Anthrax immune globulin

Anthrax

Intravenous Anthrax Exposure Indicated for treatment of inhalational anthrax in combination with appropriate antibacterial drugs >17 years: 420 units (7 vials) IV; initiate IV infusion at 0.5 mL/min for 30 min; if tolerated, may increase infusion rate by 0.5 mL/min q30min; not to exceed 2 mL/min Select initial dose based on clinical severity; severe cases may warrant use of 14 vials (840 units) in adults

Intravenous Anthrax Exposure Indicated for treatment of inhalational anthrax in combination with appropriate antibacterial drugs <16 years: 60-420 units (1-7 vials) IV; initiate IV infusion at 0.01 mL/kg/min for 30 min; if tolerated, may increase infusion rate by 0.02 mL/kg/min q30min; not to exceed 0.04 mL/kg/min Do not exceed adult infusion rate when initiating (ie, 0.5 mL/min) or for maximum infusion rate (ie, 2 mL/min) Select initial dose based on clinical severity; severe cases may warrant use of 2-14 vials (based on weight) in pediatric patients weighing >5 kg Vials needed by weight <10 kg: 1 vial 10 to <18 kg: 2 vials 18 to <25 kg: 3 vials 25 to <35 kg: 4 vials 35 to <50 kg: 5 vials 50 to <60 kg: 6 vials >60 kg: 7 vials

Use Anthrax immune globulin with caution in patients with any degree of pre-existing renal insufficiency and in patients at risk of developing renal insufficiency (including, but not limited to those with diabetes mellitus, age greater than 65 years, volume depletion, paraproteinemia, sepsis, and patients receiving known nephrotoxic drugs), administering at the minimum rate of infusion practicable. Ensure that patients are not volume-depleted before Anthrax immune globulin infusion. Do not exceed the recommended infusion rate, and follow the infusion schedule closely.

The safety and effectiveness of Anthrax immune globulin in the geriatric population (>65 years of age) have not been studied.

IV Preparation Each vial has a minimum potency of >60 units/vial Bring vials to room temperature Thaw frozen vials rapidly for immediate use by placing at room temperature for 1 hr followed by a water bath at 37°C (98.6°F) until thawed Alternatively, thaw vials by placing the required number of vials in a refrigerator at 2-8°C (36-46°F) until the vials are thawed (approximately 14 hr) Do not thaw in a microwave oven Do not refreeze vials Bring thawed vials to room temperature by letting sit on a bench for a few minutes prior to infusion Inspect vials Inspect vials to ensure the product is fully thawed and free from discoloration and particulate matter The solution should be clear or slightly opalescent Do not use solutions that are cloudy, turbid, or have particulates Inspect vials to ensure there is no damage to the seal or vial If damaged, do not use and contact the manufacturer Gently swirl upright vials by hand to ensure uniformity Do not shake the vial during preparation to avoid foaming IV infusion bag preparation Remove the protective caps from the product vials Wipe the exposed central portion of the rubber stopper with an isopropyl alcohol swab Withdraw the vial contents into a syringe, aseptically transfer into an appropriately sized IV bag, and label with the volume to be infused No further dilution is required Once punctured, use the vial contents to prepare the infusion bag and administer as soon as possible Contains no preservative IV Administration Administer in an IV line with a constant infusion pump Use of an in-line filter is optional If adverse reactions occur (eg, flushing, headache, nausea, changes in pulse rate, or blood pressure), slow the rate of infusion or temporarily stop the infusion Vials are for single use only Discard any unused portion Adult infusion rate Initial: 0.5 mL/min for 30 min If tolerated, may increase infusion rate by 0.5 mL/min q30min; not to exceed 2 mL/min Pediatric infusion rate Initial: 0.01 mL/kg/min for 30 min If tolerated, may increase infusion rate by 0.02 mL/kg/min q30min; not to exceed 0.04 mL/kg/min Do not exceed adult infusion rate when initiating (ie, 0.5 mL/min) or for maximum infusion rate (ie, 2 mL/min)

History of anaphylaxis or prior severe systemic reaction associated with the parenteral administration of this or other human immune globulin preparations IgA deficiency with antibodies against IgA and a history of IgA hypersensitivity, as it contains trace amounts of IgA (<40 mcg/mL)

Falsely high blood glucose levels Maltose in immune globulin products, including anthrax immune globulin, may give falsely high blood glucose levels with some blood point-of-care glucose testing systems (eg, those based on the GDH-PQQ or glucose-dye-oxidoreductase methods), possibly resulting in inappropriate administration of insulin and life-threatening hypoglycemia To avoid interference by maltose, perform blood glucose measurements with a glucose-specific method (monitor and test strips) Thrombosis May occur with immune globulin products Risk factors 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 also occur in the absence of known risk factors For patients at risk of thrombosis, administer at the minimum infusion rate practicable Ensure adequate hydration in patients before administration Hypersensitivity reactions may occur Contains maltose; may interfere with certain types of blood glucose monitoring systems Thrombosis may occur following treatment with immune globulin products Adverse reactions (eg, chills, fever, headache, nausea, vomiting) may be related to the rate of infusion; follow closely the recommended infusion rate Hemolytic anemia and hemolysis may develop; anthrax immune globulin may contain blood group antibodies that may act as hemolysins and induce in vivo coating of red blood cells with immune globulin, causing a positive direct antiglobulin reaction and hemolysis Aseptic meningitis syndrome, noncardiogenic pulmonary edema, and blood-borne infections may occur in association with administration of immune globulin products Renal impairment Acute renal dysfunction, acute renal failure, osmotic nephropathy, acute tubular necrosis, proximal tubular nephropathy, and death may occur upon use of immune globulin intravenous products Caution with any degree of pr

Not Classi Pregnancy & Lactation There are no human data to establish the presence or absence of associated risk during pregnancy or while breastfeeding

Ciprofloxacin and Levofloxacin Based on animal studies, Anthrax immune globulin did not interfere with antibiotic therapy. Concomitant administration of Anthrax immune globulin with levofloxacin or ciprofloxacin in exposed rabbits and cynomolgus macaques, respectively, did not reduce the efficacy of antibacterial therapy. Live, Attenuated Vaccines Immune globulin administration may impair the efficacy of live attenuated vaccines such as measles, rubella, mumps and varicella. Defer vaccination with live virus vaccines until approximately three months after administration of Anthrax immune globulin. Revaccinated people who received Anthrax immune globulin shortly after live virus vaccination three months after the administration of the Anthrax immune globulin.

>10% Headache (20.4%) 1-10% Nausea (9.3%) Infusion site pain (9.3%) Infusion site swelling (7.4%) Back pain (3.7%)

Purified human intravenous immune globulin G (IgG) containing polyclonal antibodies that provides passive immunization that neutralizes anthrax toxin Binds to protective antigen (PA) to prevent PA-mediated cellular entry of anthrax edema factor and lethal factor Administered in combination with appropriate antibiotic therapy as the immune globulin by itself is not known to have direct antibacterial activity against anthrax bacteria, which otherwise may continue to grow and produce anthrax toxins It is prepared using plasma collected from healthy, screened donors who have been immunized with anthrax vaccine adsorbed