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1 Indications And Usage Anthim ® Is A Monoclonal Antibody Directed Against The Protective Antigen Of Bacillus Anthracis. It Is Indicated In Adult And Pediatric Patients For Treatment Of Inhalational Anthrax Due To B. Anthracis In Combination With Appropriate Antibacterial Drugs And, For Prophylaxis Of Inhalational Anthrax When Alternative Therapies Are Not Available Or Are Not Appropriate. ( 1.1 ) Limitations Of Use Anthim Should Only Be Used For Prophylaxis When Its Benefit For Prevention Of Inhalational Anthrax Outweighs The Risk Of Hypersensitivity And Anaphylaxis. ( 1.2 , 5.1 ) The Effectiveness Of Anthim Is Based Solely On Efficacy Studies In Animal Models Of Inhalational Anthrax. ( 1.2 , 14 ) There Have Been No Studies Of The Safety Or Pharmacokinetics (pk) Of Anthim In The Pediatric Population. Dosing In Pediatric Patients Was Derived Using A Population Pk Approach. ( 1.2 , 8.4 ) Anthim Does Not Have Direct Antibacterial Activity. Anthim Should Be Used In Combination With Appropriate Antibacterial Drugs. ( 1.2 ) Anthim Is Not Expected To Cross The Blood-Brain Barrier And Does Not Prevent Or Treat Meningitis. ( 1.2 ) 1.1 Inhalational Anthrax Anthim Is Indicated In Adult And Pediatric Patients For The Treatment Of Inhalational Anthrax Due To Bacillus Anthracis In Combination With Appropriate Antibacterial Drugs. Anthim Is Indicated For Prophylaxis Of Inhalational Anthrax Due To B. Anthracis When Alternative Therapies Are Not Available Or Not Appropriate [see Indications And Usage ( 1.2 )]. 1.2 Limitations Of Use Anthim Should Only Be Used For Prophylaxis When Its Benefit For Prevention Of Inhalational Anthrax Outweighs The Risk Of Hypersensitivity And Anaphylaxis [see Warnings And Precautions ( 5.1 )]. The Effectiveness Of Anthim Is Based Solely On Efficacy Studies In Animal Models Of Inhalational Anthrax. It Is Not Ethical Or Feasible To Conduct Controlled Clinical Trials With Intentional Exposure Of Humans To Anthrax [see Clinical Studies ( 14 )] . Safety And Pk Of Anthim Have Been Studied In Adult Healthy Volunteers. There Have Been No Studies Of Safety Or Pk Of Anthim In The Pediatric Population. A Population Pk Approach Was Used To Derive Intravenous Infusion Dosing Regimens That Are Predicted To Provide Pediatric Patients With Exposure Comparable To The Observed Exposure In Adults [see Use In Specific Populations ( 8.4 )] . Anthim Binds To The Protective Antigen (pa) Component Of B. Anthracis Toxin; It Does Not Have Direct Antibacterial Activity. Anthim Is Not Expected To Cross The Blood-Brain Barrier And Does Not Prevent Or Treat Meningitis. Anthim Should Be Used In Combination With Appropriate Antibacterial Drugs.
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