative Nurse (ACHPN®)
  • NP - Advanced Health Assessment and Diagnostic Reasoning Nurse Practitioner
  • NP - Advanced Neurovascular Practitioner Certification (ANVP-BC®)
  • NP - Advanced Oncology Certified Nurse Practitioner (AOCNP®)
  • NP - Advanced Pathophysiology Nurse Practitioner
  • NP - Advanced Pharmacology Nurse Practitioner
  • NP - Advanced Physiology Nurse Practitioner
  • NP - Biostatistics and Epidemiology Nurse Practitioner
  • NP - Board Certified Advanced Diabetes Management (BC-ADM®)
  • NP - Cardiovascular Nurse Practitioner (CVNP-BC®)
  • NP - Certified Addictions Registered Nurse - Advanced Practice (CARN-AP®)
  • NP - Certified Continence Care Nurse - Advanced Practice (CCCN-AP®)
  • NP - Certified Midwife (CNM®/CM®)
  • NP - Certified Nephrology Nurse - Nurse Practitioner™ (CNN-NP™)
  • NP - Certified Ostomy Care Nurse - Advanced Practice (COCN-AP®)
  • NP - Certified Pediatric Nurse Practitioner - Acute Care (CPNP-AC®)
  • NP - Certified Pediatric Nurse Practitioner – Primary Care (CPNP-PC®)
  • NP - Certified Urologic Nurse Practitioner (CUNP®)
  • NP - Certified Wound Care Nurse - Advanced Practice (CWCN-AP® / AWCC™)
  • NP - Certified Wound Ostomy Continence Nurse - Adv. Practice (CWOCN-AP®)
  • NP - Dermatology Certified Nurse Practitioner (DCNP®)
  • NP - Emergency Nurse Practitioner (ENP®)
  • NP - Ethics & Legal Issues Nurse Practitioner
  • NP - Family Nurse Practitioner (ANCC/FNP-BC™ or AANP/FNP-C®)
  • NP - Health Promotion and Disease Prevention Nurse Practitioner
  • NP - Neonatal Nurse Practitioner (NNP-BC®)
  • NP - Nurse Executive Advanced Certification (NEA-BC®)
  • NP - Orthopedic Nurse Practitioner (ONP-C®)
  • NP - Pediatric Primary Care Mental Health Specialist (PMHS®)
  • NP - Psychiatric-Mental Health Nurse Practitioner Certification (PMHNP-BC™)
  • NP - Theory and Evidence-Based Practice Nurse Practitioner
  • NP - Women's Health Nurse Practitioner (WHNP®)
  • Nuclear Medicine
  • Nurse - Ambulatory Care Nursing Certification (AMB-BC™)
  • Nurse - Assisted Living Nursing Certification (C-AL®)
  • Nurse - Bariatric (CBN®)
  • Nurse - Cardiac Medicine Certification (CMC®) Adult
  • Nurse - Cardiac-Vascular Nursing Certification (CV-BC™)
  • Nurse - Cardiovascular Nursing (CVN®)
  • Nurse - Case Management Certification (CMGT-BC™)
  • Nurse - Certified Addictions Registered Nurse (CARN®)
  • Nurse - Certified Anticoagulation Care Provider (CACP®)
  • Nurse - Certified Breast Care Nurse (CBCN®)
  • Nurse - Certified Clinical Transplant Nurse (CCTN®)
  • Nurse - Certified Continence Care Nurse (CCCN®)
  • Nurse - Certified Diabetes Care and Education Specialist® (CDCES®)
  • Nurse - Certified Emergency Nurse® (CEN®)
  • Nurse - Certified Flight Registered Nurse (CFRN®)
  • Nurse - Certified Foot Care Nurse (CFCN®)
  • Nurse - Certified Gastroenterology Registered Nurse (CGRN®)
  • Nurse - Certified Hemodialysis Nurse (CHN®)
  • Nurse - Certified Hospice and Palliative Nurse (CHPN®)
  • Nurse - Certified Hyperbaric Registered Nurse® (CHRN®)
  • Nurse - Certified Infection Control (CIC®)
  • Nurse - Certified Managed Care Nurse (CMCN®)
  • Nurse - Certified Nephrology Nurse (CNN®)
  • Nurse - Certified Neuroscience Registered Nurse (CNRN®)
  • Nurse - Certified Nurse Educator (CNE®)
  • Nurse - Certified Nurse Manager and Leader (CNML®)
  • Nurse - Certified Occupational Health Nurse (COHN® and COHN-S®)
  • Nurse - Certified Ostomy Care (COCN®) / Ostomy Management Specialist (OMS®)
  • Nurse - Certified Otorhinolaryngology Nurse (CORLN®)
