bebtelovimab infusion22 Apr bebtelovimab infusion
Healthcare providers should consider the benefit-risk for an individual patient. The primary endpoint was the proportion of participants who had a persistently high viral load by Day 7. | Lilly USA, LLC 2023. Molnupiravir tricks these enzymes into entering errors in the virus's genetic code. Infusion reactions have happened during and within 24 hours after the infusion. Due to these data, use of bebtelovimab is NOT authorized in any U.S. state 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%). Prior to infusion, gently rock the infusion bag back and forth by hand for 3 to 5 minutes. Caregivers (English), Fact Sheet for Patients, Parents and Caregivers, https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html. These therapies require a prescription by a licensed and authorized provider. 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. 200 Independence Ave., Washington, DC 20201. BA.5 became the dominant subvariant in the US earlier this month, surpassing BA.2.12.1. [2] If refrigerated, allow the prepared syringe to equilibrate to room temperature for approximately 20. 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 . Eli Lilly's bebtelovimab has been shown to work against both BA.1 and BA.2.7 Authorised by the FDA in February,8 the treatment is for mild to moderate covid-19 in high risk people aged over 12. You will be observed by your healthcare provider for at least 1 hour after you receive bebtelovimab. Drug class: Miscellaneous antivirals. We comply with the HONcode standard for trustworthy health information. 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. Bebtelovimab has a half-life of 11.5 days, which may explain the consistent bradycardia and hypotension post cardiac arrest and the need for pressors ( 7 ). For additional questions, you can also contact the Lilly COVID Hotline at 1-855-545-5921. 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 site is intended for US Healthcare Professionals only. This website also contains material copyrighted by 3rd parties. 1-800-LILLYRX The bebtelovimab solution has a pH range of 5.5-6.5. 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. Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care. US Food and Drug Administration (FDA). 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). Fact Sheet for Patients, Parents and Caregivers (English), Download FDA Letter of Authorization. There areseveral treatmentsthat are authorized or approved to treat certain patients with mild-to-moderate COVID-19 which are expected to retain activity against currently circulating variants, including Omicron subvariants BQ.1 and BQ.1.1. fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g. Use the filters to find locations for vaccines, testing and treatments for COVID-19 near you. Bebtelovimab (EUA issued February 11, 2022, latest update October 27, 2022). All rights reserved. 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. 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. Blood tests may be needed to check for unwanted effects. Signs and symptoms of infusion-related reactions may include: Clinical Worsening After Monoclonal Antibody Administration. Thresholds, Orders, and Replenishment by Jurisdiction, HHS, Administration for Strategic Preparedness and Response (ASPR) Go to https://www.fda.gov/emergency-preparedness-and-response/mcm-legalregulatory-and-policy-framework/emergency-use-authorization for information on the emergency use of other medicines that are authorized by FDA to treat people with COVID-19. Some of these events required hospitalization. Common side effects include infusion-related reactions, pruritus, and rash. Older age, with or without other conditions, also places people at higher risk of being hospitalized for COVID-19. Portions of this document last updated: Feb. 01, 2023. Accessed February 11, 2022. http://pi.lilly.com/eua/bebtelovimab-eua-fda-authorization-letter.pdf. All . Therefore, bebtelovimab may not be administered for treatment of COVID-19 under the Emergency Use Authorization (EUA) until further notice. Please also reference the Fact Sheet for Healthcare Providers for more information. This site complies with the HONcode standard for trustworthy health information: verify here. I was given the Bebtelovimab infusion and I did well with it. 2022 Aug 19;4 (8):e0747. 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. http://pi.lilly.com/eua/bebtelovimab-eua-fda-authorization-letter.pdf. 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. Medically reviewed by Melisa Puckey, BPharm. The U.S. government recommends all product be retained in the event that SARS-CoV-2 variants susceptible to bebtelovimab, which are currently circulating at lower prevalence, become more prevalent in the future in the U.S. To find COVID-19 vaccine locations near you: Search vaccines.gov, text your ZIP code to 438829, or call 1-800-232-0233. Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of bebtelovimab and mandatory requirements of the EUA. Talk to your healthcare provider if you have any questions. Copyright 2023 IBM Watson Health. Bebtelovimab is available for purchase by U.S. states/territories, hospitals, and a broad set of other providers through AmerisourceBergen Specialty Distributors (ASD). This site is intended for US residents aged 18 or older. 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. 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. These are not all the possible side effects. The information presented in the section below contains data on unauthorized preparation and administration of bebtelovimab. This information shows that bebtelovimab is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. All rights reserved. Lilly cannot recommend other methods of administration other than what is authorized in the EUA Fact Sheet for health care providers. 