REMS@FDA Updates

Summary of REMS@FDA Website Updates for July and August, 2021 1. Yescarta and Tecartus (axicabtagene ciloleucel)  modified July 14, 2021 to makes changes to the REMS Adverse Reaction Management Guide, REMS Program Training, and REMS Website to align with the approved U.S. Package Insert for Yescarta. 2. Clozapine modified July 29, 2021 to: Make changes to the frequency of the submission of patient monitoring via a new Patient Status Form and make changes to the pharmacy operations to verify safe use conditions for a REMS dispense authorization. Revise the third goal to read from "ensuring compliance with the monitoring schedule for absolute neutrophil count (ANC) prior to dispensing clozapine" to "ensuring prescribers submit documentation that periodic monitoring of patients is performed to identify severe neutropenia. 3. Thalomid (thalidomide) modified August 5, 2021 to: Remove the mobile app for physicians Include the Patient REMS Application Clarify language regarding the question for prescribers about days of therapy being prescribed Add new language for reporting pregnancies Change the disclosure language on the Patient-Physician Agreement Forms (PPAFs) Add new election checkbox on the PPAFs for patients to request Thalomid REMS education material 4. Pomalyst (pomalidomide) modified August 5, 2021 to remove the mobile app for physicians, inclusion of the Patient REMS Application, clarifying language regarding the question for prescribers about days of therapy being prescribed, new language for reporting pregnancies, modification to the disclosure language on the Patient-Physician Agreement Forms (PPAFs), and a new election checkbox on the PPAFs for patients to request Pomalyst REMS education materials. 5. Lenalidomide modified August 5, 2021 to: Remove reference to the Prescriber mobile app in the Prescriber Enrollment Form and Prescriber Guide. Update disclosure language and add new checkbox for patients to request Lenalidomide REMS materials in the Patient-Physician Agreement Forms (PPAFs). Add reference to Patient Companion app in the Pharmacy training, Patient Guide, and REMS Website. 6. Copiktra revised on August 10, 2021 to reflect changes to the name of the applicant holder. 7. Mycophenolate modified August 11, 2021 to make changes to the Mycophenolate risk evaluation and mitigation strategy (REMS) website screenshots (non-CE and CE) to align the data insights section of the Patient Overview page with the data insights from the Patient Brochure. 8. Xywav and Xyrem (calcium, magnesium, potassium, and sodium oxybates) modified August 12, 2021 to: Make changes to the REMS materials to align with the new indication of Idiopathic Hypersomnia for Xywav. Make changes to the REMS assessment timetable. Change the reporting interval for the Knowledge, Attitude, and Behavior Surveys from annually to every other year. Make changes to the Patient Counseling Checklist to capture additional information regarding concomitant medication and alcohol use. 9. Vigabatrin Shared System REMS added ANDAs 212626 and 213390. 10. Mycophenolate Shared System REMS added ANDA 214525. 11. Opioid Analgesic REMS added the following: Buprenorphine Buccal Films, ANDA 211594 Morphine Sulfate Extended-Release Capsules, ANDA 203158 Oxycodone Hydrochloride and Acetaminophen Oral Solution, ANDA 201448 Manage Subscriptions  |  Unsubscribe All  |  Help This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA