RHM Administration of Monoclonal Antibodies

[Pages:22]RHM Administration of Monoclonal Antibodies

Treatment and Prophylaxis Guidance; Infusion Site Considerations and Examples September 2021

Introduction & Overview

? Audience: Colleagues and Clinicians at Trinity Health Regional Health Ministries (RHM), Emergency Departments, Urgent Care, Infusion Clinics, and Ambulatory Clinics

? Purpose: Early intervention with monoclonal antibody treatment or prophylaxis may reduce the risk of severe illness and hospitalization for people with COVID-19 who are at high risk of developing more serious illness. Trinity Health RHMs should ensure monoclonal antibody treatment is available for all eligible individuals.

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Eligible Population for receipt of Monoclonal Antibodies

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Eligibility requirements for monoclonal antibody treatment or prophylaxis of COVID-19

Monoclonal antibody therapy is currently authorized to treat mild to moderate COVID-19 in adult and pediatric patients 12 years of age and older weighing at least 40kg (89 pounds) with the following risk factors.

? Are older in age (e.g., age > 65 years of age).

? Are obese (Body Mass Index >35) or are overweight (e.g., adults with BMI >25, or if age 12-17, have BMI >85th percentile for their age and gender based on CDC growth charts.

? Are pregnant

? Have chronic kidney disease

? Have diabetes

? Have immunosuppressive disease or are receiving immunosuppressive treatment (e.g., steroids)

? Have cardiovascular disease (e.g., past heart attack, stents, bypass surgery, atrial fibrillation, CHF) or hypertension (high blood pressure)

? Have chronic lung diseases (chronic obstructive pulmonary disease, moderate to severe asthma, interstitial lung disease, cystic fibrosis, or pulmonary hypertension)

? Have sickle cell disease

? Have a neurodevelopmental disorder (e.g., cerebral palsy) or other condition that confers with medical complexity

? Have a medical-related technological dependence (e.g., tracheostomy, gastrostomy, home ventilator, or positive pressure ventilation (not related to COVID-19))

? Have other conditions considered by their health care provider to place them at higher risk for progression of disease severity as further described by CDC.

? Other medical conditions or factors (e.g., race or ethnicity) may also place individual patients at high risk for progression to severe COVID-19. For additional information on medical conditions and factors associated with increased risk for progression to severe COVID-19, see the CDC website: Certain Medical Conditions and Risk for Severe COVID-19 Illness.

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Additional eligibility requirements for prophylaxis of COVID-19

Post-exposure prophylaxis of COVID-19 in individuals who are at high risk of progression to severe COVID-19 and are:

? Not fully vaccinated or who are not expected to mount an adequate immune response to complete vaccination (for example, individuals with immunocompromising conditions including those taking immunosuppressive medications) and

- Have been exposed to an individual infected with COVID-19 consistent with close contact criteria per CDC, or

- Who are at high risk of exposure to an individual infected with COVID-19 because of occurrence of COVID-19 infection in other individuals in the same institutional setting (for example, nursing home or correctional facility).

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Post Exposure Prophylaxis Eligibility

***Immunocompromising Conditions and Medications

? Been receiving active cancer treatment for tumors or cancers of the blood

? Received an organ transplant and are taking medicine to suppress the immune system

? Received a stem cell transplant within the last 2 years or are taking medicine to suppress the immune system

? Moderate or severe primary immunodeficiency (such as DiGeorge syndrome, Wiskott-Aldrich syndrome)

? Advanced or untreated HIV infection

? Active treatment with high-dose corticosteroids or other drugs that may suppress your immune response

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Monoclonal Antibodies Routes of Administration

? For Treatment, Intravenous Infusion is strongly recommended. - Subcutaneous injection is an alternative route of administration for the Regeneron product (Regen-CoV) when intravenous infusion is not feasible and would lead to a delay in treatment.

? For Post-exposure Prophylaxis, intravenous infusion can be used for either product - Subcutaneous injection can be used for the Regeneron (Regen-CoV) product only.

? Regardless of the route of administration, both require a 1-hour postinfusion monitoring period.

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Playbook and Resources to Support Monoclonal Antibody Infusion Sites

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