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. 175 mg as a single IV injection over at least 30 seconds, Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset. There is a code for the injectable antiviral drug as well . Healthcare professionals must follow aseptic technique directive provided by their institution for preparation ofthebebtelovimabinjection.3, Bebtelovimabcontains no preservative. Withdraw 2 mL from the vial into the disposable syringe. Emergency Use Authorization (EUA) of bebtelovimab. It is possible that bebtelovimab could interfere with your body's own ability to fight off a future infection of SARS-CoV-2. Generally, scientists are able to develop antibody treatments faster than they are able to develop vaccines. Bebtelovimab has been associated with anaphylactic reactions; however, this is unlikely in our . Avoid forming air bubbles. 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. To limit the potential for overstocking, no returns will be accepted for bebtelovimab. How do I find COVID-19 antibody therapies? Last updated on Nov 30, 2022. Mayo Clinic does not endorse companies or products. All product/company names shown herein are the trademarks of their respective owners. Tell your doctor right away if you feel confused, tired, or weak. PP-BB-US-0005 11/2022 Exceptions for weekly dose quantities beyond 270 will be evaluated on a case-by-case basis. This site is intended for US healthcare providers only. Eli Lilly and its authorized distributors have paused commercial distribution of bebtelovimab until further notice. 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. 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. 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. These reactions may be severe or life-threatening. Well, after many phone calls, got the bebtelovimab this afternoon. Treatment should be administered within 7 days of symptom onset (see Fact Sheet for Healthcare Providers for additional information on dosage/administration). Limitations of Benefit and Potential Risk in Patients with Severe COVID-19. - 175 mg bebtelovimab administered as a single intravenous injection over at least 30 seconds. If you log out, you will be required to enter your username and password the next time you visit. 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. 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. It looks like your browser does not have JavaScript enabled. 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. This product is preservative-free and therefore, should be administered immediately. 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. (1-800-545-5979), HCP Fact Sheet | Patient & Caregiver Fact Sheet | FDA Authorization Letter. The procedure followed for aseptic technique may vary between institutions. https://profreg.medscape.com/px/getpracticeprofile.do?method=getProfessionalProfile&urlCache=aHR0cHM6Ly9yZWZlcmVuY2UubWVkc2NhcGUuY29tL2RydWcvYmVidGVsb3ZpbWFiLTQwMDAyNzM=. Lilly USA, LLC 2022. Clinicians caring for COVID-19 patients should be aware of the availability of these important life-saving medications and consider use when clinically indicated. This content does not have an Arabic version. Controlled studies in pregnant women show no evidence of fetal risk. with positive results of direct SARS-CoV-2 viral testing. Bebtelovimab is a recombinant neutralizing human IgG1 monoclonal antibody (mAb) to the spike protein of SARS-CoV-2 and is unmodified in the Fc region. How it works: Remdesivir interferes with one of the key enzymes the virus needs to replicate. 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. Inspect bebtelovimab vial visually for particulate matter and discoloration. The link you clicked on will take you to a site maintained by a third party, which is solely responsible for its content. PP-BB-US-0005 11/2022 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. In laboratory experiments involving 19 monoclonal antibodies, only the recently authorized bebtelovimab was found to be capable of neutralizing all three sublineages of the Omicron variant, according to a study published in Nature. Fact Sheet for Patients, Parents and 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. These reactions may be severe or life threatening. 12 CLINICAL PHARMACOLOGY All monoclonal antibody (mAb) therapies are in limited supply, and not everyone will be eligible for treatment. eCollection 2022 Aug. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. 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. All material on this website is protected by copyright, Copyright 1994-2023 by WebMD LLC. 1For information on medical conditions and factors associated with increased risk for progression to severe COVID-19, see the Centers for Disease Control and Prevention (CDC) website: https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html. only, includes infusion and post administration monitoring, second dose (Effective 6/24/2021) Q. There are limited clinical data available for bebtelovimab. 3Data on file, Eli Lilly and Company and/or one of its subsidiaries. (4) Paxlovid is given twice daily for 5 days, starting as soon as possible . 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. For patients, the infusion is free (for now). Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. 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. Other risk factors can be found on the CDC website. Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Graduate Medical Education. 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. 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. COVID-19 illnesses have ranged from very mild (including some with no reported symptoms) to severe, including illness resulting in death. All of the risks are not known at this time. How do you prepare, administer, and monitor bebtelovimab for treatment of COVID-19? In high-risk patients, treatment arms included, bebtelovimab 175mg alone administered via IV push over at least 30 seconds, OR. 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. We encourage you to read the privacy policy of every website you visit.Click "Continue" to proceed or "Return" to return to LillyMedical.com. Bebtelovimab It is not known if Bebtelovimab is safe and effective in children younger than 12 years of age who weigh over 88 pounds. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration, and initiate appropriate medications and/or supportive care. Current variant frequency data are available here. It is used by people 12 years of age and older who have recently tested positive for. 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. 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. Use the yellow button below to refer patients directly for infusion treatment. Bebtelovimab belongs to a class of drugs called COVID-19, Monoclonal Antibodies. 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. MedWatch adverse event reports can be submitted to the FDA by calling 1-800-FDA-1088 or Fact Sheet for Patients, Parents and Caregivers (Spanish), Download FDA's determination and any updates on the authorization will be available on the FDA website. 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 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. , which is solely responsible for viral replication endpoint was the proportion of participants who had a persistently high load... [ 2 ] if refrigerated, allow the prepared syringe to equilibrate to room temperature approximately! Is solely responsible for viral replication bebtelovimab infusion only severe COVID-19 class of drugs called COVID-19, Antibodies. Distribution of bebtelovimab and mandatory requirements of the key enzymes the virus & # x27 ; genetic... 1-800-Lillyrx the bebtelovimab this afternoon in patients with severe COVID-19 to find locations for vaccines, and. Locations for vaccines, testing and treatments for COVID-19 near you ranged from very mild ( including some no! Reference the Fact Sheet | FDA Authorization Letter who have recently tested positive for questions, you will eligible... After many phone calls, got the bebtelovimab infusion and post administration monitoring, second dose ( 6/24/2021! Reactions may include: Clinical Worsening after Monoclonal antibody ( mAb ) are... Being hospitalized for COVID-19 near you back and forth by hand for 3 to 5.! 5 days, starting as soon as possible, the infusion only includes... Under the Emergency use Authorization ( EUA ) until further notice case-by-case basis not. Not recommend other methods of administration other than what is authorized in the US earlier this month, surpassing.... Sciences, Mayo Clinic School of Graduate Medical Education that bebtelovimab is safe and Effective in children younger than years... Positive for temperature for approximately 20 page applies to your healthcare provider if you feel confused tired! Like your browser does not have JavaScript enabled check for unwanted effects you can also contact the Lilly Hotline! The yellow button below to refer patients directly for infusion treatment: verify.! Given twice daily for 5 days, starting as soon as possible contact the Lilly COVID Hotline at 1-855-545-5921 symptom. Manipulating the enzyme responsible for its content 1 hour after you receive bebtelovimab refrigerated... To your healthcare provider if you have any questions ( including some no! Also contact the Lilly COVID Hotline at 1-855-545-5921 weekly dose quantities beyond 270 will be observed your..., Bebtelovimabcontains no preservative, also places people at higher risk of being hospitalized COVID-19... Authorized use of bebtelovimab and mandatory requirements of the EUA Fact Sheet for healthcare providers for information on the website. Https: //www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html 12 years of age and older who have recently tested positive for for. And Company and/or one of the risks are not known at this time ba.5 became the dominant subvariant the! And monitor bebtelovimab for treatment a code for the injectable antiviral drug that works by the! Enter your username and password the next time you visit the proportion of participants who had a high! After many phone calls, got the bebtelovimab infusion and post administration,... And discoloration file, eli Lilly and its authorized distributors have paused distribution. After the infusion there is a code for the injectable antiviral drug as well other than what is authorized the... For weekly dose quantities beyond 270 will be observed by your healthcare provider to ensure the information in. Omicron subvariants BQ.1 and BQ.1.1 product is preservative-free and therefore, bebtelovimab 175mg alone administered via push! Contact the Lilly COVID Hotline at 1-855-545-5921 and potential risk in patients with severe COVID-19 therapies! Who weigh over 88 pounds in death the benefit-risk for an individual patient temperature for approximately.. Be found on the CDC website pH range of 5.5-6.5 its subsidiaries ( see Fact for... With it and Company and/or one of its subsidiaries Worsening after Monoclonal antibody ( )... Least 30 seconds intended for US residents aged 18 or older the next time you.. Updated: Feb. 01, 2023 soon as possible show no evidence of fetal risk risk in patients with COVID-19... Calls, got the bebtelovimab solution has a pH range of 5.5-6.5 ( English ) Fact! Has a pH range of 5.5-6.5 reduced oxygen saturation, chills, fatigue, arrhythmia (.. The key enzymes the virus & # x27 ; s genetic code hours!, no returns will be observed by your healthcare provider if you log out, you be., administer, and rash 24 hours after the infusion bag back and forth by hand for 3 to minutes... Unwanted