Monoclonal Antibody Treatment

Eligibility for Treatment

To be a candidate for mAB treatment, in addition to a positive SARS-CoV-2 viral test, need to be deemed to be at high risk for progressing to severe COVID-19 or requiring hospitalization.  Patients are considered high risk if they meet at least 1 of the following criteria:

• Body mass index (BMI) greater than or equal to 35
• 65 years or older
• Chronic kidney disease
• Diabetes
• Immunosuppressive disease or receiving immunosuppressive therapy
• 55 years or older AND have:
• Cardiovascular disease OR
• Hypertension OR
• Chronic obstructive pulmonary disease (COPD) or other chronic respiratory disease

Residents are NOT eligible for mAB treatment if they meet any of the following criteria:

• is hospitalized due to COVID-19 or meets hospitalization criteria (RR _ 30, HR _ 130, SBP < 90)
• require oxygen therapy due to COVID-19, require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity
• is on hospice, is hospice-eligible, has had a hospice consult in the previous 6 months, or has a life expectancy of less than 6 months (clinician judgment or MDS J1400)

The benefit of mAB treatment has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients requiring high flow oxygen or mechanical ventilation with COVID-19.

Ordering and Distribution

Once prescribed by a physician, facility staff will order treatment product directly from the pharmacy. The ordering process is the same as that of any other medication order. HealthDirect has been approved to dispense mAB treatment products, but supply is limited and the federal government is responsible for the appropriate allocation of BAM, and CAS/IMD to state and territory health departments based on COVID-19 rates.

Preparation of mAB Treatment

Both BAM, and CAS/IMD are administered intravenously. At the pharmacy, a qualified HealthDirect team member will prepare treatment solution for infusion in accordance with manufacturer instructions, using aseptic technique. After preparation at the pharmacy, treatment solution will be delivered to your facility for administration.

Administration of Bamlanivimab

 BAM infusion solution should be administered by a qualified healthcare professional in a setting in which healthcare providers have immediate access to medications used to treat a severe infusion reaction and the ability to activate the emergency medical system, as necessary.

• Gather the materials for infusion:
  • Polyvinyl chloride (PVC) or polyethylene (PE)-lined PVC infusion set
  • Use of an in-line or add-on 0.20/0.22 micron polyethersulfone (PES) filter is strongly recommended.
• Attach the infusion set to the IV bag.
• Prime the infusion set.
• Administer the entire infusion solution in the bag via pump or gravity over at least 60 minutes.
• Once infusion is complete, flush the infusion line to ensure delivery of the required dose.
• Clinically monitor patients during administration and observe patients for at least 1 hour after infusion is complete.
• If the infusion must be discontinued due to an infusion reaction, discard any unused product.
• The use of closed system transfer devices (CSTDs), elastomeric pumps, and pneumatic transport with BAM has not been studied.

Administration of Casirivimab/Imdevimab

CAS/IMD infusion solution should be administered by a qualified healthcare professional using aseptic technique, in a setting in which healthcare providers have immediate access to medications used to treat a severe infusion reaction and the ability to activate the emergency medical system, as necessary.

• Gather the materials for infusion:
  • Polyvinyl chloride (PVC), Polyethylene (PE)-lined PVC, or Polyurethane (PU) infusion set
  • In-line or add-on 0.2 micron polyethersulfone (PES) filter
• Attach the infusion set to the IV bag.
• Prime the infusion set.
• Administer as an IV infusion via pump or gravity over at least 60 minutes through an intravenous line containing a sterile, in-line or add-on 0.2-micron polyethersulfone (PES) filter.
• The prepared infusion solution should not be administered simultaneously with any other medication. The compatibility of casirivimab and imdevimab injection with IV solutions and medications other than 0.9% Sodium Chloride Injection is not known. Clinically monitor patients during administration and observe patients for at least 1 hour after infusion is complete.
• After infusion is complete, flush with 0.9% Sodium Chloride Injection.
• Discard unused product.
• Clinically monitor patients during administration and observe patients for at least 1 hour after infusion is complete.

Treatment and Reporting of Adverse Reactions

With both mAB treatment options there is a potential for serious hypersensitivity reaction, including anaphylaxis. Below are guidelines for treatment of adverse reactions.

For any hypersensitivity reactions:

• Provide supplemental oxygen via nasal cannula to keep oxygen saturation > 94%
• Obtain vital signs and oxygen saturation every 10 minutes
• Provide symptomatic management per below protocol
• Contact physician
• Report FDA MedWatch event report

For fever/chills:

• acetaminophen 1000mg po one time

For itching, rash, hives, or flushing:

• diphenhydramine 25mg via IV push over 60 seconds one time
• famotidine 20mg diluted with 0.9% sodium chloride to a volume of 5-10ml via IV push over 5-10 minutes one time
• If patient desires to continue infusion, decrease infusion rate by half.

For shortness of breath, wheezing, or chest tightness:

• Discontinue mAb infusion
• diphenhydramine 50mg via IV push over 2 minutes one time
• albuterol 2.5mg/3mL via nebulizer one time
• methylprednisolone 125mg in dextrose 5% IV piggyback over 30 minutes

For stridor, severe bronchospasm, sensation of throat closure or choking, or SBP < 90

• Discontinue mAb infusion
• Evaluate airway
• Epinephrine 0.3mg IM into anterolateral thigh one time
• Place patient into recumbent position with lower extremities elevated
• Give 0.9% sodium chloride 500mL bolus one time
• Activate EMS / Call 911

All adverse reactions should be reported to FDA MedWatch.  Reports can be submitted multiple ways:

• Online: fda.gov/medwatch/report.htm
• By using a postage-paid Form FDA 3500 (available at http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM163919.pdf ) and returning by mail (MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787), or by fax (1-800-FDA-0178)
• Call 1-800-FDA-1088 to request a reporting form