Suppl. 1475.pdf (1.07 MB)
Download fileSupplementary Figures – Turalio Risk Evaluation and Mitigation Strategy for treatment of tenosynovial giant cell tumor: framework and experience
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posted on 2022-02-03, 10:57 authored by Figshare Future Science GroupFigshare Future Science Group, Charles Dharmani, Eric Wang, Maribel Salas, Colleen McCabe, Alvileen Diggs, Youngsook Choi, Jason Jiang, Vicki L. Keedy
Supplemental Figure 1. Modified FDA framework for benefit-risk counseling to patients about drugs with a REMS* [1]
Supplementary Figure 2. Turalio® REMS Patient Enrollment Form [2]
Supplementary Figure 3. Turalio® REMS Prescriber Enrollment Form [3]
Supplementary Figure 4. Turalio® REMS Liver Adverse Event Reporting Form [4]
Supplemental Figure 5. Turalio® REMS Pharmacy Enrollment Form [5]
Supplemental Figure 6. Turalio REMS framework
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Funding
Daiichi Sankyo, Inc.
History
References
- https://www.fda.gov/media/107591/download
- https://www.turaliorems.com/pdfs/TURALIO_REMS_Patient_Enrollment_Form
- https://www.turaliorems.com/pdfs/TURALIO_REMS_Prescriber_Enrollment_Form
- https://www.turaliorems.com/pdfs/TURALIO_Liver_Adverse_Event_Reporting_Form
- https://www.turaliorems.com/pdfs/TURALIO_REMS_Pharmacy_Enrollment_Form
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Keywords
Risk minimization measuresRisk Evaluation and Mitigation Strategy (REMS)Elements to assure safe use (ETASU)PexidartinibTenosynovial giant cell tumor (TGCT)HepatotoxicityREMS frameworkTuralio REMS ProgramLiver adverse event reporting criteriaKnowledge, Attitude, and Behavior (KAB) assessmentCancer Therapy (excl. Chemotherapy and Radiation Therapy)