What is Transmucosal Immediate Release Fentanyl?
TIRF (transmucosal immediate-release fentanyl) medicines contain fentanyl, a prescription opioid pain reliever. TIRF medicines are used to manage breakthrough pain in adults with cancer who are routinely taking other opioid pain medicines around-the-clock for pain.
What is the TIRF program?
The Transmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) Program is an FDA-required program designed to ensure informed risk-benefit decisions before initiating treatment, and while patients are treated to ensure appropriate use of TIRF medicines.
When did REMS start?
The REMS program was formalized in 2007. The FDA determines as part of the drug approvals process that a REMS is necessary, and the drug company develops and maintains the individual program. REMS applies only to specific prescription drugs, but can apply to brand name or generic drugs.
What does transmucosal mean?
Medical Definition of transmucosal : relating to, being, or supplying a medication that enters through or across a mucous membrane (as of the mouth) transmucosal fentanyl Noven Pharmaceuticals develops transdermal and transmucosal drug delivery systems and technologies. —
What is transmucosal route?
Transmucosal routes include intranasal, buccal, sublingual and rectal. They are non-invasive routes for systemic drug delivery with the possibility of self-administration, or administration by family caregivers.
Is clozapine a REMS drug?
On July 29, 2021, FDA approved modifications to the Clozapine Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drug outweigh the risk of severe neutropenia. The Clozapine REMS is a shared system REMS for all approved clozapine products.
What is REMS product?
A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.
How many REMS products are there?
As of October 2020, there are 59 products with FDA-authorized REMS programs. Of those 59 products, 51 require “Elements to Assure Safe Use” (ETASU).
Is transmucosal the same as sublingual?
You can give drugs transmucosally at three sites: inside the cheek (buccally), under the tongue (sublingually), or on the tongue (translingually).
What is transmucosal buprenorphine?
Transmucosal formulations of buprenorphine exist, among others, as dissolving films (buccal or sublingual) of either plain buprenorphine at low doses (micrograms) intended for chronic pain management, or as a combination of buprenorphine and naloxone (the latter is intended as a deterrent for misuse through injection …
How do you administer transmucosal?
Passing directly into the bloodstream, they take action quickly while avoiding the damaging effects of gastric juices and liver metabolism. You can give drugs transmucosally at three sites: inside the cheek (buccally), under the tongue (sublingually), or on the tongue (translingually).
Can a pharmacist dispensed clozapine?
Pharmacists will need to go to www.clozapineREMS.com or call the Clozapine Call Center at 1-888-586-0758 to verify information and obtain a REMS dispense authorization to dispense clozapine. The Pre-Dispense Authorization (PDA) will be replaced by a REMS Dispense Authorization (RDA).
Which drugs have REMS programs?
REMS@FDA
| Name | REMS Approved | ETASU |
|---|---|---|
| Lenalidomide Shared System REMS | 05/21/2021 | ETASU |
| Lotronex (alosetron hydrochloride), tablet NDA #021107 | 09/02/2010 | ETASU |
| Macitentan Shared System REMS | 04/06/2021 | ETASU |
| Mifepristone Shared System REMS | 04/11/2019 | ETASU |
What is transmucosal medication?
4. Oral transmucosal delivery. Oral transmucosal delivery refers to the systemic delivery of drug through the mucous membrane of the oral cavity. It is a popular route of drug administration used in palliative care compared to other transmucosal routes, due to its convenience and ease of administration [4].
What are the restrictions for dispensing clozapine?
Treatment should not be initiated if WBC < 3.5 k/µL. Clozapine cannot be dispensed if the WBC < 3 k/µL or if the ANC < 0.5 k/µL. 9. It is preferred that the WBC / ANC be entered on-line by the physician or a member of the clinical team.
How many days supply of clozapine can be dispensed?
Note that even though blood tests are required daily, the pharmacy can dispense up to 7-day supply of medication.
How can I get prescribed clozapine?
Severe neutropenia (absolute neutrophil count (ANC) less than 500/µL), can lead to serious and fatal infections. To receive treatment, a patient must be enrolled in the Clozapine REMS program by a certified doctor. Pharmacies must be certified in the Clozapine REMS to receive and dispense clozapine.