Ansuvimab-Zykl: uses, dosing, side effects & brands

The following clinically significant adverse reactions are described elsewhere in the labeling: • Hypersensitivity Reactions Including Infusion-Associated Events [see Warnings and Precautions (5.1) ] The most frequently reported adverse events (≥ 5%) after administration of EBANGA were pyrexia, tachycardia, diarrhea, vomiting, hypotension, tachypnea, and chills. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Emergent BioSolutions at 1-800-768-2304 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice. Overall, 424 adult and pediatric participants with Orthoebolavirus zairense infection received EBANGA in one clinical trial and as part of an expanded access program during the 2018 Orthoebolavirus zairense outbreak in the Democratic Republic of Congo (DRC). In the PALM trial, the safety of EBANGA was evaluated in a multi-center, open-label, randomized controlled trial, in which 173 participants (119 adults and 54 pediatric participants) with confirmed Orthoebolavirus zairense infection received EBANGA as a single 50 mg/kg IV infusion and 168 participants received an investigational control [see Clinical Studies (14) ] . All participants received optimized standard of care…

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Interaction with live vaccine indicated for prevention of Orthoebolavirus zairense infection: No vaccine interaction studies have been performed. EBANGA may reduce the efficacy of the live vaccine. The interval between administration of EBANGA therapy and live vaccination should be in accordance with current vaccination guidelines. ( 7.1 ) 7.1 Vaccine Interactions No vaccine-therapeutic interaction studies have been performed in human participants using EBANGA. However, because of the potential for EBANGA to inhibit replication of a live vaccine virus indicated for prevention of Orthoebolavirus zairense infection and possibly reduce the efficacy of the vaccine, avoid the concurrent administration of a live vaccine during treatment with EBANGA. The interval between administration of EBANGA therapy and live vaccination should be in accordance with current vaccination guidelines. The efficacy of EBANGA among participants who reported receipt of a recombinant live vaccine prior to their enrollment in the PALM trial was similar to participants who did not report receiving a vaccine prior to enrollment.