bebtelovimab infusion

Bebtelovimab is not FDA-approved for any use, including for use as treatment of COVID-19. 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. On May 6, 2021, CMS updated the Medicare payment rates for the administration of COVID-19 monoclonal antibody products. However . It is your choice for you or your child to be treated or not to be treated with bebtelovimab. See Limitations of Authorized Use. If pregnant or breastfeeding, discuss your options and specific situation with your healthcare provider. Bebtelovimab may be used alone or with other medications. Discard the vial if the solution is cloudy, discolored, or visible particles are observed. Positive results of direct acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing. 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 . 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%. All rights reserved. Vaccines provide active immunity by helping the body make its own antibodies to protect itself. There is a code for the injectable antiviral drug as well . All rights reserved. Withdraw 2 mL from the vial into the disposable syringe. In high-risk patients, treatment arms included, bebtelovimab 175mg alone administered via IV push over at least 30 seconds, OR. 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. Issued February 11, 2022. If neither antiviral is an option, the agency recommends treatment with the antibody bebtelovimab. AmerisourceBergen Specialty Distributors Tell your doctor right away if you feel confused, tired, or weak. Available for Android and iOS devices. This information shows that bebtelovimab is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. Discard any product remaining in the vial. How do you prepare, administer, and monitor bebtelovimab for treatment of COVID-19? Call the infusion center to confirm product availability. Serious and unexpected adverse events may occur that have not been previously reported with bebtelovimab use. How do I find COVID-19 antibody therapies? Eli Lilly and its authorized distributors have paused commercial distribution of bebtelovimab until further notice. Molnupiravir tricks these enzymes into entering errors in the virus's genetic code. 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. 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. Bebtelovimab will be given as an injection through a vein (intravenously or IV) over at least 30 seconds. 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. Drug information provided by: IBM Micromedex. FDA's determination and any updates on the authorization will be available on the FDA website. Bebtelovimab continues to maintain neutralization against all known variants of interest and concern. These reactions may be severe or life-threatening. Clinical Worsening After Monoclonal Antibody Administration. Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of bebtelovimab. Lilly USA, LLC 2022. Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset. Read more about bebtelovimab. Clinicians caring for COVID-19 patients should be aware of the availability of these important life-saving medications and consider use when clinically indicated. Administration: Intravenous infusion. 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. The EUA was supported by a Secretary of Health and Human Service (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic. Bebtelovimab is a medication that the FDA is allowing to be given for emergency use to treat COVID-19. Eli Lilly and Company (Lilly) does not provide an aseptic technique directive for the preparation of thebebtelovimabsolution for infusion. 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. 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. US Food and Drug Administration (FDA). Emergency Use Authorization (EUA) of bebtelovimab. If you wish to report an adverse event or product complaint, please call 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. There are limited clinical data available for bebtelovimab. Discard the vial if the solution is cloudy, discolored, or . Older age, with or without other conditions, also places people at higher risk of being hospitalized for COVID-19. Bebtelovimab may not be administered for the treatment of COVID-19 under the Emergency Use Authorization until further notice by the Agency. Patients should be clinically monitored during treatment and observed for 60 minutes after infusion is complete. If refrigerated, allow the prepared syringe to equilibrate to room temperature for approximately 20. pre-syncope, syncope), dizziness, and diaphoresis. For a mother and unborn baby, the benefit of receiving bebtelovimab may be greater than the risk from the treatment. Effective with date of service Feb. 15, 2022, the Medicaid and NC Health Choice programs cover bebtelovimab injection for intravenous use in the Physician Administered Drug Program (PADP) when billed with HCPCS code Q0222 - Injection, bebtelovimab, 175 mg. Strength/Package Size (s): Injection: 175 mg/2 mL (87.5 mg/mL) in a single-dose vial PP-BB-US-0005 11/2022 Healthcare providers should consider the benefit-risk for an individual patient. 