Ansuvimab-zykl
What Is Ansuvimab-zykl ?[edit | edit source]
- Ansuvimab-zykl (EBANGA) is a Zaire ebolavirus glycoprotein (EBOV GP)-directed human monoclonal antibody.
What are the uses of this medicine?[edit | edit source]
- This medication is 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.
How does this medicine work?[edit | edit source]
- Ansuvimab-zykl is a recombinant human monoclonal antibody with antiviral activity against Zaire ebolavirus.
- Ansuvimab-zykl blocks binding of EBOV GP1 to the Neiman Pick cell receptor 1 in host cells (IC50 value of 0.09 μg/mL), inhibiting virus entry into the host cell.
Who Should Not Use this medicine ?[edit | edit source]
This medicine have fallowing limitations:
- The efficacy of EBANGA 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.
Is this medicine FDA approved?[edit | edit source]
- It was approved for use in the United States in 2020.
How should this medicine be used?[edit | edit source]
- The recommended dose of EBANGA for adult and pediatric patients is 50 mg/kg reconstituted, further diluted, and administered as a single intravenous infusion over 60 minutes.
What are the dosage forms and brand names of this medicine?[edit | edit source]
This medicine is available in fallowing doasage form:
- As injection: 400 mg of ansuvimab-zykl, available as an off-white to white lyophilized powder in single-dose vial for reconstitution and further dilution.
This medicine is available in fallowing brand namesː
- EBANGA
What side effects can this medication cause?[edit | edit source]
Common possible side effects of this medicine include:
- pyrexia
- tachycardia
- diarrhea
- vomiting
- hypotension
- tachypnea
- chills
What special precautions should I follow?[edit | edit source]
- Inform patients that hypersensitivity reactions including infusion-associated events have been reported during and post-infusion with EBANGA and to immediately report if they experience any symptoms of systemic hypersensitivity reactions.
- Monitor all patients for signs and symptoms including, but not limited to, hypotension, chills and elevation of fever, during and following EBANGA infusion.
- In the case of severe or life-threatening hypersensitivity reactions, discontinue the administration of EBANGA immediately and administer appropriate emergency care.
- Instruct patients with Zaire ebolavirus not to breastfeed because of the risk of passing Zaire ebolavirus to the baby.
What to do in case of emergency/overdose?[edit | edit source]
Can this medicine be used in pregnancy?[edit | edit source]
- Zaire ebolavirus infection is life-threatening for both the mother and fetus and treatment should not be withheld due to pregnancy.
Can this medicine be used in children?[edit | edit source]
- This medicine can be used in pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection.
- The safety and effectiveness of EBANGA for the treatment of infection caused by Zaire ebolavirus have been established in pediatric patients from birth to less than 18 years of age.
What should I know about storage and disposal of this medication?[edit | edit source]
- Store refrigerated at 2ºC to 8ºC (36ºF to 46ºF) in the original carton to protect from light. Do not freeze.
- Do not shake.
- Prior to reconstitution, allow EBANGA vial(s) to reach ambient temperature (15°C to 27°C [59°F to 81°F]) for approximately 20 minutes.
- After reconstitution, the entire storage time for reconstituted solution in the vial and the diluted solution in the IV bag should be protected from light and limited to 4 hours at either ambient temperature 15°C to 27°C (59°F to 81°F) or refrigerated at 2°C to 8°C (36°F to 46°F).
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