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Evusheld EUA

Evusheld EUA

On 12/08/2021, the FDA issued an Emergency Use Authorization (EUA) for the medication Evusheld (tixagevimab/cilgavimab). Designed to block viral attachment and entry into the cells, Evusheld is a long-acting monoclonal antibody (mAb) therapy used for pre-exposure prophylaxis (PrEP) of COVID-19 in adults and children >12 years and weighing at least 40kg. Only individuals who have immunocompromise due to a medical treatment or condition are eligible to receive this medication and the very few who are determined to be ineligible for additional vaccination because of a severe reaction to an earlier vaccination.  Individuals who have received the COVID-19 vaccine must wait at least 2 weeks before receiving Evusheld. Unlike other mAb medications used for COVID-19, Evusheld is not a treatment for COVID-19, it is only for PrEP (prevention). Evusheld is NOT a substitute for vaccination.

Evusheld may be given to individuals >12 years old and weighing at least 40kg who are not currently infected with COVID-19, have not had a known exposure to someone with SARS-CoV-2 and:

  • May NOT mount an adequate immune response to COVID-19 vaccination
  • May not be eligible for COVID-19 vaccination due to a history of severe adverse reaction (severe allergic reaction) to either the COVID-19 vaccine, or the COVID-19 vaccine components.
  • Have moderate to severe immune compromise related to a medical condition or receipt of immunosuppressive medications or treatments
  • Medical conditions/treatments that may result in severe immunocompromise may include but are not limited to:
    • Active treatment for solid tumor and hematologic malignancies.
    • Receipt of solid-organ transplant and taking immunosuppressive therapy.
    • Receipt of chimeric antigen receptor (CAR)-T-cell or hematopoietic stem cell transplant within two years of transplantation or taking immunosuppression therapy.
    • Moderate or severe primary immunodeficiency.
    • Advanced/untreated HIV infection.
    • Active treatment with high dose corticosteroids, alkylating agents, antimetabolites, chemotherapy, tumor necrosis blockers, and other immunosuppressive biologic agents.

Evusheld is not authorized for use in individuals:

  • Requiring treatment for COVID-19.
  • Post exposure prophylaxis (PEP) of COVID-19 in individuals who have been exposed to someone with SARS-CoV-2.
  • As a substitute for vaccination for those who are eligible for COVID-19 vaccination.

Dosing and Administration of Evusheld:

  • Only a qualified health care provider such as a (e.g., physician, nurse practitioner, or physician assistant) may prescribe Evusheld. A healthcare provider or designee such as a nurse may administer Evusheld by intramuscular injection.  
  • Evusheld is packaged in a single carton containing:
    • Tixagevimab 150mg/1.5ml grey top vial
    • Cilgavimab 150mg/1.5ml white -top vial
  • Administered as two separate intramuscular injections, preferably in the gluteal area.
  • Monitor for at least one hour following injection.
  • While SARS-CoV-2 remains in circulation, individuals who are eligible for injection can be re-dosed every 6 months.
  • Reported side effects may include hypersensitivity to the medication, bleeding from the injection site, headache, fatigue, and nausea.
  • For individuals with coagulation disorders, Evusheld must be administered with caution.

Cardiovascular Adverse Events

In PROVENT Clinical Trial of Evusheld, there was a higher rate of cardiovascular serious adverse events (SAEs), including myocardial infarction (one fatal SAE) and cardiac failure, in subjects who received Evusheld compared to placebo. All subjects who experienced cardiac SAEs had
cardiac risk factors and/or a prior history of cardiovascular disease, and there was no clear temporal
pattern. A causal relationship between Evusheld and these events has not been established.

Clinicians must carefully consider the risks and benefits prior to initiating Evusheld in individuals at high risk for cardiovascular events and advise individuals to seek immediate medical attention if they experience any signs or symptoms suggestive of a cardiovascular event.

All adverse reactions must be reported to the FDA using FDA form 3500 FDA ADVERSE REACTIONS.

Distribution of Evusheld in Michigan

Because of the very limited supply of Evusheld nationally, Michigan has determined that the most effective way to make this medication readily available is by distributing it to 17 healthcare systems throughout the state. These healthcare systems were identified in collaboration with the Michigan Health and Hospital Association (MHA) and the amounts distributed to each healthcare system was based on MHA data indicating the number of patients with a diagnosis of an immunocompromising condition. Each healthcare system is expected to develop internal processes for the ethical and priority-based allocation of the medication to eligible patients. For patients cared for through independent hospitals and other healthcare providers and who are not affiliated with one of the Evusheld healthcare systems, will be able to access Evusheld for patients by contacting mdhhs-covid-therapies@michigan.gov.

