Antibody Resource Guide

COVID-19 Antibody Treatment Resource Guide

The National Infusion Center Association has developed the resources described below in our antibody treatment resource guide to support prescribers, infusion providers, and patients in the safe and efficient use of COVID-19 antibody treatments.  These resources can be found in the COVID-19 Antibody Treatment Resource Center.

Locating Sites of Care

NICA COVID-19 Locator 

Use NICA’s COVID-19 Therapy Locator Tool to identify sites of care administering COVID-19 antibody therapies.

Prescribers & Patients: 

  • Simply enter your city and state or your zip code and click “search” 
  • Click on a location to view site details including phone number, hours of operation, website,  amenities, and more.  
  • If results do not populate for the area searched, try widening the search radius. If there are still no  results to display, contact your local/regional health authorities as your state may not have opted into our antibody therapy locator program yet. 

Infusion Providers: 

  • Be sure patients can find your infusion site by “claiming” your location and adding pertinent details  to the profile like phone number, hours of operation, amenities, and more.  
  • Consider using the URL field to direct prescribers and patients to pertinent information on your  center’s website, such as patient arrival instructions, required forms, etc.  
  • If you need assistance claiming your center or building out your profile, email [email protected].

This national map is maintained by the Department of Health and Human Services and displays locations that have received shipments of COVID-19 antibody therapies.  

  • If results do not populate for the area searched, try widening the search radius. If there are still no  results to display, contact your local/regional health authorities as your state may not have opted to have their antibody therapy locations displayed. 
  • It is important to note that locations are displayed based on the address where medication was  shipped (e.g., centralized pharmacy, warehouse) and may not reflect the location/address where  patient care is provided. 

COVID-19 Antibody Treatment Indication Checklist

This checklist is intended to help prescribers determine if treatment with COVID-19 antibodies is  authorized for use in accordance with the Emergency Use Authorization (EUA) requirements.  • If COVID-19 antibody treatment is not indicated, the checklist can be included in the medical  record to document the clinical decision-making process.  

  • If COVID-19 antibody treatment is indicated, the checklist can accompany the medication order to  document eligibility criteria and support medical necessity. Individual infusion site documentation requirements may vary

COVID-19 Antibody Treatment Order Set

An order set is developed for each approved COVID-19 antibody therapy and serves as the prescription  for treatment. 

  • Facilitates proper prescribing by capturing the necessary elements of a valid, complete COVID-19 antibody treatment infusion order 
  • Captures criteria for authorized use mandatory reporting requirements per EUA.  • Guides infusion clinician in safe administration by prompting best practices and adherence to  administration requirements.
  • Supports continuity of care by prompting the infusion provider to send records of completed  treatment to the prescriber. 

Coding Guide

List of common diagnosis codes that may apply to eligible patients.‡ 

  • Provides prescriber with easy access to codes needed to complete order set and indications  checklist 
  • ICD-10 data helps public health officials understand which patient populations are receiving  COVID-19 therapeutics to support efforts aimed at equitable allocation and distribution of  COVID-19 therapeutics. 

Referral Checklist

Many HCPs prescribing COVID-19 antibody treatments may be unfamiliar with the infusion referral  process. As COVID-19 antibody treatments are thought to be most effective when given as early as  possible in the disease course, it is critical to streamline the referral process to reduce unnecessary delays  to expedite access to treatment and optimize outcomes. This checklist provides a template overview of  necessary steps to refer a patient for COVID-19 antibody treatment. 

  • Infusion sites of care are encouraged to download and modify this checklist to create a custom  checklist including any unique, site-specific requirements. 

Patient Education: Preparing for a COVID-19 Antibody Infusion

Prescribers can provide and review this handout with patients to help them understand and prepare for  their infusion to promote treatment acceptance and adherence.  

  • Includes a field for prescriber to indicate facility name and phone number where referral/order  was sent, with instruction for patients to call if they have not received an appointment promptly.  This is intended to reduce treatment delays or patients “timing out” of treatment eligibility due to  communication challenges. 

Casirivimab + Imdevimab Flowsheet / Bamlanivimab Flowsheet

The flowsheet, sometimes called a treatment note, is used to document all care associated with  administration of COVID-19 antibody therapies.  

  • Guides the clinician to follow industry standards and best practices as well as adhere to  administration and documentation requirements under the EUA. This is not an all-inclusive list of diagnoses meeting EUA criteria for high risk for progressing to severe  COVID-19 and/or hospitalization.
  • Provides a detailed record to fax to the referring prescriber for inclusion in the patient’s medical  record.
  • Especially helpful for temporary sites of care or other infusion providers using paper  documentation. 

