Version May 2024
COVID-19, mild to moderate (off-label use):
Note: Due to concerns of decreased susceptibility among SARS-CoV-2 variants, the FDA revoked the emergency use authorization (EUA) for bamlanivimab monotherapy in the United States effective April 16, 2021 (Ref). However, bamlanivimab may still be available in Canada. Reserve for patients with positive SARS-CoV-2 direct viral testing who are at high risk for progression to severe disease or hospitalization; refer to Canadian product monograph for more information on patients at high risk for progression to severe disease. Use is not authorized for patients who are hospitalized or require new or increased oxygen therapy due to COVID-19; outcomes may be worse if used in patients requiring high-flow oxygen or mechanical ventilation. Consider local prevalence of SARS-CoV-2 variants when evaluating treatment options.
IV: Weight ≥40 kg: 700 mg as a single dose; administer as soon as possible after a positive SARS-CoV-2 test and within 10 days of symptom onset.
There are no dosage adjustments provided (has not been studied); however, renal impairment is not expected to affect the exposure of bamlanivimab.
There are no dosage adjustments provided (has not been studied).
Refer to adult dosing.
(For additional information see "Bamlanivimab (United States: Authorization withdrawn): Pediatric drug information")
COVID-19, mild to moderate:
Note: Due to concerns of decreased susceptibility among SARS-CoV-2 variants, the FDA revoked the emergency use authorization (EUA) for bamlanivimab monotherapy in the United States effective April 16, 2021 (Ref). Circulating SARS-CoV-2 variants may be associated with resistance to bamlanivimab; there is a potential risk of treatment failure. Bamlanivimab is only for use in patients who are at high-risk of progression to severe disease or hospitalization; refer to Canadian product monograph for more information on patients at high risk for progression to severe disease. Bamlanivimab should NOT be used in patients who are hospitalized due to severe COVID-19 respiratory disease or in patients with COVID-19 requiring high flow oxygen or mechanical ventilation.
Health Canada interim order: Children ≥12 years and Adolescents weighing ≥40 kg: IV: 700 mg as a single dose; administer as soon as possible after a positive SARS-CoV-2 test and within 10 days of symptom onset. Note: Bamlanivimab has not been studied in pediatric patients; Health Canada's interim order for use in pediatric patients ≥12 years of age weighing ≥40 kg is based on likelihood of exposures similar to adults.
There are no dosage adjustments provided (has not been studied); however, renal impairment is not expected to affect bamlanivimab exposure.
There are no dosage adjustments provided (has not been studied).
Hypersensitivity reactions, including anaphylaxis, and infusion related reactions, have been reported with bamlanivimab. Patients may experience altered mental status, angioedema, asthenia, bronchospasm, cardiac arrhythmia (including atrial fibrillation, sinus tachycardia, bradycardia), chest pain or discomfort, chills, diaphoresis, dizziness, dyspnea, fatigue, fever, headache, hypertension, hypotension, myalgia, nausea, pruritus, rash (including urticaria), reduced oxygen saturation, and throat irritation with infusion related reactions, but most reactions were mild in severity (Ref). Slower infusion rates may be considered. All reactions were reversible; severe reactions required discontinuation and treatment (Ref).
Onset: Rapid; most infusion related reactions occurred during infusion (Ref).
The following adverse drug reactions and incidences are derived from the original FDA issued emergency use authorization (EUA) (FDA 2021a). However, the FDA revoked the EUA for bamlanivimab monotherapy in the United States effective April 16, 2021 (FDA 2021b).
