COVID-19 Therapeutics Fact Sheets and Guidance

Patient and Provider Fact Sheets

Casirivimab/Imdevimab

• Fact Sheet for Healthcare Providers (PDF) | Spanish
• Fact Sheet for Patients, Parents and Caregivers (PDF) | Spanish

Bamlanivimab/Etesevimab

• Fact Sheet for Healthcare Providers (PDF)
• Fact Sheet for Patients, Parents and Caregivers (PDF) | Spanish

Sotrovimab

• Fact Sheet for Healthcare Providers (PDF)
• Fact Sheet for Patients, Parents and Caregivers (PDF) | Spanish

Evusheld

• Frequently Asked Questions on the Emergency Use Authorization for Evusheld (tixagevimab co-packaged with cilgavimab) for Pre-exposure Prophylaxis (PrEP) of COVID-19 (CDC) (PDF)
• Fact Sheet for Healthcare Providers (PDF)
• Fact Sheet for Patients, Parents and Caregivers (PDF) | Spanish

Paxlovid

• Fact Sheet for Healthcare Providers (PDF)
• Fact Sheet for Patients, Parents and Caregivers (PDF) | Spanish
• Frequently Asked Questions on the Emergency Use Authorization for Paxlovid (PDF)
• Emergency Use Authorization (EUA) 105 Paxlovid Letter of Authorization (PDF)
• Frequently Asked Questions on the Emergency Use Authorization for Paxlovid for Treatment of COVID-19 (PDF)

Molnupiravir

• Fact Sheet for Healthcare Providers (PDF)
• Fact Sheet for Patients, Parents and Caregivers (PDF) | Spanish
• Emergency Use Authorization (EUA) 108 Molnupiravir Letter of Authorization (PDF)
• Frequently Asked Questions on the Emergency Use Authorization for Molnupiravir for Treatment of COVID-19 (PDF)

Bebtelovimab

• Bebtelovimab Fact Sheet
• Fact Sheet for Patients, Parents, and Caregivers
• EUA Letter of Authorization
• Frequently Asked Questions for Bebtelovimab

Clinical Resources and Information

• COVID-19 therapeutics decision aid (PDF) (U.S. Office of the Assistant Secretary for Preparedness and Response)
• Side-by-side overview of mAb therapeutics (ASPR)
• What's new in treatment guidelines (National Institutes of Health)

Guidance for Health Care Providers

State Resources

• Overview of WA State Order Process for COVID-19 Therapeutics (PDF)
• Interim Guidance on Monoclonal Antibody Use in Washington (PDF)
• PREP Act Authorization for Hospital Distribution of Antivirals (PDF) (1/4/2022)
• Interim DOH Guidance on Prioritization for Use of Molnupiravir (PDF)
• Interim DOH Guidance on Prioritization for Use of Paxlovid (PDF)
• Interim DOH Guidance on Prioritization for Use of EVUSHELD™ (PDF)
• Apple Health (Medicaid) monoclonal antibody treatment for COVID-19 clinical policy (PDF) (Health Care Authority)

Federal Resources

• Claims Reimbursement to Providers and Facilities - Frequently Asked Questions (Health Resources & Services Administration)
• General mAb information for providers (U.S. Department of Health and Human Services)
• Subcutaneous administration factsheet (PDF) (U.S. Department of Health and Human Services)
• Administrating mAbs checklist (PDF) (U.S. Department of Health and Human Services)
• Federal response playbook (PDF) (U.S. Department of Health and Human Services)
• Medicare reimbursement information (U.S. Centers for Medicare & Medicaid Services)
• Educational videos on monoclonal antibodies, including lessons learned, provider experiences, events and administering mAbs in your facility (U.S. Department of Health and Human Services)
• HRSA Health Center COVID-19 Therapeutics Program Participants (Health Resources & Services Administration)
• Uninsured Program Fact Sheet (PDF) (Health Resources & Services Administration)
• Statement on Patient Prioritization for Outpatient Therapies (National Institutes of Health)

