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4 best practices for safely handling monoclonal antibodies

Published Date
AuthorMaggie Stewart

美国食品和药物管理局(FDA)最近美联社proved Emergency Use Authorization (EUA) for the monoclonal antibody treatment REGEN-COV (a combination of casirivimab and imdevimab). This treatment is for prophylactic use after exposure to COVID-19. Specifically, the FDA has authorized it for patients over 12 years old who are not fully vaccinated or who have compromised immune systems and are at risk for developing a severe case of the disease.1

"Monoclonal antibodies (mAbs) are an incredible advancement in the fight against COVID-19," says Veronica Crawford, RN, BSN, clinical support manager at McKesson Medical-Surgical. In a June article published in the Open Forum on Infectious Diseases, researchers found that using mAbs as a therapy in ambulatory patients with COVID-19 was associated with a 77% decrease in the odds that they would be seen in the emergency room or hospitalized within the 30 days after diagnosis.2

While REGEN-COV can help reduce the risk of hospitalization, there are a variety of safety considerations to take into account for the safe handling of monoclonal antibodies.

Select the appropriate setting for REGEN-COV administration

One best practice for safe use of mAbs is selecting the appropriate setting for administering the treatment.

According to the FDA, healthcare providers should administer monoclonal antibodies to patients only in locations where there is immediate access to medications to treat reactions such as anaphylaxis or other severe adverse events. You should also be able to access emergency medical services (EMS) if needed.3

Many settings have the potential to meet these requirements, and the Department of Health and Human Services (HHS) specifically mentions the following sites:4

  • Healthcare facilities
  • Long-term care facilities
  • Dialysis centers
  • Urgent care centers
  • Federally-qualified health centers
  • Allocation/distribution programs

When we asked Crawford about these settings — and which ones in particular she thinks hold the biggest opportunities for development as mAb administration sites — she also mentioned home and mobile sites as well as ambulatory infusion suites.

"The drug has already proven itself effective, so it's a matter of getting it into bodies," Crawford says. "If we had the ability to administer by meeting people where they are — home, via mobile buses — then it's my belief that we may have a greater impact on those most susceptible who lack resources, knowledge or access."

Develop a good plan for the infusion center

If you're thinking about turning your facility into an infusion center for mAb administration, there's good news: The FDA has developed a decision-making tool called the COVID-19Monoclonal Antibody Therapeutics Calculator for Infusion Sites("mAbs Calculator" for short) to help you decide if you can safely administer mAbs. The tool also provides useful information on what procedural, infrastructural or staffing changes you would need to make to qualify.5

"It's absolutely a great tool — especially for facilities what aren't accustomed to scheduling infusions or accommodating wait times amid social distancing guidelines and the one-hour mandatory clinical monitoring after administration," Crawford says. She notes that this calculator can help a clinic to ensure that both nursing and nonclinical/support staff is adequate. This is an important factor in smooth and efficient clinic operations, as well as in helping to prevent patient frustration or delays in treatment.

You can also refer to theMonoclonal Antibody Infusion Center Modelfor guidelines to help you develop a physical and logistical plan.6The document includes suggestions for staffing, establishing optimal patient flow, developing stations and precautions and infection control procedures that promote patient and provider safety.

Store and handle monoclonal antibodies correctly

It's essential "that the facility has a process which ensures the proper handling of the product, from the time it is received until it is infused," Crawford says. "Proper education on this is crucial."

The first steps will be to set up your facility space, train staff on the correct processes and create systems for verification and monitoring in accordance with guidelines published by the FDA. You'll need to store vials of the casirivimab and imdevimab in their original cartons in a refrigerated space, with an optimal temperature range of 36 to 46 degrees Fahrenheit. Keeping the medications in their original cartons protects them from exposure to light.3

当你准备药物,不要动摇the vials. Since neither medication contains preservatives, you should use the preparations immediately. However, if this is not possible, you can store prepared infusion solutions in the refrigerator for up to 36 hours or at room temperature for up to four hours.3

Understand safety considerations for the subcutaneous route

The ideal route for administering REGEN-COV is intravenous (IV) infusion. Alternatively, you can also use the subcutaneous (SQ) route when IV administration is not feasible or would lead to a delay in treating the patient.7

Adhere to safety guidelines when you deliver REGEN-COV subcutaneously:7

  • Allow vials to warm to room temperature by setting them out for around 20 minutes before you prepare the syringes
  • Do not shake the vials
  • Prepare four separate syringes
  • Administer the medication in different sites, choosing sites on quadrants of the thigh, the back of the upper arm or the abdomen

"The pitfalls of the subcutaneous route primarily revolve around the injection itself and the assurance that the injection sites are appropriate," Crawford says. Specifically, the waistline area and two inches around the navel are contraindicated, as is injection into skin that is discolored, sore or scarred.7

She notes, however, that there are benefits to having this option. "The addition of the ability to administer SQ has provided us with subsequent decreases in positive cases as well as duration of symptoms and viral load." A September 2021 article in the New England Journal of Medicine found that subcutaneous injections of REGEN-COV prevented infection in household members of infected individuals. It also was able to reduce the duration of symptoms and viral load for those who did become infected.8

To sum up, REGEN-COV has been approved by the FDA for post-exposure prophylaxis in certain populations of high risk patients. While these therapies represent a potentially powerful treatment in the fight against COVID-19, there are safety considerations to take into account. You should be well versed in safe and proper handling of mAbs in order to ensure consistent quality of care for patients receiving these therapies.

1:https://s3.amazonaws.com/external_clips/attachments/4107222/original/HHS_ASPR_Tx_Distro__Admin_Stakeholder_Updates_1629300372
2:https://academic.oup.com/ofid/article/8/7/ofab315/6297422
3:https://www.fda.gov/media/145611/download
4:https://www.phe.gov/emergency/events/COVID19/therapeutics/information-for-infusion-sites/Pages/default.aspx
5:https://www.phe.gov/emergency/mAbs-calculator/Pages/default.aspx
6:https://www.phe.gov/emergency/events/COVID19/investigation-MCM/Documents/Monoclonal-Antibody-Infusion-Center-Model-508.pdf
7:https://www.phe.gov/emergency/events/COVID19/therapeutics/Pages/REGEN-COV-Subcutaneous-Injection-Instructions-for-Healthcare-Providers.aspx
8.https://www.nejm.org/doi/full/10.1056/NEJMoa2109682

Be advised that information contained herein is intended to serve as a useful reference for informational purposes only and is not complete clinical information. This information is intended for use only by competent healthcare professionals exercising judgment in providing care. McKesson cannot be held responsible for the continued currency of or for any errors or omissions in the information.

© 2021 McKesson Medical-Surgical Inc.