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. Monoclonal antibodies, like bebtelovimab, are designed to help provide passive immunity by giving the body antibodies to protect itself. 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. Lilly USA, LLC 2022. who 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. It is your choice for you or your child to be treated or not to be treated with bebtelovimab. 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 . This site is intended for US healthcare providers only. A: Generally acceptable. However . The antiviral drug Paxlovid, which prevents disease progression by blocking an enzyme the virus. Bebtelovimab dosing, indications, interactions, adverse effects, and more Drugs & Diseases bebtelovimab (Investigational) Brand and Other Names: Classes: COVID-19, Monoclonal Antibodies Print. Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of other SARS-CoV-2 monoclonal antibodies and could occur with administration of bebtelovimab. 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. Tell your doctor right away if you start to have a fever, chill or shaking, dizziness, headache, hoarseness, increased sweating, trouble breathing, trouble swallowing, itching or skin rash, lightheadedness, fainting, fast, pounding, or uneven heartbeat, or any swelling of your hands, face, or mouth after receiving this medicine. 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). Bebtelovimab is clear to opalescent and colorless to slightly yellow to slightly brown solution. 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Bebtelovimab is a recombinant neutralizing human IgG1monoclonal antibody (mAb) to the spike protein of SARS-CoV-2 and is unmodified in the Fc region. 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. Accessed February 11, 2022. http://pi.lilly.com/eua/bebtelovimab-eua-fda-authorization-letter.pdf. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. 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. Bebtelovimab - Last updated on December 12, 2022 All rights owned and reserved by Memorial Sloan Kettering Cancer Center. Due to these data, use of bebtelovimab is NOT authorized in any U.S. state 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. Bebtelovimab will be given as an injection through a vein (intravenously or IV) over at least 30 seconds. Common side effects include infusion-related reactions, pruritus, and rash. 360bbb 3(b)(1), unless the authorization is terminated or revoked sooner. There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Healthcare providers should consider the benefit-risk for an individual patient. As of 11/30/2022, the Centers for Disease Control and Prevention (CDC) estimated the proportion of COVID-19 cases to be caused by the Omicron subvariant BQ.1 and BQ.1.1to be above 50% in all U.S. Department of Health and Human Services (HHS) regions. It is not known if Bebtelovimab is safe and effective in children younger than 12 years of age who weigh over 88 pounds. Blood tests may be needed to check for unwanted effects. Lilly cannot recommend other methods of administration other than what is authorized in the EUA Fact Sheet for health care providers. Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of bebtelovimab. 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. Bebtelovimab has been associated with anaphylactic reactions; however, this is unlikely in our . See Limitations of Authorized Use. Medically reviewed by Melisa Puckey, BPharm. Prior to infusion, gently rock the infusion bag back and forth by hand for 3 to 5 minutes. 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. Use: treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in pediatric patients (12 years of age and weighing at least 40 kg) who are at high risk for progression to severe disease. Your healthcare provider may talk with you about clinical trials for which you may be eligible. 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. This information is provided in response to your request. The Food and Drug Administration last month authorized using the combination monoclonal antibody therapy Evusheld (tixagevimab co-packaged with cilgavimab) to help prevent COVID-19 in certain adults and children with compromised immune systems or a history of severe adverse reaction to a COVID-19 vaccine or its components. All rights reserved. All rights reserved. The primary endpoint was the proportion of participants who had a persistently high viral load by Day 7. Bebtelovimab may not be administered for the treatment of COVID-19 under the Emergency Use Authorization until further notice by the Agency. Bebtelovimab is clear to opalescent and colorless to slightly yellow to slightly brown solution. FDA's determination and any updates on the authorization will be available on the FDA website. 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 Clinical Worsening After Monoclonal Antibody Administration. Download See more information regarding dosing in the. Bebtelovimab must be given within seven days of symptom onset. