EVUSHELD trade name for tixagevimab and cilgavimab.
It is a prexposure prophylaxis monoclonal antibody combination.
There are limited clinical data available.
It is no longer authorized for emergency use because it’s likely an effective against more than 90% of Covid-19 variance now circulating.
Should be given every six months to maintain protection against infection.
It is contraindicated in individuals with previous severe hypersensitivity reactions, including anaphylaxis, to EVUSHELD.
Clinically monitoring individuals after injections and observation for at least 1 hour.
It contains polysorbate 80, which is in some COVID-19 vaccines and is structurally similar to polyethylene glycol, an ingredient in other COVID-19 vaccines.
It is an intramuscular injection.
A higher proportion of subjects who received EVUSHELD versus placebo reported myocardial infarction and cardiac failure serious adverse events.
The most common adverse events are headache, fatigue and cough.
There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
There are no available data on the presence of tixagevimab or cilgavimab in human milk or animal milk, the effects on the breastfed infant, or the effects of the drug on milk production.
Maternal IgG is known to be present in human milk.
It is not authorized for use in pediatric individuals under 12 years of age or weighing less than 40 kg.
Its safety and effectiveness have not been established in pediatric individuals.
There is a potential risk of treatment failure due to the development of viral variants that are resistant to tixagevimab and cilgavimab administered together.
It is authorized for use for the pre-exposure prophylaxis of COVID-19 in adults and pediatric individuals (12 years of age and older weighing at least 40 kg): Who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARS-CoV-2 and
Who have moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments and may not mount an adequate immune response to COVID-19 vaccination or for whom vaccination with any available COVID-19 vaccine, according to the approved or authorized schedule, is not recommended due to a history of severe adverse reaction to a COVID-19 vaccine(s) and/or COVID-19 vaccine component(s).
Pre-exposure prophylaxis with EVUSHELD is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended.
EVUSHELD should be administered at least two weeks after vaccination.