What is a TIRF REMS?
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.
What is a requirement of the TIRF?
Require that prescribers document a patient’s opioid tolerance with each prescription of a TIRF medicine for outpatient use. Require outpatient pharmacies dispensing TIRF medicines to document and verify a patient’s opioid tolerance before dispensing.
How do I enroll a patient in REMS?
Enroll in the REMS by completing the Patient Enrollment Form with the prescriber. Enrollment information will be provided to the REMS. Receive counseling from the prescriber on the risk of serious birth defects using the Guide for Female Patients.
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.
How do I get certified to prescribe clozapine?
If you need to prescribe clozapine but are not yet certified in the Clozapine REMS Program, go immediately to www.clozapinerems.com. Once a prescriber is certified, his/her prescriber designees must also enroll online at www.clozapinerems.com .
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).
Can clozapine be transferred between pharmacies?
Inpatient pharmacies do not need to obtain a PDA before dispensing clozapine. Patients currently treated with clozapine will be automatically transferred to the REMS program. Clozapine is an antipsychotic drug used to treat schizophrenia in patients whose symptoms are not controlled with standard treatment.
What medications can have a REMS?
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 are REMS medications?
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.
Can you dispense clozapine without REMS?
The agency confirmed that pharmacists can dispense clozapine without a REMS dispense authorization and wholesalers can continue to ship clozapine to pharmacies and other health care settings.
Does clozapine require REMS?
In the United States, the Food and Drug Administration (FDA) requires regular blood count monitoring of all patients taking clozapine. The requirements to prescribe, dispense, and receive clozapine are incorporated into a single, shared program called the Clozapine Risk Evaluation and Mitigation Strategy (REMS).