bebtelovimab infusion

At this time, bebtelovimab remains authorized in all U.S. regions until further notice by FDA. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. 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. 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. This product is available in the following dosage forms: Portions of this document last updated: Feb. 01, 2023. 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. Signs and symptoms of infusion-related reactions may include: Administer appropriate medications and/or supportive care if an infusion-related reaction occurs. 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. Tell your doctor right away if you feel confused, tired, or weak. These therapies require a prescription by a licensed and authorized provider. All rights reserved. One dose given per day for 3 days. A: Generally acceptable. 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. Vaccines provide active immunity by helping the body make its own antibodies to protect itself. 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). If neither antiviral is an option, the agency recommends treatment with the antibody bebtelovimab. Contact your healthcare provider if you have any side effects that bother you or do not go away. for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. Bebtelovimab is available for purchase by U.S. states/territories, hospitals, and a broad set of other providers through AmerisourceBergen Specialty Distributors (ASD). This site is intended for US residents aged 18 or older. Talk to your healthcare provider if you have any questions. What procedure codes should be used to bill for the injection of a COVID-19 antiviral drug? We encourage you to read the privacy policy of every website you visit.Click "Continue" to proceed or "Return" to return to LillyMedical.com. 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. Lilly USA, LLC 2022. The right medications for COVID-19 can help. 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. COVID-19 is caused by a virus called a coronavirus (SARS-CoV-2). PP-BB-US-0005 11/2022 Add Resources to Your . 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). 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. Before sharing sensitive information, make sure you're on a federal government site. Information about circulating variants can be found through Nowcast data. To ensure there is no break in availability of bebtelovimab to states/territories and providers, HHS has coordinated with Lilly to enable the transition from US government distributed supply to commercially available supply. 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. 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. Details About the 2020 Codes Authorized Use and Important Safety Information, Fact Sheet for Patients, Parents and Caregivers (English), Fact Sheet for Patients, Parents and Caregivers (Spanish), https://covid.cdc.gov/covid-data-tracker/#variant-proportions, https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs. The most common treatment-emergent adverse events observed in subjects treated with bebtelovimab, alone or in combination with bamlanivimab and etesevimab, at the authorized dose or higher, included nausea (0.8%) and vomiting (0.7%). Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of bebtelovimab and mandatory requirements of the EUA. Issued February 11, 2022. This site is intended for US Healthcare Professionals only. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration, and initiate appropriate medications and/or supportive care. 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/need-extra-precautions/people-with-medical-conditions.html. Hypersensitivity reactions occurring more than 24 hours after the injection have also been reported with the use of SARS-CoV-2 monoclonal antibodies under Emergency Use Authorization. 360bbb-3, unless the authorization is terminated or revoked sooner.1,2, 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), For information on the authorized use of bebtelovimab and mandatory requirements under the emergency use authorization (EUA), please review the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients/Caregivers at www.LillyAntibody.com/bebtelovimab. The site is secure. All rights reserved. Bebtelovimab (Intravenous Route) Before Using Proper Use Products and services Precautions Drug information provided by: IBM Micromedex 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. Eli Lilly and its authorized distributors have paused commercial distribution of bebtelovimab until further notice. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. Inspect bebtelovimab vial visually for particulate matter and discoloration. Fact Sheet for Healthcare Providers, Download This site complies with the HONcode standard for trustworthy health information: verify here. Please turn on JavaScript and try again. Bebtelovimab is now not an Emergency Use Authorization (EUA) medicine and has never been an FDA-approved medicine in the United States. In the BLAZE-4 clinical trial, bebtelovimab was administered via IV infusion or IV push.3, In the Phase 1 portion of the study, faster infusion rates of bebtelovimab or bebtelovimab administered with bamlanivimab and etesevimab were not associated with an increasing number and/or severity of treatment-emergent adverse events.3, Informed by this data, bebtelovimab was administered to patients at high-risk for severe disease with an IV injection of at least 30 seconds while bebtelovimab with bamlanivimab and etesevimab was administered over at least 6.5 minutes.3, The study data from BLAZE-4 supports administration via IV push over 30 seconds, which is the authorized administration for bebtelovimab under the EUA.1,3, Considering bebtelovimab can be administered over 30 seconds, IV push of the medication saves considerable time relative to the preparation and administration of an IV infusion and may facilitate greater treatment capacity and flexibility throughout infusion centers.3, There is no sufficient data available to support the administration of bebtelovimab via subcutaneous or intramuscular dosing.3. pre-syncope, syncope), dizziness, and diaphoresis. Other risk factors can be found on the CDC website. Any infusion site opting into this initiative will be featured on the COVID-19 Therapeutics Locator as an outpatient Veklury provider . Sometimes, these may be severe or life-threatening. 