Anthrasil

— THERAPEUTIC DISORDERS TREATED —
  • Bacterial infections

Anthrasil Generic Name & Formulations

General Description

Anthrax immune globulin intravenous (human) ≥60 Units; per vial; soln for IV infusion; preservative-free; contains maltose.

Pharmacological Class

Immune globulin.

How Supplied

Single-dose vial (50mL)—1, 7

Generic Availability

NO

Anthrasil Indications

Indications

Treatment of inhalational anthrax in combination with appropriate antibacterial drugs.

Limitations of Use

Has no direct antibacterial activity. Does not cross the blood-brain barrier. Does not prevent or treat meningitis. Pediatric, geriatric, or obese patients: not studied.

Anthrasil Dosage and Administration

Adult

Give by slow IV infusion using an infusion pump. Initial rate (1st 30mins): 0.5mL/min. Incremental rate if tolerated (every 30mins): 1mL/min. Max rate: 2mL/min. ≥17yrs: give 7 vials (420 Units). Base initial dose, adjustments, or repeat doses on clinical severity and response; severe cases may need 14 vials (840 Units). For substantial hemorrhage, significant compartmental fluid losses, or impaired/delayed immune response: consider initial dose of 840 Units and repeat dosing.

Children

Give by slow IV infusion using an infusion pump. Initial rate (1st 30mins): 0.01mL/kg/min. Incremental rate if tolerated (every 30mins): 0.02mL/kg/min. Max rate: 0.04mL/kg/min (do not exceed Adult rate). <1–≤16yrs: give 1–7 vials (60–420 Units) based on patient weight (see full labeling). Base initial dose, adjustments, or repeat doses on clinical severity and response; severe cases may need 2–14 vials (based on weight) in those weighing >5kg.

Anthrasil Contraindications

Contraindications

IgA-deficiency with antibodies against IgA and a history of IgA hypersensitivity.

Anthrasil Boxed Warnings

Boxed Warning

Interactions with glucose monitoring systems. Thrombosis.

Anthrasil Warnings/Precautions

Warnings/Precautions

Have appropriate equipment, medication (including epinephrine), and trained personnel readily available. Monitor and discontinue immediately if severe hypersensitivity reactions occur. Increased thrombosis risk in cardiovascular disorders, advanced age, impaired cardiac output, hypercoagulable disorders, prolonged immobilization, history of arterial or venous thrombosis, estrogen use, indwelling central vascular catheter, and/or known or suspected hyperviscosity; infuse at minimum rate practicable; monitor. Ensure adequate hydration. Consider baseline assessment of blood viscosity in those at risk of hyperviscosity, including cryoglobulins, chylomicronemia, markedly high triglycerides, or monoclonal gammopathies. Pre-existing renal insufficiency or risk of (eg, diabetes mellitus, age >65yrs, volume depletion, paraproteinemia, sepsis, taking nephrotoxic drugs); infuse at minimum rate practicable; monitor. Assess renal function, urine output, BUN, serum creatinine, prior to initial infusion and periodically thereafter; consider discontinuing if renal function deteriorates. