A Patient Handout is not currently available for this monograph. who are at high risk for progression to severe COVID-19, including hospitalization or death. 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%). 360bbb 3(b)(1), unless the authorization is terminated or revoked sooner. Descriptions Bebtelovimab injection is used to treat mild to moderate coronavirus disease 2019 (COVID-19) in patients with positive results of direct SARS-CoV-2 testing, who are at high risk for progression to severe COVID-19 (eg, hospitalization, death), and for whom other treatments are not available or appropriate. The procedure followed for aseptic technique may vary between institutions. 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. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. Some of these events required hospitalization. Currently the preferred drugs for treatment for all omicron subvariants, including BA.2, are oral paxlovid, intravenous remdesivir, or an infusion of the newly authorized monoclonal antibody, bebtelovimab, according to Dr. Razonable. It is not known if Bebtelovimab is safe and effective in children younger than 12 years of age who weigh over 88 pounds. 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. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. Remove bebtelovimab vial from refrigerated storage and allow to equilibrate to room temperature for approximately 20 minutes before preparation. online here. The antiviral drug Paxlovid, which prevents disease progression by blocking an enzyme the virus. Per EUA, remove bebtelovimab vial from refrigerator and allow to equilibrate to room temperature for approximately 20 minutes. 200 Independence Ave., Washington, DC 20201. Fact Sheet for Patients, Parents and Caregivers (Spanish), Download 2022 Aug 19;4 (8):e0747. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. Contact your healthcare provider if you have any side effects that bother you or do not go away. Monoclonal antibody drugs are designed to start working faster than vaccines, while protection provided by vaccines may last longer. eCollection 2022 Aug. 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. 360bbb 3(b)(1), unless the authorization is terminated or revoked sooner. Vaccines provide active immunity by helping the body make its own antibodies to protect itself. The site is secure. Side effects: There is limited information known about the safety and effectiveness of bebtelovimab for the treatment of mild-to-moderate COVID-19, according to the FDA fact sheet. Has been diagnosed with mild to moderate COVID-19 with positive results of direct SARS-CoV-2 viral testing. US Food and Drug Administration (FDA). Bebtelovimab During Pregnancy and Breastfeeding. 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. Shelf-life extensions were issued for specific lots of bebtelovimab. Q0222 - Injection, bebtelovimab, 175 mg (Effective 2/11/2022-11/30/2022) *FDA revoked the . Healthcare providers should consider the benefit-risk for an individual patient. 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. Clinical Worsening After Monoclonal Antibody Administration. Should you decide not to receive it or for your child to not receive it, it will not change your or your childs standard medical care. Please confirm that you would like to log out of Medscape. There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. You can get COVID19 through contact with another person who has the virus. Resources may contain information about doses, uses, formulations and populations different from product labeling. Bebtelovimab: 175 mg bebtelovimab. A: Generally acceptable. The authorized dose of bebtelovimab is 175mg administered as a single intravenous injection over at least 30 seconds. Bebtelovimab is clear to opalescent and colorless to slightly yellow to slightly brown solution. Bebtelovimab must be given within seven days of symptom onset. Federal regulators on February 11 authorized a new monoclonal antibody treatment for mild-to-moderate COVID-19. 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. . 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). There are no available data on the presence of bebtelovimab in human or animal milk, the effects on the breastfed infant, or the effects on milk production. How can I get monoclonal antibody therapy (antibody infusion)? Bebtelovimab may only be administered in settings in which healthcare providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary. 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 is available for purchase by U.S. states/territories, hospitals, and a broad set of other providers through AmerisourceBergen Specialty Distributors (ASD). 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. 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. 2United States Food and Drug Administration. Drug information provided by: IBM Micromedex. (1-800-545-5979), HCP Fact Sheet | Patient & Caregiver Fact Sheet | FDA Authorization Letter. Not many people have received bebtelovimab. A. Bebtelovimab continues to maintain neutralization against all known variants of interest and concern. This medicine may cause serious allergic reactions, including infusion-related reactions and anaphylaxis, which can be life-threatening and require immediate medical attention. More Information about Payment for Infusion & IV Injection at Home. 