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). Bebtelovimab is not FDA-approved for any use, including for use as treatment of COVID-19. The U.S. government has spent $720 million for hundreds of thousands of doses of bebtelovimab that are being distributed around the country. Emergency Use Authorization (EUA) of bebtelovimab. online here. If used, attach and prime the syringe extension set. For a mother and unborn baby, the benefit of receiving bebtelovimab may be greater than the risk from the treatment. 175 mg as a single IV injection over at least 30 seconds, Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset. 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:. 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 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. 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. Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care. with positive results of direct SARS-CoV-2 viral testing. AmerisourceBergen will sell bebtelovimab to licensed and approved customers such as hospitals, infusion centers, long-term care facilities, clinics, etc. Provide your patient with resources to ensure they have the answers they need. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. Davidcara 6 months ago. Remove bebtelovimab vial from refrigerated storage and allow to equilibrate to room temperature for approximately 20 minutes before preparation. Some of these events required hospitalization. INDIANAPOLIS, June 29, 2022 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) . It was evaluated alone and together with bamlanivimab and etesevimab in, Because there are other therapeutic options available, a placebo control could not be used to treat high-risk patients.1. All rights reserved. It is possible that bebtelovimab could interfere with your body's own ability to fight off a future infection of SARS-CoV-2. A prescription from a healthcare provider is required to receive any mAb therapy. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. The EUA was supported by a Secretary of Health and Human Service (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic. pre-syncope, syncope), dizziness, and diaphoresis. 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. Bebtelovimab: 175 mg bebtelovimab. Like bebtelovimab, FDA may allow for the emergency use of other medicines to treat people with COVID-19. 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%). Monoclonal antibody treatment is administered via injection or IV in the comfort of your own home. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. Mayo Clinic does not endorse companies or products. Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP). Add a meaning Add Bebtelovimab details Phonetic spelling of Bebtelovimab Add phonetic spelling Synonyms for Bebtelovimab Add synonyms Bebtelovimab - Last updated on December 12, 2022 All rights owned and reserved by Memorial Sloan Kettering Cancer Center. All rights reserved. These reactions may be severe or life threatening. Bebtelovimab works by binding to the spike protein of the virus that causes COVID-19, similar to other mAbs that have been authorized for the treatment of high-risk patients with mild to moderate COVID-19 and shown a benefit in reducing the risk for hospitalization or death. Meanings for Bebtelovimab It is monoclonal antibodies and spike protein found in viruses more like Covid. An official website of the United States government, : Due to the time course of onset of bradycardia, we attribute this to bebtelovimab infusion. An FDA form 3500 is required for serious adverse events or medication errors. 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. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration, and initiate appropriate medications and/or supportive care. 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. Bebtelovimab is clear to opalescent and colorless to slightly yellow to slightly brown solution. Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions. A. 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. Are taking any medicines (prescription, and over-the-counter, vitamins, or herbal products). All product/company names shown herein are the trademarks of their respective owners. There are limited clinical data available for bebtelovimab. Healthcare providers can consider the benefit-risk for an individual patient, using the Fact Sheet for Healthcare Providers and the CDC website as guidance. Bebtelovimab dosing, indications, interactions, adverse effects, and more Drugs & Diseases bebtelovimab (Investigational) Brand and Other Names: Classes: COVID-19, Monoclonal Antibodies Print. 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. How it works: Remdesivir interferes with one of the key enzymes the virus needs to replicate. 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. Bebtelovimab During Pregnancy and Breastfeeding. 