Skip to main content

Bamlanivimab Neutralizing IgG1 Monoclonal Antibody for Treatment of COVID-19

Bamlanivimab is a neutralizing IgG1 monoclonal antibody that binds to the receptor-binding domain of the spike protein of SARS-CoV-2. The FDA has authorized the emergency use of bamlanivimab for the treatment of COVID-19 under an Emergency Use Authorization (EUA).

" Based on a review of the topline data from the planned interim analysis of Trial J2W-MC-PYAB, also called BLAZE-1 (NCT04427501), an ongoing randomized, double-blind, placebo controlled, Phase 2 dose-finding trial of bamlanivimab monotherapy in outpatients with mild to moderate COVID-19, it is reasonable to believe that bamlanivimab may be effective for the treatment of mild to moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization, and that, when used under the conditions described in this authorization, the known and potential benefits of bamlanivimab outweigh the known and potential risks of such product." -FDA

Criteria for Issuance of Authorization
  • SARS-CoV-2 can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus;
  • Based on the totality of scientific evidence available to FDA, it is reasonable to believe that bamlanivimab may be effective in treating mild to moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization, and that, when used under the conditions described in this authorization, the known and potential benefits of bamlanivimab outweigh the known and potential risks of such product; and. There is no adequate, approved, and available alternative to the emergency use of bamlanivimab for the treatment of mild to moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.
LIMITATIONS OF AUTHORIZED USE 
Bamlanivimab is not authorized for use in patients:
  • who are hospitalized due to COVID-19, 
  • who require oxygen therapy due to COVID-19, 
  • who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.
  • The benefit of treatment with bamlanivimab has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.
DOSAGE
 The dosage of bamlanivimab in adults and pediatric patients 12 years of age and older weighing at least 40 kg is a single IV infusion of 700 mg bamlanivimab administered over at least 60 minutes. Bamlanivimab should be given as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 10 days of symptom onset.

ADVERSE EVENTS 
  • Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions
  • There is a potential for serious hypersensitivity reaction, including anaphylaxis, with the administration of bamlanivimab. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive therapy.
  •  Infusion-related reactions have been observed with the administration of bamlanivimab. Signs and symptoms of infusion-related reactions may include fever, chills, nausea, headache, bronchospasm, hypotension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, dizziness. If an infusion-related reaction occurs, consider slowing or stopping the infusion and administer appropriate medications and/or supportive care.  

For more, visit 
http://pi.lilly.com/eua/bamlanivimab-eua-factsheet-hcp.pdf
https://www.fda.gov/media/143602/download


Comments

Popular posts from this blog

Carbohydrate Metabolism: MCQs and answers on Glycolysis & Gluconeogenesis

                                      MCQ on Glycolysis & Gluconeogenesis 1) Which of the following enzyme is not involved in galactose metabolism? a) Glucokinase b) Galactokinase c) Galactose-1-Phosphate Uridyl transferase d) UDP-Galactose 4- epimerase 2) Which of the following enzyme is defective in galactosemia (type I) - a fatal genetic disorder in infants? a) Glucokinase b) Galactokinase c) Galactose-1-Phosphate Uridyl transferase d) UDP-Galactose 4- epimerase 3) In the liver, the accumulation of which of the following metabolite attenuates the inhibitory of ATP on phosphofructokinase? a) Glucose-6-Phosphate b) Citrate c) Fructose-1,6-Bisphosphate d) Fructose-2,6-Bisphosphate 4) Mutation in which of the following enzymes leads to a glycogen storage disease known as "Tarui’s disease"? a) Glucokinase b) Phosphofructokinase c) Phosphoglucomutase d) Pyruvate Kinase 5) E...

MCQs and Answers on cultivation (culture/incubation), Isolation and Identification of microorganisms: Medical Microbiology

40 plus questions - Multiple Choice Questions on Classification, Culture, and Identification of the microorganisms 1. Which of the following microorganism has the cocci cell shapes and sizes arranged usually in tetrad structures? a)  Streptococcus pneumoniae b)  Staphylococcus aureus c)  Chlamydia trachomatis d)  Neisseria meningitidis 2. What are the different growth morphology and cell structures used for the classification of fungi? Select all the correct answers: a) Yeast b) Mold c) Mycelia d) Protozoa 3. Which of the following media is formulated with additional nutrients to support the growth of fastidious or nutritionally demanding bacteria that may not grow well on basic media? a) Differential media b) Enriched media c) Nutrient agar (media) d) Selective media 4. Which of the following metabolic characteristic is a distinguishing characteristic and identification of colonies of  E. coli ? a) Hydrogen sulfide formation b) Indole Formation c) Lactose fe...

Multiple Choice Questions (MCQs) on Diabetes Mellitus: Pathogenesis, Diagnosis and Treatment

                                        MCQs on Diabetes mellitus 1) Diabetes mellitus is a disorder characterized by hyperglycemia.  Which of the following is not the common characteristic features of type 2 diabetes mellitus ? a) Impaired insulin secretion b) Increased Insulin resistance  c) Diabetic ketoacidosis d) Excessive hepatic glucose production 2) Which of the following are the characteristic features of type 1 diabetes mellitus? a) Type 1 diabetes is caused by an absolute deficiency of insulin. b) Type 1 diabetes is associated with the autoimmune destruction of beta cells.  c) Patients with  uncontrolled type 1 diabetes present with diabetic ketoacidosis d) All of the above   3) Which of the following serum measurements are not used for the diagnosis of diabetes mellitus? a) Fasting blood glucose d) Postprandial blood glucose  c) Insulin ...