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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 Access Program, Otfc May Be Dispensed Only To Outpatients Enrolled In The Program [See Warnings And Precautions ( 5.7 )] . For Inpatient Administration Of Otfc (E.g., Hospitals, Hospices, And Long-Term Care Facilities That Prescribe For Inpatient Use), Patient And Prescriber Enrollment Is Not Required. Otfc Is An Opioid Agonist 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 Oral Hydrocodone Per Day, Or An Equianalgesic Dose Of Another Opioid. Patients Must Remain On Around-The-Clock Opioids While 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 Or Dental Pain. ( 4 ) As A Part Of The Tirf Rems Access Program, Otfc May Be Dispensed Only To Outpatients Enrolled In The Program. ( 5.7 ) For Inpatient Administration Of Otfc (E.g., Hospitals, Hospices, And Long-Term Care Facilities That Prescribe For Inpatient Use), Patient And Prescriber Enrollment Is Not Required.
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