BEBTELOVIMAB injection, solution

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

Bebtelovimab (UNII: 8YL4SYR6CU) (Bebtelovimab - UNII:8YL4SYR6CU)

Disponível em:

Eli Lilly and Company

Via de administração:

INTRAVENOUS

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of bebtelovimab for the treatment of mild-to-moderate coronavirus disease 2019 (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 risk1 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 [see Clinical Studies (14.4)] . LIMITATIONS OF AUTHORIZED USE - 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. FDA's determination and any updates will be available at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs .2 - FDA's determination and any updates will be available at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs .2 - Bebtelovimab is not authorized for use in patients, who: are hospitalized due to COVID-19, OR require oxygen therapy and/or respiratory support due to COVID-19, OR 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. - are hospitalized due to COVID-19, OR - require oxygen therapy and/or respiratory support due to COVID-19, OR - 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. Treatment with bebtelovimab has not been studied in patients hospitalized due to 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 [see Warnings and Precautions (5.3)] . Bebtelovimab is not FDA-approved for any use, including for use as treatment of COVID-19 [see Emergency Use Authorization (1)] . 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. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Justification for Emergency Use of Drugs During the COVID-19 Pandemic There is currently an outbreak of Coronavirus Disease 2019 (COVID-19) caused by SARS-CoV-2, a novel coronavirus. The Secretary of HHS has declared that: - A public health emergency related to COVID-19 has existed since January 27, 2020. - Circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic (March 27, 2020 declaration). An EUA is a FDA authorization for the emergency use of an unapproved product or unapproved use of an approved product (i.e., drug, biological product, or device) in the United States under certain circumstances including, but not limited to, when the Secretary of HHS declares that there is a public health emergency that affects the national security or the health and security of United States citizens living abroad, and that involves biological agent(s) or a disease or condition that may be attributable to such agent(s). Criteria for issuing an EUA include: - The biological agent(s) can cause a serious or life-threatening disease or condition; - Based on the totality of the available scientific evidence (including data from adequate and well-controlled clinical trials, if available), it is reasonable to believe that the product may be effective in diagnosing, treating, or preventing the serious or life-threatening disease or condition; and The known and potential benefits of the product - when used to diagnose, prevent, or treat such disease or condition - outweigh the known and potential risks of the product, taking into consideration the material threat posed by the biological agent(s); - the product may be effective in diagnosing, treating, or preventing the serious or life-threatening disease or condition; and - The known and potential benefits of the product - when used to diagnose, prevent, or treat such disease or condition - outweigh the known and potential risks of the product, taking into consideration the material threat posed by the biological agent(s); - There is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating the serious or life-threatening disease or condition. Information Regarding Available Alternatives for the EUA Authorized Use Veklury (remdesivir) is FDA-approved for the treatment of 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, who are not hospitalized and have mild-to-moderate COVID-19, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Veklury is administered via intravenous infusion for a total treatment duration of 3 days. Although Veklury is an approved alternative treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, FDA does not consider Veklury to be an adequate alternative to bebtelovimab for this authorized use because it may not be feasible or practical for certain patients (e.g., it requires a 3-day treatment duration). Other therapeutics are currently authorized for the same use as bebtelovimab. For additional information on all products authorized for treatment or prevention of COVID-19, please see https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization . For information on clinical studies of bebtelovimab and other therapies for the treatment of COVID-19, see www.clinicaltrials.gov . No contraindications have been identified based on the limited available data for the emergency use of bebtelovimab authorized under this EUA. Risk Summary Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients [see Warnings and Precautions (5.1)] . There are risks to the mother and fetus associated with untreated COVID-19 in pregnancy as well as potential risks to the fetus associated with severe maternal hypersensitivity and infusion-related reactions (see Clinical Considerations) . There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Bebtelovimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus. There are maternal and fetal risks associated with untreated COVID-19 in pregnancy (see Clinical Considerations) . Data Nonclinical reproductive toxicity studies have not been performed with bebtelovimab. In tissue cross reactivity studies using human fetal tissues, no binding of clinical concern was detected for bebtelovimab. Human immunoglobulin G1 (IgG1) antibodies are known to cross the placental barrier; therefore, bebtelovimab has the potential to be transferred from the mother to the developing fetus. It is unknown whether the potential transfer of bebtelovimab provides any treatment benefit or risk to the developing fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo-fetal risk 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. Maternal Adverse Reactions Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care [see Warnings and Precautions (5.1)] . Risk Summary 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. Maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for bebtelovimab and any potential adverse effects on the breastfed child from bebtelovimab or from the underlying maternal condition. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. Bebtelovimab is not authorized for use in pediatric individuals under 12 years of age or weighing less than 40 kg. The safety and effectiveness of bebtelovimab have not been assessed in pediatric patients. The recommended dosing regimen in patients 12 years to less than 18 years of age, weighing at least 40 kg, is expected to result in comparable serum exposures of bebtelovimab as those observed in adults. Of the 602 patients receiving bebtelovimab in BLAZE-4, 10.5% were 65 years of age and older and 3.3% were 75 years of age and older. Based on population PK analyses of samples from 573 patients over an age range of 14 to 89 years, there was no impact of age on PK. Therefore, there is no difference in the PK of bebtelovimab in geriatric patients compared to younger patients.

