The one-time Monoclonal Antibody (mAb) Therapy (infusion) is available for treating providers to order for qualifying high-risk outpatients diagnosed with COVID-19 and we currently have many openings available.
The FDA has expanded the criteria for referring a patient to Monoclonal Antibody (mAb) Therapy, allowing for more provider discretion.
The following medical conditions or other factors may place individuals at higher risk of progression to severe COVID-19. For all patients (adults ≥ 18 years of age or pediatric patients ≥ 12 years of age weighing at least 40kg), at least one of the following criteria must be met:
- Age ≥ 65 Years of Age
- Obesity or being overweight
- Adults: Body Mass Index (BMI) > 25
- Pediatrics: > 85th percentile for age & gender based on CDC growth charts
- Pregnancy
- Chronic Kidney Disease
- Diabetes Mellitus
- Immunosuppressive Disease or immunosuppressive treatment
- Cardiovascular Disease (including but not limited to congenital heart disease, hypertension, coronary artery disease)
- Chronic Lung Disease (including but not limited to COPD, moderate to several asthma, interstitial lung disease, cystic fibrosis, pulmonary hypertension)
- Sickle Cell Disease
- Neurodevelopmental disorders (including but not limited to cerebral palsy)
- Having a medical-related technological dependence not related to COVID-19 (including but not limited to tracheostomy, gastrostomy, positive pressure ventilation)
- Other conditions that confer medical complexity (including but not limited to genetic or metabolic syndromes and several congenital anomalies)
Other medical conditions or factors (e.g., race or ethnicity) may also place individual patients at high risk for progression to severe COVID-19 and authorization of monoclonal antibody therapy under the EUA is not limited to the medical conditions or factors listed above. For additional information on medical conditions and factors associated with increased risk for progression to severe COVID-19, see the CDC website. Healthcare providers should consider the benefit-risk for an individual patient.
Referral resources, including forms and updated Monoclonal Antibody (mAb) Therapy Quick Guide and Fact Guide for Patients, are available on our COVID-19 For Providers website.