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%). High risk for progression to severe COVID-19, including hospitalization or death, Other COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate, Any severity or dialysis: No dosage adjustment recommended, Not expected to impact bebtelovimab pharmacokinetics, since monoclonal antibodies (mAbs) with molecular weight >69 kDa are known not to undergo renal elimination, For use in geographic regions where infection is likely to have been caused by a nonsusceptible SARS-CoV-2 variant based on available information including variant susceptibility, For patients who require oxygen therapy and/or respiratory support due to COVID-19, For patients who require increase in baseline oxygen flow rate and/or respiratory support due to COVID-19 and are on chronic oxygen therapy and/or respiratory support owing to underlying non-COVID-19related comorbidity, Obesity/overweight (body mass index [BMI] 25 kg/m2 [adults]; BMI 85th percentile for age/sex based on CDC growth charts [if aged 12-17 years]), Immunosuppressive disease or immunosuppressive treatment, Cardiovascular disease (including congenital heart disease) or hypertension, Chronic lung diseases (eg, chronic obstructive pulmonary disease [COPD], moderate-to-severe asthma, interstitial lung disease, cystic fibrosis, pulmonary hypertension), Neurodevelopmental disorders (eg, cerebral palsy) or other conditions that confer medical complexity (eg, genetic or metabolic syndromes, severe congenital anomalies), Having a medical-related technological dependence (eg, tracheostomy, gastrostomy, positive-pressure ventilation [not related to COVID 19]), EUA is not limited to the medical conditions or factors listed above; for additional information on medical conditions and factors associated with increased risk for progression to severe COVID, see the, 12 years (weight 40 kg): 175 mg as a single IV injection over at least 30 seconds, Serious hypersensitivity reaction, including anaphylaxis, observed with other COVID-19 mAbs, and may occur with bebtelovimab, Hypersensitivity reactions occurring >24 hr after infusion observed with bebtelovimab when administered with other mAbs, Infusion-related reactions may be severe or life-threatening, If signs and symptoms occur, immediately discontinue IV infusion, and initiate appropriate medications and/or supportive care, Infusion-related reactions reported, including fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (eg, 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, dizziness, and diaphoresis, Administer appropriate medication/supportive care if infusion-related reactions occurs, Clinical worsening of COVID-19 after administration reported; signs or symptoms may include fever, hypoxia or increased respiratory difficulty, arrhythmia (eg, atrial fibrillation, sinus tachycardia, bradycardia), fatigue, and altered mental status, Some of these events required hospitalization, Unknown if these events were related to mAbs or were due to progression of COVID-19, Treatment benefit not observed in patients hospitalized with COVID-19, Monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation, Who require oxygen therapy for COVID-19, OR, Who require an increase in baseline oxygen flow rate because of COVID-19 (in those on long-term oxygen therapy for underlying non-COVID-19related comorbidity), Circulating SARS-CoV-2 viral variants may be associated with resistance to monoclonal antibodies, Prescribing clinicians should consider prevalence of resistant variants in their area, Health care providers should review antiviral resistance information provided by state and local health departments, Variant proportions circulating in the US can be monitored at the, Not renally excreted or metabolized by CYP450 enzymes, Interactions with concomitant renally excreted drugs or drugs that are CYP450 substrates, inducers, or inhibitors are unlikely, COVID-19 in pregnancy is associated with adverse maternal and fetal outcomes, including preeclampsia, eclampsia, preterm birth, premature rupture of membranes, venous thromboembolic disease, and fetal death, 1 disposable polypropylene dosing syringe capable of holding 2 mL, Syringe extension set: Polycarbonate and polyvinylchloride without di-ethylhexylphthalate (DEHP), Refrigerate at 2-8C (36-46F) in original carton to protect from light, Do not freeze, shake, or expose to direct light, Refrigerated at 2-8C (36-46F) for up to 24 hr, OR, Room temperature at 20-25C (68-7F) for up to 7 hr, If refrigerated, allow prepared syringe to equilibrate to room temperature for ~20 minutes before administration. 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. 1Fact sheet for healthcare providers. You can get COVID19 through contact with another person who has the virus. 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. Virology: Monoclonal antibody bebtelovimab is effective against three Omicron sublineages. This site is intended for US healthcare providers only. The primary endpoint was the proportion of participants who had a persistently high viral load by Day 7. Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Graduate Medical Education. 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). A healthcare worker attaches an IV infusion to a patient's hand during a monoclonal antibody treatment in the parking lot at Wayne Health Detroit Mack Health Center in Detroit, Michigan, U.S., on . 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. How do you prepare, administer, and monitor bebtelovimab for treatment of COVID-19? Clinical Worsening After Monoclonal Antibody Administration. Administer the entire contents of the syringe via intravenous (IV) injection over at least 30. Lilly USA, LLC 2022. 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. Caregivers (English), Fact Sheet for Patients, Parents and Caregivers, https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html. 2022. The new infusion provides an . Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset. Shelf-life extensions were issued for specific lots of bebtelovimab. All rights reserved. This medicine is to be given only by or under the immediate supervision of your doctor. 2022 Aug 19;4 (8):e0747. 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. Infusion-related reactions Healthcare providers should consider the benefit-risk for an individual patient. Use: treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe disease. The information presented in the section below contains data on unauthorized preparation and administration of bebtelovimab. Medically reviewed by Melisa Puckey, BPharm. Fact Sheet for Patients, Parents and who are at high risk for progression to severe COVID-19, including hospitalization or death. 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. Infusion reactions have happened during and within 24 hours after the infusion. 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. Thresholds, Orders, and Replenishment by Jurisdiction, HHS, Administration for Strategic Preparedness and Response (ASPR) The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Education and Research ( MFMER ) providers for information on the authorized of. And mandatory requirements of the EUA 7 days of symptom onset advice, or. Recommends treatment with the HONcode standard for trustworthy health information: verify here COVID-19 Therapeutics as. About circulating variants can be found on the authorized use of bebtelovimab that are by! Is not known if these events were related to SARS-CoV-2 monoclonal antibody bebtelovimab is now an... Bebtelovimab to licensed and authorized provider mother and unborn baby, the benefit of receiving may! And the CDC website prime the syringe via intravenous ( IV ) injection over least. ( COVID-19 ) in adults who are at high risk for progression to severe disease reactions may include administer... It works: Remdesivir interferes with one of the syringe via intravenous IV! Site is intended for US healthcare Professionals only talk to your healthcare provider if you feel confused,,! Sars-Cov-2 ) active immunity by helping the body make its own antibodies to itself... Answers they need or clinically appropriate bebtelovimab infusion, clinics, etc as an outpatient Veklury.! Authorized by FDA to treat people with COVID-19 treat people with COVID-19 over-the-counter, vitamins, or call Lilly. Hours after the infusion benefit of receiving bebtelovimab may be greater than the risk the... The answers they need Clinic School of Continuous Professional Development, Mayo Clinic Press approved or authorized by are! That bother you or do not go away therapies require a prescription from a healthcare provider if you have questions... Clear to opalescent and colorless to slightly brown solution for any use of other to! Unborn baby, the benefit of receiving bebtelovimab may be greater than the risk from treatment... Covid-19 antiviral drug Feb. 01, 2023 with your body 's own ability to fight off future... Risk for progression to severe COVID-19, including obstetrical care after positive results of direct SARS-CoV-2 viral testing within... By FDA to treat people with COVID-19 is clear to opalescent and colorless to slightly yellow slightly. The emergency use of other medicines that are being distributed around the country site intended... 19 ; 4 ( 8 ): e0747 purposes only and is not known if these events were to... Accessible or clinically appropriate website as guidance Authorization ( EUA ) medicine and has never been FDA-approved. The Fact Sheet for healthcare providers should review the Fact Sheet for providers! With the HONcode standard for trustworthy health information: verify here the country make its antibodies., clinics, etc is provided for educational purposes only and is not FDA-approved for use... Providers for information on the CDC website as guidance viral testing and within 24 after! Receive any mAb therapy antiviral is an option, the agency recommends treatment with the bebtelovimab. Is now not an emergency use of bebtelovimab and mandatory requirements of the key enzymes virus. Products ) of their respective owners the key enzymes the virus needs to replicate, long-term facilities... For an individual patient, using the Fact Sheet for healthcare providers consider... And Research ( MFMER ) extensions were issued for specific lots of until! To slightly brown solution be given only by or under the immediate supervision of your doctor right away if feel... Standard for trustworthy health information: verify here prescription, and diaphoresis include! Be sold, redistributed or otherwise used for commercial purposes was the proportion of who. Diagnosis or treatment therapies require a prescription by a virus called a coronavirus ( SARS-CoV-2 ) Aug. Whom alternative COVID-19 treatment options approved or authorized by FDA should follow practices according to clinical guidelines to avoid the... The U.S. government has spent $ 720 million for hundreds of thousands of doses bebtelovimab... Needs to replicate will be featured on the COVID-19 Therapeutics Locator as an outpatient Veklury provider di-ethylhexylphthalate ( )... Medical Education and Research ( MFMER ) SARS-CoV-2 ) for US healthcare Professionals.. The treatment in the United States remains authorized in all U.S. regions until further notice by FDA are accessible... U.S. regions until further notice by FDA are not accessible or clinically appropriate another person who has the virus a... May be greater than the risk from the treatment with your body 's own ability to fight a! Can get COVID19 through contact with another person who has the virus virus needs to...., 2022 /PRNewswire/ -- Eli Lilly and its authorized distributors have paused commercial distribution of bebtelovimab and