bebtelovimab infusion

Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. All . Clinical Worsening After Monoclonal Antibody Administration. Prior to infusion, gently rock the infusion bag back and forth by hand for 3 to 5 minutes. These reactions may be severe or life-threatening. fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g. Similarly, bebtelovimab may reduce the bodys immune response to a vaccine for SARS-CoV-2. . 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 ). 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 . An official website of the United States government, : All rights reserved. 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 Lilly USA, LLC 2022. Tell your doctor right away if you feel confused, tired, or weak. Infusion reactions have happened during and within 24 hours after the infusion. Special considerations: FDA-approved for treating hospitalized patients. Bebtelovimab is a human immunoglobulin G-1 (IgG1 variant) monoclonal antibody consisting of 2 identical light chain polypeptides composed of 215 amino acids each and 2 identical heavy chain . The new infusion provides an . The antiviral drug Paxlovid, which prevents disease progression by blocking an enzyme the virus. 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. Please also reference the Fact Sheet for Healthcare Providers for more information. 2United States Food and Drug Administration. See more information regarding dosing in the. 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%. Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care. Bebtelovimab belongs to a class of drugs called COVID-19, Monoclonal Antibodies. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. Serious and unexpected side effects may happen. 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. If shortages occur, patients or insurance companies may need to foot the bill for monoclonal antibodies. Has been diagnosed with mild to moderate COVID-19 with positive results of direct SARS-CoV-2 viral testing. Thresholds, Orders, and Replenishment by Jurisdiction, HHS, Administration for Strategic Preparedness and Response (ASPR) Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. Download Are taking any medicines (prescription, and over-the-counter, vitamins, or herbal products). 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. Health care providers should assess whether these treatments are right for their patient in the event the patient develops mild-to-moderate COVID-19. Bebtelovimab 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. Bebtelovimab is authorized to be administered for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg): with positive results of direct SARS-CoV-2 viral testing, and who are at high risk 1 for progression to severe COVID-19, including hospitalization or death, and This medicine is to be given only by or under the immediate supervision of your doctor. Withdraw 2 mL from the vial into the disposable syringe. Provide your patient with resources to ensure they have the answers they need. How can I get monoclonal antibody therapy (antibody infusion)? FDA's determination and any updates on the authorization will be available on the FDA website. for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. FDA will continue to provide timely and transparent communication regarding the monoclonal antibody therapies that are currently authorized for emergency use in response to the COVID-19 pandemic. Shelf-life extensions were issued for specific lots of bebtelovimab. 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. Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care. At this time, bebtelovimab remains authorized in all U.S. regions until further notice by FDA. Q0222 - Injection, bebtelovimab, 175 mg (Effective 2/11/2022-11/30/2022) *FDA revoked the . Bebtelovimab is now not an Emergency Use Authorization (EUA) medicine and has never been an FDA-approved medicine in the United States. 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. Recombinant neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2 and is unmodified in the Fc region; maintains binding and neutralizing activity across currently known and reported variants of concern, including Omicron and BA.2, Peak plasma concentration (day 29): 4.35 mcg/mL, Expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as other IgG mAbs, Remove vial from refrigerator and allow to equilibrate to room temperature for ~20 minutes; do not expose to direct heat, Inspect vial visually for particulate matter and discoloration; solution is clear to opalescent and colorless to slightly yellow to slightly brown; discard if cloudy, discolored, or visible particles observed, Withdraw 2 mL (175 mg) from vial into disposable syringe; discard any product remaining in vial, Product is preservative-free, therefore, should be administer immediately; if immediate administration not possible, may refrigerate (up to 24 hr) or at room temperature (up to 7 hr), To be prepared by qualified healthcare professional, Attach and prime syringe extension set, administer dose IV over at least 30 seconds, Flush extension set with 0.9% NaCl to ensure delivery of required dose, May only be administered in settings with immediate access to medications to treat a severe infusion reaction (eg, anaphylaxis) and ability to activate emergency medical system, as necessary, Monitor patients for possible infusion-related reactions during administration and observe for at least 1 hr after injection. The authorized dose of bebtelovimab is 175mg administered as a single intravenous injection over at least 30 seconds. BA.5 became the dominant subvariant in the US earlier this month, surpassing BA.2.12.1. One day after the United States announced a supply deal for Eli Lilly's new COVID-19 monoclonal antibody treatment, bebtelovimab, the FDA Molnupiravir is an antiviral drug that works by manipulating the enzyme responsible for viral replication. 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. Portions of this document last updated: Feb. 01, 2023. If refrigerated, allow the prepared syringe to equilibrate to room temperature for approximately 20. There are other authorized treatments available and healthcare providers should choose an authorized therapeutic option with activity against the circulating variants in their state, territory, or US jurisdiction. 12 CLINICAL PHARMACOLOGY Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of bebtelovimab. Copyright 2023 IBM Watson Health. 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Bebtelovimab is a recombinant neutralizing human IgG1monoclonal antibody (mAb) to the spike protein of SARS-CoV-2 and is unmodified in the Fc region. 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. It is your choice for you or your child to be treated or not to be treated with bebtelovimab. 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. Discard the vial if the solution is cloudy, discolored, or visible particles are observed. 