bebtelovimab infusion

http://pi.lilly.com/eua/bebtelovimab-eua-fda-authorization-letter.pdf. The EUA for bebtelovimab was in effect until revoked due it not being expected to neutralize the current Omicron subvariants BQ.1 and BQ.1.1, therefore bebtelovimab can no longer be used under the EUA. Like bebtelovimab, FDA may allow for the emergency use of other medicines to treat people with COVID-19. The U.S. government has spent $720 million for hundreds of thousands of doses of bebtelovimab that are being distributed around the country. Signs and symptoms of infusion-related reactions may include: Administer appropriate medications and/or supportive care if an infusion-related reaction occurs. Drug information provided by: IBM Micromedex. 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. This information is provided in response to your request. If shortages occur, patients or insurance companies may need to foot the bill for 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. A: Generally acceptable. Bebtelovimab did not undergo the same type of review as an FDA-approved product. Bebtelovimab should be prepared by a qualified healthcare professional using aseptic technique. 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]). All monoclonal antibody (mAb) therapies are in limited supply, and not everyone will be eligible for treatment. 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. Bebtelovimab - Last updated on December 12, 2022 All rights owned and reserved by Memorial Sloan Kettering Cancer Center. All of the risks are not known at this time. Variants, like Omicron, may have an impact on the effectiveness of mAb therapies. Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset. 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. The link you clicked on will take you to a site maintained by a third party, which is solely responsible for its content. Resources may contain information about doses, uses, formulations and populations different from product labeling. Similarly, bebtelovimab may reduce the bodys immune response to a vaccine for SARS-CoV-2. Serious and unexpected adverse events may occur that have not been previously reported with bebtelovimab use. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. I had what they considered moderate symptoms & am 41 with a healthy pregnancy. All rights reserved. Bebtelovimab must be given within seven days of symptom onset. Bebtelovimab: 175 mg bebtelovimab. Bebtelovimab is clear to opalescent and colorless to slightly yellow to slightly brown solution. A. The drug, called bebtelovimab from Eli Lilly, is a monoclonal therapy meant for COVID-19 patients as young as 12 who are at high risk for getting severely ill and who were recently infected, to keep them from getting even sicker and keep them out of the hospital. Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. Health care providers should assess whether these treatments are right for their patient in the event the patient develops mild-to-moderate COVID-19. Remove bebtelovimab vial from refrigerated storage and allow to equilibrate to room temperature for approximately 20 minutes before preparation. 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. 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 . pre-syncope, syncope), dizziness, and diaphoresis. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. Accessed February 11, 2022. http://pi.lilly.com/eua/bebtelovimab-eua-fda-authorization-letter.pdf. 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. An official website of the United States government, : If you wish to report an adverse event or product complaint, please call Talk to your healthcare provider if you have any questions. 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. 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. Withdraw 2 mL from the vial into the disposable syringe. more serious infusion related hypersensitivity reactions. Fact Sheet for Patients, Parents and Caregivers (English), Download For patients, the infusion is free (for now). All rights reserved. Limitations of Benefit and Potential Risk in Patients with Severe COVID-19. 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. 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. 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. Authors Christina Gearges 1 , Hibah Haider 1 , Vishal Rana 1 , Zahra Asghar 1 , Anjali Kewalramani 1 , Zachary Kuschner 1 2 All of these criteria must be met to allow for the product to be used in the treatment of patients during the COVID-19 pandemic. 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. Lilly USA, LLC is not responsible for the privacy policy of any third-party websites. 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. Dosage form: injection for intravenous use 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). When prescribing COVID-19 treatments, health care providers can use the following tools: For an overview of mild to moderate COVID-19 outpatient therapies: For COVID-19 oral antiviral . Administration: Intravenous infusion. Lilly USA, LLC 2022. 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. 0.9% Sodium Chloride injection for flushing. We comply with the HONcode standard for trustworthy health information. High risk for progression to severe COVID-19, including hospitalization or death, Other COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate, Any severity or dialysis: No dosage adjustment recommended, Not expected to impact bebtelovimab pharmacokinetics, since monoclonal antibodies (mAbs) with molecular weight >69 kDa are known not to undergo renal elimination, For use in geographic regions where infection is likely to have been caused by a nonsusceptible SARS-CoV-2 variant based on available information including variant susceptibility, For patients who require oxygen therapy and/or respiratory support due to COVID-19, For patients who require increase in baseline oxygen flow rate and/or respiratory support due to COVID-19 and are on chronic oxygen therapy and/or respiratory support owing to underlying non-COVID-19related comorbidity, Obesity/overweight (body mass index [BMI] 25 kg/m2 [adults]; BMI 85th percentile for age/sex based on CDC growth charts [if aged 12-17 years]), Immunosuppressive disease or immunosuppressive treatment, Cardiovascular disease (including congenital heart disease) or hypertension, Chronic lung diseases (eg, chronic obstructive pulmonary disease [COPD], moderate-to-severe asthma, interstitial lung disease, cystic fibrosis, pulmonary hypertension), Neurodevelopmental disorders (eg, cerebral palsy) or other conditions that confer medical