What is a REMS?A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program. The U.S. Food and Drug Administration (FDA) can require a REMS for certain medications. The purpose of a REMS is to reduce the number or seriousness of injuries related to the use of the medication.
How to say REMS in English
What are TIRF medicines?
A transmucosal immediate-release fentanyl (TIRF) medicine is a prescription medicine that contains fentanyl, a very strong opioid pain reliever.
TIRF medicines are used to manage breakthrough cancer pain in patients who are already routinely taking another opioid pain medicine around-the-clock.
TIRF medicines are started only after you have been taking other opioid pain medicines and your body has become used to them (meaning you are opioid tolerant).
Brand Name Products
ABSTRAL®
ACTIQ®
FENTORA®
LAZANDA®
ONSOLIS®
SUBSYS®
Generic Products
Oral Transmucosal Fentanyl Citrate Lozenge
Oral Transmucosal Fentanyl Citrate Buccal Tablets
What is Opioid Tolerant?
Patients considered opioid tolerant are those who are taking around-the-clock medicine consisting of at least 60 mg of oral morphine per day, or at least 25 mcg per hour of transdermal fentanyl, or at least 30 mg of oral oxycodone per day, or at least 8 mg of oral hydromorphone per day, or at least 25 mg oral oxymorphone per day, or at least 60 mg oral hydrocodone per day or an equianalgesic dose of another opioid medication daily for a week or longer. Patients must remain on around-the- clock opioids when taking a TIRF medicine.
What is Naloxone?Naloxone is a medicine that helps reverse an opioid overdose.
Naloxone is sprayed inside your nose or injected into your body. Some naloxone products are designed for people to use in their home.
Naloxone is never a substitute for emergency medical care. Get emergency help or call 911 right away if you take too much of your TIRF medicine, because you may have had an opioid overdose.
See the Patient Counseling Guide for more information.
Patient
To receive treatment, a patient must be enrolled in the TIRF REMS by a certified doctor.
ATTENTION: The TIRF REMS is no longer accepting enrollments for new Patients. For more information contact the TIRF REMS Call Center at 1-866-822-1483.