The safety of raxibacumab has been evaluated in 326 healthy adult volunteers treated with the recommended dose. Infusion reactions were reported in clinical trials including reports of rash, urticaria (hives) and pruritus (itching). If these reactions occur, slow or interrupt raxibacumab infusion and administer appropriate treatment based on the severity of the reaction. Patients should be premedicated with diphenhydramine (an antihistamine) before treatment. The most frequently reported adverse reactions (less than or equal to 1.5%) were rash, pain in an extremity (arms and legs), pruritus (itching) and somnolence.The recommended adult dosage of raxibacumab is a single dose of 40 mg/kg given intravenously over a period of two hours and 15 minutes. Administer diphenhydramine within an hour of treatment to reduce the risk of infusion reactions. The recommended dose for children is based on weight.
GSK Receives FDA Approval For Raxibacumab Anti-toxin For The Treatment Of Inhalational Anthrax
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