Anthrax immune globulin human

ANTHRASIL is an Anthrax Immune Globulin Intravenous (Human) indicated for the treatment of inhalational anthrax in adult and pediatric patients in combination with appropriate antibacterial drugs. The effectiveness of ANTHRASIL is based solely on efficacy studies conducted in animal models of inhalational anthrax [See

The polyclonal immune globulin G in ANTHRASIL is a passive immunizing agent that neutralizes anthrax toxin. ANTHRASIL binds to protective antigen (PA) to prevent PA mediated cellular entry of anthrax edema factor and lethal factor. ANTHRASIL is administered in combination with appropriate antibiotic therapy as the product by itself is not known to have direct antibacterial activity against anthrax bacteria, which otherwise may continue to grow and produce anthrax toxins.

For intravenous use only. Dosing of ANTHRASIL a Select initial dose based on clinical severity, severe cases may warrant use of 14 vials (840 units) in adults and 2 to 14 vials (based on weight) in pediatric patients weighing >5 kg. Patient Group Dose a Starting Infusion Rate (first 30 min) Incremental Infusion Rate if Tolerated (every 30 min) Max Infusion Rate Adults (≥17 years) 7 vials (420 units) 0.5 mL/min 1 mL/min 2 mL/min Pediatric <1 year to ≤16 years 1–7 vials (60–420 units) based on patient weight 0.01 mL/kg/min (do not exceed the adult rate) 0.02 mL/kg/min 0.04 mL/kg/min (do not exceed the adult rate) Adjust dose and consider redosing based on clinical severity and response to treatment. Weight-based Pediatric Dose Body Weight (kg) Vials per Dose a Body Weight (kg) Vials per Dose a Select initial dose based on clinical severity.

• ANTHRASIL is contraindicated in individuals with a history of anaphylaxis or prior severe systemic reaction associated with the parenteral administration of this or other human immune globulin preparations. • ANTHRASIL is contraindicated in IgA-deficient patients with antibodies against IgA and a history of IgA hypersensitivity, as it contains trace amounts of IgA (less than or equal to 40 mcg per mL) [See

Boxed warning (interactions with glucose monitoring systems and thrombosis •): Maltose in immune globulin products, including ANTHRASIL, may give falsely high blood glucose levels with some blood point-of-care glucose testing systems (for example those based on the GDH-PQQ or glucose-dye-oxidoreductase methods) resulting in inappropriate administration of insulin and life-threatening hypoglycemia. • Hypersensitivity reactions including anaphylaxis. • Interference with blood and urine glucose testing. • Thrombosis may occur. Monitor patients at risk. • Monitor renal function and urine output in patients at risk of acute renal dysfunction/failure. • Infuse ANTHRASIL at the minimum rate practicable in patients at risk of thrombosis or renal failure. • Monitor for clinical signs and symptoms of hemolysis and hemolytic anemia. • Aseptic meningitis syndrome (AMS).

The most common adverse reactions to ANTHRASIL observed in >5% of subjects in the healthy volunteer clinical trial were headache, infusion site pain, nausea, infusion site swelling, and back pain. The safety profile of the product may be different in patients with severe inhalational/systemic anthrax from that seen in the healthy volunteer trial. The incidence and/or severity of some adverse reactions to ANTHRASIL and other intravenous immune globulin products may be related to the total protein/polyclonal antibody load administered. The most common adverse reactions to ANTHRASIL observed in >5% of healthy volunteers in clinical trials were headache, infusion site pain and swelling, nausea, and back pain.

Ciprofloxacin and Levofloxacin Based on animal studies, ANTHRASIL did not interfere with antibiotic therapy. Concomitant administration of ANTHRASIL with levofloxacin or ciprofloxacin in exposed rabbits and cynomolgus macaques, respectively, did not reduce the efficacy of antibacterial therapy.

Store frozen at or below ≤-15°C (≤5°F) until required for use.