  • Nurse - Certified Pediatric Emergency Nurse (CPEN®)
  • Nurse - Certified Pediatric Hematology Oncology Nurse (CPHON®)
  • Nurse - Certified Pediatric Nurse (CPN®)
  • Nurse - Certified Perioperative Nurse (CNOR®)
  • Nurse - Certified Peritoneal Dialysis Nurse (CPDN®)
  • Nurse - Certified Plastic Surgery Nurse (CPSN®)
  • Nurse - Certified Post and Ambulatory Perianesthesia Nurse (CPAN® / CAPA®)
  • Nurse - Certified Professional in Health Care Risk Management (CPHRM®)
  • Nurse - Certified Professional in Healthcare Quality (CPHQ®)
  • Nurse - Certified Radiology Nurse (CRN©)
  • Nurse - Certified Registered Nurse in Ophthalmology (CRNO®)
  • Nurse - Certified Registered Nurse Infusion (CRNI®)
  • Nurse - Certified Rehabilitation Registered Nurse (CRRN®)
  • Nurse - Certified Transport Registered Nurse (CTRN®)
  • Nurse - Certified Urologic Registered Nurse (CURN®)
  • Nurse - Certified Wound Care Nurse (CWCN® / WCC®)
  • Nurse - Critical Care Registered Nurse - Adult (CCRN®)
  • Nurse - Critical Care Registered Nurse - Neonatal (CCRN®)
  • Nurse - Critical Care Registered Nurse - Pediatric (CCRN®)
  • Nurse - Dermatology Nurse Certified (DNC®)
  • Nurse - Emergency Nurse Pediatric Certification© (ENPC®)
  • Nurse - Gerontology Nursing Certification (GERO-BC™)
  • Nurse - Informatics Nursing Certification (NI-BC™)
  • Nurse - Inpatient Obstetric Nursing (RNC-OB®)
  • Nurse - International Board Certified Lactation Consultant® (IBCLC®)
  • Nurse - Low Risk Neonatal Intensive Care Nursing (RNC-LRN®)
  • Nurse - Maternal Newborn Nursing (MNN®)
  • Nurse - Medical-Surgical Nursing Certification (MEDSURG-BC™)
  • Nurse - Nationally Certified School Nurse (NCSN®)
  • Nurse - Neonatal Pediatric Transport (C-NPT®)
  • Nurse - Nurse Executive Certification (NE-BC®)
  • Nurse - Nursing Professional Development Certification (NPD-BC™)
  • Nurse - Oncology Certified Nurse (OCN®)
  • Nurse - Orthopedic Nurse Certification (ONC®)
  • Nurse - Pain Management Nursing Certification (PMGT-BC™)
  • Nurse - Progressive Care Certified Nurse (PCCN®) - Adult
  • Nurse - Psychiatric-Mental Health Nursing Certification (PMH-BC™)
  • Nurse - Registered Nurse First Assistant (RNFA©)
  • Nurse - Sexual Assault Nurse Examiner (SANE®)
  • Nurse - Stroke Certified Registered Nurse (SC-RN®)
  • Nurse - Trauma Certified Registered Nurse (TCRN®)
  • Nurse - Vascular Access Board Certified Nursing (VA-BC®)
  • Nutrition - Nursing Student
  • Nutrition Medicine
  • Obesity Medicine
  • Ob-Gyn - CREOG® In-Service
  • Ob-Gyn - Gynecologic Oncology
  • Ob-Gyn - Maternal-Fetal Medicine
  • Ob-Gyn - MRCOG UK and Ireland Part 1
  • Ob-Gyn - MRCOG UK and Ireland Part 2 and Part 3
  • Ob-Gyn - Obstetrics and Gynecology
  • Ob-Gyn - Reproductive Endocrinology and Infertility
  • Ob-Gyn - Urogynecology and Reconstructive Pelvic Surgery
  • Occupational Medicine
  • Occupational Therapist Registered (NBCOT® OTR®)
  • Ohio State CME CE Requirements
  • Oklahoma State CME CE Requirements
  • Oncology
  • Ophthalmology
  • Ophthalmology - Cataract
  • Ophthalmology - Cornea and External Eye Disease
  • Ophthalmology - Glaucoma
  • Ophthalmology - Medical and Surgical Retina
  • Ophthalmology - Neuro-Ophthalmology
  • Ophthalmology - Oculoplastic Surgery
  • Ophthalmology - Optics
  • Ophthalmology - Pediatric and Strabismus
  • Ophthalmology - Uveitis
  • Ophthamology - Trauma
  • Optometry - Advanced Medical Care
  • Optometry - Applied Basic Science (ABS®)
  • Optometry - Patient Assessment and Management (PAM®)
