EBANGA (ansuvimab-zykl)

Limited data from 18 healthy subjects 22 to 56 years of age suggests that the pharmacokinetic profile of ansuvimab-zykl is consistent with the profile of other IgG1 monoclonal antibodies. Pharmacokinetic data are not available for Zaire ebolavirus infected patients. Specific Populations The effect of age, renal impairment or hepatic impairment on the pharmacokinetics of ansuvimab-zykl is unknown.

The efficacy of EBANGA has been evaluated in 174 subjects with confirmed Zaire ebolavirus infection in the PALM trial, a multi-center, open-label, randomized, controlled trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID; NCT03719586). The trial was conducted in the North Kivu and Ituri provinces in the Democratic Republic of Congo, where an outbreak began in August 2018, and enrolled 681 subjects of all ages, including pregnant women, with documented Zaire ebolavirus infection and symptoms of any duration who were receiving oSOC. Subjects were randomized to re...

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 Ridgeback Biotherapeutics, LP at 1-833-846-3789 or FDA at 1-800-FDA-1088 or www.fd...

None . None.

Hypersensitivity Reactions Including Infusion-Associated Events: Hypersensitivity reactions including infusion-associated events have been reported with EBANGA. These may include acute, life-threatening reactions during and after the infusion. Monitor patients and in the case of severe or life-threatening hypersensitivity reactions, discontinue the administration of EBANGA immediately and administer appropriate emergency care. ( 5.1 ) 5.1 Hypersensitivity Reactions Including Infusion-Associated ...

7 DRUG INTERACTIONS Interaction with live vaccine indicated for prevention of Zaire ebolavirus 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-therapeuti...