|
1 Indications And Usage Fentanyl Buccal Tablet 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. Patients Considered Opioid Tolerant Are Those Who Are Taking Around-The-Clock Medicine Consisting Of At Least 60 Mg Of Oral Morphine Per Day, At Least 25 Mcg Per Hour Of Transdermal Fentanyl, 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 Daily For A Week Or Longer. Patients Must Remain On Around-The-Clock Opioids While Taking Fentanyl Buccal Tablet. Fentanyl Buccal Tablet Is An Opioid Agonist 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. ( 1 ) 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 Per Hour Of Transdermal Fentanyl, 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 Daily For A Week Or Longer. Patients Must Remain On Around-The-Clock Opioids While Taking Fentanyl Buccal Tablet. 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. As A Part Of The Tirf Rems Access Program, Fentanyl Buccal Tablet May Be Dispensed Only To Patients Enrolled In The Tirf Rems Access Program. For Inpatient Administration Of Fentanyl Buccal Tablet (E.g., Hospitals, Hospices, And Long-Term Care Facilities That Prescribe For Inpatient Use), Patient And Prescriber Enrollment Is Not Required. 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, Fentanyl Buccal Tablet May Be Dispensed Only To Outpatients Enrolled In The Program [See Warnings And Precautions (5.7) ] . For Inpatient Administration Of Fentanyl Buccal Tablet (E.g., Hospitals, Hospices, And Long-Term Care Facilities That Prescribe For Inpatient Use), Patient And Prescriber Enrollment Is Not Required.
|