  • Oral And Maxillofacial Surgery
  • Oregon State CME CE Requirements
  • Orthopedic Surgery
  • Osteopathic Neuromusculoskeletal Medicine (OMT/NMM®/OMM®)
  • Otolaryngology - Head and Neck Surgery
  • PA - Cardiovascular and Thoracic Surgery (CAQ-CVTS®)
  • PA - Cardiovascular Physician Assistant/Associate (CVPA-BC®)
  • PA - Clinical Knowledge Rating and Assessment
  • PA - Dermatology (CAQ-Derm® or NBDPA™)
  • PA - Emergency Medicine (CAQ-EM®)
  • PA - Emergency Medicine End of Rotation
  • PA - End of Curriculum
  • PA - Family Medicine End of Rotation
  • PA - Hospital Medicine (CAQ-HM®)
  • PA - Internal Medicine End of Rotation
  • PA - Nephrology (CAQ-Neph®)
  • PA - Obstetrics and Gynecology (CAQ-OBGYN®)
  • PA - Occupational Medicine (CAQ-OM®)
  • PA - Orthopedic (CAQ-OS®)
  • PA - Palliative Medicine and Hospice Care (CAQ-PMHC®)
  • PA - PANCE®
  • PA - PANRE®
  • PA - Pediatric (CAQ-Peds®)
  • PA - Pediatric End of Rotation
  • PA - Psychiatric and Behavioral Health End of Rotation
  • PA - Psychiatry (CAQ-Psy®)
  • PA - Surgery End of Rotation
  • PA - Womens Health End of Rotation (Gyn, Sexual, & Reproductive Health)
  • Pain Medicine
  • Pakistan - 1st Professional MBBS
  • Pakistan - 2nd Professional MBBS
  • Pakistan - 3rd Professional MBBS
  • Pakistan - 4th Professional MBBS
  • Pakistan - Final Professional MBBS
  • Pakistan FCPS Part I (Basic Science)
  • Pathology - Anatomic
  • Pathology - Blood Banking Transfusion Medicine
  • Pathology - Chemical
  • Pathology - Clinical
  • Pathology - Cytopathology
  • Pathology - Forensics
  • Pathology - Hematopathology
  • Pathology - Microbiology
  • Pathology - Molecular Genetic
  • Pathology - Neuropathology
  • Pathology - Pediatric
  • Pathophysiology - Nursing Student
  • Pediatric
  • Pediatric - Cardiology
  • Pediatric - Child Abuse
  • Pediatric - Critical Care
  • Pediatric - Developmental Behavioral
  • Pediatric - Emergency Medicine
  • Pediatric - Endocrinology
  • Pediatric - Gastroenterology
  • Pediatric - Hematology-Oncology
  • Pediatric - Hospital Medicine
  • Pediatric - Infectious Diseases
  • Pediatric - MRCPCH UK
  • Pediatric - Neonatal Perinatal
  • Pediatric - Nephrology
  • Pediatric - Neurology
  • Pediatric - Pulmonology
  • Pediatric - Rehabilitation Medicine
  • Pediatric - Rheumatology
  • Pediatric Advanced Life Support® (PALS®)
  • Pediatric Surgery
  • Pennsylvania State CME CE Requirements
  • Pharmacology PN - Nursing Student
  • Pharmacology RN - Nursing Student
  • Pharmacy - Ambulatory Care (BCACP®)
  • Pharmacy - Applied Toxicology (ABAT®)
  • Pharmacy - Cardiology (BCCP®)
  • Pharmacy - Certified Pharmacy Technician (PTCB® CPhT®)
  • Pharmacy - Critical Care (BCCCP®)
  • Pharmacy - Emergency Medicine (BCEMP®)
  • Pharmacy - Geriatric (BCGP®)
  • Pharmacy - Infectious Disease (BCIDP®)
  • Pharmacy - NAPLEX®
  • Pharmacy - Nutrition Support (BCNSP®)
  • Pharmacy - Oncology (BCOP®)
  • Pharmacy - Pediatric (BCPPS®)
  • Pharmacy - Pharmacotherapy (BCPS®)
  • Pharmacy - Psychiatric (BCPP®)
  • Physical Medicine and Rehabilitation
  • Physical Therapy - Geriatric Clinical Specialist (ABPTS® APTA® GCS)
  • Physical Therapy - Neurology Clinical Specialist (ABPTS® APTA® NCS)
  • Physical Therapy - Orthopedic Clinical Specialist (ABPTS® APTA® OCS)
  • Physical Therapy - Pediatric Clinical Specialist (ABPTS® APTA® PCS)
  • Physical Therapy - Physical Therapist (NPTE-PT)®
  • Physical Therapy - Physical Therapist Assistant (NPTE-PTA)®
