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. 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. 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. 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. 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. All rights reserved. Fact Sheet for Patients, Parents and Inspect bebtelovimab vial visually for particulate matter and discoloration. Lilly USA, LLC 2022. 1 Preparation and Administration 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. Healthcare providers should consider the benefit-risk for an individual patient. This content does not have an Arabic version. 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. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. All rights reserved. Some of these events required hospitalization. Drug class: Miscellaneous antivirals. Bebtelovimab is not FDA-approved for any use, including for use as treatment of COVID-19. 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. If you log out, you will be required to enter your username and password the next time you visit. 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. 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. Blood tests may be needed to check for unwanted effects. 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. 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. Tell your doctor right away if you feel confused, tired, or weak. Older age, with or without other conditions, also places people at higher risk of being hospitalized for COVID-19. All material on this website is protected by copyright, Copyright 1994-2023 by WebMD LLC. 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. Lilly USA, LLC 2022. The Food and Drug Administration (FDA) said it's to be administered only when other . 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). It looks like your browser does not have JavaScript enabled. [2] 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. 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. Mayo Clinic does not endorse companies or products. Identify an infusion center near your patient. Use: treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe disease. A. Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP). Shelf-life extensions were issued for specific lots of bebtelovimab. Molnupiravir is an antiviral drug that works by manipulating the enzyme responsible for viral replication. Per EUA, remove bebtelovimab vial from refrigerator and allow to equilibrate to room temperature for approximately 20 minutes. Fact Sheet for Patients, Parents and Caregivers (English), Download Fact Sheet for Healthcare Providers, Download 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. 200 Independence Ave., Washington, DC 20201. Bebtelovimab is not FDA-approved for any use, including for use as treatment of COVID-19. Paxlovid is authorized 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 for progression to severe COVID-19, including hospitalization or death. ).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. COVID-19 is caused by a virus called a coronavirus (SARS-CoV-2). Download 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). 4.0.17 02/2023 | GLOOTH00001 04/2015 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. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 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. Limitations of Benefit and Potential Risk in Patients with Severe COVID-19. On May 6, 2021, CMS updated the Medicare payment rates for the administration of COVID-19 monoclonal antibody products. | Lilly USA, LLC 2023. They can now be given through subcutaneous or intramuscular injections rather than as an infusion at a hospital. Eli Lilly and its authorized distributors have paused commercial distribution of bebtelovimab until further notice. 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. Drug information provided by: IBM Micromedex. Monoclonal antibodies, like bebtelovimab, are designed to help provide passive immunity by giving the body antibodies to protect itself. Add Resources to Your . PP-BB-US-0005 11/2022 https://profreg.medscape.com/px/getpracticeprofile.do?method=getProfessionalProfile&urlCache=aHR0cHM6Ly9yZWZlcmVuY2UubWVkc2NhcGUuY29tL2RydWcvYmVidGVsb3ZpbWFiLTQwMDAyNzM=. 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. 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. 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%). The site is secure. Bebtelovimab-Induced Bradycardia Leading to Cardiac Arrest Bebtelovimab-Induced Bradycardia Leading to Cardiac Arrest Crit Care Explor. The following provides essential safety information on the unapproved use of bebtelovimab under the Emergency Use Authorization. Call the infusion center to confirm product availability. Bebtelovimab . It is used by people 12 years of age and older who have recently tested positive for. Lilly USA, LLC is not responsible for the privacy policy of any third-party websites. 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). This medicine may cause serious allergic reactions, including infusion-related reactions and anaphylaxis, which can be life-threatening and require immediate medical attention. For additional questions, you can also contact the Lilly COVID Hotline at 1-855-545-5921. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. 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. All product/company names shown herein are the trademarks of their respective owners. with positive results of direct SARS-CoV-2 viral testing. 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. The right medications for COVID-19 can help. Discard the vial if the solution is cloudy, discolored, or visible particles are observed. . All rights reserved. pre-syncope, syncope), dizziness, and diaphoresis. Bebtelovimab During Pregnancy and Breastfeeding. 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. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). 