1% to 10%:
Dermatologic: Pruritus (2%) (table 1)
|
Drug (Bamlanivimab) |
Placebo |
Population |
Dose |
Indication |
Number of Patients (Bamlanivimab) |
Number of Patients (Placebo) |
Source |
|---|---|---|---|---|---|---|---|
|
2% |
1% |
Adults |
700 mg |
COVID-19, mild to moderate |
101 |
156 |
FDA 2021a |
Hypersensitivity: Hypersensitivity reaction (2%; including type 1 hypersensitivity reaction, flushing, and facial swelling) (table 2)
|
Drug (Bamlanivimab) |
Placebo |
Population |
Indication |
Number of Patients (Bamlanivimab) |
Number of Patients (Placebo) |
Source |
|---|---|---|---|---|---|---|
|
2% |
1% |
Adults |
COVID-19, mild to moderate |
309 |
156 |
FDA 2021a |
Nervous system: Dizziness (3%) (table 3), headache (3%) (table 4)
|
Drug (Bamlanivimab) |
Placebo |
Population |
Dose |
Indication |
Number of Patients (Bamlanivimab) |
Number of Patients (Placebo) |
Source |
|---|---|---|---|---|---|---|---|
|
3% |
2% |
Adults |
700 mg |
COVID-19, mild to moderate |
101 |
156 |
FDA 2021a |
|
Drug (Bamlanivimab) |
Placebo |
Population |
Dose |
Indication |
Number of Patients (Bamlanivimab) |
Number of Patients (Placebo) |
Source |
|---|---|---|---|---|---|---|---|
|
3% |
2% |
Adults |
700 mg |
COVID-19, mild to moderate |
101 |
156 |
FDA 2021a |
Frequency not defined:
Hypersensitivity: Anaphylaxis
Miscellaneous: Infusion related reaction (including severe infusion related reaction)
Hypersensitivity to bamlanivimab or any component of the formulation or container.
Other warnings/precautions:
• Antiviral resistance: Development of SARS-CoV-2 variants that are resistant to bamlanivimab may increase risk of treatment failure; use of bamlanivimab alone should only be considered if other monoclonal antibodies that retain neutralization activity against prevalent variants are not available.
• Clinical worsening: Clinical worsening of COVID-19, including signs or symptoms of altered mental status, arrhythmia (atrial fibrillation, bradycardia, tachycardia), fatigue, fever, hypoxia, or increased respiratory difficulty, has been reported in the 24 hours after administration of bamlanivimab; some of these events required hospitalization. It is not known if these events were related to bamlanivimab.
• Limitations of use: Bamlanivimab is not authorized for use in patients who are hospitalized due to COVID-19, require oxygen therapy due to COVID-19, or 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. Benefit of treatment has not been observed in patients hospitalized due to COVID-19 (Lundgren 2020). Monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen therapy or mechanical ventilation.
Investigational agent; approved under interim authorization by Health Canada November 2020.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, Intravenous [preservative free]:
Generic: Bamlanivimab 700 mg/20 mL (20 mL [DSC])
Yes
Solution (Bamlanivimab Intravenous)
700 mg/20 mL (per mL): $0.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, Intravenous:
Generic: Bamlanivimab 700 mg/20 mL ([DSC])
The distribution of bamlanivimab alone has stopped as of March 24, 2021 in response to the sustained increase in SARS-CoV-2 viral variants in the United States that are resistant to bamlanivimab administered alone as well as the availability of other authorized monoclonal antibody therapies that are expected to retain activity to these variants. All treatment delivery sites will continue to be able to order bamlanivimab and etesevimab, to be administered together, from the authorized distributer following existing ordering and reporting procedures. Additionally, sites can order etesevimab alone to pair with the current supply of bamlanivimab the site has available. Sites of care can submit requests for etesevimab directly to AmerisourceBergen via C19 Therapies Direct Order Request (http://www.smartsheet.com); for more information visit: https://app.smartsheet.com/b/form/255d164d67834793b4ab549e160941e8.
IV: Must be diluted prior to administration. If diluted solution is refrigerated following preparation, allow solution to come to room temperature (~20 minutes) prior to administration. Administer as an IV infusion over ≥60 minutes. Administer through a PVC or polyethylene-lined PVC infusion set containing a 0.2 or 0.22 micron in-line polyethersulfone filter. Slow or stop infusion and treat as appropriate if an infusion-related reaction occurs. Flush infusion line with NS following completion of infusion.