  • Physical Therapy - Sports Clinical Specialist (ABPTS® APTA® SCS)
  • Plastic Surgery
  • Podiatry - APMLE® Part 1
  • Podiatry - APMLE® Part 2
  • Podiatry - APMLE® Part 3
  • Podiatry Foot and Ankle Surgery
  • Podiatry Medicine
  • Professional Ethics, Leadership, and Management - Nursing Student
  • Psychiatry
  • Psychiatry - Addiction
  • Psychiatry - Child and Adolescent
  • Psychiatry - Consultation-Liaison
  • Psychiatry - Forensic
  • Psychiatry - Geriatric
  • Psychology - Examination for Professional Practice In Psychology (EPPP®)
  • Psychology - Neuropsychology
  • Psychology - Psychopharmacology Examination (PEP®)
  • Public Health and
General Preventive Medicine
  • Puerto Rico State CME CE Requirements
  • Pulmonary
  • Quality Board
  • Radiation Oncology
  • Radiologic Technologist - Magnetic Resonance Imaging (ARRT-MRI®)
  • Radiologic Technologist - Radiography (ARRT-R®)
  • Radiology - Breast
  • Radiology - Cardiac
  • Radiology - Diagnostic Radiology Qualifying (Core)
  • Radiology - Gastrointestinal
  • Radiology - Genitourinary
  • Radiology - Musculoskeletal
  • Radiology - Neuroradiology
  • Radiology - Pediatric
  • Radiology - Physics and Safety
  • Radiology - Thoracic
  • Radiology - Ultrasound
  • Radiology - Vascular and Interventional
  • Radiology Technology - Computed Tomography (ARRT-CT® or NMTCB-CT®)
  • Radiology Technology - Nuclear Medicine (ARRT® or NMTCB-CNMT®)
  • Radiology Technology - Vascular Interventional Radiography
  • Registered Cardiovascular Invasive Specialist (RCIS)®
  • Registered Dietitian (RD®) / Registered Dietitian Nutritionist (RDN®)
  • Respiratory Therapist - Certified or Registered (CRT® or RRT®)
  • Respiratory Therapy - Adult Critical Care Specialist (RRT-ACCS®)
  • Respiratory Therapy - Neonatal and Pediatric (RRT-NPS®)
  • Respiratory Therapy - Pulmonary Function Technologist (CPFT® or RPFT®)
  • Rheumatology
  • Rhode Island State CME CE Requirements
  • Sleep
  • Social Work - ASWB® Advanced Generalist
  • Social Work - ASWB® Bachelors and Associate
  • Social Work - ASWB® Clinical
  • Social Work - ASWB® Masters
  • Sonography - Cardiac Sonographer
  • Sonography - Registered Diagnostic Medical Sonographer® (RDMS-Ob/Gyn®)
  • Sonography - Registered Diagnostic Medical Sonographer®-Abdomen (RDMS-AB®)
  • Sonography - Vascular (ADRMS® RVT®, ARRT® VS®, CCI® RVS®)
  • South Carolina State CME CE Requirements
  • South Dakota State CME CE Requirements
  • Speech-Language Pathology Praxis® (SLP®)
  • SPEX®
  • Spinal Cord Injury Medicine
  • Spine Surgery
  • Sports Medicine
  • Surgical Critical Care
  • Tennessee State CME CE Requirements
  • Texas State CME CE Requirements
  • Thoracic Surgery
  • Toxicology
  • Transesophageal Echocardiography
  • Transplant Hepatology
  • UK - Medical Licensing Assessment (UKMLA/MLA)
  • UK - Multi-Specialty Recruitment Assessment (MSRA - CPS)
  • UK - Prescribing Safety Assessment (PSA)
  • UK Overseas Registration (ORE)
  • UK PLAB 1
  • Undersea and Hyperbaric
  • Urology
  • Urology - Pediatric
  • USMLE® Step 1
  • USMLE® Step 2
  • USMLE® Step 3
  • Utah State CME CE Requirements
  • Vascular Medicine (ABVMVascular Medicine (ABVM®)
  • Vascular Surgery
  • Venous, Lymphatic, and Phlebology Medicine
  • Vermont State CME CE Requirements
  • Virgin Islands State CME CE Requirements
  • Virginia State CME CE Requirements
  • Washington State CME CE Requirements
  • West Virginia State CME CE Requirements
  • Wisconsin State CME CE Requirements
  • Wound
  • Wyoming State CME CE Requirements