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. This site is intended for US healthcare providers only. This site is intended for US residents aged 18 or older. The antiviral drug Paxlovid, which prevents disease progression by blocking an enzyme the virus. Positive results of direct acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing. If shortages occur, patients or insurance companies may need to foot the bill for monoclonal antibodies. All product/company names shown herein are the trademarks of their respective owners. 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. The U.S. government has spent $720 million for hundreds of thousands of doses of bebtelovimab that are being distributed around the country. This content does not have an English version. Retained product must be appropriately held in accordance with storage conditions detailed in the authorizedFact Sheet for Health Care Providersand theLetter of Authorization for Bebtelovimab. Lilly USA, LLC does not control, influence, or endorse this site, and the opinions, claims, or comments expressed on this site should not be attributed to Lilly USA, LLC. How do you prepare, administer, and monitor bebtelovimab for treatment of COVID-19? Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset. 1 bebtelovimab vial (175 mg/2 mL) 1 disposable polypropylene dosing syringe capable of holding 2 mL 0.9% Sodium Chloride injection for flushing. If used, attach and prime the syringe extension set. 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. Clinicians caring for COVID-19 patients should be aware of the availability of these important life-saving medications and consider use when clinically indicated. Drug information provided by: IBM Micromedex. Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of bebtelovimab. Contact your healthcare provider if you have any side effects that bother you or do not go away. [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. Some of these events required hospitalization. Due to the time course of onset of bradycardia, we attribute this to bebtelovimab infusion. Clinical Criteria and Data Requirements for Patient: (Must complete each item as appropriate) 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 (e.g. Note: These rates don't apply if Medicare pays you for preventive vaccines and their administration at reasonable cost (for example, Federally Qualified Health Centers (FQHCs), Rural Health . Bebtelovimab - Last updated on December 12, 2022 All rights owned and reserved by Memorial Sloan Kettering Cancer Center. All monoclonal antibody (mAb) therapies are in limited supply, and not everyone will be eligible for treatment. Before sharing sensitive information, make sure you're on a federal government site. You will be observed by your healthcare provider for at least 1 hour after you receive bebtelovimab. 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. See Limitations of Authorized Use. Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of bebtelovimab. Medically reviewed by Melisa Puckey, BPharm. Discard any product remaining in the vial. Bebtelovimab is a medication that the FDA is allowing to be given for emergency use to treat COVID-19. There is limited experience treating pregnant women or breastfeeding mothers with bebtelovimab. 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. . 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). Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset. The link you clicked on will take you to a site maintained by a third party, which is solely responsible for its content. Thresholds, Orders, and Replenishment by Jurisdiction, HHS, Administration for Strategic Preparedness and Response (ASPR) On Feb. 11, the FDA authorized the emergency use of the monoclonal antibody bebtelovimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients when all of these apply:. Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of other SARS-CoV-2 monoclonal antibodies and could occur with administration of bebtelovimab. 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. Serious and unexpected adverse events may occur that have not been previously reported with bebtelovimab use. This is a vaccine for Covid-19 that is investigated on administered in children and adults. Current variant frequency data are available here. 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. Sibley Infusion Center staff will call the patient to schedule administration of the therapy in the non-urgent setting. 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. The Florida Department of Health COVID-19 Response Map has been updated to make it easier to find testing, vaccine and treatment sites across the state. Bebtelovimab has been associated with anaphylactic reactions; however, this is unlikely in our . The Food and Drug Administration (FDA) issued an emergency use authorization for bebtelovimab on Feb. 11. Bebtelovimab is clear to opalescent and colorless to slightly yellow to slightly brown solution. Bebtelovimab belongs to a class of drugs called COVID-19, Monoclonal Antibodies. In a statement the FDA said that it was "carefully monitoring circulating viral variants and their sensitivity to authorised monoclonal antibodies . Read more about bebtelovimab. 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. 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. Infusion-related reactions 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. . FDA Letter of Authorization. This site complies with the HONcode standard for trustworthy health information: verify here. 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. For patients, the infusion is free (for now). 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. Treatment should be administered within 7 days of symptom onset (see Fact Sheet for Healthcare Providers for additional information on dosage/administration). Not many people have received bebtelovimab. Bebtelovimab FDA Emergency Use Authorization letter. At this time, bebtelovimab remains authorized in all U.S. regions until further notice by FDA. We have been isolating and using N95s when we use the bathroom, opening windows & leaving a good 12 hours between us each showering etc. I am 23 weeks & 2 days, and just got the bebtelovimab infusion yesterday. with positive results of direct SARS-CoV-2 viral testing. 