Skip to main content

Bamlanivimab

Class: Monoclonal Antibodies
- SARS-CoV-2-specific Monoclonal Antibody

Warning

Special Alerts:

Effective April 16, 2021, FDA revoked the emergency use authorization (EUA) for use of bamlanivimab alone (monotherapy) for the treatment of mild to moderate COVID-19. Because of a sustained increase in SARS-CoV-2 viral variants in the US that are resistant to bamlanivimab alone and because testing technologies are not available to enable healthcare providers to test individual COVID-19 patients for SARS-CoV-2 viral variants prior to initiation of SARS-CoV-2-specific monoclonal antibody treatment, there is an increased risk of treatment failure if bamlanivimab is administered alone. Therefore, based on the totality of scientific evidence available, FDA concluded that the known and potential benefits of bamlanivimab alone no longer outweigh the known and potential risks of monotherapy with the drug. The EUA for use of bamlanivimab in a combined regimen with eteseivimab remains unchanged. Healthcare facilities that have existing supplies of bamlanivimab (without etesevimab), should contact the authorized US distributor (AmerisourceBergen) to obtain etesevimab to pair with their supply of bamlanivimab for use under the EUA for bamlanivimab and etesevimab.

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are cautioned that Bamlanivimab is not an approved treatment for coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2, but rather, is being investigated for and is currently available under an FDA emergency use authorization (EUA) for the treatment of mild to moderate COVID-19 in certain outpatients. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to the information contained in the accompanying monograph, and specifically disclaims all such warranties. Readers of this information are advised that ASHP is not responsible for the continued currency of the information, for any errors or omissions, and/or for any consequences arising from the use of the information contained in the monograph in any and all practice settings. Readers are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Introduction

Antiviral; recombinant human IgG1 neutralizing monoclonal antibody specific for SARS-CoV-2 virus.

Uses for Bamlanivimab

Coronavirus Disease 2019 (COVID-19)

Being investigated for and has been used in treatment of COVID-19 caused by SARS-CoV-2. Also being investigated for prevention of COVID-19.

One of several SARS-CoV-2-specific monoclonal antibodies being evaluated for treatment and prevention of COVID-19.

Although efficacy and safety for treatment of COVID-19 not definitely established, bamlanivimab is available under an FDA emergency use authorization (EUA) for treatment of mild to moderate COVID-19 in certain outpatients at risk for progressing to severe COVID-19 and/or hospitalization.

Circulating SARS-CoV-2 viral variants with reduced susceptibility to bamlanivimab reported (see Actions and Spectrum); the drug is no longer being distributed in the US for use alone as monotherapy (see notification at the beginning of this monograph).

On November 9, 2020, FDA issued an EUA that permits use of bamlanivimab for treatment of mild to moderate COVID-19 in adults and pediatric patients ≥12 years of age weighing ≥40 kg with positive results of direct SARS-CoV-2 viral testing who are at high risk for progressing to severe COVID-19 and/or hospitalization. The EUA requires that the drug be administered by a health care provider in an outpatient setting via IV infusion using the dosages recommended in the EUA. (See Dosage and Administration.) The EUA was reissued on February 25, 2021 and March 2, 2021 to incorporate new conditions, including a requirement that the manufacturer establish a process for monitoring genomic databases for emergence of global viral variants of SARS-CoV-2 and, if requested by FDA, assess activity of bamlanivimab against any global SARS-CoV-2 variants of interest.

FDA issued the EUA for bamlanivimab after concluding that emergency use of the drug for treatment of COVID-19 met criteria for issuance of an EUA for the following reasons: SARS-CoV-2 can cause a serious or life-threatening disease or condition, including severe respiratory illness; based on the totality of scientific evidence available to FDA, it is reasonable to believe that bamlanivimab may be effective in treating mild to moderate COVID-19 in adults and pediatric patients ≥12 years of age weighing ≥40 kg who have positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization and, when used under the conditions described in the EUA, known and potential benefits of the drug outweigh known and potential risks; and there are no adequate, approved, and available alternatives to emergency use of bamlanivimab for treatment of COVID-19 in such patients.