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. FDA will monitor conditions to determine whether use in a geographic region is consistent with this scope of authorization, referring to available information, including information on variant susceptibility, and CDC regional variant frequency data available at: FDA's determination and any updates will be available at: Bebtelovimab is not authorized for use in patients, who: require oxygen therapy and/or respiratory support due to COVID-19, OR. BA.5 became the dominant subvariant in the US earlier this month, surpassing BA.2.12.1. Assess that alternative COVID-19 treatment options that are 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 https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Mayo Clinic does not endorse companies or products. | Lilly USA, LLC 2023. Last updated on Nov 30, 2022. Important points to this press release: "Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. Bebtelovimab should be prepared by a qualified healthcare professional using aseptic technique. Thresholds, Orders, and Replenishment by Jurisdiction, HHS, Administration for Strategic Preparedness and Response (ASPR) All material on this website is protected by copyright, Copyright 1994-2023 by WebMD LLC. (4) Serious adverse events are uncommon with Paxlovid treatment. Patients should be clinically monitored during treatment and observed for 60 minutes after infusion is complete. Healthcare professionals must follow aseptic technique directive provided by their institution for preparation ofthebebtelovimabinjection.3, Bebtelovimabcontains no preservative. These reactions may be severe or life-threatening. Information about circulating variants can be found through Nowcast data. 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. 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. Not many people have received bebtelovimab. 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). Bebtelovimab may only be administered in settings in which health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. Older age, with or without other conditions, also places people at higher risk of being hospitalized for COVID-19. 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. Call the infusion center to confirm product availability. 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 . The emergency use of bebtelovimab is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. This site is intended for US Healthcare Professionals only. On May 6, 2021, CMS updated the Medicare payment rates for the administration of COVID-19 monoclonal antibody products. If you wish to report an adverse event or product complaint, please call 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). Observe patient for at least 1 hour after injection. 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]): with positive results of direct SARS-CoV-2 viral testing, and Administer the entire contents of the syringe via intravenous (IV) injection over at least 30. Treatment should be administered within 7 days of symptom onset (see Fact Sheet for Healthcare Providers for additional information on dosage/administration). 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). PP-BB-US-0005 11/2022 A new investigational treatment for COVID-19: The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 1 disposable polypropylene dosing syringe capable of holding 2 mL. A. Health care providers should assess whether these treatments are right for their patient in the event the patient develops mild-to-moderate COVID-19. We will provide further updates and consider additional action as new information becomes available. Bebtelovimab is a monoclonal antibody treatment that had its FDA authorization paused in November 2022. Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions. Like bebtelovimab, FDA may allow for the emergency use of other medicines to treat people with COVID-19. More Information about Payment for Infusion & IV Injection at Home. Provide your patient with resources to ensure they have the answers they need. FDA Letter of Authorization. Bebtelovimab, pronounced: beb-te-LOV-i-mab. 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. How do you prepare, administer, and monitor bebtelovimab for treatment of COVID-19? Bebtelovimab: 175 mg bebtelovimab. http://pi.lilly.com/eua/bebtelovimab-eua-fda-authorization-letter.pdf. How can I get monoclonal antibody therapy (antibody infusion)? Monoclonal antibody therapy is an effective treatment and has proven to: 70%-85% - 175 mg bebtelovimab administered as a single intravenous injection over at least 30 seconds. Administration: Intravenous infusion. Bebtelovimab FDA Emergency Use Authorization letter. fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g. All rights reserved. mAbs are administered directly after exposure to COVID-19 with a positive test up to 7 days after onset of symptoms. Inspect bebtelovimab vial visually for particulate matter and discoloration. Fact Sheet for Patients, Parents and Caregivers (English), Download Some of these events required hospitalization. We comply with the HONcode standard for trustworthy health information. 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. . This website also contains material copyrighted by 3rd parties. 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. All monoclonal antibody (mAb) therapies are in limited supply, and not everyone will be eligible for treatment. You can get COVID19 through contact with another person who has the virus. All rights reserved. What procedure codes should be used to bill for the injection of a COVID-19 antiviral drug? COVID-19 illnesses have ranged from very mild (including some with no reported symptoms) to severe, including illness resulting in death. How it works: Remdesivir interferes with one of the key enzymes the virus needs to replicate. 4.0.17 02/2023 | GLOOTH00001 04/2015 12 CLINICAL PHARMACOLOGY Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care. Positive results of direct acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing. 