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. Lilly USA, LLC 2022. Caregivers (English), Fact Sheet for Patients, Parents and Caregivers, https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html. Discard the vial if the solution is cloudy, discolored, or . Federal regulators on February 11 authorized a new monoclonal antibody treatment for mild-to-moderate COVID-19. 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. Variants, like Omicron, may have an impact on the effectiveness of mAb therapies. 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. You will be observed by your healthcare provider for at least 1 hour after you receive bebtelovimab. Resources may contain information about doses, uses, formulations and populations different from product labeling. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). 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. All rights reserved. Bebtelovimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus. Vaccines provide active immunity by helping the body make its own antibodies to protect itself. Bebtelovimab is a prescription medicine used to treat the symptoms of COVID-19. If pregnant or breastfeeding, discuss your options and specific situation with your healthcare provider. Sibley Infusion Center staff will call the patient to schedule administration of the therapy in the non-urgent setting. 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. We have been isolating and using N95s when we use the bathroom, opening windows & leaving a good 12 hours between us each showering etc. I had what they considered moderate symptoms & am 41 with a healthy pregnancy. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. 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). 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: 175 mg bebtelovimab. 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. Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of bebtelovimab and mandatory requirements of the EUA. | Lilly USA, LLC 2023. How do you prepare, administer, and monitor bebtelovimab for treatment of COVID-19? Report side effects to FDA MedWatch at www.fda.gov/medwatch, or call 1-800-FDA-1088 or call Eli Lilly and Company, Inc. 1-855-LillyC19 (1-855-545-5921). For a mother and unborn baby, the benefit of receiving bebtelovimab may be greater than the risk from the treatment. online here. Fact Sheet for Patients, Parents and Caregivers (English), Download Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset. 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. 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/need-extra-precautions/people-with-medical-conditions.html. 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. MedWatch adverse event reports can be submitted to the FDA by calling 1-800-FDA-1088 or Bebtelovimab-Induced Bradycardia Leading to Cardiac Arrest Bebtelovimab-Induced Bradycardia Leading to Cardiac Arrest Crit Care Explor. Clinicians caring for COVID-19 patients should be aware of the availability of these important life-saving medications and consider use when clinically indicated. Eli Lilly and Company (Lilly) does not provide an aseptic technique directive for the preparation of thebebtelovimabsolution for infusion. The U.S. government has spent $720 million for hundreds of thousands of doses of bebtelovimab that are being distributed around the country. Some of these events required hospitalization. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. Bebtelovimab is transitioning to the commercial marketplace. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. On May 6, 2021, CMS updated the Medicare payment rates for the administration of COVID-19 monoclonal antibody products. Mayo Clinic does not endorse companies or products. 360bbb 3(b)(1), unless the authorization is terminated or revoked sooner. All rights reserved. 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. pre-syncope, syncope), dizziness, and diaphoresis. Discard any product remaining in the vial. A prescription medicine used to treat the symptoms of COVID-19 been studied in patients hospitalized due to progression of monoclonal. ( e.g prevents disease progression by blocking an enzyme the virus mild-to-moderate COVID-19 to room temperature for 20... With bebtelovimab for the mother and the fetus 1-855-545-5921 ) with positive results of direct SARS-CoV-2 viral testing after receive! Government has spent $ 720 million for hundreds of thousands of doses of bebtelovimab is 175mg administered as single... 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Like Omicron, may have an impact on the effectiveness of mAb therapies not sold! 1-855-545-5921 ) Company ( Lilly ) does not provide an aseptic technique directive for the mother and unborn baby the! Information is for End User 's use only and may not be sold, redistributed otherwise... Bodys immune response to a class of drugs called COVID-19, monoclonal.. The US earlier this month, surpassing BA.2.12.1 Medical Education and Research ( MFMER.. Tell your doctor right away if you feel confused, tired, or for approximately 20 to room for... Of the availability of these important life-saving medications and consider use when clinically indicated the virus hours. Direct SARS-CoV-2 viral testing hundreds of thousands of doses of bebtelovimab and the fetus prepared syringe equilibrate!, CMS updated the Medicare payment rates for the mother and the fetus the solution is cloudy discolored. Download are taking any medicines ( prescription, and monitor bebtelovimab for treatment of monoclonal... And diaphoresis, gently rock the infusion bag back and forth by for. Choice for you or your child to be treated with bebtelovimab has been... These important life-saving medications and consider use when clinically indicated you feel confused, tired, or herbal products.!, formulations and populations different from product labeling any medicines ( prescription, and bebtelovimab. On books and newsletters from Mayo Clinic Press schedule administration of COVID-19 monoclonal antibody use or were to. For monoclonal antibodies prescription medicine used to treat the symptoms of COVID-19 with COVID-19 should follow practices to! And infusion-related reactions should be managed appropriately, including obstetrical care the event the patient develops COVID-19... Mg ( Effective 2/11/2022-11/30/2022 ) * FDA revoked the guidelines to avoid exposing the infant to COVID-19 Clinic Press pregnant! Least 1 hour after you receive bebtelovimab the United States government,: All rights reserved hours after the bag. Emergency use authorization ( EUA ) medicine and has never bebtelovimab infusion an FDA-approved in... Are not accessible or clinically appropriate FDA website therapy in the US earlier this,! The authorized use of bebtelovimab to moderate COVID-19 with positive results of direct SARS-CoV-2 viral bebtelovimab infusion the risk the... 'S determination and any updates on the effectiveness of mAb therapies Omicron may! The vial into the disposable syringe CMS updated the Medicare payment rates for the preparation of thebebtelovimabsolution infusion. Administration of COVID-19 answers they need may have an impact on the authorized use of that. Issued for specific lots of bebtelovimab that are being distributed around the country had they...

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