COVID-19 Guidance On Therapeutics
Early treatment and post-exposure prophylaxis
In November, the U.S. Food and Drug Administration issued an Emergency Use Authorization to allow the use of monoclonal antibodies for the treatment of mild to moderate symptoms of COVID-19 in adults and pediatric patients. Monoclonal antibody treatment can be used in people 12 years of age and older who weigh at least 88 pounds (40 kg) who are at high risk for severe COVID-19, including hospitalization or death for:
- Treatment of mild to moderate symptoms of COVID-19. To be eligible, patients must:
- Test positive for SARS-CoV-2.
- Be within 10 days of the start of their symptoms.
- Not be hospitalized.
- Prevention of COVID-19 in people who have had close contact or are at high risk of being in close contact with someone with COVID-19, such as people in the same institutional setting (for example, nursing homes or prisons) where COVID-19 is circulating. To be eligible, people:
- Must not be fully vaccinated against COVID-19, or
- Are not expected to build up enough of an immune response to the complete COVID-19 vaccination (for example, someone with immunocompromising conditions, including someone who is taking immunosuppressive medications).
Bamlanivimab/etesevimab has been authorized by the FDA for early treatment and prevention of COVID 19 in children <12 years of age including newborns.
Prioritization: UPDATED NIH TREATMENT AND PRIORITIZATION STATEMENTS FOR NON HOSPITALIZED PATIENTS WHEN OMICRON IS PREDOMINANT CIRCULATING VARIANT
- NIH has recently updated its statement for the treatment of COVID 19 in non-hospitalized patients.
- NIH has recently updated its statement to help prioritization when supplies are low.
HHS has transitioned from direct ordering of monoclonal antibodies to a state-coordinated distribution system. Hospitals and other administration sites will no longer order from AmeriSource Bergen directly. The federal government will determine the total allocation amount for each state based upon state cases and hospitalizations, and utilization as reported to HHS Protect / TeleTracking. ADH will determine which sites will receive MAbs and allocation amount.
There are multiple REGEN-COV packaging variations (co-formulated, non-co-formulated doses). Please verify package inserts upon delivery and follow proper administration procedures for the version your site received. Additionally, all REGEN-COV products can be administered via intravenous infusion and/or subcutaneous injections.
**1/25/22, the government announced no further shipments of BAM/ETE or REGEN-COV for current and future cycles. FDA no longer recommends the use of Regeneron-COV and BAM/ETE. Please see this link for the latest update regarding therapeutics.
**NOTE**: No product returns will be accepted at this time; HHS has directed all facilities keep their stock on hand until we receive further guidance.
Ritonavir boosted nirmatrelavir (Paxlovid) and molnupiravir were approved under EUA by the FDA for treatment of early COVID 19 infection. These treatments should be given within the first 5 days of symptom onset. Initial distribution of these oral medications is limited to selected sites and further sites will continue to be added.
Paxlovid and molnupiravir may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs in the therapeutic class to which these drugs belong (i.e., anti-infectives).
- ATTENTION: Click here for the Oral Antiviral Participation Survey
- ATTENTION: Click here for the Oral Antiviral Order Form
**ORAL ANTIVIRAL TREATMENTS ARE DRIVE-THRU OR CURBSIDE ONLY! PLEASE DO NOT ENTER STORES!**
Pre Exposure Prophylaxis
A new monoclonal antibody (tixagevimab/cilgavimab) for the prevention of COVID-19 has been authorized by the FDA under EUA that may be used in immunocompromised patients and patients who have a medical contraindication to receiving a vaccine for COVID-19. Medical conditions or treatments that may result in moderate to severe immune compromise and an inadequate immune response to COVID-19 vaccination include but are not limited to:
- Active treatment for solid tumor and hematologic malignancies
- Receipt of solid-organ transplant and taking immunosuppressive therapy
- Receipt of chimeric antigen receptor (CAR)-T-cell or hematopoietic stem cell transplant (within 2 years of transplantation or taking immunosuppression therapy)
- Moderate or severe primary immunodeficiency (e.g., DiGeorge syndrome, Wiskott-Aldrich syndrome)
- Advanced or untreated HIV infection (people with HIV and CD4 cell counts
- ATTENTION: Click here for the Pre-Exposure Participation Survey
- ATTENTION: Click here for the Pre-Exposure Prophylaxis Order Form
Orders must be placed by COB each Tuesday. The order should be based upon the 7 day average of what your facility uses, and you should only order what you expect to use in one week. Most shipments will go directly to your facility from Amerisource Bergen. For all new sites, or special circumstances, MAbs will come directly from ADH and delivery will be coordinated with the site.
Locations in Arkansas Receiving COVID-19 Therapeutics
- FDA EUA of COVID-19 Therapeutic Products
- Walmart COVID-19 Medication
- NIH statement on drug interactions with paxlovid
- EUA Paxlovid Dispensing Information
- EUA Molnupiravir prescriber checklist
- COVID-19 Therapeutic Decision Aid
- COVID-19 Drug Interactions