A FDA C128490 Structured Product Labeling Risk Evaluation and Mitigation Strategies Terminology C128899 REMS Approval C FDA C128491 Structured Product Labeling REMS Requirement Terminology C128504 Enroll in the REMS C FDA C128492 Structured Product Labeling REMS Protocol Terminology C128535 Pharmacotherapy Discontinuation C FDA C107675 Structured Product Labeling Race Terminology C16352 Black or African American C FDA C54599 Structured Product Labeling Limitation of Use Terminology C41332 ADVERSE REACTION C FDA C54599 Structured Product Labeling Limitation of Use Terminology C50646 CONTRAINDICATION C FDA C54599 Structured Product Labeling Limitation of Use Terminology C54346 DOSE MODIFICATION C FDA C54599 Structured Product Labeling Limitation of Use Terminology C54350 SECOND LINE TREATMENT C FDA C54599 Structured Product Labeling Limitation of Use Terminology C54351 USE WITH CAUTION C FDA C54599 Structured Product Labeling Limitation of Use Terminology C54352 LIMITED OR NO INFORMATION C FDA C54599 Structured Product Labeling Limitation of Use Terminology C54708 INTERACTION C FDA C54599 Structured Product Labeling Limitation of Use Terminology C60654 CONDITIONAL APPROVAL C FDA C54599 Structured Product Labeling Limitation of Use Terminology C60655 DURATION OF USE