What are the requirements of the TIRF program?
The strengthened TIRF REMS program now requires the following:
- Prescribers must document a patient’s opioid tolerance with each prescription of a TIRF medicine for outpatient use.
- Outpatient pharmacies dispensing TIRF medicines must document and verify a patient’s opioid tolerance before dispensing.
What is the TIRF REMS 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.
Who is the manufacturer of Fentora?
CDR submission: Fentora® (fentanyl) buccal/sublingual effervescent tablet 100 mcg, 200 mcg, 400 mcg, 800 mcg. Company: Teva Canada Innovation [CONFIDENTIAL manufacturer’s submission].
What does TIRF mean?
Total Internal Reflection Fluorescence (TIRF) Microscopy.
What is the generic name for fentora?
Fentora (fentanyl citrate) is a narcotic (opioid) pain medicine used to treat “breakthrough” cancer pain that is not controlled by other medicines.
Can you overdose on fentora?
Accidental Ingestion Accidental ingestion of even one dose of FENTORA, especially by children, can result in a fatal overdose of fentanyl [see Warnings and Precautions (5.2)].
Is TIRF a word?
“According to Transport Canada, drugs, other than alcohol, are found in about one-third of the fatally injured drivers in Canada who are tested for drugs,” notes TIRF President and CEO Robyn Robertson….TIRF.
| Acronym | Definition |
|---|---|
| TIRF | The Indian Rafting Foundation |
What does fentora treat?
Fentora (fentanyl buccal tablets) is a an opioid pain medication used for the treatment of breakthrough pain in cancer patients receiving opioid treatment and who have become tolerant to it.
How do you take fentora?
The FENTORA tablet should be left between the cheek and gum or under the tongue until it has disintegrated, which usually takes approximately 14-25 minutes. After 30 minutes, if remnants from the FENTORA tablet remain, they may be swallowed with a glass of water.
How to enroll in the REMS program for TIRF?
Review the Prescribing Information for the TIRF medicines. Counsel the patient using the Medication Guide for any new TIRF medicine not previously prescribed. Provide a copy to the patient. Enroll in the REMS Program by completing the Patient Enrollment Form with the prescriber.
When does the FDA require a REMS program?
Under the Food and Drug Administration Amendments Act of 2007, FDA has the authority to require Applicants or Application holders to develop and comply with REMS programs if FDA determines a REMS is necessary to ensure that the benefits of a drug outweigh its risks.
How to re-enroll in the REMS program?
Enroll in the REMS Program by completing the Patient Enrollment Form with the prescriber. Enrollment information will be provided to the REMS Program. | Patient Enrollment Form | Re-enroll in the REMS program by completing the Patient Enrollment Form with the prescriber.
What are the requirements for a TIRF prescriber?
Prescribers must complete the following requirements to be enrolled: i. Review the TIRF REMS Access education materia s (TIRF REMS Access Education Program), including the FuPrlel scribing Information (FPI) for each TIRF medicine,