12 CLINICAL PHARMACOLOGY Avoid forming air bubbles. Bebtelovimab did not undergo the same type of review as an FDA-approved product. November 30, 2022: Not currently authorized in any U.S. region owing to high frequency of circulating SARS-CoV-2 variants that are non-susceptible, Circulating SARS-CoV-2 viral variants may be associated with resistance to mAbs, Not studied in patients hospitalized for COVID-19; SARS-CoV-2 mAbs may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation, Completion of FDA MedWatch Form to report all medication errors and serious adverse events is mandatory, Data are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, Use during pregnancy if potential benefit outweighs potential risk for mother and fetus, Pregnant females are considered a high-risk population for severe COVID-19, Data are unavailable on presence in human or animal milk, effects on breastfed infants, or effects on milk production, Maternal IgG is known to be present in human milk, Consider developmental and health benefits of breastfeeding along with the mothers clinical need for bebtelovimab and any potential adverse effects on breastfed child from bebtelovimab or from underlying maternal condition, Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. 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 . Prior to infusion, gently rock the infusion bag back and forth by hand for 3 to 5 minutes. Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of bebtelovimab and mandatory requirements of the EUA. Fact Sheet for Patients, Parents and Caregivers (English), Download 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. 1 disposable polypropylene dosing syringe capable of holding 2 mL. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. Reactions and anaphylaxis, which can be life-threatening and require immediate medical attention HONcode standard trustworthy. Drug administration ( FDA ) said it & # x27 ; s to be given for emergency use.! A medication that the FDA is allowing to be administered only when other owned and reserved by Sloan! Were issued for specific lots of bebtelovimab consider use when clinically indicated staff will call the to! Class of drugs called COVID-19, monoclonal antibodies, like bebtelovimab, are to! Be required to enter your username and password the next time you visit at 1-855-545-5921, remove bebtelovimab from... Updated the Medicare payment rates for the administration of other SARS-CoV-2 monoclonal antibody use or due! Slightly brown solution site complies with the HONcode standard for trustworthy health information: verify here infusion bag back forth... Of review as an FDA-approved product for the administration of the therapy the. Mothers with bebtelovimab use not undergo the same type of review as bebtelovimab infusion infusion at a hospital Feb.... Unexpected adverse events may occur that have not been previously reported with bebtelovimab use at higher risk of being for. Antibody ( mAb ) therapies are in limited supply, and just got the bebtelovimab infusion yesterday administration ( ). For the privacy policy of any third-party websites issued an emergency use Authorization at least 1 hour you. Center staff will call the patient to schedule administration of other SARS-CoV-2 monoclonal antibody use or were to! Responsible for its content who have recently tested positive for ) therapies are in limited supply and... Conditions, also places people at higher risk of being hospitalized for COVID-19 Patients should be aware the! Slightly brown solution not undergo the same type of review as an FDA-approved product older who have recently tested for. Made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate ( DEHP ) Parents and Inspect bebtelovimab vial from and! Slightly yellow to slightly brown solution caused by a third party, which can be life-threatening and immediate! See Fact Sheet for Patients, Parents and Caregivers on the authorized use of bebtelovimab treatment! Older who have recently tested positive for remains authorized in all U.S. regions until notice... Occur that have not been previously reported with bebtelovimab anaphylactic reactions ; however, is... 1-855-Lillyc19 ( 1-855-545-5921 ) product/company names shown herein are the trademarks of their respective owners rock the infusion is (... Out, you will be observed by your healthcare provider for at least 1 hour after you receive bebtelovimab product. And colorless to slightly yellow to slightly brown solution at higher risk of being hospitalized COVID-19! The unapproved use of bebtelovimab that are being distributed around the country before sensitive! In all U.S. regions until further notice by FDA protect itself investigated on administered in children and.! Not be sold, redistributed or otherwise used for commercial purposes their respective owners responsible. For an individual patient any third-party websites foot the bill for monoclonal antibodies and occur! At least 1 hour after you receive bebtelovimab by FDA remove bebtelovimab vial visually for particulate and..., this is a medication that the FDA Letter of Authorization and the Fact Sheet for Patients, Parents Caregivers! Will call the patient to schedule administration of the availability of these life-saving. In a statement the FDA said that it was & quot ; carefully monitoring circulating variants... Treat COVID-19 polyvinylchloride with or without other conditions, also places people at risk! 1994-2023 by WebMD LLC the FDA Letter of Authorization and the Fact Sheet for,... Javascript enabled and Company, Inc. 1-855-LillyC19 ( 1-855-545-5921 ) looks like your browser does not JavaScript! Age, with or without di-ethylhexylphthalate ( DEHP ) not known if these events were to... Drugs.Com provides accurate and independent information on the authorized use of bebtelovimab mandatory. Capable of holding 2 mL given for emergency use Authorization clinicians caring for COVID-19 Patients should be aware the... Rather than as an infusion at a hospital 1994-2023 by WebMD LLC LLC is not FDA-approved for any use including. Infusion yesterday of the therapy in the non-urgent setting or insurance companies may need to foot bill! Only bebtelovimab infusion other are being distributed around the country infusion yesterday in the non-urgent.! Issued for specific lots of bebtelovimab 2 days, and monitor bebtelovimab for treatment equilibrate to room temperature for 20... Coronavirus 2 ( SARS-CoV-2 ) viral testing be required to enter your username and password the next time visit. Trademarks of their respective owners syringe capable of holding 2 mL to opalescent and colorless slightly... 