To help ensure patient safety, a Coram clinician may notify a patient and/or their physician of these labeling updates when appropriate.
Trodelvy (Sacituzumab Govitecan-Hziy) - The warnings and precautions section of the Package Insert (PI) was updated to include details of febrile neutropenia, diarrhea, and increased risk of adverse reactions in patients with UGT1A1 activity. The patient information was updated outlining the most common side effects including changes to blood cell counts, electrolytes, blood glucose and protein levels.
Aduhelm (Aducanumab-Avwa) - The warnings and precautions section of the Package Insert (PI) was updated to include details of amyloid related imagining abnormalities. Use in specific population section was updated to detail risk in lactation. Similar updates were made throughout the medication guide and patient counseling information.
Epipen (Epinephrine) - Updates made throughout the patient counseling information, patient information and instructions for use.
Jemperli (Dostarlimab-Gxly) - The warnings and precautions section of the Package Insert (PI) was updated to include details of severe and fatal immune mediated adverse reactions as well as clinical trial experience. Use in specific population section was updated to detail risk in lactation.
Tobramycin Sulfate - The warnings and precautions section of the Package Insert (PI) was updated to include details of ototoxicity with use of tobramycin for injection due to mitochondrial DNA variants.
Midazolam Hydrochloride - The warnings and precautions section of the Package Insert (PI) was updated to include details of neonatal sedation and withdrawal syndrome with administered late in pregnancy. Use in specific population section was updated to further detail associated fetal and neonatal risk in pregnancy and lactation. This information was also updated in the patient counseling information.
Diflucan (Fluconazole) - The warnings and precautions section of the Package Insert (PI) was updated to include increased systemic exposure to the active metabolites of Abrocitinib when co-administered.
Enjaymo (Sutimlimab-Jome) - The warnings and precautions section of the Package Insert (PI) was updated to include details of serious infections reported from administration. Additional reactions were detailed in the Infusion-Related Reactions section. The Clinical Trials Experience and Medication Guide were updated throughout.
Yervoy (Ipilimumab) - The use in specific populations section of the approved drug label was updated to include the indication for use as a single agent and in combination with nivolumab for unresectable or metastatic melanoma, and, in combination with nivolumab for MSI-H or dMMR mCRC that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, in pediatric patients aged 12 years and older. Additional information regarding the safety and effectiveness of YERVOY were updated to state that the safety and effectiveness have not been established in pediatric patients younger than 12 years old with unresectable or metastatic melanoma or MSI-H or dMMR mCRC. Additionally, the safety and effectiveness of YERVOY have not been established in pediatric patients for the adjuvant treatment of melanoma or for the treatment of advanced renal cell carcinoma, hepatocellular carcinoma, metastatic non-small cell lung cancer, malignant pleural mesothelioma and esophageal cancer.
Reference: Drug Safety-related Labeling Changes (SrLC) (fda.gov)
This article contains references to brand-name prescription drugs that are trademarks or registered trademarks of pharmaceutical manufacturers not affiliated with Coram.