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1 Indications And Usage Raxibacumab Is Indicated For The Treatment Of Adult And Pediatric Patients With Inhalational Anthrax Due To Bacillus Anthracis In Combination With Appropriate Antibacterial Drugs, And For Prophylaxis Of Inhalational Anthrax When Alternative Therapies Are Not Available Or Are Not Appropriate. ( 1 ) Limitations Of Use: • The Effectiveness Of Raxibacumab Is Based Solely On Efficacy Studies In Animal Models Of Inhalational Anthrax. ( 1.2 , 14.1 ) • There Have Been No Studies Of Raxibacumab In The Pediatric Population. Dosing In Pediatric Patients Was Derived Using An Extrapolation Approach. ( 1.2 , 8.4 ) • Raxibacumab Does Not Cross The Blood-Brain Barrier And Does Not Prevent Or Treat Meningitis. Raxibacumab Should Be Used In Combination With Appropriate Antibacterial Drugs. ( 1.2 ) 1.1 Inhalational Anthrax Raxibacumab Is Indicated For The Treatment Of Adult And Pediatric Patients With Inhalational Anthrax Due To Bacillus Anthracis In Combination With Appropriate Antibacterial Drugs. Raxibacumab Is Also Indicated For Prophylaxis Of Inhalational Anthrax When Alternative Therapies Are Not Available Or Are Not Appropriate. 1.2 Limitations Of Use The Effectiveness Of Raxibacumab 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 ( 14.1 ).] Safety And Pharmacokinetics (Pk) Of Raxibacumab Have Been Studied In Adult Healthy Volunteers. There Have Been No Trials Of Safety Or Pk Of Raxibacumab In The Pediatric Population. An Extrapolation Approach Was Used To Derive 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 ).] Raxibacumab Binds To The Protective Antigen (Pa) Of B. Anthracis ; It Does Not Have Direct Antibacterial Activity. Raxibacumab Does Not Cross The Blood-Brain Barrier And Does Not Prevent Or Treat Meningitis. Raxibacumab Should Be Used In Combination With Appropriate Antibacterial Drugs.
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