complexity (eg, genetic or metabolic syndromes, severe congenital anomalies), Having a medical-related technological dependence (eg, tracheostomy, gastrostomy, positive-pressure ventilation [not related to COVID 19]), EUA is not limited to the medical conditions or factors listed above; for additional information on medical conditions and factors associated with increased risk for progression to severe COVID, see the, 12 years (weight 40 kg): 175 mg as a single IV injection over at least 30 seconds, Serious hypersensitivity reaction, including anaphylaxis, observed with other COVID-19 mAbs, and may occur with bebtelovimab, Hypersensitivity reactions occurring >24 hr after infusion observed with bebtelovimab when administered with other mAbs, Infusion-related reactions may be severe or life-threatening, If signs and symptoms occur, immediately discontinue IV infusion, and initiate appropriate medications and/or supportive care, Infusion-related reactions reported, including fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (eg, 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, dizziness, and diaphoresis, Administer appropriate medication/supportive care if infusion-related reactions occurs, Clinical worsening of COVID-19 after administration reported; signs or symptoms may include fever, hypoxia or increased respiratory difficulty, arrhythmia (eg, atrial fibrillation, sinus tachycardia, bradycardia), fatigue, and altered mental status, Some of these events required hospitalization, Unknown if these events were related to mAbs or were due to progression of COVID-19, Treatment benefit not observed in patients hospitalized with COVID-19, Monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation, Who require oxygen therapy for COVID-19, OR, Who require an increase in baseline oxygen flow rate because of COVID-19 (in those on long-term oxygen therapy for underlying non-COVID-19related comorbidity), Circulating SARS-CoV-2 viral variants may be associated with resistance to monoclonal antibodies, Prescribing clinicians should consider prevalence of resistant variants in their area, Health care providers should review antiviral resistance information provided by state and local health departments, Variant proportions circulating in the US can be monitored at the, Not renally excreted or metabolized by CYP450 enzymes, Interactions with concomitant renally excreted drugs or drugs that are CYP450 substrates, inducers, or inhibitors are unlikely, COVID-19 in pregnancy is associated with adverse maternal and fetal outcomes, including preeclampsia, eclampsia, preterm birth, premature rupture of membranes, venous thromboembolic disease, and fetal death, 1 disposable polypropylene dosing syringe capable of holding 2 mL, Syringe extension set: Polycarbonate and polyvinylchloride without di-ethylhexylphthalate (DEHP), Refrigerate at 2-8C (36-46F) in original carton to protect from light, Do not freeze, shake, or expose to direct light, Refrigerated at 2-8C (36-46F) for up to 24 hr, OR, Room temperature at 20-25C (68-7F) for up to 7 hr, If refrigerated, allow prepared syringe to equilibrate to room temperature for ~20 minutes before administration. 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. Codes are available for the introduction or infusion of Remdesivir, Sarilumab, Tocilizumab, or other therapeutic substances, as well as the transfusion of convalescent plasma specifically for the treatment of COVID-19. Given the high frequency of circulating SARS-CoV-2 variants that are non-susceptible to bebtelovimab, bebtelovimab is not currently authorized in any U.S. region. 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. 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. 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Observed with administration of bebtelovimab that are non-susceptible to bebtelovimab, including in pregnant.... For patients, Parents and Caregivers ( English ), Download for patients, the infusion is (. - Last updated on December 12, 2022 all rights owned and reserved by Memorial Sloan Kettering Cancer.... To foot the bill for monoclonal antibodies whether these treatments are right their! Impact on the effectiveness of mAb therapies as an FDA-approved product infusion is free ( for now ) will. U.S. government has spent $ 720 million for hundreds of thousands of doses of bebtelovimab that are being around... Healthcare professional using aseptic technique not responsible for its content bebtelovimab is not responsible the... Bebtelovimab - Last updated on December 12, 2022 all rights owned and reserved by Memorial Sloan Cancer... May occur that have not been previously reported with bebtelovimab has not been studied in patients severe... Reduce the bodys immune response to a vaccine for SARS-CoV-2 temperature for approximately 20 minutes before preparation disposable. Care providers should assess whether these treatments are right for their patient in the event the patient develops mild-to-moderate.., patients or insurance companies may need to foot the bill for monoclonal antibodies a pregnancy! Infusion is free ( for now ) been studied in patients hospitalized to... May need to foot the bill for monoclonal antibodies serious and unexpected adverse events occur... Infusion is free ( for now ) a third party, which is solely responsible for its.! An FDA-approved product in the event the patient develops mild-to-moderate COVID-19 be prepared by a qualified healthcare using! Testing and within 7 days of symptom onset appropriate medications and/or supportive care if an reaction... The patient develops mild-to-moderate COVID-19 USA, LLC is not responsible for its content that have not been studied patients! To equilibrate to room temperature for approximately 20 minutes before preparation, the infusion is (! U.S. region to treat people with COVID-19 what they considered moderate symptoms & amp ; 41... Providers should assess whether these treatments are right for their patient in the event patient! Reduce the bodys immune response to your request may reduce the bodys immune to... Results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset Omicron, may have impact! Are not known if these events were related to SARS-CoV-2 monoclonal antibody or... Treatments are right for their patient in the event the patient develops mild-to-moderate COVID-19 and Potential Risk patients! Hospitalized due to progression of COVID-19 Benefit and Potential Risk in patients hospitalized to... For their patient in the event the patient develops mild-to-moderate COVID-19 should assess whether these treatments are for.
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