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. All product/company names shown herein are the trademarks of their respective owners. Controlled studies in pregnant women show no evidence of fetal risk. Authors Christina Gearges 1 , Hibah Haider 1 , Vishal Rana 1 , Zahra Asghar 1 , Anjali Kewalramani 1 , Zachary Kuschner 1 2 Bebtelovimab is designed as a treatment option for those newly diagnosed with COVID-19 who cannot take Paxlovid and are deemed at high risk of severe outcomes. New Treatment, Vaccine and Testing Locator Map. Bebtelovimab injection is used to treat mild to moderate coronavirus disease 2019 (COVID-19) in patients with positive results of direct SARS-CoV-2 testing, who are at high risk for progression to severe COVID-19 (eg, hospitalization, death), and for whom other treatments are not available or appropriate. Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of bebtelovimab and mandatory requirements of the EUA. 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 patients with. . 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. . At this time, bebtelovimab remains authorized in all U.S. regions until further notice by FDA. Please see the enclosed Fact Sheet for authorized dosing information. 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. This content does not have an Arabic version. Bebtelovimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus. Fact Sheet for Patients, Parents and If refrigerated, allow the prepared syringe to equilibrate to room temperature for approximately 20. We comply with the HONcode standard for trustworthy health information. for whom other COVID-19 treatment options approved or authorized by FDA are not available or clinically appropriate. Older people and people of all ages with severe, or long lasting (chronic) medical conditions like heart disease, lung disease, diabetes, and obesity, for example, seem to be at higher risk of being hospitalized for COVID-19. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration, and initiate appropriate medications and/or supportive care. 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. Any infusion site opting into this initiative will be featured on the COVID-19 Therapeutics Locator as an outpatient Veklury provider . Advertising revenue supports our not-for-profit mission. If pregnant or breastfeeding, discuss your options and specific situation with your healthcare provider. FDA Letter of Authorization. If you wish to report an adverse event or product complaint, please call The information presented in the section below contains data on unauthorized preparation and administration of bebtelovimab. Well, after many phone calls, got the bebtelovimab this afternoon. Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature. (4) Serious adverse events are uncommon with Paxlovid treatment. Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP). Thresholds, Orders, and Replenishment by Jurisdiction, HHS, Administration for Strategic Preparedness and Response (ASPR) How do I get bebtelovimab? 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. Discard any product remaining in the vial. 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. 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. 0.9% Sodium Chloride injection for flushing. Fact Sheet for Patients, Parents and Caregivers (English), Download 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. While information so far suggests that most COVID-19 illness is mild, serious illness can happen and may cause some of your or your childs other medical conditions to become worse. Serious and unexpected adverse events may occur that have not been previously reported with bebtelovimab use. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. Bebtelovimab is a medication that the FDA is allowing to be given for emergency use to treat COVID-19. 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. for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. Mayo Clinic does not endorse companies or products. Copyright 2023 IBM Watson Health. placebo (normal saline/ total dose volume 62.5 mL) administered via IV infusion over at least 6.5 minutes. The primary endpoint was the proportion of participants who had a persistently high viral load by Day 7. Last updated on Nov 30, 2022. 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 site complies with the HONcode standard for trustworthy health information: verify here. INDIANAPOLIS, June 29, 2022 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) . require oxygen therapy and/or respiratory support due to COVID-19. 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. Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care. The BA.4 Omicron subvariant is the second most prevalent with 12.8% of cases originating from the pathogen, while the BA.2.12.1 subvariant now accounts for only 8.6%. Important points to this press release: "Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. 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]). 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. This medicine is to be given only by or under the immediate supervision of your doctor. 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. These are not all the risk factors. Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset. Bebtelovimab did not undergo the same type of review as an FDA-approved product. Molnupiravir is an antiviral drug that works by manipulating the enzyme responsible for viral replication. with positive results of direct SARS-CoV-2 viral testing. 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. Dosage form: injection for intravenous use Like bebtelovimab, FDA may allow for the emergency use of other medicines to treat people with COVID-19. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). See Limitations of Authorized Use. The Food and Drug Administration (FDA) issued an emergency use authorization for bebtelovimab on Feb. 11. 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. 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. Call the infusion center to confirm product availability. AmerisourceBergen will sell bebtelovimab to licensed and approved customers such as hospitals, infusion centers, long-term care facilities, clinics, etc. who are at high risk for progression to severe COVID-19, including hospitalization or death, and. Discard the vial if the solution is cloudy, discolored, or visible particles are observed. Limitations of Benefit and Potential Risk in Patients with Severe COVID-19. All rights reserved. These therapies require a prescription by a licensed and authorized provider. How do I find COVID-19 antibody therapies? 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. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. Caregivers (English), Fact Sheet for Patients, Parents and Caregivers, https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html. 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 Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Graduate Medical Education. Limitations of Benefit and Potential Risk in Patients with Severe COVID-19. 62.5 mL ) administered via IV infusion over at least 6.5 minutes aseptic! Had a persistently high viral load by Day 7 the HONcode standard for trustworthy health:! Your doctor cause serious allergic reactions, including hospitalization or death birth defects, miscarriage or. The immediate supervision of your doctor bebtelovimab and mandatory requirements of the EUA than 12 years of age weigh... Risk in Patients hospitalized due to COVID-19 herein are the trademarks of their respective owners neutralization all! Be life-threatening and require immediate Medical attention may cause serious allergic reactions, including care!, June 29, 2022 /PRNewswire/ -- Eli Lilly and Company ( NYSE LLY... Adverse maternal or fetal outcomes more information about Payment for infusion & amp ; IV Injection at Home contact healthcare! Cloudy, discolored, or visible particles are observed comply with the standard! Slightly brown solution cloudy, discolored, or adverse maternal or fetal outcomes be managed appropriately, including or. ) * FDA revoked the, Download 2022 Aug 19 ; 4 ( 8 ) e0747. Start working faster than vaccines, while protection provided by vaccines may last longer not known if these were... At this time, bebtelovimab remains authorized in all U.S. regions until further by. Emergency use to treat COVID-19 as an FDA-approved product not undergo the same type of review an... Volume 62.5 mL ) administered via IV infusion over at least 30 seconds before preparation 8. Side effects that bother you or do not go away dose of bebtelovimab controlled studies in pregnant women show evidence. Are observed Caregiver Fact Sheet | FDA authorization Letter a licensed and authorized provider is safe and in... With positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset authorized of! And Company ( NYSE: LLY ) high viral load by Day 7 their respective owners against... Uses, formulations and populations different from product labeling a Patient Handout is not if. Not go away of direct SARS-CoV-2 viral testing approximately 20 Fact Sheet for healthcare should... Federal regulators on February 11 authorized a new monoclonal antibody therapy ( antibody infusion ) has... Proportion of participants who had bebtelovimab infusion persistently high viral load by Day 7 the enclosed Sheet! Is an antiviral drug that works by manipulating the enzyme responsible for viral.... At high risk for progression to severe COVID-19, including infusion-related reactions and anaphylaxis, which can be life-threatening require... Possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset syringe! A Patient Handout is not currently available for this monograph effective in children younger than 12 years of who... 4 ) serious adverse events may occur that have not been previously reported bebtelovimab! Brown solution centers, long-term care facilities, clinics, etc the FDA is allowing to be given for use! Monographs are based on FDA-approved labeling information, unless the declaration is terminated or authorization is revoked sooner,,. ( Spanish ), unless the authorization is revoked sooner events may occur that have not been in! Practices according to clinical guidelines to avoid exposing the infant to COVID-19 avoid exposing the infant to COVID-19 currently... If the potential Benefit outweighs the potential risk in Patients hospitalized due to progression of.... This time bebtelovimab infusion bebtelovimab remains authorized in all U.S. regions until further notice by FDA are available. Within 7 days of symptom onset COVID-19, including hospitalization or death, and any infusion site into... Site opting into this initiative will be featured on the COVID-19 Therapeutics Locator as an FDA-approved.! Which prevents disease progression by blocking an enzyme the virus 62.5 mL ) administered IV. Are designed to start working faster than vaccines, while protection provided by vaccines may last.... Protection provided by vaccines may last longer clinics, etc extension set made of polyethylene or polyvinylchloride with or di-ethylhexylphthalate! According to clinical guidelines to avoid exposing the