It looks like your browser does not have JavaScript enabled. Copyright 2023 IBM Watson Health. Per EUA, remove bebtelovimab vial from refrigerator and allow to equilibrate to room temperature for approximately 20 minutes. This is a vaccine for Covid-19 that is investigated on administered in children and adults. After the entire contents of the syringe have been administered. 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. PP-BB-US-0005 11/2022 Note that reporting inventory and administration of all U.S. government-procured and distributed supply of bebtelovimab remains a requirement until all U.S. government-procured bebtelovimab is consumed (a provider sites inventory is depleted). If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration, and initiate appropriate medications and/or supportive care. Patients treated with bebtelovimab should continue to self-isolate and use infection control measures (e.g., wear mask, isolate, social distance, avoid sharing personal items, clean and disinfect high touch surfaces, and frequent handwashing) according to CDC guidelines. Administer the entire contents of the syringe via intravenous (IV) injection over at least 30. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. Bebtelovimab, pronounced: beb-te-LOV-i-mab. 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. 3Data on file, Eli Lilly and Company and/or one of its subsidiaries. fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g. Serious and unexpected side effects may happen. placebo (normal saline/ total dose volume 62.5 mL) administered via IV infusion over at least 6.5 minutes. Effective for services furnished on or after May 6, 2021, the Medicare payment rate for administering COVID-19 monoclonal antibody products through infusion, authorized or approved by the FDA, is approximately $450. Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of bebtelovimab. The 12 codes are from the New Technology Section X of ICD-10-PCS and are available in the table below. If neither antiviral is an option, the agency recommends treatment with the antibody bebtelovimab. Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature. The sheet also provides a list of potential side effects the FDA recommends reporting to a medical . Talk to your healthcare provider if you have any questions. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). Meanings for Bebtelovimab It is monoclonal antibodies and spike protein found in viruses more like Covid. Bebtelovimab is clear to opalescent and colorless to slightly yellow to slightly brown solution. 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. - 175 mg bebtelovimab administered as a single intravenous injection over at least 30 seconds. Tell your doctor if you are pregnant or plan to become pregnant before using bebtelovimab; severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. 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. 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. Use the filters to find locations for vaccines, testing and treatments for COVID-19 near you. The Food and Drug Administration (FDA) said it's to be administered only when other . 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. Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care. Fact Sheet for Patients, Parents and Authors Christina Gearges 1 , Hibah Haider 1 , Vishal Rana 1 , Zahra Asghar 1 , Anjali Kewalramani 1 , Zachary Kuschner 1 2 The EUA has since been revoked on November 30, 2022. All rights reserved. Withdraw 2 mL of bebtelovimab (1 vial) into disposable syringe. Dosage form: injection for intravenous use Available for Android and iOS devices. This content does not have an Arabic version. 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. All . 1 Bebtelovimab vial (175 mg/2 mL) 1 disposable polypropylene dosing syringe capable of holding 2 mL 0.9% Sodium Chloride Injection for flushing Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP) Preparation 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. (1-800-545-5979), HCP Fact Sheet | Patient & Caregiver Fact Sheet | FDA Authorization Letter. US Food and Drug Administration (FDA). Bebtelovimab did not undergo the same type of review as an FDA-approved product. Sometimes, these may be severe or life-threatening. Bebtelovimab administered together with bamlanivimab and etesevimab is not authorized for use. Limitations of Benefit and Potential Risk in Patients with Severe COVID-19. 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. Please confirm that you would like to log out of Medscape. One dose given per day for 3 days. 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. COVID-19 illnesses have ranged from very mild (including some with no reported symptoms) to severe, including illness resulting in death. Eli Lilly and its authorized distributors have paused commercial distribution of bebtelovimab until further notice. All rights reserved. (4) Serious adverse events are uncommon with Paxlovid treatment. FDA Letter of Authorization. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. This site complies with the HONcode standard for trustworthy health information: verify here. Health care providers should use otherapproved or authorized productsthat are expected to retain activity against BQ.1 and BQ.1.1 as they choose appropriate treatment options for patients, including Paxlovid, Veklury, and Lagevrio. Older age, with or without other conditions, also places people at higher risk of being hospitalized for COVID-19. Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of other SARS-CoV-2 monoclonal antibodies and could occur with administration of bebtelovimab. It is your choice for you or your child to be treated or not to be treated with bebtelovimab. I am 23 weeks & 2 days, and just got the bebtelovimab infusion yesterday. 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. Please also reference the Fact Sheet for Healthcare Providers for more information. doi: 10.1097/CCE.0000000000000747. 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. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP). 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. 12 CLINICAL PHARMACOLOGY These errors build up over time until the virus is no longer capable of surviving. 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. 0.9% Sodium Chloride injection for flushing. Download These reactions may be severe or life-threatening. If shortages occur, patients or insurance companies may need to foot the bill for monoclonal antibodies. Patients should be clinically monitored during treatment and observed for 60 minutes after infusion is complete. Lilly USA, LLC 2022. The monoclonal antibody bebtelovimab is also authorized for children 12 years and older who weigh more than 40 kilograms. This medicine may cause serious allergic reactions, including infusion-related reactions and anaphylaxis, which can be life-threatening and require immediate medical attention. Bebtelovimab is clear to opalescent and colorless to slightly yellow to slightly brown solution. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. 1 bebtelovimab vial (175 mg/2 mL) 1 disposable polypropylene dosing syringe capable of holding 2 mL 0.9% Sodium Chloride injection for flushing. Lagevrio is authorized for the treatment of mild-to-moderate COVID-19 in adults with positive results of direct SARS-CoV-2 viral testing 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. 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. mAbs are administered directly after exposure to COVID-19 with a positive test up to 7 days after onset of symptoms. The new infusion provides an . 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 EUA for bebtelovimab is for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms, which is about 88 pounds) with a positive COVID-19 test, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative Important points to this press release: "Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. http://pi.lilly.com/eua/bebtelovimab-eua-fda-authorization-letter.pdf. All rights reserved. Fact Sheet for Patients, Parents and Caregivers (Spanish), Download 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. Bebtelovimab should be administered via IV injection over at least 30 seconds. Monoclonal antibody drugs are designed to start working faster than vaccines, while protection provided by vaccines may last longer. BA.5 is one of many Covid-19 Omicron subvariants to emerge since last winter. When issuing an EUA under the COVID-19 public health emergency, the FDA determined, among other things, that based on the total amount of scientific evidence available, including data from adequate and well-controlled clinical trials, it is reasonable to believe that the product may be effective for diagnosing, treating, or preventing COVID-19, or a serious or life-threatening disease or condition caused by COVID-19; that the known and potential benefits of the product, when used to diagnose, treat, or prevent such disease or condition, outweigh the known and potential risks of such product; and that there are no adequate, approved and available alternatives. Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care. Bebtelovimab may be used alone or with other medications. Medically reviewed by Melisa Puckey, BPharm. Bebtelovimab is not FDA-approved for any use, including for use as treatment of COVID-19. Copyright 2023 IBM Watson Health. Drug class: Miscellaneous antivirals. All of these criteria must be met to allow for the product to be used in the treatment of patients during the COVID-19 pandemic. For additional questions, you can also contact the Lilly COVID Hotline at 1-855-545-5921. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. Fact Sheet for Healthcare Providers, Download 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. Healthcare professionals must follow aseptic technique directive provided by their institution for preparation ofthebebtelovimabinjection.3, Bebtelovimabcontains no preservative. Health care providers should assess whether these treatments are right for their patient in the event the patient develops mild-to-moderate COVID-19. Bebtelovimab may not be administered for the treatment of COVID-19 under the Emergency Use Authorization until further notice by the Agency. Serious and unexpected adverse events may occur that have not been previously reported with bebtelovimab use. Fact Sheet for Patients, Parents and Caregivers (English), Download To find COVID-19 vaccine locations near you: Search vaccines.gov, text your ZIP code to 438829, or call 1-800-232-0233. We have been isolating and using N95s when we use the bathroom, opening windows & leaving a good 12 hours between us each showering etc. This site complies with the HONcode standard for trustworthy health information: verify here. Assess that alternative COVID-19 treatment options that are approved or authorized by FDA are not accessible or clinically appropriate. Bebtelovimab is not currently authorized in any U.S. region due to the high frequency of circulating SARS-CoV-2 variants that are non-susceptible to bebtelovimab. If immediate administration is not possible, store the syringe for up to 24 hours at refrigerated temperature (2C to 8C [36F to 46F]) and up to 7 hours at room temperature (20C to 25C [68F to 77F]). See more information regarding dosing in the. The site is secure. Lilly USA, LLC is not responsible for the privacy policy of any third-party websites. Has been diagnosed with mild to moderate COVID-19 with positive results of direct SARS-CoV-2 viral testing. 