The EUA for bamlanivimab defines patients at high risk for progressing to severe COVID-19 and/or hospitalization as those who meet at least one of the following criteria: body mass index (BMI) ≥35, chronic kidney disease, diabetes mellitus, immunosuppressive disease, or immunosuppressive treatment; ≥65 years of age; ≥55 years of age with cardiovascular disease, hypertension, COPD, or other chronic respiratory disease; 12–17 years of age with BMI ≥85th percentile for their age and gender based on CDC growth charts, sickle cell disease, congenital or acquired heart disease, neurodevelopmental disorder such as cerebral palsy, medical-related technological dependence (such as tracheostomy, gastrostomy, or positive-pressure ventilation not related to COVID-19), or asthma, reactive airway disease, or other chronic respiratory disease that requires daily medication for control.

Bamlanivimab is not authorized under the EUA for use in patients who are hospitalized due to COVID-19, require oxygen therapy due to COVID-19, or are on chronic oxygen therapy due to an underlying non-COVID-19-related comorbidity and require an increase in baseline oxygen flow rate due to COVID-19. Benefit not observed when used in patients hospitalized due to COVID-19; SARS-CoV-2-specific monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalized COVID-19 patients requiring high-flow oxygen or mechanical ventilation.

If a patient is hospitalized for reasons other than COVID-19 (e.g., an elective orthopedic procedure) and reports mild to moderate symptoms of COVID-19, confirmed with positive results of a direct SARS-CoV-2 viral test, FDA states that treatment with bamlanivimab may be appropriate if the patient is also at high risk for progressing to severe COVID-19 and/or hospitalization for COVID-19 and terms and conditions of the EUA are met.

The EUA for bamlanivimab authorizes that distribution of the drug will be controlled by the US government for use consistent with the terms and conditions of the EUA. (See Restricted Distribution under Preparations.)

To mitigate risks of this unapproved drug, the EUA includes certain mandatory requirements (including providing information to the patient or parent/caregiver and ensuring that all medication errors and serious adverse events potentially attributable to the drug are reported to FDA).

Consult bamlanivimab EUA letter of authorization, EUA fact sheet for health care providers, and EUA fact sheet for patients, parents, and caregivers for additional information.

Bamlanivimab Dosage and Administration

General

  • Circulating SARS-CoV-2 viral variants with reduced susceptibility to bamlanivimab reported (see Actions and Spectrum); the drug is no longer being distributed in the US for use alone as monotherapy (see notification at the beginning of this monograph).

  • Must be administered to outpatients in a setting in which health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS) as necessary.

  • Must clinically monitor patient during IV infusion of bamlanivimab and observe patient for at least 1 hour after completion of the infusion. (See Sensitivity and Infusion-related Reactions under Cautions.)

  • Advise patients treated with bamlanivimab to continue to self-isolate and use infection control measures (e.g., wear mask, isolate, socially distance, avoid sharing personal items, clean and disinfect “high touch” surfaces, wash hands frequently) according to CDC guidelines.

Administration

IV Administration

Administer only by IV infusion.

For solution and drug compatibility information, see Compatibility under Stability.

Do not administer simultaneously through same IV infusion line with other drugs.

After IV infusion is completed, flush infusion line with 0.9% sodium chloride injection to ensure delivery of entire dose.

Dilution

Solution concentrate (700 mg/20 mL [35 mg/mL]) must be diluted in 0.9% sodium chloride prior to IV infusion.

Remove single-dose vial from refrigerated storage (see Storage under Stability) and allow to equilibrate to room temperature for approximately 20 minutes before preparing dilution for IV infusion.

Should appear as a clear to opalescent and colorless to slightly yellow to slightly brown solution; do not shake vials.

Dilute bamlanivimab solution concentrate in a 50-, 100-, 150-, or 250-mL prefilled, polyvinyl chloride (PVC) or polyethylene (PE)-lined PVC IV infusion bag containing 0.9% sodium chloride injection. Withdraw 20 mL of solution concentrate (700 mg of bamlanivimab) from the vial and transfer into the IV bag containing 0.9% sodium chloride. Gently invert bag by hand approximately 10 times; do not shake.

Administer immediately following dilution. If immediate administration not possible, may store diluted solution for up to 7 hours at room temperature (20–25°C) or for up to 24 hours in a refrigerator (2–8°C), including infusion time. If diluted solution was refrigerated, allow it to equilibrate to room temperature for approximately 20 minutes prior to administration; do not expose to direct heat.

Use a PVC or PE-lined PVC infusion set to administer the diluted bamlanivimab solution. Use of an inline or add-on 0.2- or 0.22-µm polyethersulfone (PES) filter is strongly recommended.

Closed system transfer devices (CSTDs), elastomeric pumps, and pneumatic transport not evaluated for use with bamlanivimab.

Contains no preservatives; discard any unused solution concentrate or diluted solution of the drug. If the IV infusion is discontinued because of an infusion reaction (see Sensitivity and Infusion-related Reactions under Cautions), discard any unused portion.

Rate of Administration

Depending on size of prefilled IV infusion bag used to prepare diluted bamlanivimab solution, administer by IV infusion over at least 16–60 minutes via pump or gravity. (See Table 1.)

Table 1. Recommended IV Infusion Rate of Bamlanivimab (700 mg Diluted in 0.9% Sodium Chloride) in Adults and Pediatric Patients ≥12 Years of Age Weighing ≥40 kg1

Size of IV Infusion Bag Prefilled with 0.9% Sodium Chloride Used to Prepared the Dilution

Maximum Infusion Rate

Minimum Infusion Time

50 mL

270 mL/hr

16 minutes

100 mL

270 mL/hr

27 minutes

150 mL

270 mL/hr

38 minutes

250 mL

270 mL/hr

60 minutes

Dosage

Pediatric Patients

Coronavirus Disease 2019† (COVID-19)
Outpatients with Mild to Moderate COVID-19†
IV

FDA EUA that permits use for treatment of mild to moderate disease (see Coronavirus Disease 2019 [COVID-19] under Uses) states that pediatric patients ≥12 years of age weighing ≥40 kg who are outpatients at high risk for progressing to severe COVID-19 and/or hospitalization should receive a single dose of 700 mg. Administer as soon as possible after positive viral test for SARS-CoV-2 and within 10 days of symptom onset.

Adults

Coronavirus Disease 2019† (COVID-19)
Outpatients with Mild to Moderate COVID-19†
IV

FDA EUA that permits use for treatment of mild to moderate disease (see Coronavirus Disease 2019 [COVID-19] under Uses) states that adults who are outpatients at high risk for progressing to severe COVID-19 and/or hospitalization should receive a single dose of 700 mg. Administer as soon as possible after positive viral test for SARS-CoV-2 and within 10 days of symptom onset.

Prescribing Limits

Pediatric Patients

Coronavirus Disease 2019† (COVID-19)
IV

Single dose.

Adults

Coronavirus Disease 2019† (COVID-19)
IV

Single dose.

Special Populations

Hepatic Impairment

Mild hepatic impairment: Dosage adjustment not needed.

Moderate or severe hepatic impairment: Not studied.

Renal Impairment

Dosage adjustment not needed.

Geriatric Patients

Dosage adjustment not needed.

Cautions for Bamlanivimab

Contraindications

  • None.

  • Must not use in patients with known hypersensitivity to any ingredient in the preparation. (See Sensitivity and Infusion-related Reactions under Cautions.)

Warnings/Precautions

Sensitivity and Infusion-related Reactions

Serious hypersensitivity reactions, including anaphylaxis, reported. Nonserious immediate hypersensitivity events (e.g., mild pruritus or flushing, moderate facial swelling) reported in an ongoing clinical trial.

Infusion-related reactions reported; such reactions may be severe or life-threatening. Signs and symptoms of infusion-related reactions may include fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmias (e.g., atrial fibrillation, sinus tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash (including urticaria), pruritus, myalgia, dizziness, or diaphoresis.

At least one case of anaphylaxis and other cases of serious infusion-related reactions reported in ongoing clinical trials; bamlanivimab infusion was stopped and the reactions resolved after appropriate treatment. All such reactions required treatment, including use of epinephrine in at least one patient.

If signs and symptoms of anaphylaxis or other clinically important hypersensitivity reaction occur, immediately discontinue bamlanivimab IV infusion and initiate appropriate medications and/or supportive care.

If an infusion-related reaction occurs, slow or stop bamlanivimab IV infusion and initiate appropriate medications and/or supportive care.

Clinical Worsening after Bamlanivimab Administration

Clinical worsening of COVID-19, including signs or symptoms of fever, hypoxia or increased respiratory difficulty, arrhythmias (e.g., atrial fibrillation, sinus tachycardia, bradycardia), fatigue, and altered mental status, reported following administration of bamlanivimab; hospitalization required in some cases. It is not known if these events were related to the drug or occurred because of progression of COVID-19.

Limitations of Benefit and Potential for Risk in Patients with Severe COVID-19

Not authorized for use under the EUA in patients who are hospitalized due to COVID-19, require oxygen therapy due to COVID-19, or are on chronic oxygen therapy due to an underlying non-COVID-19-related comorbidity and require an increase in baseline oxygen flow rate due to COVID-19.

Benefit not observed when used in patients hospitalized due to COVID-19. SARS-CoV-2-specific monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalized COVID-19 patients requiring high-flow oxygen or mechanical ventilation.

EUA Requirements for Patient Monitoring and Mandatory FDA MedWatch Reporting

Safety and efficacy not established. FDA issued an EUA that permits use of bamlanivimab for treatment of coronavirus disease 2019 (COVID-19) in certain adults and pediatric patients with mild to moderate COVID-19 in an outpatient setting via IV infusion using the dosages recommended in the EUA. (see Coronavirus Disease 2019 [COVID-19] under Uses)

Only limited data available to date regarding adverse effects associated with use of bamlanivimab. Serious and unexpected adverse events may occur that have not been previously reported with the drug.

Completion of FDA MedWatch forms to report all medication errors and all serious adverse events potentially related to bamlanivimab is mandatory. Consult FDA fact sheet for health care providers that is provided with the drug and available at FDA website for requirements and instructions regarding reporting of adverse reactions and medication errors.

Specific Populations

Pregnancy

Data insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Estimated background risk of major birth defects and miscarriage related to COVID-19 unknown.

Use during pregnancy only if potential benefit outweighs potential risk for the woman and fetus. Dosage adjustment not recommended if used in pregnant women.

NIH panel states do not withhold SARS-CoV-2-specific monoclonal antibody therapy from a pregnant woman who has a condition that poses a high risk of progression to severe COVID-19 if clinician thinks potential benefit of the drug outweighs potential risk.

Nonclinical reproductive toxicity studies not performed. In a tissue cross-reactivity study with bamlanivimab using human fetal tissues, no binding of clinical concern was detected. Human IgG1 antibodies are known to cross the placenta; therefore, bamlanivimab has potential to be transferred from the pregnant woman to developing fetus. Not known whether such potential placental transfer provides any treatment benefit or risk to the developing fetus.

Lactation

Not known whether bamlanivimab distributes into human or animal milk, has effects on breast-fed infant, or affects milk production. Maternal IgG is known to be present in human milk.

Consider the developmental and health benefits of breast-feeding along with the mother’s clinical need for bamlanivimab and any potential adverse effects on the breast-fed child from the drug or from the underlying maternal condition. Women with COVID-19 who are breast-feeding should follow clinical guidelines to avoid exposing the infant to the virus.

Pediatric Use

Safety and efficacy not assessed in pediatric patients. FDA EUA permits use of bamlanivimab for treatment of mild to moderate COVID-19 in certain pediatric patients ≥12 years of age weighing ≥40 kg (see Coronavirus Disease 2019 [COVID-19] under Uses). Use not authorized for patients weighing <40 kg.

The EUA-recommended dosage is expected to result in serum exposures of the drug in patients ≥12 years of age weighing ≥40 kg that are comparable to those observed in adults, based on a pharmacokinetic modeling approach accounting for effects of age-associated body weight changes on clearance and volume of distribution.

Geriatric Use

At the time of an interim analysis of an ongoing trial evaluating bamlanivimab for treatment of mild to moderate COVID-19 in outpatients (BLAZE-1), 11% of patients treated with bamlanivimab were ≥65 years of age and 3% were ≥75 years of age. Based on population pharmacokinetic analyses, there is no difference in pharmacokinetics of the drug in geriatric patients compared with younger patients.

Hepatic Impairment

Mild hepatic impairment: Based on a population pharmacokinetic analysis, bamlanivimab clearance is approximately 20% higher than that in patients with normal hepatic function. This effect is statistically significant, but not clinically meaningful.

Moderate or severe hepatic impairment: Not studied.

Renal Impairment

Not expected to affect bamlanivimab exposure; drug not eliminated by renal excretion.

Common Adverse Effects

Based on data from interim analysis of ongoing study in outpatients with mild to moderate COVID-19 (BLAZE-1), most frequent adverse effects reported with single 700-mg dose were nausea (3%), dizziness (3%), headache (3%). Adverse effects reported in 23% of patients who received bamlanivimab (single 700-mg, 2.8-g, or 7-g dose) and 26% of those who received placebo.

Interactions for Bamlanivimab

Not metabolized by CYP isoenzymes and not renally excreted; interactions unlikely if used concomitantly with drugs that are substrates, inducers, or inhibitors of CYP isoenzymes or with drugs that are renally excreted.

Specific Drugs

Drug

Interaction

Comments

COVID-19 vaccines

Data not available; not known whether prior receipt of SARS-CoV-2-specific antibody therapy (e.g., bamlanivimab) interferes with immune response to COVID-19 vaccines

To avoid potential interference with vaccine immune response, CDC's Advisory Committee on Immunization Practices (ACIP) recommends deferring COVID-19 vaccination for ≥90 days after such antibody therapy based on estimated half-life of SARS-CoV-2 antibody therapies and evidence suggesting SARS-CoV-2 reinfection uncommon in first 90 days after initial infection

If COVID-19 subsequently develops in a vaccinated individual, ACIP states prior receipt of COVID-19 vaccine should not affect treatment decisions, including use of SARS-CoV-2-specific antibody therapies, or timing of such treatment

Bamlanivimab Pharmacokinetics

Absorption

Plasma Concentrations

Pharmacokinetic profile is linear and dose proportional following IV infusion of single doses ranging from 700 mg to 7 g.

No differences in pharmacokinetics between ambulatory patients with moderate to mild disease COVID-19 and hospitalized patients with moderate to severe COVID-19.

In a phase 2 trial evaluating bamlanivimab doses of 700 mg to 7 g (up to 10 times higher than recommended dose) in patients with mild to moderate COVID-19, a flat exposure-response relationship for efficacy was identified based on viral load and clinical outcomes.

Following single 700-mg bamlanivimab dose given by IV infusion over 1 hour, mean peak concentration was 196 mcg/mL; the drug was quantifiable for at least 29 days (mean concentration 22 mcg/mL on day 29).

Distribution

Extent

Not known whether distributed into human or animal milk.

