Ebanga Generic Name & Formulations
Legal Class
Rx
General Description
Ansuvimab-zykl 400mg; per vial; lyophilized pwd for IV infusion after reconstitution and dilution; preservative-free.
Pharmacological Class
Human IgG1 monoclonal antibody.
How Supplied
Single-dose vials—1, 4, 8, 36
Manufacturer
Generic Availability
NO
Ebanga Indications
Indications
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.
Limitations of Use
Not established for other species of the Ebolavirus and Marburgvirus genera.
Ebanga Dosage and Administration
Adults and Children
See full labeling. Give 50mg/kg as a single IV infusion over 60mins.
Ebanga Contraindications
Not Applicable
Ebanga Boxed Warnings
Not Applicable
Ebanga Warnings/Precautions
Warnings/Precautions
Monitor for hypersensitivity reactions including infusion-associated events. Discontinue immediately and treat if severe or life-threatening hypersensitivity reactions occur. Pregnancy (do not withhold treatment). Nursing mothers.
Ebanga Pharmacokinetics
See Literature
Ebanga Interactions
Interactions
Avoid concomitant live vaccines.
Ebanga Adverse Reactions
Adverse Reactions
Pyrexia, tachycardia, diarrhea, vomiting, hypotension, tachypnea, chills.
Ebanga Clinical Trials
See Literature
Ebanga Note
Not Applicable
Ebanga Patient Counseling
See Literature