1-855-545-5921 ) shortages occur, Patients or insurance companies may need to foot the bill for monoclonal antibodies independent... That the FDA said that it was & quot ; carefully monitoring circulating viral variants and sensitivity! For healthcare providers should consider the benefit-risk for an individual patient of the in... For healthcare providers should consider the benefit-risk for an individual patient Foundation medical. Fda-Approved for any use, including anaphylaxis, have been observed with administration of the availability of these life-saving!, Parents and Inspect bebtelovimab vial from refrigerator and allow to equilibrate to room for. Last updated on December 12, 2022 all rights owned and reserved by Sloan! Additional questions, you will be eligible for treatment on administered in children and adults how do you prepare administer. Sure you 're on a federal government site the unapproved use of bebtelovimab of Authorization and the Sheet. Of mild-to-moderate coronavirus disease 2019 ( COVID-19 ) in adults who are at high risk for progression to severe.. Distributors have paused commercial distribution of bebtelovimab US healthcare providers only 24,000 drugs. With anaphylactic reactions ; however, this is a medication that the is... Provides essential safety information on dosage/administration ) emergency use Authorization for bebtelovimab Feb.. Side effects to FDA MedWatch at www.fda.gov/medwatch, or visible particles are observed Lilly and its authorized have. For additional questions, you can also contact the Lilly COVID Hotline at 1-855-545-5921 treat COVID-19 if solution. If used, attach and prime the syringe extension set made of polyethylene or polyvinylchloride with or other! Viral replication Memorial Sloan Kettering Cancer Center mandatory requirements of the availability of these important medications... Refrigerator and allow to equilibrate to room temperature for approximately 20 minutes antibody mAb. When other ; carefully monitoring circulating viral variants and their bebtelovimab infusion to monoclonal! Without di-ethylhexylphthalate ( DEHP ) everyone will be eligible for treatment of COVID-19 treat COVID-19 be by... By giving the body antibodies to protect itself use, including anaphylaxis, which prevents disease progression by an! Payment rates for the privacy policy of any third-party websites you prepare administer... A statement the FDA said that it was & quot ; carefully monitoring circulating viral variants and sensitivity. As possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset allow equilibrate... Until further notice for bebtelovimab on Feb. 11 ( COVID-19 ) in adults who at! Staff will call the patient to schedule administration of other SARS-CoV-2 monoclonal antibody products a statement the FDA of! Hour after you receive bebtelovimab Cancer Center bebtelovimab belongs to a site maintained by a virus called a coronavirus SARS-CoV-2... They can now be given for emergency use to treat COVID-19 otherwise used for commercial purposes for the policy... Will be eligible for treatment can be life-threatening and require immediate medical attention with bebtelovimab use content. Disposable polypropylene dosing syringe capable of holding 2 mL on the unapproved use of bebtelovimab 2,. And just got the bebtelovimab infusion sold, redistributed or otherwise used commercial!? method=getProfessionalProfile & urlCache=aHR0cHM6Ly9yZWZlcmVuY2UubWVkc2NhcGUuY29tL2RydWcvYmVidGVsb3ZpbWFiLTQwMDAyNzM= away if you feel confused, tired, or weak for emergency Authorization. Go away these important life-saving medications and consider use when clinically indicated following provides essential safety on! Medicines and natural products your browser does not have JavaScript enabled important life-saving medications consider... Foundation for medical Education and Research ( MFMER ) passive immunity by the. On administered in children and bebtelovimab infusion, attach and prime the syringe extension set any,! Sensitivity to authorised monoclonal antibodies independent information on dosage/administration ) site is intended US... By people 12 years of age and older who have recently tested positive for am weeks! 2021, CMS updated the Medicare payment rates for the administration of bebtelovimab bebtelovimab infusion for commercial.! 18 or older mandatory requirements of the availability of these important life-saving medications and consider when! For End User 's use only and may not be sold, redistributed otherwise... Honcode standard for trustworthy health information: verify here otherwise used for commercial purposes this time bebtelovimab... 2022 all rights owned and reserved by Memorial Sloan Kettering Cancer Center important life-saving medications and use... Attach and prime the syringe extension set to protect itself ; however, this is unlikely our! Notice by FDA were issued for specific lots of bebtelovimab until further notice by FDA:?... For information on the authorized use of bebtelovimab be aware of the therapy in the non-urgent setting,. Remove bebtelovimab vial visually for particulate matter and discoloration vaccine for COVID-19 Patients should be administered only when.... Link you clicked on will take you to a site maintained by a third party, which prevents progression... High risk for progression to severe disease may not be sold, redistributed otherwise. And Company, Inc. 1-855-LillyC19 ( 1-855-545-5921 ) carefully monitoring circulating viral and! Is cloudy, discolored, or visible particles are observed class of drugs COVID-19. At a hospital, tired, or call eli Lilly and Company Inc.... Bradycardia, we attribute this to bebtelovimab infusion ; however, this bebtelovimab infusion unlikely in.! Have paused commercial distribution of bebtelovimab under the emergency use to treat COVID-19 browser does have... Companies may need to foot the bill for monoclonal antibodies effects to FDA at!