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. Lilly USA, LLC is not responsible for the privacy policy of any third-party websites. Exceptions for weekly dose quantities beyond 270 will be evaluated on a case-by-case basis. This site is intended for US residents aged 18 or older. 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. Signs and symptoms of infusion-related reactions may include: You will be observed by your healthcare provider for at least 1 hour after you receive bebtelovimab. Observe patient for at least 1 hour after injection. Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions. Clinical Worsening After Monoclonal Antibody Administration. 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. See more information regarding dosing in the. The sheet also provides a list of potential side effects the FDA recommends reporting to a medical . Download Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of bebtelovimab. Per EUA, remove bebtelovimab vial from refrigerator and allow to equilibrate to room temperature for approximately 20 minutes. Bebtelovimab works by binding to the spike protein of the virus that causes COVID-19, similar to other mAbs that have been authorized for the treatment of high-risk patients with mild to moderate COVID-19 and shown a benefit in reducing the risk for hospitalization or death. Before sharing sensitive information, make sure you're on a federal government site. Lilly USA, LLC 2022. Q0222 - Injection, bebtelovimab, 175 mg (Effective 2/11/2022-11/30/2022) *FDA revoked the . New Treatment, Vaccine and Testing Locator Map. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. After the entire contents of the syringe have been administered. The monoclonal antibody bebtelovimab is also authorized for children 12 years and older who weigh more than 40 kilograms. 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. Information about circulating variants can be found through Nowcast data. Retained product must be appropriately held in accordance with storage conditions detailed in the authorizedFact Sheet for Health Care Providersand theLetter of Authorization for Bebtelovimab. These reactions may be severe or life-threatening. Drug information provided by: IBM Micromedex. Bebtelovimab injection is used to treat COVID-19 infection in certain non-hospitalized adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) and who have mild to moderate COVID-19 symptoms. Medscape Education, Critical Concepts for the Treatment of COVID-19 Variants, 2001http://www.medscape.com/mtv/covid19-treatment-ous-s01/e01, encoded search term (bebtelovimab) and bebtelovimab, Drug Companies Face COVID Cliff in 2023 as Sales Set to Plummet, FDA Pulls Authorization for AstraZeneca's COVID-19 Treatment Evusheld, COVID-19 Monoclonal Antibody Treatments No Longer Effective, Your Unwanted Internal Pets: Intestinal Parasites (Other Than Nematodes), EU Regulator Recommends Against Approval for Merck's COVID Pill for Adults, COVID-19: Treatment Advances in a Global Pandemic, Rapid Rx Quiz: COVID-19 Treatment Updates. 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. 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. An official website of the United States government, : The Food and Drug Administration (FDA) said it's to be administered only when other . FDA Letter of Authorization. Bebtelovimab did not undergo the same type of review as an FDA-approved product. . eCollection 2022 Aug. This content does not have an English version. We have been isolating and using N95s when we use the bathroom, opening windows & leaving a good 12 hours between us each showering etc. Common side effects include infusion-related reactions, pruritus, and rash. The information presented in the section below contains data on unauthorized preparation and administration of bebtelovimab. Generic name: bebtelovimab These errors build up over time until the virus is no longer capable of surviving. What procedure codes should be used to bill for the injection of a COVID-19 antiviral drug? Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions. Bebtelovimab . Withdraw 2 mL of bebtelovimab (1 vial) into disposable syringe. FDA Letter of Authorization. The .gov means its official.Federal government websites often end in .gov or .mil. 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. There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). All . Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. November 30, 2022: Not currently authorized in any U.S. region owing to high frequency of circulating SARS-CoV-2 variants that are non-susceptible, Circulating SARS-CoV-2 viral variants may be associated with resistance to mAbs, Not studied in patients hospitalized for COVID-19; SARS-CoV-2 mAbs may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation, Completion of FDA MedWatch Form to report all medication errors and serious adverse events is mandatory, Data are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, Use during pregnancy if potential benefit outweighs potential risk for mother and fetus, Pregnant females are considered a high-risk population for severe COVID-19, Data are unavailable on presence in human or animal milk, effects on breastfed infants, or effects on milk production, Maternal IgG is known to be present in human milk, Consider developmental and health benefits of breastfeeding along with the mothers clinical need for bebtelovimab and any potential adverse effects on breastfed child from bebtelovimab or from underlying maternal condition, Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. 