Drip Rate Tables

In sites of care administering infusions by gravity (as opposed to with an infusion pump or other rate control device), HCPs will be required to calculate the appropriate drip rate using the volume to be infused  and drop factor of the administration set used (infusion tubing). As many HCPs may be unfamiliar with the  calculations required, these tables provide the appropriate drip rates for administration of both products  using administration sets with any drop factor.

Casirivimab + Imdevimab Medication Safety Alert

Casirivimab and Imdevimab are supplied in multiple packaging configurations and have unique preparation  requirements that may increase risk for medication errors. 

  • Provides considerations and strategies to reinforce use of proper quantities/combinations of  product to prepare a single dose. 

Patient Education: COVID-19 Antibody Treatment Discharge Instructions

This patient handout explains signs and symptoms to watch for and report following a COVID-19 antibody  infusion.  

  • Provides home care instructions for discomfort at the IV site 
  • Reinforces the need to continue isolation to prevent disease transmission
  • Lists emergency warning signs that necessitate seeking medical attention

NICA Standards for In-Office Infusion

View NICA’s minimum standards for the administration of intravenous and injectable medication in an  outpatient setting. 

Eli Lilly Bamlanivimab Playbook

NICA collaborated with Eli Lilly to develop this playbook with in-depth information about preparation and  administration of bamlanivimab as well as other considerations for operationalizing an infusion site. 

Regeneron Casirivimab + Imdevimab Emergency Use Authorization (EUA) Guidebook

NICA collaborated with Regeneron to develop this playbook with in-depth information about preparation  and administration of casirivimab + imdevimab as well as other considerations for operationalizing an  infusion site. 

Report an Adverse Event to MedWatch

Healthcare providers must submit a report on all medication errors and all serious adverse events  potentially related to COVID-19 antibody therapy. 

Multilingual COVID-19 Resources

The CDC has developed the COVID-19 Communication Toolkit: For Migrants, Refugees, and Other  Limited-English-Proficient Populations in various languages. Resources are available in Spanish, Simplified  Chinese, Korean, Tagalog, Hmoob (Hmong), Af Soomaali (Somali), and Vietnamese.

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Updates in the Treatment and Prevention of COVID-19​

EUA of Bamlanivimab Plus Etesevimab Expanded to Include Younger Pediatric Patients

The emergency use authorization (EUA) for bamlanivimab plus etesevimab now includes an indication for treatment and post-exposure prophylaxis for children and newborn babies who are at high risk for severe disease. The expansion of the EUA is supported by a trial of 125 pediatric patients with at least one risk factor for severe illness; the study had safety and efficacy data similar to findings for adolescents and adults.

For more information visit www.fda.gov/news-events/press-announcements/fda-expands-authorization-two-monoclonal-antibodies-treatment-and-post-exposure-prevention-covid-19

 

Oral Antiviral Therapies With Emergency Use Authorization (EUA) for COVID-19

Two new oral antiviral therapies received emergency use authorization (EUA) for COVID-19: Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged) and molnupiravir. Both therapies are authorized for the treatment of mild-to-moderate COVID-19 in certain people who are at high risk of progressing to severe illness.

In the EPIC-HR clinical trial, nirmatrelvir/ritonavir significantly reduced the risk of hospitalization or death from any cause by 88% compared with placebo. This treatment is indicated for adults and pediatric patients, 12 years of age and older who weigh at least 40 kilograms. Side effects include an impaired sense of taste, diarrhea, high blood pressure, and muscle aches. The safety and effectiveness of this combination therapy continue to be evaluated.

The main outcome measure of the MOVe-OUT trial of molnupiravir was the percentage of people who were hospitalized or died due to any cause during 29 days of follow-up. Compared with 9.7% of people who received placebo, 6.8% of those in the molnupiravir group were hospitalized or died. One person who received molnupiravir died versus nine people in the placebo group. Molnupiravir is not recommended for pregnant women or for those people younger than 18 years of age because of its effect on bone and cartilage growth.

For more information regarding the EUA for these oral antivirals, visit the following FDA URLs:

www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-oral-antiviral-treatment-covid-19

www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-oral-antiviral-treatment-covid-19-certain

 

FDA Authorized Emergency Use Authorization (EUA) for Long-Acting Monoclonal Antibodies as Pre-Exposure Prophylaxis of COVID-19

Evusheld (tixagevimab co-packaged with cilgavimab and administered together) has been granted EUA for the prevention of COVID-19 in certain people with compromised immune systems or with a history of severe adverse reactions to a COVID-19 vaccine or any of its components. This combination is not meant to be a substitute for vaccination for those who have no contraindications to a COVID-19 vaccine.

The PROVENT clinical trial demonstrated a 77% reduction in the risk of developing COVID-19 compared with placebo, and protection appears to have been maintained through six months. Safety and efficacy of the tixagevimab/cilgavimab combination continues to be investigated.

For more information, visit www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-new-long-acting-monoclonal-antibodies-pre-exposure