ENTYVIO (VEDOLIZUMAB) - The Clinical Trials Experience section of the Package Insert was updated extensively. The Drug Interactions section was updated to state “avoid the concomitant use of ENTYVIO with natalizumab products”. The Patient Counseling Information was updated with regards to subcutaneous dosing technique. The medication guide was also updated extensively.
ABRILADA (ADALIMUMAB-AFZB) - The Warnings and Precautions section of the Package Insert was updated to include Uveitis (UV) under malignancies in adults. The Clinical Trials Experience section was updated to detail infections, tuberculosis and opportunistic infections, liver enzyme elevations and other adverse reactions relating to UV.
ENTYVIO (VEDOLIZUMAB) - The Clinical Trials Experience section of the Package Insert was updated extensively. The Drug Interactions section was updated to state “avoid the concomitant use of ENTYVIO with natalizumab products”. The Patient Counseling Information was updated with regards to subcutaneous dosing technique. The medication guide was also updated extensively.
ABRILADA (ADALIMUMAB-AFZB) - The Warnings and Precautions section of the Package Insert was updated to include Uveitis (UV) under malignancies in adults. The Clinical Trials Experience section was updated to detail infections, tuberculosis and opportunistic infections, liver enzyme elevations and other adverse reactions relating to UV.
HULIO (ADALIMUMAB-FKJP) - The Warnings and Precautions section of the Package Insert was updated to include Uveitis (UV) under malignancies in adults. The Clinical Trials Experience section was updated to detail infections, tuberculosis and opportunistic infections, liver enzyme elevations and other adverse reactions relating to UV.
YUFLYMA (ADALIMUMAB-AATY) - The Use in Specific Populations section of the Package Insert was updated to detail Juvenile Idiopathic Arthritis and Pediatric Chron’s Disease. The medication guide was also updated to detail storage of the various doses and dosage forms.
ILARIS (CANAKINUMAB) - The Warnings and Precautions section of the Package Insert was updated to state “avoid administering ILARIS to patients during an active infection requiring medical intervention. Discontinue ILARIS if a patient develops a serious infection.” Additional adverse reactions such as serious infections, immunosuppression, hypersensitivity, and macrophage activation syndrome were details. The Use in Specific Populations section was updated to provide guidance in pregnancy, pediatric and geriatric use.
NIVESTYM (FILGRASTIM-AAFI) - The Warnings and Precautions section of the Package Insert was updated to include extramedullary hematopoiesis as an adverse reaction with post-marketing experience.
RELEUKO (FILGRASTIM-AYOW) - The Warnings and Precautions section of the Package Insert was updated to include extramedullary hematopoiesis as an adverse reaction with post-marketing experience.
ADUHELM (ADUCANUMAB-AVWA) - A new Boxed Warning was added the approved drug label detailing Amyloid Related Imaging Abnormalities. This information was also updated throughout the Warnings and Precautions and Patient Counseling Information sections of the Package Insert.
BAVENCIO (AVELUMAB) - The Warnings and Precautions section of the Package Insert was updated to detail severe and fatal immune-mediated adverse reactions and infusion-related reaction. The Adverse Reactions section was updated to detail the most frequent serious reactions being general physical health deterioration, anemia, abdominal pain, acute kidney injury, sepsis, hyponatremia, and infusion-related reaction. Additional Clinical Trial Experience data was provided as well as Use in Geriatric population.
Reference: Drug Safety-related Labeling Changes (SrLC) (fda.gov)
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