Bamlanivimab (Investigational)

Bamlanivimab (Investigational) is used for: COVID-19 infection,(Emergency use authorization)

COVID-19 (EUA) Emergency use authorization (EUA) issued by the FDA for treatment of mild-to-moderate COVID-19 in patients aged >12 years who weigh >40 kg with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization Adult Injection 700 mg as a single IV infusion over 60 minutes Administer as soon as possible after positive viral test for SARS-CoV-2 and within 10 days of symptom onset in patients at high-risk for progressing to severe COVID-19 and/or hospitalization Hepatic impairment Mild: No dose adjustment required Moderate or severe: Not studied

Renal impairment Mild, moderate, or severe: No dose adjustment required

Patient selection High-risk defined as meeting at least 1 of these criteria BMI >35 Chronic kidney disease Diabetes Immunosuppressive disease Receiving immunosuppressive treatment Age >65 years Age >55 years and have cardiovascular disease, hypertension, or COPD/chronic respiratory disease Additional high-risk factors in patients aged 12-17 years BMI >85th percentile for their age and sex based on CDC growth charts Sickle cell disease Congenital or acquired heart disease Neurodevelopmental disorders (eg, cerebral palsy) Medical-related technological dependence (eg, tracheostomy, gastrostomy, positive-pressure ventilation [not related to COVID-19]) Asthma, reactive airway disease, or other chronic respiratory disease requiring daily medication for control IV Preparation Remove drug from refrigerator and allow drug to equilibrate to room temperature (~20 min) before preparation; do not expose to direct heat Inspect for particulate matter and discoloration; solution should appear clear to slightly opalescent and colorless to slightly yellow to brown Gently invert vial by hand ~10 times; do not shake Dilution Withdraw 70 mL from 250-mL 0.9% NaCl bag Add bamlanivimab 700 mg (20 mL) to the 0.9% NaCl bag to total 200 mL; discard any product remaining in vial Gently invert IV bag by hand ~10 times to mix; do not shake Administer immediately after preparation; if unable to administer immediately, store according to directions IV Administration Therapy may only be administered in settings in which healthcare providershave immediate access to medications to treat a severe infusion reaction, such asanaphylaxis, and the ability to activate the emergency medical system (EMS), asnecessary If solution refrigerated, allow to equilibrate to room temperature for ~20 minutes Administer IV via pump or gravity over at least 60 minutes Infuse by PVC infusion set containing 0.20/0.22-micron in-line polyethersulfone (PES) filter Attach infusion set to IV bag and prime infusion set Flush line after infusion completed to ensure entire dose delivered Discard unused product Monitor during infusion and observe patients for at least 1 hr after infusion completed Treated patients should continue to self-isolate and use infection control measures (eg, wear mask, isolate, social distance, avoid sharing personal items, clean and disinfect “high touch” surfaces, frequent handwashing) according to CDC guidelines

Limitations of use Benefit of treatment not been observed in patients hospitalized due to COVID-19 Monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation Not authorized for use in patients who are hospitalized due to COVID-19, OR who require oxygen therapy due to COVID-19, OR who require an increase in baseline oxygen flow rate due to COVID-19 in those on long-term oxygen therapy due to underlying non-COVID-19-related comorbidity Hypersensitivity Potential for serious hypersensitivity reaction, including anaphylaxis If signs and symptoms occur, immediately discontinue IV infusion and initiate appropriate medications and/or supportive care Infusion-related reactions reported, including fever, chills, nausea, headache, bronchospasm, hypotension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, dizziness Severe COVID-19 Treatment benefit not been observed in patients hospitalized due to COVID-19 Monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation Therefore, bamlanivimab is not authorized for use in patients who are hospitalized due to COVID-19, OR who require oxygen therapy due to COVID-19, OR who require an increase in baseline oxygen flow rate due to COVID-19 in those on long-term oxygen therapy due to underlying non-COVID-19-related comorbidity

Pregnancy Insufficient data to evaluate drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes Use during pregnancy only if the potential benefit outweighs the potential risk for the mother and fetus No dosage adjustment recommended by the manufacturer Lactation Data are unknown regarding presence in human or animal milk, effects on breastfed infants, or effects on milk production Maternal IgG is known to be present in human milk No dosage adjustment recommended by the manufacturer

Not renally excreted or metabolized by CYP450 enzymes Interactions with concomitant renally excreted drugs or drugs that are CYP450 substrates, inducers, or inhibitors are unlikely

Side effects of Bamlanivimab (Investigational) : 1-10% *Denotes incidence lower than placebo Nausea (3%)* Dizziness (3%) Headache (3%) Pruritus (2%) Immediate nonserious hypersensitivity (2%) Diarrhea (1%)* Vomiting (1%)*

Bamlanivimab is a recombinant neutralising human IgG1κ monoclonal antibody that binds to the receptor-binding domain of the spike protein of SARS-CoV-2 and prevents the attachment of spike protein with the human ACE2 (a cell surface protein) receptor. The Covid-19 treatment is unmodified in the fragment crystallizable (Fc) region.