Parenteral: IV: Must be diluted prior to administration. If diluted solution is refrigerated following preparation, allow solution to come to room temperature (~20 minutes) prior to administration. Administer as an IV infusion over ≥60 minutes. Administer through a PVC or polyethylene-lined PVC infusion set containing a 0.2 or 0.22 micron in-line or add-on polyethersulfone filter. Entire infusion solution in the bag should be administered; flush line with NS following completion of infusion to ensure entire dose is administered. Slow or interrupt infusion and treat as appropriate if the patient develops any signs of infusion-related reaction (eg, urticaria, pruritus, rash, swelling of the face, chest discomfort); if severe or life-threatening hypersensitivity reactions occur, immediately discontinue infusion and initiate appropriate medications and/or supportive care.
See Off-label uses.
COVID-19, mild to moderate
Bamlanivimab may be confused with belimumab
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
The emergency use authorization for bamlanivimab monotherapy in the United States has been revoked (FDA 2021b). The original bamlanivimab clinical trials required male and female patients of reproductive potential to use effective contraception during the study (Gottlieb 2021).
The emergency use authorization for bamlanivimab monotherapy in the United States has been revoked (FDA 2021b). Nonclinical reproductive toxicity studies have not been conducted (FDA 2021a).
Bamlanivimab is a humanized monoclonal antibody (IgG1). Human IgG crosses the placenta. Fetal exposure is dependent upon the IgG subclass, maternal serum concentrations, placental integrity, newborn birth weight, and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis and the highest during the third trimester (Clements 2020; Palmeira 2012; Pentsuk 2009). The potential benefits or risks of in utero exposure to bamlanivimab to the fetus are not known (FDA 2021a).
The risk of severe illness from COVID-19 infection is increased in symptomatic pregnant patients compared to nonpregnant patients. Pregnant and recently pregnant patients with moderate or severe infection are at increased risk of complications such as hypertensive disorders of pregnancy, postpartum hemorrhage, or other infections compared to pregnant patients without COVID. Symptomatic pregnant patients may require ICU admission, mechanical ventilation, or ventilatory support (ECMO) compared to symptomatic nonpregnant patients. Other adverse pregnancy outcomes include preterm birth and stillbirth. The risk of coagulopathy, cesarean delivery, and maternal death may be increased; neonates have an increased risk for NICU admission. Maternal age and comorbidities such as diabetes, hypertension, lung disease, and obesity may also increase the risk of severe illness in pregnant and recently pregnant patients (ACOG 2023; NIH 2022).
The original clinical trials of bamlanivimab did not include persons who were pregnant (Gottlieb 2021). Information related to the treatment of COVID-19 during pregnancy continues to emerge; refer to current guidelines for the treatment of pregnant patients.
Data collection to monitor maternal and infant outcomes following exposure to COVID-19 during pregnancy is ongoing. Health care providers are encouraged to enroll patients exposed to COVID-19 during pregnancy in the Organization of Teratology Information Specialists pregnancy registry (1-877-311-8972; https://mothertobaby.org/join-study/).
It is not known if bamlanivimab is present in breast milk.
Bamlanivimab is a humanized monoclonal antibody (IgG1). Human IgG is present in breast milk; concentrations are dependent upon IgG subclass and postpartum age (Anderson 2021).
The original bamlanivimab clinical trials did not include patients who were breastfeeding (Gottlieb 2021). The emergency use authorization for bamlanivimab monotherapy in the United States has been revoked (FDA 2021b).
Information related to COVID-19 and breastfeeding is available from the World Health Organization (https://www.who.int/news/item/28-04-2020-new-faqs-address-healthcare-workers-questions-on-breastfeeding-and-covid-19).
Monitor for infusion-related reactions (eg, fever, chills, hypotension, rash, pruritus) and hypersensitivity/anaphylaxis during and after infusion.
Bamlanivimab is a recombinant neutralizing human IgG1k monoclonal antibody to the spike protein of SARS-CoV-2. Bamlanivimab binds to the spike protein, blocking attachment to the human ACE2 receptor.
Pediatric: Clinical trials have not been performed; serum exposures in patients ≥12 years of age and weighing ≥40 kg are expected to be similar to those observed in adults based on pharmacokinetic modeling.
آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟
