Ansuvimab-zykl
Class: Monoclonal Antibodies
Brands: Ebanga
Introduction
Ansuvimab-zykl is a monoclonal antibody antiviral agent.
Uses for Ansuvimab-zykl
Ansuvimab-zykl has the following uses:
Ansuvimab-zykl is a Zaire ebolavirus glycoprotein (EBOV GP)-directed human monoclonal antibody indicated for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection.
Ansuvimab-zykl has the following limitations of use:
The efficacy of ansuvimab-zykl has not been established for other species of the Ebolavirus and Marburgvirus genera.
Zaire ebolavirus can change over time, and factors such as emergence of resistance or changes in viral virulence could diminish the clinical benefit of antiviral drugs. Consider available information on drug susceptibility patterns for circulating Zaire ebolavirus strains when deciding whether to use ansuvimab-zykl.
Ansuvimab-zykl Dosage and Administration
General
Ansuvimab-zykl is available in the following dosage form(s) and strength(s):
For injection: 400 mg lyophilized powder in a single-dose vial for reconstitution and further dilution.
Dosage
It isessentialthat the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:
Pediatric Patients
Dosage and Administration
The recommended dose of ansuvimab-zykl is 50 mg/kg reconstituted, further diluted, and administered as a single intravenous infusion over 60 minutes.
See the manufacturer's labeling for instructions on preparation, dilution and administration of ansuvimab-zykl injection.
Adults
Dosage and Administration
The recommended dose of ansuvimab-zykl is 50 mg/kg reconstituted, further diluted, and administered as a single intravenous infusion over 60 minutes.
See the manufacturer's labeling for instructions on preparation, dilution and administration of ansuvimab-zykl injection.
Cautions for Ansuvimab-zykl
Contraindications
None.
Warnings/Precautions
Hypersensitivity Reactions Including Infusion-associated Events
Hypersensitivity reactions including infusion-associated events have been reported with ansuvimab-zykl. These may include acute, life-threatening reactions during and after the infusion. Monitor all patients for signs and symptoms including, but not limited to, hypotension, chills and elevation of fever during and following ansuvimab-zykl infusion. In the case of severe or life-threatening hypersensitivity reactions, discontinue the administration of ansuvimab-zykl immediately and administer appropriate emergency care.
Infusion could not be completed in 1% of subjects who received ansuvimab-zykl due to infusion-associated adverse events. The rate of infusion of ansuvimab-zykl may be slowed or interrupted if the patient develops any signs of infusion-associated events or other adverse even...