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Mechanism of Action

OTFC is a solid formulation of lipophilic fentanyl citrate. Its mechanism of action involves acting as an agonist on mu-receptors in the brain and spinal cord, resulting in therapeutic outcomes of sedation and analgesia. As the lozenges of OTFC dissolve, 25% of the total fentanyl is absorbed across the oral mucosa, while the remainder 75% is swallowed. One-third of the 75% escapes the first-pass metabolism and is slowly absorbed in the intestines. OTFC's rapid absorption across the oral mucosa coupled with its fast diffusion across the blood-brain barrier establishes its rapid onset. Delivery of fentanyl as OTFC via the oral mucosa is advantageous due to the nature of the oral mucosa. The oral mucosa is highly permeable and vascular, allowing lipophilic compounds to diffuse across the mucosa into the bloodstream easily. The oral mucosa has a uniform temperature and increased surface area, accentuating the delivery of OTFC. [[12]](/content/point-of-care/26285#ref_16083461 ""/index.html) [[13]](/content/point-of-care/26285#ref_1619560 ""/index.html)

Administration

OTFC is available as a sweetened lozenge with a fentanyl citrate base for oral administration by sucking to facilitate oral transmucosal absorption. OTFC is available in six different dosages based on the strength of the fentanyl citrate base: 200, 400, 600, 800, 1200, and 1600 micrograms. In BTP, it is necessary to initially establish control of chronic pain using long-term opioids. Afterward, OTFC is used to treat the episodic breakthrough pains that occur. It is necessary to titrate under supervision to establish the correct dosage for controlling BTP. Start with 200 micrograms; if the BTP remains uncontrolled after 15 minutes, the patient should wait 15 more minutes and then take another lozenge (30 minutes total after the first lozenge). The patient may receive no more than two lozenges per episode of BTP during the titration period to minimize adverse side effects. If the pain is relieved after the second dose of 200 micrograms, then for the next episode of BTP, one 400 microgram lozenge is used. If pain relief of a BTP episode requires more than two lozenges, an increase of OTFC strength is applied to the next BTP episode. After establishing the correct strength of OTFC for the control of a BTP episode, a limit of 4 units per day is set. OTFC has a rapid onset of analgesia with peak effects occurring at 20 to 40 minutes after administration and lasting 2 to 3 hours. [[2]](/content/point-of-care/26285#ref_10068176 ""/index.html) [[5]](/content/point-of-care/26285#ref_16766468 ""/index.html) [[14]](/content/point-of-care/26285#ref_18454617 ""/index.html) [[15]](/content/point-of-care/26285#ref_18298711 ""/index.html)