Literature

• Intramuscular AZD7442 (Tixagevimab– Cilgavimab) for Prevention of Covid-19 (The New England Journal of Medicine)
• Neutralization of SARS-CoV-2 Omicron BA.2 by Therapeutic Monoclonal Antibodies (BioRxiv)
• Antibody Evasion Properties of SARS-CoV-2 Omicron Sublineages (BioRxiv)
• Will a rising Omicron variant scramble antibody treatments? (Nature)
• Effectiveness of Monoclonal Antibodies in Preventing Severe COVID-19 With Emergence of the Delta Variant (Mayo Clinic Proceedings)
• Unravelling the molecular interactions between the SARS-CoV-2 RBD spike protein and various specific monoclonal antibodies (Biochimie)
• Monoclonal antibody treatment for COVID-19 in solid organ transplant recipients (Transplant Infectious Disease Journal)
• The use of neutralizing monoclonal antibodies and risk of hospital admission and mortality in patients with COVID-19: a systematic review and meta-analysis of randomized trials (Journal of Immunopharmacology and Immunotoxicology)
• Effectiveness of monoclonal antibody therapy for COVID-19 patients using a risk scoring system (Journal of Infection and Chemotherapy)
• Updated Guidance on Use and Prioritization of Monoclonal Antibody Therapy for Treatment of COVID-19 in Adolescents (Journal of The Pediatric Infectious Disease Society)
• Realizing the Potential of Anti–SARS-CoV-2Monoclonal Antibodies for COVID-19 Management (Rajesh T. Gandhi, MD, Massachusetts General Hospital)
  
• Clinical outcomes of monoclonal antibody therapy during a COVID-19 outbreak in a skilled nursing facility—Arizona, 2021 (Journal of The American Geriatrics Society)
• Monoclonal Antibody Treatment of Breakthrough COVID-19 in Fully Vaccinated Individuals with High-Risk Comorbidities (The Journal of Infectious Diseases)
• Resistance Mutations in SARS-CoV-2 Delta Variant after Sotrovimab Use (The New England Journal of Medicine)
• Management of Drug Interactions With Nirmatrelvir/Ritonavir (Paxlovid®): Resource for Clinicians (Infectious Diseases Society of America)
• Tixagevimab/cilgavimab pre-exposure prophylaxis is associated with lower breakthrough infection risk in vaccinated solid organ transplant recipients during the Omicron wave (MedRxiv)
• Intramuscular AZD7442 (Tixagevimab–Cilgavimab) for Prevention of Covid-19 (The New England Journal of Medicine) 
• Real-world effectiveness of molnupiravir and nirmatrelvir/ritonavir against mortality, hospitalization, and in-hospital outcomes among community-dwelling, ambulatory COVID-19 patients during the BA.2.2 wave in Hong Kong: an observational study (MedRxiv)
• As reports of ‘Paxlovid rebound’ increase, Covid researchers scramble for answers (STAT)
• Effectiveness of Paxlovid in Reducing Severe COVID-19 and Mortality in High Risk Patients (Oxford Academic)
• Neutralisation sensitivity of SARS-CoV-2 omicron subvariants to therapeutic monoclonal antibodies (The Lancet) 
• Nirmatrelvir Resistant SARS-CoV-2 Variants with High Fitness in Vitro (BioRxiv)
• The substitutions L50F, E166A and L167F in SARS-CoV-2 3CLpro are selected by a protease inhibitor in vitro and confer resistance to nirmatrelvir (BioRxiv)
• Dispensing of Oral Antiviral Drugs for Treatment of COVID-19 by Zip Code-Level Social Vulnerability- United States, December, 23 2021- May 21, 2022 (CDC)
• Hospitalization and Emergency Department Encounters for COVID-19 After Paxlovid Treatment- California, December 2021-May 2022 (CDC)