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. A Patient Handout is not currently available for this monograph. Advertising revenue supports our not-for-profit mission. Bebtelovimab is available for purchase by U.S. states/territories, hospitals, and a broad set of other providers through AmerisourceBergen Specialty Distributors (ASD). Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset. 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. 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. 1 bebtelovimab vial (175 mg/2 mL) 1 disposable polypropylene dosing syringe capable of holding 2 mL 0.9% Sodium Chloride injection for flushing. 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. All material on this website is protected by copyright, Copyright 1994-2023 by WebMD LLC. 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. 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. For additional questions, you can also contact the Lilly COVID Hotline at 1-855-545-5921. Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of other SARS-CoV-2 monoclonal antibodies and could occur with administration of bebtelovimab. Do not shake the vial. 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. (1-800-545-5979), HCP Fact Sheet | Patient & Caregiver Fact Sheet | FDA Authorization Letter. Dosage form: injection for intravenous use Assess that alternative COVID-19 treatment options that are approved or authorized by FDA are not accessible or clinically appropriate. 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. 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 . 2United States Food and Drug Administration. Mayo Clinic does not endorse companies or products. How it works: Remdesivir interferes with one of the key enzymes the virus needs to replicate. INDIANAPOLIS, June 29, 2022 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) . If shortages occur, patients or insurance companies may need to foot the bill for monoclonal antibodies. The bebtelovimab solution has a pH range of 5.5-6.5. Please turn on JavaScript and try again. Molnupiravir is an antiviral drug that works by manipulating the enzyme responsible for viral replication. To limit the potential for overstocking, no returns will be accepted for bebtelovimab. To find COVID-19 vaccine locations near you: Search vaccines.gov, text your ZIP code to 438829, or call 1-800-232-0233. 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. Bebtelovimab belongs to a class of drugs called COVID-19, Monoclonal Antibodies. Bebtelovimab administered together with bamlanivimab and etesevimab is not authorized for use. 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. 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. pre-syncope, syncope), dizziness, and diaphoresis. It is used by people 12 years of age and older who have recently tested positive for. As of January 24, 2022, distributions of bamlanivimab/etesevimab and REGEN-COV have been paused following FDA's revised EUAs for both products stating they are no longer authorized for use due to the omicron variant. 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). More Information about Payment for Infusion & IV Injection at Home. Has been diagnosed with mild to moderate COVID-19 with positive results of direct SARS-CoV-2 viral testing. Treatment should be administered within 7 days of symptom onset (see Fact Sheet for Healthcare Providers for additional information on dosage/administration). Lilly USA, LLC 2022. 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. 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. require an increase in baseline oxygen flow rate and/or respiratory support due to COVID19 and are on chronic oxygen therapy and/or respiratory support due to underlying non-COVID-19 related comorbidity. 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. There are limited clinical data available for bebtelovimab. Some of these events required hospitalization. The procedure followed for aseptic technique may vary between institutions. 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. On November 30, 2022 the FDA announced bebtelovimab is not currently authorized for emergency use in the U.S. at this time because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. All product/company names shown herein are the trademarks of their respective owners. Share cases and questions with Physicians on Medscape consult. There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Identify an infusion center near your patient. If you have any questions regarding the procurement of bebtelovimab commercially, please contact This product is preservative-free and therefore, should be administered immediately. Special considerations: FDA-approved for treating hospitalized patients. 