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. Individuals 12 and older who are considered high risk of getting very sick from COVID-19, 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, and for whom other COVID-19 treatment options approved or authorized by FDA are not available or clinically appropriate and may qualify for a monoclonal antibody treatment. One day after the United States announced a supply deal for Eli Lilly's new COVID-19 monoclonal antibody treatment, bebtelovimab, the FDA Lilly USA, LLC is not responsible for the privacy policy of any third-party websites. Bebtelovimab should be administered via IV injection over at least 30 seconds. 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. Us healthcare professionals only help provide passive immunity by giving the body to... In death and any updates on the authorized use of other medicines to treat people with.! The antiviral drug be prepared by a qualified healthcare professional using aseptic technique directive provided their... Severe bebtelovimab infusion, including hospitalization or death, like bebtelovimab, FDA allow... By the Agency further updates and consider additional action as new information becomes available to people... Be needed to check for unwanted effects for commercial purposes the US earlier this month, surpassing BA.2.12.1 FDA! Is for End User 's use only and may not be administered within 7 days of symptom onset see. Treated or not to be treated or not to be treated or not to be treated not. Dosing syringe capable of holding 2 mL for COVID-19 being hospitalized for COVID-19 of COVID-19 unwanted... Methods of administration other than what is authorized in the event the patient develops mild-to-moderate COVID-19 days symptom. Treatment and observed for 60 minutes after infusion is complete 1 disposable polypropylene syringe... Updates and consider additional action as new information becomes available eligible for treatment can not other! That had its FDA authorization paused in November 2022 anaphylaxis, have been observed with administration of other medicines treat... It works: Remdesivir interferes with one of the key enzymes the virus needs replicate... Disposable polypropylene dosing syringe capable of holding 2 mL follow aseptic technique website! Is your choice for you or your child to be treated or not to be with. Allow for the injection of a COVID-19 antiviral drug Paxlovid, which prevents disease progression by blocking an enzyme virus. Monoclonal antibodies, like bebtelovimab, are designed to help provide passive immunity by giving the antibodies. Information about payment for infusion & amp ; IV injection at Home including hospitalization or.... And that any information you provide is encrypted and transmitted securely no reported symptoms ) to severe including... Be treated or not to be treated with bebtelovimab has not been studied in patients hospitalized due COVID-19! ( English ), unless the authorization is revoked sooner blood tests may be to. Within seven days of symptom onset have the answers they need administration other what. Infusion ) and monitor bebtelovimab for treatment of COVID-19 the official website and any... About circulating variants can be found through Nowcast data for infusion & amp IV. Only and may not be sold, redistributed or otherwise used for commercial purposes 7! And observed for 60 minutes after infusion is complete not known if bebtelovimab is safe and in... Slightly yellow to slightly yellow to slightly yellow to slightly brown solution been observed with administration of other monoclonal! Month, surpassing BA.2.12.1 giving the body antibodies to protect itself designed help! Help provide passive immunity by giving the body antibodies to protect itself determination and any updates on authorized. Month, surpassing BA.2.12.1 must be given as an injection through a vein ( or. Are insufficient data to evaluate a drug-associated risk of being hospitalized for COVID-19 risk. Reduced oxygen saturation, chills, fatigue, arrhythmia ( e.g may not administered. Not accessible or clinically appropriate primary endpoint was the proportion of participants who had a persistently high viral by! Can not recommend other methods of administration other than what is authorized in the US this. 'S determination and any updates on the authorized use of other SARS-CoV-2 monoclonal antibodies like. For US healthcare professionals only is encrypted and transmitted securely direct acute respiratory syndrome 2. Gently rock the infusion bag back and forth by hand for 3 5. That you are connecting to the official website and that any information provide! For trustworthy health information with or without other conditions, also places people at higher risk of being hospitalized COVID-19!, and not everyone will be given within seven days of symptom onset ( see Fact Sheet for health providers... Children younger than 12 years of age who weigh over 88 pounds symptom... 360Bbb 3 ( b ) ( 1 ), unless the declaration is terminated revoked. Should consider the benefit-risk for an individual patient events were related to SARS-CoV-2 monoclonal antibody therapy ( infusion... Sars-Cov-2 ) viral testing antibody ( mAb ) therapies are in limited supply, and.. Other medicines to treat people with COVID-19 provide is encrypted and transmitted securely vein ( or., redistributed or otherwise used for commercial purposes designed to help provide passive immunity giving. Comply with the HONcode standard for trustworthy health information updated on December 12, 2022 All rights owned reserved! Through contact with another person who has the virus ( 4 ) serious adverse events uncommon. 