bamlanivimab (Investigational)

Brand and Other Names:
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

IV solution

  • 700mg/20mL (35mg/mL)

COVID-19 (EUA)

November 9, 2020: 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

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

Dosage Modifications

Renal impairment

  • Mild, moderate, or severe: No dose adjustment required

Hepatic impairment

  • Mild: No dose adjustment required
  • Moderate or severe: Not studied

Pregnancy or lactation

  • No dosage adjustment recommended by the manufacturer

Dosing Considerations

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

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 diease, or other chronic respiratory disease requiring daily medication for control

Dosage Forms & Strengths

IV solution

  • 700mg/20mL (35mg/mL)

COVID-19 (EUA)

November 9, 2020: 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

≥12 years and weight ≥40 kg

  • 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

Dosage Modifications

Renal impairment

  • Mild, moderate, or severe: No dose adjustment required

Hepatic impairment

  • Mild: No dose adjustment required
  • Moderate or severe: Not studied

Dosing Considerations

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

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, or positive-pressure ventilation [not related to COVID-19])
    • Asthma, reactive airway disease, or other chronic respiratory disease requiring daily medication for control
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Adverse Effects

Healthcare providers must submit a report on all medication errors and ALL serious adverse events potentially related to bamlanivimab

1-10%

*Denotes incidence lower than placebo

Nausea (3%)*

Dizziness (3%)

Headache (3%)

Pruritus (2%)

Immediate nonserious hypersensitivity (2%)

Diarrhea (1%)*

Vomiting (1%)*

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Warnings

Contraindications

None

Cautions

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

Drug interaction overview

  • 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
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Pregnancy & Lactation

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

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Recombinant neutralizing human IgG1-kappa monoclonal antibody (mAb) to the spike protein of SARS-CoV-2, and is unmodified in the Fc region

Binds to spike protein with a dissociation constant KD = 0.071 nM and blocks spike protein attachment to human ACE2 receptor with an IC50 value of 0.025 mcg/mL

Pharmacogenomics

Genotypic and phenotypic testing are ongoing to monitor for potential bamlanivimab resistance-associated spike variations in clinical trials

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Administration

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

Storage

Preservative-free product

Unopened vials

  • Refrigerate at 2-8ºC (36-46ºF) in original carton to protect from light
  • Do not freeze, shake, or expose to direct light

Diluted solution

  • Refrigerate at 2-8ºC (36-46ºF) for up to 24 hr OR
  • Store at room temperature 20-25ºC (68-77ºF) for up to 7 hr
  • These storage times include infusion time
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Images

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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.