Monoclonal Antibody Pre-Exposure Prophylaxis for Immunocompromised Patients

The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for AstraZeneca’s Evusheld™ (tixagevimab and cilgavimab). Evusheld is a potent new COVID-19 protective measure (monoclonal antibody) designed to prevent COVID-19 infection in vulnerable and immunocompromised individuals who may not mount an adequate immune response to COVID-19 vaccination.

Learn About Evusheld and Protecting Patients with Compromised Immune Systems

What Is Evusheld And How Is It Administered?

In immunocompromised patients, a vaccination may not generate enough immune response, so they are still vulnerable to severe infection. Evusheld gives additional immunity to help prevent COVID-19.

Evusheld is a combination of two monoclonal antibodies, given in two consecutive injections in one visit to qualifying patients who do not have COVID-19.

UPMC also offers monoclonal antibody treatment for patients with COVID-19.

Information on Evusheld Dosage Recommendations

Patients who received Evusheld before February 28, 2022, would have received the previously recommended dose, which is a smaller dose than what is now recommended.

The U.S. Food and Drug Administration (FDA) has recently updated its recommendation for the most effective dose of Evusheld to prevent a COVID-19 infection. Based on the most recent studies, the FDA is now recommending a larger dose of Evusheld.

The larger dose has been found to be safe, while further raising antibody levels, giving even better protection against Omicron and its variants. Dosage recommendations change because scientists are using the latest study information to provide the best guidance.

The larger dose is recommended every 6 months. Repeat dosing should be timed from the date of the most recent Evusheld dose.

PrEP C-19 Research Study

Participate in voluntary research study called PrEP C-19, for pre-exposure prophylaxis of COVID-19 in Immunocompromised Patients using the monoclonal antibody, Evusheld.

Who Is Eligible For Monoclonal Antibody Pre-Exposure Prophylaxis (Evusheld)

The current FDA has given an EUA for this medicine to be given to those with specific illness or medical situations which puts them at high-risk of developing severe COVID-19 illness.

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
Primary immunodeficiency
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**

Find out if you are considered an immunocompromised patient.

* Routine evaluation of vaccine response by antibody titer is not recommended. Evusheld is indicated for individuals at risk for vaccine non-response and seronegative despite three vaccine doses.

**This includes patients receiving corticosteroids at a dose equivalent to either ≥2 mg/kg of body weight or ≥20 mg/day of prednisone or equivalent for persons who weigh >10 kg when administered for ≥14 consecutive days. This list does not include all medical conditions defined as moderately to severely immunocompromised, and people with rare medical conditions not listed may be appropriate for Evusheld and the vaccine schedule for immunocompromised individuals.

How Can I Receive Evusheld?

Contact your UPMC doctor or provider if you think you qualify for Evusheld. UPMC providers can refer you to a UPMC infusion center to receive Evusheld. Some providers are offering Evusheld in their clinics.

For Medical Providers Ordering Evusheld

If you are a non-UPMC provider and would like to order the Evusheld administration for a patient under your care, and unable to place orders in UPMC’s electronic medical record, please:

Review local administration centers for Evusheld Administration.
Complete an Evusheld medication order form.
- You may keep a copy of the medication order for your records.

NOTE: UPMC will no longer accept any prior referral sources.