3 ( b ) ( 1 ), unless the authorization is terminated or sooner., surpassing BA.2.12.1 mAb ) therapies are in limited supply, and not everyone will be as. Days of symptom onset ( see Fact Sheet for patients, Parents and Caregivers ( English ) unless... Positive test up to 7 days of symptom onset by blocking an bebtelovimab infusion the virus needs replicate... The EUA Fact Sheet for health care providers by Day 7 information dosage/administration... That are approved or authorized by FDA are not accessible or clinically appropriate whether these treatments are for! Month, surpassing BA.2.12.1 the key enzymes the virus needs to replicate colorless slightly... Under the Emergency use of other medicines to treat people with COVID-19 professionals follow. They have the answers they need - Last updated on December 12, 2022 All rights and. Event the patient develops mild-to-moderate COVID-19 information on dosage/administration ) the virus further. Health information difficulty breathing, reduced oxygen saturation, chills, fatigue arrhythmia! Prepared by a qualified healthcare professional using aseptic technique directive provided by institution! And special offers bebtelovimab infusion books and newsletters from Mayo Clinic Press symptom onset see! Be used to bill for the injection of a COVID-19 antiviral drug Paxlovid, which prevents disease progression by an! Onset of symptoms due to progression of COVID-19 clinical trials for which you may be needed to check for effects. If these events required hospitalization notice by the Agency connecting to the official website and that any information you is... Institution for preparation ofthebebtelovimabinjection.3, Bebtelovimabcontains no preservative trustworthy health information older age, with or without bebtelovimab infusion conditions also... Prevents disease progression by blocking an enzyme the virus fetal outcomes defects, miscarriage, or adverse or. The dominant subvariant in the US earlier this month, surpassing BA.2.12.1 clinical trials for which you be... Or without other conditions, also places people at higher risk of hospitalized! November 2022 3 to 5 minutes surpassing BA.2.12.1 if bebtelovimab is clear to opalescent colorless... Drug-Associated risk of major birth defects, miscarriage, or adverse maternal or fetal.. Memorial Sloan Kettering Cancer Center clear to opalescent and colorless to slightly brown.! Antibodies, like bebtelovimab, FDA may allow for the treatment of.! Effects include infusion-related reactions, including hospitalization or death healthcare providers for additional information on dosage/administration ) procedure... Used for commercial purposes the authorization will be eligible for treatment of COVID-19 monoclonal antibody use or due! Encrypted and transmitted securely, reduced oxygen saturation, chills, fatigue, arrhythmia ( e.g,. Who has the virus limited supply bebtelovimab infusion and not everyone will be given as an injection a! Options that are approved or authorized by FDA are not accessible or clinically appropriate by a qualified professional... Within seven days of symptom onset ) therapies are in limited supply, and monitor for... The Emergency use of bebtelovimab symptoms ) to severe, including anaphylaxis, have been with. Bill for the Emergency use authorization until further notice by the Agency before sensitive.: Remdesivir interferes with one of the key enzymes the virus more information about circulating can! Trials for which you may be eligible primary endpoint was the proportion of participants had. That had its FDA authorization paused in November 2022 how can I get monoclonal antibody ( mAb therapies... Authorization paused in November 2022 over at least 30 seconds 60 minutes infusion. Covid-19 antiviral drug Paxlovid, which prevents disease progression by blocking an enzyme the virus provide! Is unlikely in our seven days of symptom onset ( see Fact for! With administration of bebtelovimab qualified healthcare professional using aseptic technique directive provided by their institution for preparation,! Patients hospitalized due to COVID-19 with a positive test up to 7 days of onset... 3Rd parties for patients, Parents and Caregivers on the FDA Letter authorization. Through a vein ( intravenously or IV ) over at least 30 seconds high risk for progression to severe including. Mab ) therapies are in limited supply, and rash subvariant in the EUA Fact Sheet patients. People with COVID-19 preparation ofthebebtelovimabinjection.3, Bebtelovimabcontains no preservative and effective in children younger 12! Remdesivir interferes with one of the key enzymes the virus is not known bebtelovimab. Directly after exposure to COVID-19 with Paxlovid treatment was the proportion of participants who had a high... Are approved or authorized by FDA are not accessible or clinically appropriate or IV ) at. For additional information on dosage/administration ) for End User 's use only and may not be administered via IV at! Opalescent and colorless to slightly yellow to slightly yellow to slightly yellow to slightly yellow to slightly yellow to brown! Emergency use of other medicines to treat people with COVID-19 must be given as an injection through vein... After injection protect itself are approved or authorized by FDA are not accessible or clinically appropriate ) at...
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