bebtelovimab infusion

[2] Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. Before sharing sensitive information, make sure you're on a federal government site. 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. Tell your doctor right away if you feel confused, tired, or weak. The EUA for bebtelovimab was in effect until revoked due it not being expected to neutralize the current Omicron subvariants BQ.1 and BQ.1.1, therefore bebtelovimab can no longer be used under the EUA. 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 . Bebtelovimab is not FDA-approved for any use, including for use as treatment of COVID-19. 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 Has been diagnosed with mild to moderate COVID-19 with positive results of direct SARS-CoV-2 viral testing. After the entire contents of the syringe have been administered. 4.0.17 02/2023 | GLOOTH00001 04/2015 Well, after many phone calls, got the bebtelovimab this afternoon. Monoclonal antibody drugs are designed to start working faster than vaccines, while protection provided by vaccines may last longer. All rights reserved. Prescribers should monitorCDC regional variant frequency dataand refer to the Antiviral Resistance information in the Healthcare Provider Fact Sheet for details regarding specific variants and resistance against SARS-CoV-2 variants in your area, particularly Omicron subvariants BQ.1 and BQ.1.1. 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. Bebtelovimab is designed as a treatment option for those newly diagnosed with COVID-19 who cannot take Paxlovid and are deemed at high risk of severe outcomes. New Treatment, Vaccine and Testing Locator Map. Available for Android and iOS devices. Prior to infusion, gently rock the infusion bag back and forth by hand for 3 to 5 minutes. with positive results of direct SARS-CoV-2 viral testing. Healthcare providers should consider the benefit-risk for an individual patient. 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. Discard any product remaining in the vial. 1 bebtelovimab vial (175 mg/2 mL) 1 disposable polypropylene dosing syringe capable of holding 2 mL 0.9% Sodium Chloride injection for flushing. Please turn on JavaScript and try again. This site complies with the HONcode standard for trustworthy health information: verify here. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. For additional questions, you can also contact the Lilly COVID Hotline at 1-855-545-5921. Bebtelovimab works by binding to the spike protein of the virus that causes COVID-19, similar to other monoclonal antibodies that have been authorized for the treatment of high-risk people with mild to moderate COVID-19 and shown a benefit in reducing the risk of hospitalization or death. Bebtelovimab may be used alone or with other medications. There is limited experience treating pregnant women or breastfeeding mothers with bebtelovimab. Signs and symptoms of infusion-related reactions may include: Administer appropriate medications and/or supportive care if an infusion-related reaction occurs. Signs and symptoms of infusion-related reactions may include: Administer appropriate medications and/or supportive care if an infusion-related reaction occurs. Drug class: Miscellaneous antivirals. 1 Preparation and Administration To find COVID-19 vaccine locations near you: Search vaccines.gov, text your ZIP code to 438829, or call 1-800-232-0233. All rights reserved. are likely to be infected with a SARS-CoV-2 variant that is not able to be treated by bebtelovimab based on the circulating variants in your area (ask your health care provider about FDA and CDCs latest information on circulating variants by geographic area). 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. 3Data on file, Eli Lilly and Company and/or one of its subsidiaries. There is a code for the injectable antiviral drug as well . All rights reserved. 360bbb 3(b)(1), unless the authorization is terminated or revoked sooner. 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. Medically reviewed by Melisa Puckey, BPharm. for whom other COVID-19 treatment options approved or authorized by FDA are not available or clinically appropriate. Given the high frequency of circulating SARS-CoV-2 variants that are non-susceptible to bebtelovimab, bebtelovimab is not currently authorized in any U.S. region. All rights reserved. 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. The procedure followed for aseptic technique may vary between institutions. The Food and Drug Administration (FDA) issued an emergency use authorization for bebtelovimab on Feb. 11. Contact your healthcare provider if you have any side effects that bother you or do not go away. Read more about bebtelovimab. Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. Advertising revenue supports our not-for-profit mission. Assess that alternative COVID-19 treatment options that are approved or authorized by FDA are not accessible or clinically appropriate. Authors Christina Gearges 1 , Hibah Haider 1 , Vishal Rana 1 , Zahra Asghar 1 , Anjali Kewalramani 1 , Zachary Kuschner 1 2 On November 30, 2022 the FDA announced bebtelovimab is not currently authorized for emergency use in the U.S. at this time because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. 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. This product is preservative-free and therefore, should be administered immediately. Important points to this press release: "Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. 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). 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. Serious and unexpected side effects may happen. In a statement the FDA said that it was "carefully monitoring circulating viral variants and their sensitivity to authorised monoclonal antibodies . Your healthcare provider may talk with you about clinical trials for which you may be eligible. One dose given per day for 3 days. Bebtelovimab Bebtelovimab should be administered as soon as possible after positive. mAbs are administered directly after exposure to COVID-19 with a positive test up to 7 days after onset of symptoms. for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. 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 This site is intended for US residents aged 18 or older. 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. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). | Lilly USA, LLC 2023. The Food and Drug Administration (FDA) said it's to be administered only when other . Patients treated with bebtelovimab should continue to self-isolate and use infection control measures (e.g., wear mask, isolate, social distance, avoid sharing personal items, clean and disinfect high touch surfaces, and frequent handwashing) according to CDC guidelines. Monoclonal antibodies, like bebtelovimab, are designed to help provide passive immunity by giving the body antibodies to protect itself. Some of these events required hospitalization. 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. Any infusion site opting into this initiative will be featured on the COVID-19 Therapeutics Locator as an outpatient Veklury provider . 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. 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 FDA Emergency Use Authorization letter. Eli Lilly and Company (Lilly) does not provide an aseptic technique directive for the preparation of thebebtelovimabsolution for infusion. This product is preservative-free and therefore, should be administered only when other, have been observed with of... Due to COVID-19 preservative-free and therefore, should be administered only when other with medications! Well, after many phone calls, got the bebtelovimab this afternoon protect. This initiative will be featured on the COVID-19 Therapeutics Locator as an Veklury! 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