To help ensure patient safety, a Coram clinician may notify a patient and/or their physician of these labeling updates when appropriate.
BACTRIM (SULFAMETHOXAZOLE; TRIMETHOPRIM) The Warnings and Precautions section of the Approved Drug Label (ADL) was updated to include Hemophagocytic Lymphohistiocytosis (HLH). HLH is a life-threatening syndrome of pathologic immune activation characterized by clinical signs and symptoms of extreme systemic inflammation. Signs and symptoms of HLH may include fever, hepatosplenomegaly, rash, lymphadenopathy, neurologic symptoms, cytopenias, high serum ferritin, hypertriglyceridemia, and liver enzyme and coagulation abnormalities. If HLH is suspected, discontinue BACTRIM immediately and institute appropriate management. These details were also included in the Adverse Reactions, Clinical Trials Experience section.
UNASYN (AMPICILLIN SODIUM; SULBACTAM SODIUM) The Warnings and Precautions section of the ADL was updated to detail Severe Cutaneous Adverse Reactions including drug reaction with eosinophilia and systemic symptoms (DRESS). This detail was also included within the Adverse Reactions section.
LEQEMBI (LECANEMAB-IRMB) The Boxed Warning section of the ADL was updated to state that amyloid related imaging abnormalities (ARIA) can be fatal. This detail was also included within the Warnings and Precautions section and the Patient Counseling Information.
COPAXONE (GLATIRAMER ACETATE) The Use in Specific Populations, Pregnancy, Risk Summary section of the ADL was updated stating that available data from pharmacovigilance and published observational studies over decades of use with glatiramer acetate during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. All pregnancies have a background risk of birth defect, loss, or other outcomes. However, the published comparative observational studies have methodological limitations, such as short exposure duration during pregnancy, confounding, selection bias, and exposure misclassification.
HULIO (ADALIMUMAB-FKJP) The Adverse Reactions, Immunogenicity section of the ADL was updated to state that the observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of adalimumab or of other adalimumab products.
POTELIGEO (MOGAMULIZUMAB-KPKC) The Adverse Reactions, Postmarketing Experience section of the ADL was updated to include Skin and subcutaneous disorders: Granuloma.
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.