First Americans Wellness, through our clinic on the Morongo Indian Reservation, offers monoclonal antibody infusion (mAb) treatment for qualified patients (Tribal and non-Tribal) who test positive for COVID-19. The FDA has issued emergency use authorization (EUA) for mAb therapy that could help the immune system recognize and respond more effectively to the virus.

First Americans Wellness is approved to administer sotrovimab to treat mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing who are at high risk for progression to severe COVID-19, including hospitalization or death.  

This is in accordance with the Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA) for sotrovimab (https://www.fda.gov/media/149532/download). 

Who qualifies for the treatment?

The chart below can help you determine if you qualify for the mAb treatment. Contact your primary care physician or other medical healthcare professional for additional information. First Americans Wellness requires a physician’s order to deliver treatment (see sample below). The physician’s order can be faxed to 888-551-2116.

Patient Eligibility for monoclonal antibody infusion treatment

Adults and adolescents 12 years of age and older weighing at least 40 kg with positive results of direct  SARS-CoV-2 testing within 10 days of symptom onset who meet any of the criteria below. 

•       Older age (for example, age ≥65 years of age) 

•       Obesity or being overweight (for example, BMI >25 kg/m2, or if age 12-17, have BMI ≥85th percentile for their age and gender) 

•       Pregnancy 

•       Chronic kidney disease 

•       Diabetes 

•       Immunosuppressive disease or immunosuppressive treatment 

•       Cardiovascular disease (including congenital heart disease) or hypertension 

•       Chronic lung diseases (for example, chronic obstructive pulmonary disease, asthma, interstitial lung disease, cystic fibrosis, and pulmonary hypertension) 

•       Sickle cell disease 

•       Neurodevelopmental disorders (for example, cerebral palsy) or other conditions that confer  medical complexity (for example, genetic or metabolic syndromes and severe congenital anomalies)  

•       Having a medical-related technological dependence (for example, tracheostomy, gastrostomy,   or positive pressure ventilation (not related to COVID-19)

Other medical conditions or factors (for example, race or ethnicity) may also place individual patients at high risk for progression to severe COVID-19, and authorization of sotrovimab 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.

LIMITATIONS OF AUTHORIZED USE 

Sotrovimab is not authorized for use in the following patient populations: 

•  Adults or pediatric patients who are hospitalized due to COVID-19, or  

•  Adults or pediatric patients who require oxygen therapy due to COVID19, or  

•  Adults or pediatric patients who require an increase in baseline oxygen flow rate due to COVID-19 in those patients on chronic oxygen therapy due to underlying non-COVID-19related comorbidity.  

•  Sotrovimab may only be administered in settings in which health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary.  

Fact Sheet for Patients (click here)

FACT SHEET FOR HEALTH CARE PROVIDERS (Click here)

First American Wellness’ experienced medical team is trained and certified to treat COVID-19 patients. We operate under the highest safety standards in infusion therapy, adhering to the National Infusion Center Association’s Standards of Care as well as COVID-19-specific recommendations from NICA and the CDC.  Our clean, spacious, facility is dedicated to providing patients the highest level of care for their infusion treatments.

To refer your qualified COVID-19 positive patients for monoclonal antibody therapy, or for more information, please call First Americans Wellness at (951) 922-2058 to schedule an appointment for treatment. 

For more information on monoclonal antibodies for the treatment of COVID-19, please go to combatcovid.hhs.gov and click on “Learn About Treatment Options”.