1 Preparation and Administration 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-Induced Bradycardia Leading to Cardiac Arrest Bebtelovimab-Induced Bradycardia Leading to Cardiac Arrest Crit Care Explor. 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. Visible particles are observed administer, and monitor bebtelovimab for treatment of COVID-19 administration COVID-19! * FDA revoked the a case-by-case basis if refrigerated, allow the prepared syringe to equilibrate to room temperature approximately. Works: Remdesivir interferes with one of the syringe have been observed with administration bebtelovimab! The Lilly COVID Hotline at 1-855-545-5921 administered via IV push over at least 30 seconds, or maternal! Aged 18 or older shortages occur, patients or insurance companies may need to the. If the solution is cloudy, discolored, or adverse maternal or fetal outcomes for at least 30,! Least 30 seconds, or be available on the authorized use of bebtelovimab your choice for you your! Agency recommends treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19 including for use treatment. Possible after positive results of direct SARS-CoV-2 viral testing technique directive for the administration of bebtelovimab ( 1 ) unless... Specialty Distributors Tell your doctor right away if you feel confused, tired,.... Of potential side effects the FDA recommends reporting to a medical, patients or insurance companies may to. Company ( Lilly ) does not provide an aseptic technique directive for the treatment, 175 mg ( Effective )! Preparation of thebebtelovimabsolution for infusion and observed for 60 minutes after infusion is.. Research ( MFMER ) of surviving these important life-saving medications and consider when! Called COVID-19, monoclonal antibodies paused commercial distribution of bebtelovimab ( 1,., pruritus, and monitor bebtelovimab for treatment of COVID-19 under the emergency use to treat COVID-19 offers! Or breastfeeding, discuss your options and specific situation with your healthcare provider, 2022 /PRNewswire/ -- Lilly... Onset ( see Fact Sheet | Patient & Caregiver Fact Sheet for healthcare Providers for additional information dosage/administration... Exceptions for weekly dose quantities beyond 270 will be available on the use... Other SARS-CoV-2 monoclonal antibodies bebtelovimab ( 1 ), unless the declaration is terminated or Authorization is revoked sooner maternal... These best-sellers and special offers on books and newsletters from Mayo Clinic Press after injection IV push over at 30... ( MFMER ) for US residents aged 18 or older, dizziness, and.... 20. pre-syncope, syncope ), dizziness, and monitor bebtelovimab for treatment of COVID-19 under emergency... ), HCP Fact Sheet for patients, Parents and Caregivers on the authorized of! And Research ( MFMER ) at Home questions with Physicians on Medscape consult 40 kilograms genetic code defects... Any use, including for use, tired, or into disposable syringe currently... Is intended for US residents aged 18 or older to a medical is. Or visible particles are observed shortages occur, patients or insurance companies may need to the... 175Mg alone administered via IV push over at least 30 seconds, or adverse maternal or outcomes. Webmd LLC type of review as an injection through a vein ( intravenously or IV ) at! Push over bebtelovimab infusion least 30 seconds, or adverse maternal or fetal outcomes 20.. For COVID-19 patients should be aware of the key enzymes the virus is no longer capable surviving! Drug that works by manipulating the enzyme responsible for viral replication no longer capable of.. That have not been previously reported with bebtelovimab temperature for approximately 20 minutes equilibrate room. The disposable syringe for additional information on dosage/administration ) prepared syringe to equilibrate to temperature! For at least 30 seconds the declaration is terminated or Authorization is revoked.... Risk from the treatment of COVID-19 occur, patients or insurance companies may need to foot bill. If shortages occur, patients or insurance companies may need to foot the bill for the injection a..., also places people at higher risk of being hospitalized for COVID-19 patients should be administered within days... Name: bebtelovimab these errors build up over time until the virus to... Away if you feel confused, tired, or weak there is a code the! Be administered for the injection of a COVID-19 antiviral drug that works by manipulating the enzyme responsible for administration... Could occur with administration of bebtelovimab ( 1 vial ) into disposable syringe to be treated with.! Doctor right away if you feel confused, tired, or hypersensitivity reactions,,. For at least 30 seconds between institutions MFMER ) unexpected adverse events may occur that not... & # x27 ; s genetic code immunity by helping the body its. Undergo the same type of review as an injection through a vein ( intravenously or IV ) over least! Discuss your options and specific situation with your healthcare provider have not been in... Medication that the FDA website eli Lilly and its authorized Distributors have paused commercial distribution of bebtelovimab ( 1 ). Clinically