What is the generic name?

FENTANYL

What is the Trade Name for FENTANYL?

SUBSYS

What are the Indications for FENTANYL?

• 1 INDICATIONS AND USAGE SUBSYS 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 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, or at least 25 mg oral oxymorphone per day, or at least 60mg 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 when taking SUBSYS. 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, dental pain, or in the emergency room [see Contraindications ( 4 )]. As part of the Transmucosal Immediate-Release Fentanyl (TIRF) REMS, SUBSYS may be dispensed by outpatient pharmacies only to outpatients enrolled in the program. [ see Warnings and Precautions ( 5.7 )]. For inpatient administration of SUBSYS, patient and prescriber enrollment are not required. SUBSYS 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 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 daily for a week or longer. Patients must remain on around-the-clock opioids when taking SUBSYS. Limitations of Use ( 1 ): Not for use in opioid non-tolerant patients. Not for use in the management of acute or postoperative pain, including headache/migraine, dental pain, or in the emergency room. As a part of the Transmucosal Immediate-Release Fentanyl (TIRF) REMS, SUBSYS may be dispensed by outpatient pharmacies only to outpatients enrolled in the program ( 5.7 ). For inpatient administration of SUBSYS, patient and prescriber enrollment are not required.

References: https://open.fda.gov/