Adverse Effects

OTFC is an opioid, and its side effects include nausea, constipation, confusion, dizziness, somnolence, addiction, asthenia, and hypotension. The therapeutic range is 1 to 3 nanograms/milliliters. High plasma levels can lead to respiratory depression and death. Concomitant consumption of other central nervous system (CNS) depressants (i.e., alcohol, heroin, benzodiazepines) may contribute to additive adverse effects; hence, patients with multiple CNS depressant medications require careful monitoring. Similar to all opioids, avoid use in the elderly with a history of falls. [[5]](/content/point-of-care/26285#ref_16766468 ""/index.html) [[16]](/content/point-of-care/26285#ref_12906959 ""/index.html)

Contraindications

OTFC should not be administered to opioid intolerant patients to prevent fatal respiratory depression. Clinicians should not use it with patients who have acute or severe asthmatic patients. It is contraindicated in patients with gastrointestinal obstruction and patients with a known history of hypersensitivity (i.e., anaphylaxis) to fentanyl.

Monitoring

Concomitant use of cytochrome P450 3A4 (CYP3A4) inhibitors (i.e., macrolide antibiotics) results in higher fentanyl plasma levels and can contribute to fatal respiratory depression. Patients require close monitoring, and the clinician should consider reducing the OTEC dose. Similarly, discontinuation of CYP3A4 inducer medications (i.e., phenytoin) can increase plasma levels of fentanyl, resulting in prolonged OTFC adverse effects. Therefore, patients receiving OTFC and CYP3A4 inhibitors/inducers must be monitored closely and frequently, along with considering adjusting the dosing of OTFC, as needed. [[5]](/content/point-of-care/26285#ref_16766468 ""/index.html)

Toxicity

OTFC toxicity manifests as miosis, somnolence progressing to coma, airway obstruction, and respiratory depression. In overdose situations, the priority is to remove OTFC from the oral cavity, establish a patent and protected airway and administer oxygen. Intubation and mechanical ventilation of the patient are considerations if needed. For clinically significant respiratory depression secondary to OTFC overdose, an opioid antagonist, naloxone, is administered. If the respiratory recovery is suboptimal, additional naloxone is administered, and the patient is monitored until initiating patient-initiated respiration, and appropriate oxygen saturation levels return. Naloxone is FDA approved for the treatment of suspected or known opioid overdose resulting in respiratory depression. Naloxone administration can be intramuscular, intravenous, subcutaneous, or intranasal. [[17]](/content/point-of-care/26285#ref_31239953 ""/index.html)

Enhancing Healthcare Team Outcomes

Management of pain in patients with an underlying cause (i.e., cancer) is an important clinical issue since such patients experience relentless pain that is usually not appropriately treated and results in poor life outcomes. Cancer patients in moderate to severe flare-ups of episodic pain in addition to their baseline opioid controlled pain require effective medications to control such episodes. OTFC is an optimal choice to manage these episodic flare-ups of pain in cancer patients due to its pharmacokinetics (short duration and rapid onset) and noninvasive and convenient route of delivery (oral transmucosal).

Physicians prescribing this medication should be familiar with its adverse effects, indications/contraindications, and be vigilant regarding the patient’s concomitant medication use (i.e., other CNS depressants, CYP 3A4 inhibitors/inducers) to prevent toxicity or suboptimal therapeutic outcomes. Physicians are encouraged to screen patients for opioid abuse or misuse before prescribing OTFC. Physicians should educate the patient about increased risks of overdose or death associated with the use of additional CNS depressants (i.e., opioids, benzodiazepines, alcohol) with OTFC. Opioid overdose is a serious medical situation due to the high risk of fatal respiratory depression. Ultimately, the optimal approach to managing opioid overdose situations is to prevent it from happening in the first place. A comprehensive approach to preventing overdose situations involves highly regulated prescribing and dispensing policies, follow-up and monitoring processes, and complete coordination among providers via electronic healthcare records. [[18]](/content/point-of-care/26285#ref_28707421 ""/index.html) [Level 3]

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