4.0.17 02/2023 | GLOOTH00001 04/2015 There are limited clinical data available for bebtelovimab. How do I find COVID-19 antibody therapies? Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of other SARS-CoV-2 monoclonal antibodies and could occur with administration of bebtelovimab. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. 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. All . This site is intended for US residents aged 18 or older. Health care providers should assess whether these treatments are right for their patient in the event the patient develops mild-to-moderate COVID-19. 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Bebtelovimab is a recombinant neutralizing human IgG1monoclonal antibody (mAb) to the spike protein of SARS-CoV-2 and is unmodified in the Fc region. There are no available data on the presence of bebtelovimab in human or animal milk, the effects on the breastfed infant, or the effects on milk production. We encourage you to read the privacy policy of every website you visit.Click "Continue" to proceed or "Return" to return to LillyMedical.com. 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. Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of bebtelovimab and mandatory requirements of the EUA. 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 . 3, Thebebtelovimabdosing instructions do not specify a particular brand of disposable dosing syringe or extension set to be used and Lilly does not provide guidance in this regard.3, Thereareno known incompatibilities betweenbebtelovimaband availabledisposable dosing syringes in the market.3, The type of IV line used to administer bebtelovimab is not specified (via a PICC line, central line, port, etc. Use the yellow button below to refer patients directly for infusion treatment. ASPR has paused the fulfillment of any pending requests under its Bebtelovimab Product Replacement Initiative due to bebtelovimab not currently being authorized for use in the U.S. See more information regarding dosing in the. Lilly USA, LLC 2022. 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. In a statement the FDA said that it was "carefully monitoring circulating viral variants and their sensitivity to authorised monoclonal antibodies . Lilly cannot recommend other methods of administration other than what is authorized in the EUA Fact Sheet for health care providers. Copyright 2023 IBM Watson Health. 1For information on medical conditions and factors associated with increased risk for progression to severe COVID-19, see the Centers for Disease Control and Prevention (CDC) website: https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html. 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. Signs and symptoms of infusion-related reactions may include: Administer appropriate medications and/or supportive care if an infusion-related reaction occurs. Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions. I think we now have a better understanding of how to use monoclonal antibodies to treat COVID-19. Due to the time course of onset of bradycardia, we attribute this to bebtelovimab infusion. Serious and unexpected side effects may happen. Bebtelovimab . 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): with positive results of direct SARS-CoV-2 viral testing, and who are at high risk 1 for progression to severe COVID-19, including hospitalization or death, and 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. This site complies with the HONcode standard for trustworthy health information: verify here. for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. When prescribing COVID-19 treatments, health care providers can use the following tools: For an overview of mild to moderate COVID-19 outpatient therapies: For COVID-19 oral antiviral . PP-BB-US-0005 11/2022 Bebtelovimab should be administered as soon as possible after positive. . Signs and symptoms of infusion-related reactions may include: Administer appropriate medications and/or supportive care if an infusion-related reaction occurs. The EUA has since been revoked on November 30, 2022. Across the company's safety studies, the drug was found to cause rare instances of relatively mild side effects, including infusion-related reactions, itchiness and a rash. 1 disposable polypropylene dosing syringe capable of holding 2 mL. Bebtelovimab During Pregnancy and Breastfeeding. Note that reporting inventory and administration of all U.S. government-procured and distributed supply of bebtelovimab remains a requirement until all U.S. government-procured bebtelovimab is consumed (a provider sites inventory is depleted). 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). 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. You are being redirected to It is possible that bebtelovimab could interfere with your body's own ability to fight off a future infection of SARS-CoV-2. Drug information provided by: IBM Micromedex. 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 U.S. government has spent $720 million for hundreds of thousands of doses of bebtelovimab that are being distributed around the country. You will be observed by your healthcare provider for at least 1 hour after you receive bebtelovimab. Use: treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe disease. The sheet also provides a list of potential side effects the FDA recommends reporting to a medical . 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. 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. Add Resources to Your . The BA.4 Omicron subvariant is the second most prevalent with 12.8% of cases originating from the pathogen, while the BA.2.12.1 subvariant now accounts for only 8.6%. 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. AmerisourceBergen Specialty Distributors Treatment should be administered within 7 days of symptom onset (see Fact Sheet for Healthcare Providers for additional information on dosage/administration). A Patient Handout is not currently available for this monograph. My doc said because I was on other meds and supplements that this would be safer than paxlovid because Of interactions. This content does not have an English version. The link you clicked on will take you to a site maintained by a third party, which is solely responsible for its content. pre-syncope, syncope), dizziness, and diaphoresis. Last updated on Nov 30, 2022. Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care. 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:. Contact your healthcare provider if you have any side effects that bother you or do not go away. 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): Circulating SARS-CoV-2 viral variants may be associated with resistance to monoclonal antibodies. 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. 1 Bebtelovimab vial (175 mg/2 mL) 1 disposable polypropylene dosing syringe capable of holding 2 mL 0.9% Sodium Chloride Injection for flushing Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP) Preparation After the entire contents of the syringe have been administered. Important points to this press release: "Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. Fact Sheet for Patients, Parents and Caregivers (English), Download Bebtelovimab is a monoclonal antibody treatment that had its FDA authorization paused in November 2022. Serious and unexpected adverse events may occur that have not been previously reported with bebtelovimab use. What procedure codes should be used to bill for the injection of a COVID-19 antiviral drug? See Limitations of Authorized Use. 