Elimination

Metabolism

Expected to be degraded into small peptides and component amino acids in a similar manner as endogenous IgG antibodies.

Not metabolized by CYP isoenzymes.

Elimination Route

Not eliminated by renal excretion.

Half-life

Mean apparent elimination half-life: 17.6 days.

Special Populations

Pediatric patients: Pharmacokinetics not evaluated. Based on pharmacokinetic modeling approach accounting for effects of age-associated body weight changes on clearance and volume of distribution, EUA-recommended dosage is expected to result in serum exposures in patients ≥12 years of age weighing ≥40 kg comparable to those in adults.

Hepatic impairment: Mild hepatic impairment not expected to have clinically meaningful effect on bamlanivimab clearance; moderate or severe hepatic impairment not studied.

Renal impairment: Not expected to affect bamlanivimab exposure.

Based on a population pharmacokinetic analysis, pharmacokinetics not affected by age, sex, race, or disease severity or inflammation. In adults with COVID-19, body weight over range of 41–173 kg had no clinically relevant effect on pharmacokinetics of the drug.

Stability

Storage

Parenteral

Solution Concentrate for Injection, for IV Infusion

Single-dose vials of solution concentrate (700 mg/20 mL [35 mg/mL]): Refrigerate (2–8°C); store in original carton to protect from light. Do not freeze, shake, or expose to direct heat.

Diluted solution: If immediate administration not possible, may store in a refrigerator (2–8°C) for up to 24 hours or at room temperature (20–25°C) for up to 7 hours, including infusion time.

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility1

Compatible

Sodium chloride 0.9%

Actions and Spectrum

  • SARS-CoV-2-specific recombinant human monoclonal antibody; produced using a Chinese hamster ovary (CHO) cell line.

  • Binds to spike protein of SARS-CoV-2; blocks attachment of the spike protein to the human angiotensin-converting enzyme 2 (ACE2) receptor, thereby preventing the virus from entering cells and inhibiting viral replication.

  • Neutralizing activity against SARS-CoV-2 demonstrated in vitro in Vero E6 cells. In a dose-response model quantifying plaque reduction using cultured Vero E6 cells, bamlanivimab neutralized the USA/WA/1/2020 isolate of SARS-CoV-2 with an estimated 50% effective concentration (EC50) of 0.02 mcg/mL.

  • In female Rhesus macaques, single IV dose administered for prophylaxis 24 hours prior to SARS-CoV-2 inoculation resulted in up to a 4 log10 decrease in viral load (genomic RNA) and viral replication (subgenomic RNA) in bronchoalveolar lavage samples compared with control animals, but had less effect on viral RNA in throat and nasal swabs. Applicability of these findings to prophylaxis or treatment in humans not known.

  • There is a potential risk of treatment failure due to development of viral variants resistant to bamlanivimab.

  • In vitro studies using serial passage of SARS-CoV-2 and directed evolution of the spike protein identified amino acid substitutions in the spike protein receptor-binding domain (E484D/K/Q, F490S, Q493R, and S494P) that resulted in reduced susceptibility to bamlanivimab as determined in neutralization assays using SARS-CoV-2 and/or vesicular stomatitis virus-based pseudovirus.

  • Genotypic and phenotypic testing is ongoing to monitor for potential bamlanivimab resistance-associated spike variations in clinical trials. Known bamlanivimab-resistant variants at baseline observed at a frequency of 0.27% (1/375) in initial phase of a clinical trial evaluating bamlanivimab for treatment of mild to moderate COVID-19 in outpatients (BLAZE-1). In the same trial, treatment-emergent variants were detected at spike protein amino acid positions E484, F490, and S494, and included E484A/D/G/K/Q/V, F490L/S/V, and S494L/P; only E484K/Q, F490S, and S494P have been assessed phenotypically to date. Clinical relevance of these findings not known.

  • Studies ongoing to evaluate various currently circulating SARS-CoV-2 variants for potential resistance to SARS-CoV-2-specific monoclonal antibodies, including bamlanivimab. Pseudovirus harboring the E484K substitution exhibited >2360-fold reduced susceptibility to bamlanivimab; this substitution found in several lineages, including B.1.351 (South Africa origin), P.1 (Brazil origin), and B.1.526 (New York origin). Pseudovirus with the spike protein and concurrent spike substitutions present in South African B.1.351 origin variant lineage (K417N + E484K + N501Y) and Brazil origin P.1 variant lineage (K417T + E484K + N501Y) exhibited reduced susceptibility to bamlanivimab. Pseudovirus harboring L452R and spike protein from California origin variant lineage B.1.427/B.1.429 exhibited >1020-fold reduced susceptibility to bamlanivimab. Bamlanivimab retained activity (<5-fold reduction in susceptibility) against pseudovirus expressing del69-70 + N501Y spike substitutions found in B.1.1.7 variant (UK origin).

  • Not known how pseudovirus data correlate with clinical outcomes; however, bamlanivimab used alone unlikely to be active if there is >1000-fold reduction in susceptibility to the drug.

  • Although clinical impact not known, bamlanivimab resistance-associated variants could have cross-resistance to other SARS-COV-2-specific monoclonal antibodies that target the receptor-binding domain of the virus.

Advice to Patients

  • The Fact Sheet for Patients, Parents, and Caregivers: Emergency Use Authorization (EUA) of Bamlanivimab for Coronavirus Disease 2019 (COVID-19) must be provided to patients or parent/caregivers prior to administration of bamlanivimab.

  • Inform patients or parent/caregivers that FDA authorized the emergency use of bamlanivimab, which is an investigational drug that has not received FDA approval, for use in certain adults and pediatric patients with mild to moderate COVID-19 who are outpatients and at risk for progressing to severe COVID-19 and/or hospitalization.

  • Inform patients or parent/caregivers that they have the option to accept or refuse bamlanivimab.

  • Provide patients or parent/caregivers with information on available alternative treatments and the risks and benefits of those alternatives, including clinical trials.

  • Inform patients or parent/caregivers about the significant known and potential risks and benefits of bamlanivimab, and the extent to which such risks and benefits are unknown.

  • Importance of informing clinicians of any history of allergies or serious illnesses.

  • Importance of immediately reporting any allergic reactions that occur during or after receiving bamlanivimab (e.g., fever, chills, nausea, headache, shortness of breath, low or high BP, rapid or slow heart rate, chest discomfort or pain, weakness, confusion, tiredness, wheezing, rash including urticaria, pruritus, muscle aches, dizziness, sweating, swelling of the lips, face, or throat) and reporting any new or worsening COVID-19 symptoms (e.g., fever, difficulty breathing, rapid or slow heart rate, tiredness, weakness, confusion) to clinicians.

  • Advise patients treated with bamlanivimab that they should continue to self-isolate and use infection control measures (e.g., wear mask, isolate, socially distance, avoid sharing personal items, clean and disinfect “high touch” surfaces, and wash hands frequently) according to CDC guidelines.

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal supplements.

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Effective April 16, 2021, FDA revoked the EUA for use of bamlanivimab alone (monotherapy) for the treatment of mild to moderate COVID-19. Bamlanivimab is available under an FDA EUA for use in a combined regimen with etesevimab for the treatment of COVID-19. Healthcare facilities that have existing supplies of bamlanivimab (without etesevimab), should contact the authorized US distributor (AmerisourceBergen) to obtain etesevimab to pair with their supply of bamlanivimab for use under the EUA for bamlanivimab and etesevimab.

Bamlanivimab

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Concentrate for injection, for IV infusion only

700 mg/20 mL (35 mg/mL)

Bamlanivimab

Lilly

AHFS DI Essentials™. © Copyright 2022, Selected Revisions April 19, 2021. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

Show article references