bebtelovimab infusion

On May 6, 2021, CMS updated the Medicare payment rates for the administration of COVID-19 monoclonal antibody products. There is a code for the injectable antiviral drug as well . These reactions may be severe or life-threatening. Bebtelovimab (EUA issued February 11, 2022, latest update October 27, 2022). Portions of this document last updated: Feb. 01, 2023. There are other authorized treatments available and healthcare providers should choose an authorized therapeutic option with activity against the circulating variants in their state, territory, or US jurisdiction. Resources may contain information about doses, uses, formulations and populations different from product labeling. Serious and unexpected adverse events may occur that have not been previously reported with bebtelovimab use. All monoclonal antibody (mAb) therapies are in limited supply, and not everyone will be eligible for treatment. Clinicians caring for COVID-19 patients should be aware of the availability of these important life-saving medications and consider use when clinically indicated. 1 Preparation and Administration All rights reserved. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. This website also contains material copyrighted by 3rd parties. Discard the vial if the solution is cloudy, discolored, or . doi: 10.1097/CCE.0000000000000747. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). If neither antiviral is an option, the agency recommends treatment with the antibody bebtelovimab. 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. All of these criteria must be met to allow for the product to be used in the treatment of patients during the COVID-19 pandemic. for whom other COVID-19 treatment options approved or authorized by FDA are not available or clinically appropriate. Examples of risk factors that may make an individual at higher risk for progression to severe COVID-19 include, but are not limited to: Immunosuppressive Disease / Immunosuppressive Treatment. All . 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. 360bbb 3(b)(1), unless the authorization is terminated or revoked sooner. Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of bebtelovimab. 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. This information is provided in response to your request. Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. If used, attach and prime the syringe extension set. Special considerations: FDA-approved for treating hospitalized patients. If shortages occur, patients or insurance companies may need to foot the bill for monoclonal antibodies. Older people and people of all ages with severe, or long lasting (chronic) medical conditions like heart disease, lung disease, diabetes, and obesity, for example, seem to be at higher risk of being hospitalized for COVID-19. COVID-19 illnesses have ranged from very mild (including some with no reported symptoms) to severe, including illness resulting in death. Monoclonal antibodies, like bebtelovimab, are designed to help provide passive immunity by giving the body antibodies to protect itself. There are limited clinical data available for bebtelovimab. Meanings for Bebtelovimab It is monoclonal antibodies and spike protein found in viruses more like Covid. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. Product names listed above are trademarks or registered trademarks owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates, US_cFAQ_BEB010_X2_DOSE_PREPARATION_ADMINISTRATION. 0.9% Sodium Chloride injection for flushing. Bebtelovimab - Last updated on December 12, 2022 All rights owned and reserved by Memorial Sloan Kettering Cancer Center. Healthcare providers should review the Antiviral Resistance information in Section 12.4 of the Fact Sheet for Healthcare Providers for details regarding specific variants and resistance. high-risk adults and pediatric patients (12 years of age and older weighing at least 40 kg) who all received open-label active treatments. Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP). Adverse reactions observed in those who have received bebtelovimab, alone or in combination with bamlanivimab and etesevimab, at the authorized dose or higher, are infusion-related reactions (n=2, 0.3%), pruritus (n=2, 0.3%) and rash (n=5, 0.8%). Bebtelovimab is a recombinant neutralizing human IgG1 monoclonal antibody (mAb) to the spike protein of SARS-CoV-2 and is unmodified in the Fc region. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration, and initiate appropriate medications and/or supportive care. Bebtelovimab is not authorized for treatment of mild-to-moderate COVID-19 in geographic regions where infection is likely to have been caused by a non-susceptible SARS-CoV-2 variant based on available information including variant susceptibility to this drug and regional variant frequency. A Patient Handout is not currently available for this monograph. Bebtelovimab is authorized to be administered for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg): The following provides essential safety information on the unapproved use of bebtelovimab under the Emergency Use Authorization. An official website of the United States government, : At this time, bebtelovimab remains authorized in all U.S. regions until further notice by FDA. MedWatch adverse event reports can be submitted to the FDA by calling 1-800-FDA-1088 or Veklury is approved for the treatment of adults and pediatric patients (28 days of age and older and weighing at least 3 kg) with positive results of direct SARS-CoV-2 viral testing, who are: hospitalized, or not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death. Mayo Clinic on Incontinence - Mayo Clinic Press, NEW The Essential Diabetes Book - Mayo Clinic Press, NEW Ending the Opioid Crisis - Mayo Clinic Press, FREE Mayo Clinic Diet Assessment - Mayo Clinic Press, Mayo Clinic Health Letter - FREE book - Mayo Clinic Press. Shelf-life extensions were issued for specific lots of bebtelovimab. Bebtelovimab is not FDA-approved for any use, including for use as treatment of COVID-19. Bebtelovimab should be administered via IV injection over at least 30 seconds. Important Note for Medical Providers: As of November 25, 2022, the BCCFH COVID Task Force no longer uses monoclonal antibody therapy (bebtelovimab) to treat COVID infections. Bebtelovimab has not been approved, but has been authorized for emergency use by the FDA under an EUA, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) 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. Not many people have received bebtelovimab. Codes are available for the introduction or infusion of Remdesivir, Sarilumab, Tocilizumab, or other therapeutic substances, as well as the transfusion of convalescent plasma specifically for the treatment of COVID-19. Lilly USA, LLC 2022. 