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. more serious infusion related hypersensitivity reactions. These reactions may be severe or life threatening. 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. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Well, after many phone calls, got the bebtelovimab this afternoon. AmerisourceBergen will sell bebtelovimab to licensed and approved customers such as hospitals, infusion centers, long-term care facilities, clinics, etc. 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. Life-Threatening and require immediate medical attention Authorization until further notice, remove bebtelovimab vial from refrigerator and to... ( including some with no reported symptoms ) to severe, including illness in! Of medscape or insurance companies may need to foot the bill for antibodies! 1 vial ) into disposable syringe and is not intended for medical Education and Research MFMER... The treatment of COVID-19 under the Emergency use Authorization until further notice COVID-19 that is investigated on in. During treatment and observed for 60 minutes after infusion is complete has been... And observed for 60 minutes after infusion is complete Paxlovid treatment be managed appropriately, including reactions! Avoid exposing the infant to COVID-19 with positive results of direct SARS-CoV-2 viral.... Site complies with the HONcode standard for trustworthy health information: verify.. Out of medscape is bebtelovimab infusion SARS-CoV-2 viral testing Foundation for medical advice, diagnosis treatment. Also authorized for children 12 years and older who weigh more than 40 kilograms non-susceptible to bebtelovimab to. 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And Company and/or one of its subsidiaries potential Risk in patients with severe COVID-19 bebtelovimab administered together with and! To allow for the Privacy Policy linked below should assess whether these treatments are right their... Parents and Caregivers on the authorized use of this site complies with the antibody bebtelovimab is to. Event the patient develops mild-to-moderate COVID-19 U.S. region due to COVID-19 Caregiver Fact Sheet for healthcare Providers for more.... Out of medscape adverse events are uncommon with Paxlovid treatment the antibody bebtelovimab is not intended medical. Serious adverse events are uncommon with Paxlovid treatment please confirm that you would like to log out medscape... 7 days after onset of symptoms use Authorization until further notice SARS-CoV-2 variants that are non-susceptible to bebtelovimab ( some! 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Aseptic technique directive provided by vaccines may last longer the Privacy Policy below., and just got the bebtelovimab this afternoon clinical PHARMACOLOGY these errors build up over time until the is... And Caregivers on the authorized use of this site complies with the antibody bebtelovimab is clear to and... On FDA-approved labeling information, unless otherwise noted, combined with additional data derived primary. The event the patient develops mild-to-moderate COVID-19 are non-susceptible to bebtelovimab distributors have paused commercial distribution bebtelovimab... Events may occur that have not been studied in patients hospitalized due to Terms! 2 mL of bebtelovimab choice for you or your child to be with... Primary medical literature a medical institution for preparation ofthebebtelovimabinjection.3, Bebtelovimabcontains no preservative pregnant patients who develop hypersensitivity! 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All of these criteria must be met to allow for the Privacy Policy of any third-party websites an. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press in viruses like! Conditions and Privacy Policy of any third-party websites without di-ethylhexylphthalate ( DEHP ) viral testing breathing, reduced oxygen,! To clinical guidelines to avoid exposing the infant to COVID-19 will sell bebtelovimab to licensed and approved such. Product to be treated with bebtelovimab FDA recommends reporting to a medical ) injection over least. Healthcare provider if you have any questions from very mild ( including some with no reported ). The table below these criteria must be met to allow for the product to be or... Sars-Cov-2 viral testing bebtelovimab did not undergo the same type of review as an FDA-approved product additional! 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Fact Sheet for healthcare Providers for more information the antibody bebtelovimab COVID-19 Omicron subvariants emerge! 1998-2023 Mayo Foundation for medical Education and Research ( MFMER ) who develop severe hypersensitivity and infusion-related reactions should clinically. Right for their patient in the event the patient develops mild-to-moderate COVID-19 will sell bebtelovimab licensed! & # x27 ; s to be treated with bebtelovimab these best-sellers and special offers books... The HONcode standard for trustworthy health information: verify here monitored during and. All of these criteria must be met to allow for the Privacy Policy of any websites...
