Data from FDA - Curated by Toby Galbraith - Last updated 15 May 2017
FDA (Food and Drug Administration, USA)
• IgA deficiency with antibodies against IgA and a history of IgA hypersensitivity (4)
WARNING: INTERACTIONS WITH GLUCOSE MONITORING SYSTEMS AND THROMBOSIS
See full prescribing information for complete boxed warning.
• 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. To avoid interference by maltose contained in ANTHRASIL, perform blood glucose measurements in patients receiving ANTHRASIL with a glucose-specific method (monitor and test strips).
• Thrombosis may occur with immune globulin products, including ANTHRASIL. Risk factors may include advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.
• For patients at risk of thrombosis, administer ANTHRASIL at the minimum infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity.
• Hypersensitivity reactions including anaphylaxis (5.1)
• Interference with blood and urine glucose testing (5.2, 5.9)
• Thrombosis may occur. Monitor patients at risk (5.3)
• Monitor renal function and urine output in patients at risk of acute renal dysfunction/failure (5.4)
• Infuse ANTHRASIL at the minimum rate practicable in patients at risk of thrombosis or renal failure (5.5)
• Monitor for clinical signs and symptoms of hemolysis and hemolytic anemia (5.6)
• Aseptic meningitis syndrome (AMS) (5.7)
• Transfusion-related Acute Lung Injury (TRALI) (5.10)
• Transmission of infectious agents from human plasma (5.11)
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 (6.1).
Dosing of ANTHRASIL
|Patient Group||Dosea||Starting Infusion Rate (first 30 min)||Incremental Infusion Rate if Tolerated (every 30 min)||Max Infusion Rate|
|Adults (≥17 years)||7 vials
|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)|
aSelect 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.
Adjust dose and consider redosing based on clinical severity and response to treatment (2.1)
Weight-based Pediatric Dose
|Body Weight (kg)||Vials per Dosea||Body Weight (kg)||Vials per Dose|
|<5||1||25 to <35||4|
|<10||1||35 to <50||5|
|10 to <18||2||50 to <60||6|
|18 to <25||3||≥60||7|
aSelect initial dose based on clinical severity. Dose may be doubled for severe cases in patients >5 kg.
Administer ANTHRASIL by slow intravenous infusion using an infusion pump (maximum 2 mL per minute).
|Date First Approved||05-10-2015|
|Marketing authorisation holder||Cangene Corporation|