Key Information for Clinicians and Staff
Tixagevimab-Cilgavimab (Evusheld) is authorized under EUA for COVID-19 pre-exposure prophylaxis.
Key details include:
- Tixagevimab-Cilgavimab (Evusheld) consists of two monoclonal antibodies that target the receptor binding domain of the SARS-CoV-2 spike protein and inhibit virus attachment.
- It is given as two consecutive intramuscular injections during one visit.
- The goal of receiving pre-exposure prophylaxis is to reduce the risk of symptomatic COVID-19 infection in patients:
- Who are moderately or severely immunosuppressed due to a medical condition and/or medication that may limit the effectiveness of COVID-19 vaccination or;
- For whom receipt of all of the available COVID-19 vaccines are not recommended due to prior severe adverse reaction or contraindication.
- Patients must wait to receive COVID-19 mAb pre-exposure prophylaxis for specific durations following a COVID-19 exposure (5 days), diagnosis (30 days), or COVID-19 vaccination (14 days).
- No guidance can currently be given as to how long this prophylaxis will remain effective or the efficacy against future COVID-19 variants. Due to decreased efficacy against some Omicron variants, the dosing of Tixagevimab-Cilgavimab (Evusheld) has been modified as of February 24, 2022.
- COVID-19 pre-exposure prophylaxis with a monoclonal antibody called Tixagevimab-Cilgavimab (Evusheld) is indicated for persons at higher risk of infection due to having a weakened immune system or contraindication to all available COVID-19 vaccines.
- It is not a replacement for vaccination.
- This monoclonal antibody may reduce the risk of COVID-19 making you sick by limiting the virus’s ability to center your cells, reinforcing your own body’s defenses against the virus and protection against becoming infected.
- We do not know how well this medication will work against future variants of COVID-19 or how long the protection will last. This is why the medication is only recommended for people at very high risk for infection due to weakened immune systems.
Tixagevimab-Cilgavimab (Evusheld) is currently available at the following locations within BILH. Please follow the instructions based on the location in which you hold ordering privileges.
- Anna Jaques Hospital
- Beth Israel Deaconess Hospital–Plymouth
- Beth Israel Deaconess Medical Center
- Beverly Hospital
- Lahey Hospital & Medical Center
- Mount Auburn Hospital
- Winchester Hospital
Who can be referred to receive Tixagevimab-Cilgavimab (Evusheld)?
- Tixagevimab-Cilgavimab (Evusheld) is authorized for pre-exposure prophylaxis in individuals who are aged >12 years and weighing >40kg AND;
- Who are not currently infected with COVID-19 or have a known recent exposure AND;
- Who are moderately to severely immunosuppressed due to a medical condition and/or take medications that may limit the effectiveness of COVID-19 vaccines OR;
- For whom COVID-19 vaccination is not recommended due to prior severe adverse reaction.
What constitutes being moderately-severely immunosuppressed?
- Please see the BILH COVID-19 Vaccination and Therapeutics – Categorization of Immunosuppression for the complete and most up-to-date categorizations.
How is Tixagevimab-Cilgavimab (Evusheld) administered?
- It is given as two consecutive intramuscular injections during one visit.
What are common side effects of Tixagevimab-Cilgavimab (Evusheld)?
- The majority of adverse events reported in the studies evaluating Tixagevimab-Cilgavimab (Evusheld) were mild and included:
- Headache
- Fatigue
- Cough
- Pain at the site of the injection
- More serious but less common adverse events included:
- Bleeding at the site of the injection: IM injections can be safely given to most patients with platelet or clotting disorders, but pressure should be held at the site of the injection to prevent bleeding.
- Serious cardiac problems including heart attacks, abnormal heart rhythms, and heart failure: In the studies evaluating Tixagevimab-Cilgavimab (Evusheld), these problems occurred in a small number of patients who had a history of heart problems and/or risk factors. It’s difficult to know if these problems were due to Tixagevimab-Cilgavimab (Evusheld), but patients with serious cardiac history should discuss these risks more with their providers prior to receiving this therapy.
- Serious allergic reaction such as anaphylaxis.
- Finally, Tixagevimab-Cilgavimab (Evusheld) has not been studied in all patient populations:
- Patients who are pregnant or breast feeding should discuss the potential risk and benefits more with their providers prior to receiving Tixagevimab-Cilgavimab (Evusheld).
Is Tixagevimab-Cilgavimab (Evusheld) a substitute for vaccination?
- No. Vaccination is still strongly recommended for any patient eligible for this therapy if not otherwise contraindicated.
What conditions affect eligibility or timing of treatment?
- Patients recently exposed (5 days after exposure), diagnosed with COVID-19 (30 days after diagnosis), or vaccinated against COVID-19 (14 days after vaccination) must wait for specified times until they are eligible to receive Tixagevimab-Cilgavimab (Evusheld).
Who should not receive Tixagevimab-Cilgavimab (Evusheld)?
- Patients with prior severe hypersensitivity reactions to the therapy or any of its components.
- This therapy is not indicated for post-exposure prophylaxis or treatment of COVID-19.
What other precautions should I know about Tixegevimab-Cilgavimab (Evusheld)?
- Patients with clinically significant bleeding disorders: As with any intramuscular injection, there is a risk of bleeding particular in patients with coagulopathies and platelet disorders.
- Patients with active or chronic cardiovascular disease and/or cardiovascular risk factors: There was a higher proportion of adverse cardiac events in patients receiving Tixagevimab-Cilgavimab compared to placebo (0.6% vs 0.2%) in one study. All patients who suffered adverse cardiac events had a history of cardiovascular disease and/or cardiac risk factors. Although no causal relationship was established between Tixagevimab-Cilgavimab and adverse cardiac events, additional caution should be applied for patients at high risk of cardiovascular events.
- Patients who are pregnant or lactating: Efficacy and safety of Tixagevimab-Cilgavimab have not yet been evaluated in these populations.