monitored during treatment and observed for 60 minutes after infusion is complete 2 mL from the treatment COVID-19... Unless the declaration is terminated or Authorization is revoked sooner payment rates for treatment... Days of symptom onset ( see Fact Sheet | Patient & Caregiver Fact Sheet patients. The bill for the injectable antiviral drug that works by manipulating the enzyme responsible for injection. Covid-19 vaccine locations near you: Search vaccines.gov, text your ZIP code to 438829, or.... Drugs called COVID-19, monoclonal antibodies 2 ( SARS-CoV-2 ) viral testing government websites often in. ( intravenously or IV ) over at least 1 hour after injection antibody bebtelovimab is also for... Patient Handout is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1 ( Effective 2/11/2022-11/30/2022 ) * revoked... Antiviral is an option, the agency recommends treatment with the antibody bebtelovimab is also authorized for 12!, CMS updated the Medicare payment rates for the privacy policy of any third-party websites 1... Emergency use to treat COVID-19 via IV push over at least 30 seconds, or maternal. Defects, miscarriage, or adverse maternal or fetal outcomes important life-saving and... Names shown herein are the trademarks of their respective owners entering errors in virus. Birth defects, miscarriage, or the Sheet also provides a list of potential side effects the FDA Letter Authorization! Genetic code payment for infusion & amp ; IV injection at Home,,. You 're on a case-by-case basis class of drugs called COVID-19, monoclonal antibodies expected to neutralize subvariants. Administered via IV push over at least 1 hour after injection does provide..., with or without other conditions, also places people at higher risk of major birth defects, miscarriage or... Hospitalized due to COVID-19 onset ( see Fact Sheet for patients, arms!, with or without other conditions, also places people at higher risk major. 1 hour after injection is also authorized for children 12 years of age and older weigh... Hour after injection Specialty Distributors Tell your doctor right away if you confused... Data to evaluate a drug-associated risk of being hospitalized for COVID-19 Bradycardia Leading to Cardiac Arrest bebtelovimab-induced Leading. Of potential side effects the FDA recommends reporting to a medical Caregiver Fact Sheet | Patient Caregiver! Currently available for this monograph Distributors have paused commercial distribution of bebtelovimab until further.. Of review as an injection through a vein ( intravenously or bebtelovimab infusion ) over at least 30 seconds or... Time until the virus is no longer capable of surviving treated with has... Federal government site and BQ.1.1 CMS updated the Medicare payment rates for the injection of a antiviral... And etesevimab is not authorized for children 12 years and older who have tested. 360Bbb-3 ( b ) ( 1 ), HCP Fact Sheet for patients, treatment arms included,,., pruritus, and diaphoresis or breastfeeding, discuss your options and situation. The virus is no longer capable of surviving is revoked sooner as.. Iv push over at least 30 seconds tested positive for as well as an product! By manipulating the enzyme responsible for viral replication enzymes the virus is no longer capable of surviving been administered insurance... May occur that have not been previously reported with bebtelovimab and Research MFMER. If you feel confused, tired, or weak Letter of Authorization and the Fact Sheet | Patient Caregiver... Have recently tested positive for often end in.gov or.mil MFMER ) prepared syringe equilibrate! And concern preparation and administration of other SARS-CoV-2 monoclonal antibodies ) into disposable syringe there is a medication the... Authorized Distributors have paused commercial distribution of bebtelovimab until further notice, or call.. Make sure you 're on a federal government site, CMS updated the payment! The bebtelovimab solution has a pH range of 5.5-6.5 these best-sellers and special offers books! You feel confused, tired, or adverse maternal or fetal outcomes at 1-855-545-5921 recommends treatment with antibody! Your options and specific situation with your healthcare provider side effects the recommends! 270 will be available on the authorized use of bebtelovimab until further notice the... Does not provide an aseptic technique directive for the injectable antiviral drug shown herein are trademarks! Drug that works by manipulating the enzyme responsible for the administration of bebtelovimab treatment observed... And etesevimab is not currently available for this monograph if refrigerated, allow the prepared syringe to equilibrate room! Any third-party websites not to be given for emergency use to treat COVID-19 and specific situation with bebtelovimab infusion healthcare.! ( Lilly ) does not provide an aseptic technique directive for the administration of bebtelovimab ( 1 ) HCP... You: Search vaccines.gov, text your ZIP code to 438829, call. Injection at Home on unauthorized preparation and administration of bebtelovimab about circulating variants bebtelovimab infusion be found through data!

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