Well, after many phone calls, got the bebtelovimab this afternoon. PP-BB-US-0005 11/2022 [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. Bebtelovimab is no longer authorized by the FDA for use in the United States, effective immediately. Bebtelovimab injection is used to treat mild to moderate coronavirus disease 2019 (COVID-19) in patients with positive results of direct SARS-CoV-2 testing, who are at high risk for progression to severe COVID-19 (eg, hospitalization, death), and for whom other treatments are not available or appropriate. Bebtelovimab is clear to opalescent and colorless to slightly yellow to slightly brown solution. Resources may contain information about doses, uses, formulations and populations different from product labeling. Share cases and questions with Physicians on Medscape consult. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. As of January 24, 2022, distributions of bamlanivimab/etesevimab and REGEN-COV have been paused following FDA's revised EUAs for both products stating they are no longer authorized for use due to the omicron variant. To find COVID-19 vaccine locations near you: Search vaccines.gov, text your ZIP code to 438829, or call 1-800-232-0233. 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. Add a meaning Add Bebtelovimab details Phonetic spelling of Bebtelovimab Add phonetic spelling Synonyms for Bebtelovimab Add synonyms Administration: Intravenous infusion. These reactions may be severe or life threatening. 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 available for purchase by U.S. states/territories, hospitals, and a broad set of other providers through AmerisourceBergen Specialty Distributors (ASD). 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. Monoclonal antibody drugs are designed to start working faster than vaccines, while protection provided by vaccines may last longer. The link you clicked on will take you to a site maintained by a third party, which is solely responsible for its content. In high-risk patients, treatment arms included, bebtelovimab 175mg alone administered via IV push over at least 30 seconds, OR. Positive results of direct acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing. It looks like your browser does not have JavaScript enabled. On May 6, 2021, CMS updated the Medicare payment rates for the administration of COVID-19 monoclonal antibody products. Please see the enclosed Fact Sheet for authorized dosing information. Go to https://www.fda.gov/emergency-preparedness-and-response/mcm-legalregulatory-and-policy-framework/emergency-use-authorization for information on the emergency use of other medicines that are authorized by FDA to treat people with COVID-19. You can also direct your patients to, Healthcare providers must provide a copy of the, Bebtelovimab must be administered as a single intravenous injection over at least 30 seconds. All rights reserved. If you wish to report an adverse event or product complaint, please call 3Data on file, Eli Lilly and Company and/or one of its subsidiaries. The procedure followed for aseptic technique may vary between institutions. Generally, scientists are able to develop antibody treatments faster than they are able to develop vaccines. Per EUA, remove bebtelovimab vial from refrigerator and allow to equilibrate to room temperature for approximately 20 minutes. Important points to this press release: "Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. Copyright 2023 IBM Watson Health. Use: treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe disease. Read more about bebtelovimab. 12 CLINICAL PHARMACOLOGY At this time, bebtelovimab remains authorized in all U.S. regions until further notice by FDA. The new infusion provides an . Bebtelovimab Replacement Requests in HPOP: Information for Providers | HHS/ASPR, U.S. Department of Health & Human Services, FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region, FDA updates the fact sheet for Bebtelovimab, Shelf-Life Extension for Specific Lots of Bebtelovimab, COVID-19 Therapeutics Locator for Providers, COVID-19 Therapeutics Thresholds by Jurisdiction, Therapeutics Clinical Implementation Guide, Side-by-Side Outpatient Therapeutics Overview, Information for LongTerm Care Facilities. 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 monoclonal antibody (mAb) therapies are in limited supply, and not everyone will be eligible for treatment. This medicine may cause serious allergic reactions, including infusion-related reactions and anaphylaxis, which can be life-threatening and require immediate medical attention. A Patient Handout is not currently available for this monograph. for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. This product is preservative-free and therefore, should be administered immediately. Lilly USA, LLC 2022. Tell your doctor if you are pregnant or plan to become pregnant before using bebtelovimab; severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. 360bbb 3(b)(1), unless the authorization is terminated or revoked sooner. Bebtelovimab dosing, indications, interactions, adverse effects, and more Drugs & Diseases bebtelovimab (Investigational) Brand and Other Names: Classes: COVID-19, Monoclonal Antibodies Print. If you log out, you will be required to enter your username and password the next time you visit. Copyright 2023 IBM Watson Health. 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. It is not known if Bebtelovimab is safe and effective in children younger than 12 years of age who weigh over 88 pounds. I was given the Bebtelovimab infusion and I did well with it. How do I find COVID-19 antibody therapies? Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. Any infusion site opting into this initiative will be featured on the COVID-19 Therapeutics Locator as an outpatient Veklury provider . Eli Lilly and Company (Lilly) does not provide an aseptic technique directive for the preparation of thebebtelovimabsolution for infusion. Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP). 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. Like bebtelovimab, FDA may allow for the emergency use of other medicines to treat people with COVID-19. Other risk factors can be found on the CDC website. ).1, In the BLAZE 4 study, extension sets could have been primed with either study drug or normal saline if allowed by site practices.3, Bebtelovimab Fact Sheet for Health Care Providers. If shortages occur, patients or insurance companies may need to foot the bill for monoclonal antibodies. I had what they considered moderate symptoms & am 41 with a healthy pregnancy. What procedure codes should be used to bill for the injection of a COVID-19 antiviral drug? 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. Download Monoclonal antibodies, like bebtelovimab, are designed to help provide passive immunity by giving the body antibodies to protect itself. The information presented in the section below contains data on unauthorized preparation and administration of bebtelovimab. 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. 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. 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%). There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. 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). Thebebtelovimabinjectionshould be prepared by a qualified healthcare professional using aseptic technique to prevent contamination from pathogens.3, Bebtelovimabis neither hazardous nor toxic when spilled.3, The bebtelovimab Fact Sheet for Healthcare Providers does not stipulate that alaminar flow cabinet, hood, or anegative air pressure roommust be used to preparetheintravenous injection.1,3, In the BLAZE-4 clinical trial protocol preparation instructions, syringes and extension sets (syringe/IV extension sets) were used when administering bebtelovimab via IV push or using a syringe pump over at least 30 seconds.3, In BLAZE-4, the type of materials provided in the clinical trial protocol preparation instructions included, polyvinylchloride (PVC) with or without DEHP and with or without a 0.20/0.22 m polyether sulfone (PES) filter, polyethylene with or without a 0.20/0.22 m PES filter.3, The use of an infusion line or extension set with an in-line filter was strongly recommended, whenever possible, to mitigate the risk of contamination. 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