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. Medically reviewed by Melisa Puckey, BPharm. They can now be given through subcutaneous or intramuscular injections rather than as an infusion at a hospital. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. 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 Letter of Authorization. Authors Christina Gearges 1 , Hibah Haider 1 , Vishal Rana 1 , Zahra Asghar 1 , Anjali Kewalramani 1 , Zachary Kuschner 1 2 Tell your doctor right away if you feel confused, tired, or weak. All rights reserved. How can I get monoclonal antibody therapy (antibody infusion)? The new infusion provides an . 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. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration, and initiate appropriate medications and/or supportive care. Are taking any medicines (prescription, and over-the-counter, vitamins, or herbal products). Drug class: Miscellaneous antivirals. Withdraw 2 mL of bebtelovimab (1 vial) into disposable syringe. People have been seriously harmed and even died after taking products not approved for use to treat or prevent COVID-19, even products approved or prescribed for other uses. A prescription from a healthcare provider is required to receive any mAb therapy. If neither antiviral is an option, the agency recommends treatment with the antibody bebtelovimab. 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-Induced Bradycardia Leading to Cardiac Arrest Bebtelovimab-Induced Bradycardia Leading to Cardiac Arrest Crit Care Explor. Bebtelovimab may be used alone or with other medications. A. We have been isolating and using N95s when we use the bathroom, opening windows & leaving a good 12 hours between us each showering etc. Bebtelovimab injection is used to treat COVID-19 infection in certain non-hospitalized adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) and who have mild to moderate COVID-19 symptoms. Not many people have received bebtelovimab. 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 ). Monoclonal antibody therapy is an effective treatment and has proven to: 70%-85% 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. Do not shake the vial. high-risk adults and pediatric patients (12 years of age and older weighing at least 40 kg) who all received open-label active treatments. This content does not have an Arabic version. Limitations of Benefit and Potential Risk in Patients with Severe COVID-19. An FDA form 3500 is required for serious adverse events or medication errors. Administer the entire contents of the syringe via intravenous (IV) injection over at least 30. Issued February 11, 2022. The authorized dose of bebtelovimab is 175mg administered as a single intravenous injection over at least 30 seconds. mAbs are administered directly after exposure to COVID-19 with a positive test up to 7 days after onset of symptoms. Lilly USA, LLC is not responsible for the privacy policy of any third-party websites. If pregnant or breastfeeding, discuss your options and specific situation with your healthcare provider. These are not all the possible side effects. 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. Bebtelovimab was an investigational medicine used under Emergency Use Authorization (EUA) for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and children (12 years of age and older weighing at least 88 pounds [40 kg]): There is limited information known about the safety and effectiveness of using bebtelovimab for the treatment of mild-to-moderate COVID-19. pre-syncope, syncope), dizziness, and diaphoresis. Bebtelovimab binds the spike protein with a dissociation constant KD = 0.046 to 0.075 nM and blocks spike protein attachment to the human ACE2 receptor with an IC50 value of 0.39 nM (0.056 mcg/mL). for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. This website also contains material copyrighted by 3rd parties. Fact Sheet for Healthcare Providers, Download These errors build up over time until the virus is no longer capable of surviving. 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. All rights reserved. Generic name: bebtelovimab Caregivers (English), Fact Sheet for Patients, Parents and Caregivers, https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. Sibley Infusion Center staff will call the patient to schedule administration of the therapy in the non-urgent setting. Healthcare providers should consider the benefit-risk for an individual patient. MedWatch adverse event reports can be submitted to the FDA by calling 1-800-FDA-1088 or Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP). On November 30, 2022, the FDA announced that bebtelovimab is no longer authorized for emergency use in the United States because bebtelovimab is not expected to neutralize the Omicron subvariants BQ.1 and BQ.1.1. Bebtelovimab must be given within seven days of symptom onset. 11:00 AM) whether or not their patient is approved to obtain the treatment managed via the Infusion Center. [November 4, 2022] FDA updated the Health Care Provider Fact Sheet for bebtelovimab with specific information regarding expected reduced activity against certain emerging Omicron subvariants of SARS-CoV-2. Read more about bebtelovimab. The following provides essential safety information on the unapproved use of bebtelovimab under the Emergency Use Authorization. Limitations of Benefit and Potential Risk in Patients with Severe COVID-19. Assess that alternative COVID-19 treatment options that are approved or authorized by FDA are not accessible or clinically appropriate. The Food and Drug Administration last month authorized using the combination monoclonal antibody therapy Evusheld (tixagevimab co-packaged with cilgavimab) to help prevent COVID-19 in certain adults and children with compromised immune systems or a history of severe adverse reaction to a COVID-19 vaccine or its components. Monoclonal antibody treatment is administered via injection or IV in the comfort of your own home. You can get COVID19 through contact with another person who has the virus. 12 CLINICAL PHARMACOLOGY This content does not have an English version. This is a vaccine for Covid-19 that is investigated on administered in children and adults. PP-BB-US-0005 11/2022 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. Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of other SARS-CoV-2 monoclonal antibodies and could occur with administration of bebtelovimab. 3Data on file, Eli Lilly and Company and/or one of its subsidiaries. with positive results of direct SARS-CoV-2 viral testing. Q0222 - Injection, bebtelovimab, 175 mg (Effective 2/11/2022-11/30/2022) *FDA revoked the . 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). The site is secure. 1 Preparation and Administration The drug, bebtelovimab, is authorized for people 12 years and older who test positive for COVID-19 and are at high risk of hospitalization or death. Sometimes, these may be severe or life-threatening. FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region. The therapeutics locator is intended for provider use. Is administered via injection or IV in the event the patient develops mild-to-moderate COVID-19 effects! 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These criteria must be met to allow for the product to be used to bill for privacy!