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NEW PRESCRIPTION PHYSICIAN FAX ORDER FORM.docxEVUSHELD: COMBINATION OF 2 MONOCLONAL ANTIBODIES WHICH ARE SARS-COV-2 SPIKE PROTEIN-DIRECTED ATTACHMENT INHIBITORS
EVUSHELD: COMBINATION OF 2 MONOCLONAL ANTIBODIES WHICH ARE SARS-COV-2 SPIKE PROTEIN-DIRECTED ATTACHMENT INHIBITORS
EVUSHELD comprises two monoclonal antibodies, tixagevimab and cilgavimab, which are authorized to be administered as two separate consecutive intramuscular (IM) injections.
As with any intramuscular injection, EVUSHELD should be given with caution to individuals with thrombocytopenia or any coagulation disorder.
Tixagevimab and cilgavimab are two recombinant human IgG1κ monoclonal antibodies with amino acid substitutions to extend antibody half-life (YTE), reduce antibody effector function, and minimize the potential risk of antibody-dependent enhancement of disease (TM).
Tixagevimab and cilgavimab can simultaneously bind to non-overlapping regions of the receptor binding domain (RBD) of SARS-CoV-2 spike protein. Tixagevimab, cilgavimab, and their combination bind to spike protein with equilibrium dissociation constants of KD = 2.76 pM, 13.0 pM and 13.7 pM, respectively, blocking its interaction with human ACE2, the SARS-CoV-2 receptor, which is required for virus attachment. Tixagevimab, cilgavimab, and their combination blocked RBD binding to human ACE2 with IC50 values of 0.32 nM (48 ng/mL), 0.53 nM (80 ng/mL), and 0.43 nM (65 ng/mL), respectively.
Serious hypersensitivity reactions, including anaphylaxis, have been observed with human immunoglobulin G1 (IgG1) monoclonal antibodies like EVUSHELD. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur while taking EVUSHELD, immediately discontinue administration and initiate appropriate medications and/or supportive care. Clinically monitor individuals after injections and observe for at least 1 hour.
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.
Eligibility Criteria:
Eligibility Criteria:
Adults and pediatric individuals (12 years of age and older weighing at least 88 pounds 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 (e.g., severe allergic reaction) to a COVID-19 vaccine(s) and/or COVID-19 vaccine component(s).
Moderate to severe immune compromise includes:
Receiving active chemotherapy for any solid tumor malignancy
Hematological malignancy
Solid organ transplant and are taking immunosuppressants
Receipt of CAR-T within 2 years or maintained on immunosuppression
Hematopoietic cell transplant within past 2 years or maintained on immunosuppression or IgG replacement
AIDS (CD4 < 200 or 15%)
GVHD receiving immunosuppression
Receiving T- or B- cell compromising drug
Anatomic or functional asplenia
Sickle cell anemia or thalassemia
Aplastic anemia
Stage IV CKD or worse (i.e., requiring renal replacement therapy)
Neutropenia (ANC < 1000)
Myelodysplastic syndrome on therapy
Age ≥65 AND
Nonresponsive antibody assay OR
2 or more impairments of Assisted Daily Living (ADL)
SARS-CoV-2 antibody seronegative after 3 previous vaccines
All other immunosuppressive conditions receiving immunotherapy
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