 

Prioritization Criteria

To assure statewide equity and fairness in providing access to Evusheld in higher risk patients, healthcare systems have been asked to adopt the MDHHS Prioritization Criteria which is based on the NIH Treatment Panel Guidelines for prioritization of outpatient therapies, revised to better meet Michigan's needs. This 2-tier system prioritizes higher risk patients over those who are eligible but at lower risk. Tier 1 patients should be treated prior to those in Tier 2. Healthcare systems may wish to establish further prioritization criteria within these tiers.  It should be noted that this medication is not FDA-approved and therefore off-label ordering is not permitted under the EUA. Clinicians affiliated with these healthcare systems should receive information on the process for accessing this medication through their respective system.

Identify and Screen Potentially Eligible Patients

Patients should be identified and screened who potentially meet the criteria. This can be accomplished through one or more processes including through an electronic medical record search for appropriate conditions or through direct referral from the patient's healthcare provider. Using a list of identified and screened patients identified above, those meeting the criteria should be placed in the order to receive Evusheld. Clinicians should receive information on this process through their healthcare system.

 

Patient Contact and Counseling

Once patients are selected, they should be contacted by a qualified healthcare provider and counseled on the potential risks and benefits of Evusheld, in accordance with the Fact Sheet for Patients and Caregivers. Special attention should be provided to those at high-risk for cardiovascular events as described in the Fact Sheet. Patients wishing to receive Evusheld are required to receive the FDA's Fact Sheet for Patients and Caregivers prior to receiving the medication.

Complete Required State and Federal Reporting

All healthcare systems must complete, in a timely manner, all required federal and state reporting requirements. Failure to comply with this may jeopardize future allocations to healthcare systems and to the state.

Monitor Safety and Effectiveness

Healthcare systems should monitor patients receiving Evusheld for safety and effectiveness in preventing COVID-19 infections, and especially hospitalizations or deaths.

 

Priority Criteria to Receive Evusheld (tixagevimab/cilgavimab) for

Pre-Exposure Prophylaxis for COVID-19 in High-Risk Individuals

Tier 1 Criteria1
  1. Patients within one year of receiving B-cell depleting therapies (e.g., rituximab, ocrelizumab, ofatumumab, alemtuzumab)
  2. Patients receiving Bruton tyrosine kinase inhibitors
  3. Chimeric antigen receptor T cell recipients
  4. Post-hematopoietic cell transplant recipients who have chronic graft versus host disease or who are taking immunosuppressive medications for another indication
  5. Patients with hematologic malignancies who are on active therapy
  6. Solid-organ transplant recipients who:
  1. are lung transplant recipients, or
  2. are within 1 year of receiving a solid-organ transplant (other than lung transplant), or
  3. solid-organ transplant recipients with recent treatment for acute rejection with T or B cell depleting agents
  1. Patients with severe combined immunodeficiencies
  2. Patients with untreated HIV who have a CD4 T lymphocyte cell count <50 cells/mm3
  3. Other patients with severe immunodeficiency to be reviewed on an individual basis by designated senior clinicians, with no established physician obligation to the patient.

Tier 2 Criteria[1]
  1. Patients with active treatment for solid tumor malignancies
  2. Patients with moderate or severe primary immunodeficiency (e.g., DiGeorge syndrome, Wiskott-Aldrich syndrome)
  3. Advanced or untreated HIV infection (people with HIV and CD4 cell counts of 50-200/mm3, history of an AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV)
  4. Active treatment with high-dose corticosteroids (i.e., =20 mg prednisone or equivalent per day when administered for =2 weeks), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive that are immunosuppressive or immunomodulatory (e.g., B-cell depleting agents), tumor-necrosis (TNF) blockers, and other biologic agents
  5. 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 (e.g., severe allergic reaction) to a COVID-19 vaccine(s)

 
 

 

[1] US Food and Drug Administration. (2021, December 20). FACT SHEET FOR HEALTHCARE PROVIDERS: EMERGENCY USE AUTHORIZATION FOR EVUSHELD™ (. Retrieved December 27, 2021, from https://www.fda.gov/media/154701/download