. For patients, the infusion is free (for now). Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Identify an infusion center near your patient. All . The therapeutics locator is intended for provider use. (1-800-545-5979), HCP Fact Sheet | Patient & Caregiver Fact Sheet | FDA Authorization Letter. I had what they considered moderate symptoms & am 41 with a healthy pregnancy. See Prescribing Information above, if applicable. were randomized 1:1:1 to receive a single infusion of a combination of 3 anti-SARS-CoV-2 mAbs (bamlanivimab, etesevimab, and bebtelovimab; n = 127), bebtelovimab alone (n = 125), or placebo (n = 128). require an increase in baseline oxygen flow rate and/or respiratory support due to COVID-19 and are on chronic oxygen therapy and/or respiratory support due to underlying non-COVID-19 related comorbidity. We will provide further updates and consider additional action as new information becomes available. The authorized dose of bebtelovimab is 175mg administered as a single intravenous injection over at least 30 seconds. Healthcare providers can consider the benefit-risk for an individual patient, using the Fact Sheet for Healthcare Providers and the CDC website as guidance. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. BA.5 became the dominant subvariant in the US earlier this month, surpassing BA.2.12.1. We comply with the HONcode standard for trustworthy health information. Recombinant neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2 and is unmodified in the Fc region; maintains binding and neutralizing activity across currently known and reported variants of concern, including Omicron and BA.2, Peak plasma concentration (day 29): 4.35 mcg/mL, Expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as other IgG mAbs, Remove vial from refrigerator and allow to equilibrate to room temperature for ~20 minutes; do not expose to direct heat, Inspect vial visually for particulate matter and discoloration; solution is clear to opalescent and colorless to slightly yellow to slightly brown; discard if cloudy, discolored, or visible particles observed, Withdraw 2 mL (175 mg) from vial into disposable syringe; discard any product remaining in vial, Product is preservative-free, therefore, should be administer immediately; if immediate administration not possible, may refrigerate (up to 24 hr) or at room temperature (up to 7 hr), To be prepared by qualified healthcare professional, Attach and prime syringe extension set, administer dose IV over at least 30 seconds, Flush extension set with 0.9% NaCl to ensure delivery of required dose, May only be administered in settings with immediate access to medications to treat a severe infusion reaction (eg, anaphylaxis) and ability to activate emergency medical system, as necessary, Monitor patients for possible infusion-related reactions during administration and observe for at least 1 hr after injection. Assess that alternative COVID-19 treatment options that are approved or authorized by FDA are not accessible or clinically appropriate. 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 (e.g. Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of bebtelovimab and mandatory requirements of the EUA. One dose given per day for 3 days. Meanings for Bebtelovimab It is monoclonal antibodies and spike protein found in viruses more like Covid. Contact your healthcare provider if you have any side effects that bother you or do not go away. Bebtelovimab has been associated with anaphylactic reactions; however, this is unlikely in our . Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care. for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. [2] eCollection 2022 Aug. Infusion-related reactions, which may occur up to 24 hours after the injection, have been observed in clinical trials of bebtelovimab when administered with other monoclonal antibodies and may occur with use of bebtelovimab alone. The drug, called bebtelovimab from Eli Lilly, is a monoclonal therapy meant for COVID-19 patients as young as 12 who are at high risk for getting severely ill and who were recently infected, to keep them from getting even sicker and keep them out of the hospital. Last updated on Nov 30, 2022. Oral Paxlovid (ritonavir-boosted nirmatrelvir) In a clinical trial, Paxlovid reduced the risk of hospitalization and death by 89% in unvaccinated outpatients with COVID-19 at higher risk of severe disease. Medically reviewed by Melisa Puckey, BPharm. All rights reserved. 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 immediate administration is not possible, store the syringe for up to 24 hours at refrigerated temperature (2C to 8C [36F to 46F]) and up to 7 hours at room temperature (20C to 25C [68F to 77F]). 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 did not undergo the same type of review as an FDA-approved product. - 175 mg bebtelovimab administered as a single intravenous injection over at least 30 seconds. Call the infusion center to confirm product availability. Bebtelovimab (EUA issued February 11, 2022, latest update October 27, 2022). All rights reserved. Bebtelovimab should be administered via IV injection over at least 30 seconds. This site complies with the HONcode standard for trustworthy health information: verify here. Bebtelovimab is available for purchase by U.S. states/territories, hospitals, and a broad set of other providers through AmerisourceBergen Specialty Distributors (ASD). On May 6, 2021, CMS updated the Medicare payment rates for the administration of COVID-19 monoclonal antibody products. See Limitations of Authorized Use. November 30, 2022: Not currently authorized in any U.S. region owing to high frequency of circulating SARS-CoV-2 variants that are non-susceptible, Circulating SARS-CoV-2 viral variants may be associated with resistance to mAbs, Not studied in patients hospitalized for COVID-19; SARS-CoV-2 mAbs may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation, Completion of FDA MedWatch Form to report all medication errors and serious adverse events is mandatory, Data are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, Use during pregnancy if potential benefit outweighs potential risk for mother and fetus, Pregnant females are considered a high-risk population for severe COVID-19, Data are unavailable on 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, Consider developmental and health benefits of breastfeeding along with the mothers clinical need for bebtelovimab and any potential adverse effects on breastfed child from bebtelovimab or from underlying maternal condition, Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. 1 Preparation and Administration My doc said because I was on other meds and supplements that this would be safer than paxlovid because Of interactions. Observe patient for at least 1 hour after injection. Use: treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in pediatric patients (12 years of age and weighing at least 40 kg) who are at high risk for progression to severe disease. Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset. 1-800-LILLYRX fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g. Authors Christina Gearges 1 , Hibah Haider 1 , Vishal Rana 1 , Zahra Asghar 1 , Anjali Kewalramani 1 , Zachary Kuschner 1 2 Bebtelovimab is a monoclonal antibody treatment that had its FDA authorization paused in November 2022. Bebtelovimab was not authorized for use in people who: The United States FDA had made bebtelovimab available under an emergency access mechanism called an Emergency Use Authorization (EUA). 360bbb 3(b)(1), unless the authorization is terminated or revoked sooner. Healthcare providers should consider the benefit-risk for an individual patient. Provide your patient with resources to ensure they have the answers they need. Withdraw 2 mL from the vial into the disposable syringe. Before receiving treatment, tell your healthcare provider about all your or your childs medical conditions including if you or your child: Interactions between bebtelovimab and other drugs are unlikely. Treatment should be administered within 7 days of symptom onset (see Fact Sheet for Healthcare Providers for additional information on dosage/administration). Bebtelovimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus. Health care providers should assess whether these treatments are right for their patient in the event the patient develops mild-to-moderate COVID-19. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 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