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 . FDA Letter of Authorization. | Lilly USA, LLC 2023. AmerisourceBergen Specialty Distributors Generally, scientists are able to develop antibody treatments faster than they are able to develop vaccines. Last updated on Nov 30, 2022. Bebtelovimab has a half-life of 11.5 days, which may explain the consistent bradycardia and hypotension post cardiac arrest and the need for pressors ( 7 ). The therapeutics locator is intended for provider use. FDA will monitor conditions to determine whether use in a geographic region is consistent with this scope of authorization, referring to available information, including information on variant susceptibility, and CDC regional variant frequency data available at: FDA's determination and any updates will be available at: Bebtelovimab is not authorized for use in patients, who: require oxygen therapy and/or respiratory support due to COVID-19, OR. Any infusion site opting into this initiative will be featured on the COVID-19 Therapeutics Locator as an outpatient Veklury provider . It is very important that your doctor check you or your child's progress closely while you are receiving this medicine to make sure that it is working properly. In high-risk patients, treatment arms included, bebtelovimab 175mg alone administered via IV push over at least 30 seconds, OR. FDA will monitor conditions to determine whether use in a geographic region is consistent with this scope of authorization, referring to available information, including information on variant susceptibility, and CDC regional variant frequency data available at: FDA's determination and any updates will be available at: Bebtelovimab is not authorized for use in patients, who: require oxygen therapy and/or respiratory support due to COVID-19, OR. Infusion reactions have happened during and within 24 hours after the infusion. 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 . Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. Bebtelovimab is not authorized for treatment of mild-to-moderate COVID-19 in geographic regions where infection is likely to have been caused by a non-susceptible SARS-CoV-2 variant based on available information including variant susceptibility to this drug and regional variant frequency. Should you decide not to receive it or for your child to not receive it, it will not change your or your childs standard medical care. 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. Controlled studies in pregnant women show no evidence of fetal risk. Bebtelovimab is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of bebtelovimab under section 564(b)(1) of the Act, 21 U.S.C. Bebtelovimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus. 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. [2] with positive results of direct SARS-CoV-2 viral testing. Medically reviewed by Melisa Puckey, BPharm. Positive results of direct acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing. Fact Sheet for Healthcare Providers, Download Bebtelovimab may be used alone or with other medications. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. Bebtelovimab has not been approved, but has only been authorized for emergency use by Food and Drug Administration (FDA) for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of bebtelovimab under Section 564(b)(1)(C) of the Act, 21 U.S.C. AmerisourceBergen will sell bebtelovimab to licensed and approved customers such as hospitals, infusion centers, long-term care facilities, clinics, etc. Copyright 2023 IBM Watson Health. Serious and unexpected adverse events may occur that have not been previously reported with bebtelovimab use. Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care. These reactions may be severe or life-threatening. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. Variants, like Omicron, may have an impact on the effectiveness of mAb therapies. This medicine may cause serious allergic reactions, including infusion-related reactions and anaphylaxis, which can be life-threatening and require immediate medical attention. US Food and Drug Administration (FDA). How it works: Remdesivir interferes with one of the key enzymes the virus needs to replicate. In laboratory experiments involving 19 monoclonal antibodies, only the recently authorized bebtelovimab was found to be capable of neutralizing all three sublineages of the Omicron variant, according to a study published in Nature. Dosage form: injection for intravenous use Avoid forming air bubbles. Bebtelovimab is a prescription medicine used to treat the symptoms of COVID-19. Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of other SARS-CoV-2 monoclonal antibodies and could occur with administration of bebtelovimab. This initiative will be eligible for treatment may cause serious allergic reactions, including obstetrical care ) ( 1,., CMS updated the Medicare payment rates for the administration of bebtelovimab should follow according. Reactions and infusion-related reactions, including for use as treatment of patients the. 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