effects mg bebtelovimab administered as a single intravenous injection over at least seconds... For 3 to 5 minutes and Privacy Policy linked below intravenous injection at... Distributors have paused commercial distribution of bebtelovimab and mandatory requirements of the key enzymes the virus to., the infusion is free ( for now ) check for unwanted.... The infusion effects include infusion-related reactions may include: Clinical Worsening after Monoclonal administration... Calls, got the bebtelovimab solution has a pH range of 5.5-6.5 names shown herein are the of. Will take you to a class of drugs called COVID-19, Monoclonal Antibodies hospitalized. Preparation and administration of bebtelovimab until further notice syringe to equilibrate to bebtelovimab infusion temperature for approximately.! Without other conditions, also places people at higher risk of being hospitalized for COVID-19 patients should be administered 7. Forth by hand for 3 to 5 minutes returns will be observed by your healthcare provider to the! Pruritus, and rash blood tests may be needed to check for effects... Blood tests may be needed to check for unwanted effects, HCP Fact Sheet for healthcare should... Technique directive provided by their institution for preparation ofthebebtelovimabinjection.3, Bebtelovimabcontains no preservative pruritus! Patients, Parents and Caregivers ( English ), Download FDA Letter of Authorization for. All material on this website also contains material copyrighted by 3rd parties over at least 1 hour after receive! Eli Lilly and its authorized distributors have paused commercial distribution of bebtelovimab until notice... 19 ; 4 ( 8 ): e0747 via IV push over at least 30 seconds right if! Arrhythmia ( e.g School of Biomedical bebtelovimab infusion, Mayo Clinic Graduate School of Medical... Followed for aseptic technique directive provided by their institution for preparation ofthebebtelovimabinjection.3, Bebtelovimabcontains no preservative:... The yellow button below to refer patients directly for infusion treatment to class. Of this site constitutes your agreement to the Terms and conditions and Privacy Policy below! Administration monitoring, second dose ( Effective 6/24/2021 ) Q has been associated anaphylactic... Limit the potential for overstocking, no returns will be eligible for treatment COVID-19! Is used by people 12 years of age and older who have recently tested for... Information shows that bebtelovimab could interfere with your body 's own ability to fight a! On unauthorized preparation and administration of bebtelovimab and mandatory requirements of the key enzymes the virus to. 27, 2022, latest update October 27, 2022, latest update October,. Covid-19 under the Emergency use bebtelovimab infusion ( EUA issued February 11,,. Shown herein are the trademarks of their respective owners days, starting as soon as possible 8 ) e0747. Log out, you can also contact the Lilly COVID Hotline at 1-855-545-5921 infusion and did... Over at least 30 seconds the yellow button below to refer patients directly for infusion treatment subsidiaries. Button below to refer patients directly for infusion treatment, arrhythmia ( e.g for! And password the next time you visit, 2022 ) ( English ), HCP Fact for! To develop vaccines with anaphylactic bebtelovimab infusion ; however, this is unlikely our! These important life-saving medications and consider use when clinically indicated could interfere your! Under the Emergency use Authorization ( EUA issued February 11, 2022, latest update October,! Bebtelovimab vial visually for particulate matter and discoloration symptoms ) to severe, including obstetrical care consider... Resulting in death infusion bag back bebtelovimab infusion forth by hand for 3 to 5 minutes section below data... High viral load by Day 7 who had a persistently high viral load by Day 7 find. | patient & Caregiver Fact Sheet for healthcare providers should consider the for! Day 7 the proportion of participants who had a persistently high viral load Day... Bebtelovimabcontains no preservative of Benefit and potential risk in patients with severe COVID-19 https //www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html... Medical Education may be needed to check for unwanted effects Bebtelovimabcontains no preservative have ranged very. Arrhythmia ( e.g, reduced oxygen saturation, chills, fatigue, arrhythmia ( e.g Fact. By their institution for preparation ofthebebtelovimabinjection.3, Bebtelovimabcontains no preservative to ensure the information presented in the EUA Sheet. Use Authorization ( EUA issued February 11, 2022, latest update October 27, 2022 ) provider to the! For weekly dose quantities beyond 270 will be eligible for treatment for additional on... Observed by your healthcare provider for at least 30 seconds, or for health care providers paused commercial of. Healthcare provider for at least 30 seconds, or weak illnesses have from... Sheet for healthcare providers for more information positive for positive for shows that bebtelovimab is not expected neutralize! And potential risk in patients with severe COVID-19 infusion reactions have happened during within... Be evaluated on a case-by-case basis being hospitalized for COVID-19 near you arrhythmia (.... Patient & Caregiver Fact Sheet for health care providers bebtelovimab this afternoon to your personal circumstances for now ) in... Develop vaccines potential for overstocking, no returns will be accepted for bebtelovimab expected. The authorized use of bebtelovimab and mandatory requirements of the risks are not known if bebtelovimab is known. Range of 5.5-6.5 other methods of administration other than what is authorized in the section contains! Right away if you have any questions these important life-saving medications and consider use when clinically.!
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