Resumo do produto:

How Supplied Bebtelovimab injection is a sterile, preservative-free clear to opalescent and colorless to slightly yellow to slightly brown solution supplied in a single-dose vial. Storage and Handling Bebtelovimab is preservative-free. Discard unused portion. Store unopened vials in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. DO NOT FREEZE, SHAKE, OR EXPOSE TO DIRECT LIGHT.

Características técnicas

BEBTELOVIMAB- BEBTELOVIMAB INJECTION, SOLUTION
ELI LILLY AND COMPANY
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FACT SHEET FOR HEALTHCARE PROVIDERS: EMERGENCY USE AUTHORIZATION
FOR BEBTELOVIMAB
HIGHLIGHTS OF EMERGENCY USE
AUTHORIZATION (EUA)
THESE HIGHLIGHTS OF THE EUA DO NOT
INCLUDE ALL THE INFORMATION NEEDED TO
USE BEBTELOVIMAB UNDER THE EUA.
SEE THE FULL FACT SHEET FOR
HEALTHCARE PROVIDERS FOR
BEBTELOVIMAB.
BEBTELOVIMAB INJECTION FOR
INTRAVENOUS USE
ORIGINAL EUA AUTHORIZED DATE:
02/2022
REVISED EUA AUTHORIZED DATE:
11/2022
----------------------------RECENT
MAJOR CHANGES-------------------------
-
Dosage and Administration, Dose
Preparation and
03/2022
Administration (2.3): updated
administration materials
Use in Specific Populations, Pregnancy
(8.1): added hypersensitivity reactions in
pregnant women
05/2022
Clinical Pharmacology, Microbiology
(12.4): updated 11/2022
neutralizing data
-------------------EMERGENCY USE
AUTHORIZATION--------------------
The U.S. Food and Drug Administration
(FDA) has issued an Emergency Use
Authorization (EUA) for the emergency
use of bebtelovimab for the treatment of
mild-to-moderate coronavirus disease
2019 (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
------------------------DOSAGE AND
ADMINISTRATION-----------------------
The dosage in adults (18 years and older)
and pediatric patients (≥12 years of age
and weighing at least 40 kg) is
bebtelovimab 175 mg administered as a
single intravenous injection over at least
30 seconds. Administer bebtelovimab as
soon as possible after positive results of
direct SARS-CoV-2 viral testing and within
7 days of symptom onset. (2.1)
---------------------DOSAGE FORMS
AND STRENGTHS----------------------
Injection: 175 mg/2 mL (87.5 mg/mL) in a
single-dose vial. (3)
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CONTRAINDICATIONS-------------------
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No contraindications have been identified
based on the limited available data for the
emergency use of bebtelovimab
a