Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. All rights reserved. with positive results of direct SARS-CoV-2 viral testing. Bebtelovimab is clear to opalescent and colorless to slightly yellow to slightly brown solution. Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP). - 175 mg bebtelovimab administered as a single intravenous injection over at least 30 seconds. The Florida Department of Health COVID-19 Response Map has been updated to make it easier to find testing, vaccine and treatment sites across the state. Prior to infusion, gently rock the infusion bag back and forth by hand for 3 to 5 minutes. only, includes infusion and post administration monitoring, second dose (Effective 6/24/2021) Q. Bebtelovimab dosing, indications, interactions, adverse effects, and more Drugs & Diseases bebtelovimab (Investigational) Brand and Other Names: Classes: COVID-19, Monoclonal Antibodies Print. Drug Safety and Availability, Recalls, Market Withdrawals and Safety Alerts, Information about Nitrosamine Impurities in Medications, Food and Drug Administration Overdose Prevention Framework, Medication Errors Related to CDER-Regulated Drug Products, Postmarket Drug Safety Information for Patients and Providers, Risk Evaluation and Mitigation Strategies | REMS, Multistate outbreak of fungal meningitis and other infections, Health Care Provider Fact Sheet for bebtelovimab. The new infusion provides an . 1 disposable polypropylene dosing syringe capable of holding 2 mL. Clinical Worsening After Monoclonal Antibody Administration. FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region. These therapies require a prescription by a licensed and authorized provider. Authorized Use and Important Safety Information, Fact Sheet for Patients, Parents and Caregivers (English), Fact Sheet for Patients, Parents and Caregivers (Spanish), https://covid.cdc.gov/covid-data-tracker/#variant-proportions, https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs, Fact Sheet for Patients, Parents and Caregivers, https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html. Emergency Use Authorization (EUA) of bebtelovimab. Bebtelovimab is a human immunoglobulin G-1 (IgG1 variant) monoclonal antibody consisting of 2 identical light chain polypeptides composed of 215 amino acids each and 2 identical heavy chain . Bebtelovimab is a medication that the FDA is allowing to be given for emergency use to treat COVID-19. Exceptions for weekly dose quantities beyond 270 will be evaluated on a case-by-case basis. Limitations of Benefit and Potential Risk in Patients with Severe COVID-19. If used, attach and prime the syringe extension set. Monoclonal antibodies, such as bebtelovimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation. If pregnant or breastfeeding, discuss your options and specific situation with your healthcare provider. Monoclonal antibodies, such as bebtelovimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation. It was evaluated alone and together with bamlanivimab and etesevimab in, Because there are other therapeutic options available, a placebo control could not be used to treat high-risk patients.1. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. Fact Sheet for Patients, Parents and Caregivers (English), Download require an increase in baseline oxygen flow rate and/or respiratory support due to COVID19 and are on chronic oxygen therapy and/or respiratory support due to underlying non-COVID-19 related comorbidity. 1,2, BLAZE-4 is a phase 2, randomized, single-dose clinical trial evaluating treatment of non-hospitalized patients with mild-to-moderate COVID-19.1, Bebtelovimab was among the treatment interventions studied in BLAZE-4. New Treatment, Vaccine and Testing Locator Map. The .gov means its official.Federal government websites often end in .gov or .mil. Bebtelovimab did not undergo the same type of review as an FDA-approved product. Observe patient for at least 1 hour after injection. Add Resources to Your . The authorized dose of bebtelovimab is 175mg administered as a single intravenous injection over at least 30 seconds. eCollection 2022 Aug. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. In low-risk patients, treatment arms included, bebtelovimab 175mg alone, added to normal saline (total dose volume 62.5 mL) administered via IV infusion over at least 6.5 minutes, OR, bebtelovimab 175mg, bamlanivimab 700 mg and etesevimab 1400 mg administered together (total dose volume 62.5 mL) via IV infusion over at least 6.5 minutes, OR. Clinical worsening of COVID-19 after administration of SARS-CoV-2 monoclonal antibody treatment has been reported and may include signs or symptoms of fever, hypoxia or increased respiratory difficulty, arrhythmia (e.g., atrial fibrillation, sinus tachycardia, bradycardia), fatigue, and altered mental status. Bebtelovimab is authorized for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and. FDA will continue to provide timely and transparent communication regarding the monoclonal antibody therapies that are currently authorized for emergency use in response to the COVID-19 pandemic. Lagevrio is authorized for the treatment of mild-to-moderate COVID-19 in adults with positive results of direct SARS-CoV-2 viral testing who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. These reactions may be severe or life-threatening. All of the risks are not known at this time. There are limited clinical data available for bebtelovimab. They have a positive COVID-19 test result; They're at high-risk for progression to severe COVID-19; Alternative COVID-19 treatment options approved or authorized by the FDA aren't accessible or . Report side effects to FDA MedWatch at www.fda.gov/medwatch, or call 1-800-FDA-1088 or call Eli Lilly and Company, Inc. 1-855-LillyC19 (1-855-545-5921). This website also contains material copyrighted by 3rd parties. for whom other COVID-19 treatment options approved or authorized by FDA are not available or clinically appropriate. Fact Sheet for Healthcare Providers, Download Withdraw 2 mL of bebtelovimab (1 vial) into disposable syringe. What procedure codes should be used to bill for the injection of a COVID-19 antiviral drug? Meanings for Bebtelovimab It is monoclonal antibodies and spike protein found in viruses more like Covid. The treatment showed efficacy against early strains of Omicron, but it proved to be ineffective against Omicron sublineages BQ.1 and BQ.1.1. Signs and symptoms of infusion-related reactions may include: Administer appropriate medications and/or supportive care if an infusion-related reaction occurs. Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of other SARS-CoV-2 monoclonal antibodies and could occur with administration of bebtelovimab. Bebtelovimab is not FDA-approved for any use, including for use as treatment of COVID-19. Signs and symptoms of infusion-related reactions may include: for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. The new monoclonal antibody treatment, bebtelovimab, is manufactured by Eli Lilly and Company, and if it receives emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA), HHS will make the treatment available to states free of charge. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. PP-BB-US-0005 11/2022 High risk for progression to severe COVID-19, including hospitalization or death, Other COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate, Any severity or dialysis: No dosage adjustment recommended, Not expected to impact bebtelovimab pharmacokinetics, since monoclonal antibodies (mAbs) with molecular weight >69 kDa are known not to undergo renal elimination, For use in geographic regions where infection is likely to have been caused by a nonsusceptible SARS-CoV-2 variant based on available information including variant susceptibility, For patients who require oxygen therapy and/or respiratory support due to COVID-19, For patients who require increase in baseline oxygen flow rate and/or respiratory support due to COVID-19 and are on chronic oxygen therapy and/or respiratory support owing to underlying non-COVID-19related comorbidity, Obesity/overweight (body mass index [BMI] 25 kg/m2 [adults]; BMI 85th percentile for age/sex based on CDC growth charts [if aged 12-17 years]), Immunosuppressive disease or immunosuppressive treatment, Cardiovascular disease (including congenital heart disease) or hypertension, Chronic lung diseases (eg, chronic obstructive pulmonary disease [COPD], moderate-to-severe asthma, interstitial lung disease, cystic fibrosis, pulmonary hypertension), Neurodevelopmental disorders (eg, cerebral palsy) or other conditions that confer medical complexity (eg, genetic or metabolic syndromes, severe congenital anomalies), Having a medical-related technological dependence (eg, tracheostomy, gastrostomy, positive-pressure ventilation [not related to COVID 19]), EUA is not limited to the medical conditions or factors listed above; for additional information on medical conditions and factors associated with increased risk for progression to severe COVID, see the, 12 years (weight 40 kg): 175 mg as a single IV injection over at least 30 seconds, Serious hypersensitivity reaction, including anaphylaxis, observed with other COVID-19 mAbs, and may occur with bebtelovimab, Hypersensitivity reactions occurring >24 hr after infusion observed with bebtelovimab when administered with other mAbs, Infusion-related reactions may be severe or life-threatening, If signs and symptoms occur, immediately discontinue IV infusion, and initiate appropriate medications and/or supportive care, Infusion-related reactions reported, including fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (eg, 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, vasovagal reactions, dizziness, and diaphoresis, Administer appropriate medication/supportive care if infusion-related reactions occurs, Clinical worsening of COVID-19 after administration reported; signs or symptoms may include fever, hypoxia or increased respiratory difficulty, arrhythmia (eg, atrial fibrillation, sinus tachycardia, bradycardia), fatigue, and altered mental status, Some of these events required hospitalization, Unknown if these events were related to mAbs or were due to progression of COVID-19, Treatment benefit not observed in patients hospitalized with 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, Who require oxygen therapy for COVID-19, OR, Who require an increase in baseline oxygen flow rate because of COVID-19 (in those on long-term oxygen therapy for underlying non-COVID-19related comorbidity), Circulating SARS-CoV-2 viral variants may be associated with resistance to monoclonal antibodies, Prescribing clinicians should consider prevalence of resistant variants in their area, Health care providers should review antiviral resistance information provided by state and local health departments, Variant proportions circulating in the US can be monitored at the, 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, COVID-19 in pregnancy is associated with adverse maternal and fetal outcomes, including preeclampsia, eclampsia, preterm birth, premature rupture of membranes, venous thromboembolic disease, and fetal death, 1 disposable polypropylene dosing syringe capable of holding 2 mL, Syringe extension set: Polycarbonate and polyvinylchloride without di-ethylhexylphthalate (DEHP), Refrigerate at 2-8C (36-46F) in original carton to protect from light, Do not freeze, shake, or expose to direct light, Refrigerated at 2-8C (36-46F) for up to 24 hr, OR, Room temperature at 20-25C (68-7F) for up to 7 hr, If refrigerated, allow prepared syringe to equilibrate to room temperature for ~20 minutes before administration. 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate ( DEHP.... 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