Raxibacumab

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. Limitations of Use: The effectiveness of raxibacumab is based solely on efficacy studies in animal models of inhalational anthrax. There have been no studies of raxibacumab in the pediatric population. Dosing in pediatric patients was derived using an extrapolation approach. 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.

Raxibacumab is a monoclonal antibody that binds the protective antigen of B. anthracis.

Premedicate with diphenhydramine. Dilute and administer as an intravenous infusion over 2 hours and 15 minutes. Adults: 40 mg/kg raxibacumab. Pediatrics greater than 40 kg: 40 mg/kg raxibacumab. Pediatrics greater than 10 kg to 40 kg: 60 mg/kg raxibacumab. Pediatrics 10 kg or less: 80 mg/kg raxibacumab.

None. None.

Boxed warning (hypersensitivity and anaphylaxis): Hypersensitivity reactions, including anaphylaxis, have been reported during or after the administration of raxibacumab by intravenous infusion. Administer raxibacumab by intravenous infusion in monitored settings where appropriate equipment, medication (including epinephrine) and personnel trained in the management of hypersensitivity, anaphylaxis, and shock are available. Hypersensitivity and Anaphylaxis: ( Boxed Warning, 2.1, 2.3, 5.1, 6.1 ) Hypersensitivity and Anaphylaxis Hypersensitivity reactions including rash, urticaria, pruritus, chills, chest and throat tightness, lip and throat swelling, and hypotension were reported in 27 (4.5%) of 606 healthy subjects during or after the administration of raxibacumab in clinical trials. Two subjects experienced anaphylaxis during the raxibacumab infusion.

Common adverse reactions in healthy adult subjects (≥1.5%) were injection site reaction, erythema and pain, headache, rash, pain in extremity, pruritus, and somnolence.

Ciprofloxacin Co-administration of 40 mg/kg raxibacumab intravenously with intravenous or oral ciprofloxacin in human subjects did not alter the PK of either ciprofloxacin or raxibacumab.

Store vial in original carton until time of use.