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COVID-19 Therapeutics Provider Information

This page includes quick summaries of the available therapeutics.
Providers must review the respective medication Fact Sheets.

Updates

General Evusheld Announcement:

The FDA announced on January 26, 2023, that the Emergency Use Authorization (EUA) for Evusheld has been revised. Evusheld is currently not authorized for use in the US. Please see the information regarding this decision here: https://www.fda.gov/drugs/drug-safety-and-availability/fda-announces-evusheld-not-currently-authorized-emergency-use-us.

Please notify providers to discontinue use of Evusheld and retain any leftover product in accordance with ASPR recommendations: https://www.fda.gov/drugs/drug-safety-and-availability/fda-announces-evusheld-not-currently-authorized-emergency-use-us. Any orders submitted this week will not be placed.

“The U.S. Government recommends that facilities and providers with Evusheld retain all product in the event that SARS-CoV-2 variants which are neutralized by Evusheld become more prevalent in the U.S. in the future. Retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers and the Letter of Authorization.”

This is guidance we recently received from CDPH with respect to the destruction of unauthorized/expired therapeutics:

Licensed provider locations with destruction procedures in place that follow all federal, state, and local regulations may destroy therapeutics on site only if:

  • Guidelines are followed on what product can be destroyed
  • Only expired product or unauthorized product that can no longer be stored
  • No unexpired product that is currently authorized for use can be destroyed
  • Sites are to follow established protocols for destruction and attest in HPOP to following all regulations
  • Quantities of any product destroyed is recorded in HPOP
  • HHS Assistant Secretary for Preparedness & Response Important Updates
  • HHS COVID-19 Therapeutics Decision Aid (updated 12/2022)
  • NIH Treatment Guidelines (updated 12/06/22)
    • When there are no logistical constraints, therapies are to be prescribed for any eligible individual.
    • If logistical constraints are faced, Providers should follow the NIH Prioritization.
  • CDC Interim Clinical Considerations for COVID-19 Treatment in Outpatients (updated 12/05/2022)
  • CDC Underlying Medical Conditions Associated with Higher Risk for Severe COVID-19: Information for Healthcare Professionals (updated 12/05/2022)
  • CDPH HEALTH ADVISORY: Reminder to Lower Barriers to Prescribing COVID-19 Therapeutics to Mitigate Impact of COVID-19 (12/02/2022)

Provider Resources

Variants & Efficacy

Shelf-life Extensions

In most cases, the packaging labels do not represent the most current expiration date for that product. Be sure to always check the relevant webpages for current product specific expiration dates.

Monoclonal Treatment

Bebtelovimab

Oral Treatment

Paxlovid

Pfizer’s Paxlovid
Type: Oral antiviral – protease inhibitor.
Administration Route: By mouth (PO) – twice daily for 5 days.
Timing: As soon as possible after diagnosis of COVID-19 and within 5 days of symptom onset.
Target Population: COVID-19 patients 12 years of age and older weighing at least 40 kg who are at high risk for progression to severe COVID-19 symptoms. Many drug-drug interactions.

Lagevrio (Molnupiravir)

Merck and Ridgeback’s Molnupiravir
Type: Oral antiviral – nucleoside analogue.
Administration Route: By mouth (PO) – every 12 hours for 5 days
Timing: As soon as possible after diagnosis of COVID-19 and within 5 days of symptom onset.
Target Population: COVID-19 patients 18 years of age and older who are at high risk for progression to severe COVID-19 symptoms. NOT recommended in pregnancy.

Intravenous Antiviral Therapy

Remdesivir

Gilead’s Veklury (Remdesivir)
Type: nucleotide analog RNA polymerase inhibitor
Administration Route: intravenous (IV) infusion over 30 to 120 minutes
Timing: For non-hospitalized patients, as soon as possible after diagnosis of COVID-19 and within 7 days of symptom onset. See Patient Information for initiation of treatment in hospitalized patients as well as the duration of treatment for hospitalized and non-hospitalized patients.
Target Population: Adults and pediatric patients (28 days of age and older and weighing at least 3 kg) with positive results of direct SARS-CoV-2 viral testing, who are hospitalized or not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.

COVID-19 Convalescent Plasma (CCP)

  • COVID-19 Convalescent Plasma EUA Letter
  • COVID-19 Convalescent Plasma Provider Fact Sheet
  • Recommendations for Investigational COVID-19 Convalescent Plasma | FDA
    • FDA issued an EUA to permit the emergency use of the unapproved product, COVID-19 convalescent plasma with high titers of anti-SARS-CoV-2 antibodies, for the treatment of COVID-19 in patients with immunosuppressive disease or receiving immunosuppressive treatment, in either the outpatient or inpatient setting. COVID-19 convalescent plasma is not authorized to treat immunocompetent patients with COVID-19.
    • Given that the clinical evidence in patients with immunosuppressive disease or receiving immunosuppressive treatment remains limited, data from additional randomized, controlled trials are needed.
    • FDA has authorized other treatments for emergency use for the treatment of COVID-19 in adults and pediatric patients in the outpatient setting. These products have more consistently demonstrated clinical benefit in this population, and do not carry some of the risks associated with transfusion of blood components.
  • COVID-19 Treatment Guidelines: Convalescent Plasma and Immune Globulins | NIH
    • Based on the available data, the Panel revised the recommendation language for the use of CCP in patients who are immunocompromised. There is currently insufficient evidence for the Panel to recommend either for or against the use of high titer CCP for the treatment of COVID 19 in hospitalized or nonhospitalized patients who are immunocompromised. Some Panel members would use CCP to treat an immunocompromised patient with significant symptoms attributable to COVID 19 and with signs of active SARS-CoV-2 replication and who is having an inadequate response to available therapies. In these cases, clinicians should attempt to obtain high titer CCP from a vaccinated donor who recently recovered from COVID 19 likely caused by a SARS-CoV-2 variant similar to the variant causing the patient’s illness.
  • CCP Resources

Telehealth

How to obtain COVID-19 Therapeutics

Paxlovid and Molnupiravir: When prescribing these medications to your patients, providers should visit the HHS Therapeutics Locator to find pharmacies with current supply of these products. Patients may also be advised of the HHS Test to Treat (T2T) program and the HHS T2T Locator map.

Remdesivir: Veklury (Remdesivir) is commercially available through Gilead Pharmaceuticals and multiple distributors. For additional purchasing information or how to access Remdesivir, Providers may email remdesivir@amerisourcebergen.com, call 1-800-746-6273, or reach out directly to your AmerisourceBergen , Cardinal, or McKesson representative.

>Funding & Reimbursement

Reporting Requirements

Reporting Requirements

Click here to view the CDPH HPoP Reporting and Transfer instructions.

Need more information?

General inquiries: COVIDTherapeutics@ventura.org
Clinical questions: COVIDRxProviders@cdph.ca.gov
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