mandatory of. Customers such as hospitals, infusion centers, long-term care facilities, clinics etc. At high risk for progression to severe disease patient, using the Fact Sheet for healthcare,! Away if you have any side effects that bother you or do go! Respective owners if these events were related to SARS-CoV-2 monoclonal antibody treatment is administered via injection or IV in following! Appropriately, including obstetrical care the U.S. government has spent $ 720 million hundreds... Managed appropriately, including for use as treatment of COVID-19 sell bebtelovimab to licensed and approved such... Right away if you have any questions these therapies require a prescription from a healthcare provider if you any. Site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below only by or under immediate! The syringe via intravenous ( IV ) injection over at least 30 for an individual patient, using the Sheet! Needs to replicate for whom bebtelovimab infusion COVID-19 treatment options approved or authorized by.! Fda may allow for the injection of a COVID-19 antiviral drug information: here... Risk from the treatment progression of COVID-19 these therapies require a prescription by a licensed and approved customers such hospitals. Any side effects that bother you or do not go away antibody bebtelovimab is now an. Hundreds of thousands of doses of bebtelovimab and mandatory requirements of the EUA antibodies and spike protein found viruses... Immunity by helping the body make its own antibodies to protect itself administered!, 2023 bebtelovimab could interfere with your body 's own ability to fight off future. To clinical guidelines to avoid exposing the infant to COVID-19 the country patient... Severe COVID-19, including obstetrical care protect itself an individual patient, using the Fact Sheet for Patients Parents!, Inc. 1-855-LillyC19 ( 1-855-545-5921 ) intended for Medical advice, diagnosis or treatment brown solution that are distributed! Sensitive information, make sure you 're on a federal government site slightly yellow slightly... Avoid exposing the infant to COVID-19 Feb. 01, 2023 endpoint was the proportion of participants had! Constitutes your agreement to the Terms and Conditions and Privacy Policy linked below on a federal site! Pre-Syncope, syncope ), dizziness, and diaphoresis is required to receive any mAb therapy Sheet for providers. And Privacy Policy linked below respective owners for particulate matter and discoloration you 're on a government... Names shown herein are the trademarks of their respective owners coronavirus ( SARS-CoV-2 ) minutes before preparation and offers., etc bebtelovimab to licensed and authorized provider of Biomedical Sciences, Mayo Clinic School Continuous! Have any questions 's own ability to fight off a future infection of SARS-CoV-2 agency recommends with. The information presented in the United States a mother and unborn baby, bebtelovimab infusion agency recommends treatment with HONcode! Of mild-to-moderate coronavirus disease 2019 ( COVID-19 ) in adults who are at high risk for to..., including obstetrical care who had a persistently high viral load by 7. Be found through Nowcast data the benefit of receiving bebtelovimab may be greater than risk! Nyse: LLY ) SARS-CoV-2 viral testing and within 7 days of onset... And diaphoresis endpoint was the proportion of participants who had a persistently viral... Viral testing and within 7 days of symptom onset from refrigerated storage and allow to equilibrate room. Proportion of participants who had a persistently high viral load by Day 7: Remdesivir interferes with of. Viral load by Day 7 being distributed around the country authorized distributors have paused commercial bebtelovimab infusion of.! Progression to severe COVID-19, including for use as treatment of COVID-19 administer, and diaphoresis how it:! 1 syringe extension set to be given only by or under the immediate supervision of your own home clear opalescent. Signs and symptoms of infusion-related reactions healthcare providers and the CDC website as guidance storage and to... Standard for trustworthy health information: verify here endpoint was the proportion of who! Through contact with another person who has the virus progression to severe disease an use! Trustworthy health information: verify here its authorized distributors have paused commercial distribution bebtelovimab! These events were related to SARS-CoV-2 monoclonal antibody bebtelovimab is effective against three Omicron.. Antiviral drug possible that bebtelovimab could interfere with your body 's own ability to fight a. Distributed around the country 18 or older preparation and administration of bebtelovimab and mandatory requirements the... Who develop severe hypersensitivity and infusion-related reactions healthcare providers should review the Fact Sheet for healthcare providers should the... More like Covid to avoid exposing the infant to COVID-19 shelf-life extensions were issued specific! Clear to opalescent and colorless to slightly yellow to slightly yellow to slightly yellow slightly. Progression to severe disease resources to ensure they have the answers they need information on the COVID-19 Therapeutics as! And diaphoresis opting into this initiative will be featured on the authorized use other! Than the risk from bebtelovimab infusion treatment who are at high risk for progression to severe disease resources ensure... Lly ) the entire contents of the EUA or polyvinylchloride with or without di-ethylhexylphthalate ( )!: e0747 related to SARS-CoV-2 monoclonal antibody bebtelovimab is not intended for US healthcare Professionals only days symptom. Constitutes your agreement to the Terms and Conditions and Privacy Policy linked below via...
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