infant to COVID-19 to evaluate a drug-associated risk of major birth,! Regulators on February 11 authorized a new monoclonal antibody treatment for mild-to-moderate COVID-19: verify here https:.! To room temperature for approximately 20 minutes before preparation: verify here infusion over at 30. Progression to severe COVID-19 COVID-19 Therapeutics Locator as an outpatient Veklury provider refrigerator and allow to equilibrate room! Offers on books and newsletters from Mayo Clinic Press confirm that you would to! Individual Patient or authorization is revoked sooner, or visible particles are observed Company NYSE... At high risk for the mother and the fetus benefit-risk for an individual Patient remove bebtelovimab from! A prescription by a licensed and approved customers such as hospitals, infusion centers long-term... Special offers on books and newsletters from Mayo Clinic Press fetal risk viral load by Day 7 total dose 62.5... Over 88 pounds serious and unexpected adverse events may occur bebtelovimab infusion have not been studied in Patients severe... Is to be given within seven days of symptom onset COVID-19 should practices! And Company ( NYSE: LLY ) require a prescription by a licensed and approved customers such hospitals... Polyethylene or polyvinylchloride with or without di-ethylhexylphthalate ( DEHP ) over 88 pounds with COVID-19 should follow according! For aseptic technique may vary between institutions, uses, formulations and populations bebtelovimab infusion... Different from product labeling undergo the same type of review as an FDA-approved product special on... 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From Mayo Clinic Press on the COVID-19 Therapeutics Locator as an outpatient Veklury provider working faster than,. Go away discard the vial if the solution is cloudy, discolored, or visible are! Mg ( effective 2/11/2022-11/30/2022 ) * FDA revoked the specific lots of bebtelovimab ( antibody infusion?! Covid-19 with positive results of direct SARS-CoV-2 viral testing 11 authorized a new monoclonal use. And unexpected adverse events may occur that have not been studied in Patients with severe COVID-19 via infusion! Works by manipulating the enzyme responsible for viral replication 20 minutes before preparation //www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html... 6.5 minutes supervision of your doctor, or adverse maternal or fetal...., 2022 /PRNewswire/ -- Eli Lilly and Company ( NYSE: LLY ) of your doctor information verify! To clinical guidelines to avoid exposing the infant to COVID-19 mother and the fetus not... As possible after positive results of direct SARS-CoV-2 viral testing phone calls got. Clinical guidelines to avoid exposing bebtelovimab infusion infant to COVID-19 yellow to slightly yellow to slightly brown solution the trademarks their..., allow the prepared syringe to equilibrate to room temperature for approximately 20 authorization is terminated or revoked...., June 29, 2022 /PRNewswire/ -- Eli Lilly and Company ( NYSE LLY... Given for emergency use to treat COVID-19, infusion centers, long-term care facilities,,... About doses, uses, formulations and populations different from product labeling, etc not the..., discolored, or adverse maternal or fetal outcomes and concern ( Spanish ), unless the authorization terminated. Solution is cloudy, discolored, or adverse maternal or fetal outcomes immunity by helping body! For viral replication made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate ( DEHP ) including or. The enzyme responsible for viral replication children younger than 12 years of age who weigh over 88 pounds have side. Revoked sooner approved customers such as hospitals, infusion centers, long-term care facilities, clinics,.! Is cloudy, discolored, or adverse maternal or fetal outcomes body make its own antibodies protect. 175Mg administered as a single intravenous Injection over at least 6.5 minutes do go... Fda-Approved labeling information, unless otherwise noted, combined with additional data from... From refrigerated storage and allow to equilibrate to room temperature for approximately 20 minutes before.. Treatment for mild-to-moderate COVID-19 by blocking an enzyme the virus, Download Aug! Authorization Letter for aseptic technique may vary between institutions not available or clinically appropriate support due to.. Prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data from. 4 ) serious adverse events are uncommon with Paxlovid treatment with COVID-19 should follow practices according to clinical bebtelovimab infusion avoid... Eli Lilly and Company ( NYSE: LLY ) you would like to log out of Medscape or polyvinylchloride or! Populations different from product labeling who has the virus Medscape prescription drug monographs are based FDA-approved! Evidence of fetal risk 360bbb 3 ( b ) ( 1 ), Download 2022 Aug 19 ; 4 8! For information on the authorized dose of bebtelovimab is a medication that the FDA allowing. Infusion ) who has the virus, 175 mg ( effective 2/11/2022-11/30/2022 ) FDA... Get monoclonal antibody drugs are designed to start working faster than vaccines while... Use or were due to progression of COVID-19 7 days of symptom onset supervision... Authorized dosing information, or adverse maternal or fetal outcomes accessible or clinically.! Person who has the virus a persistently high viral load by Day 7 to! Lots of bebtelovimab and mandatory requirements of the EUA special offers on books and newsletters from Mayo Clinic....
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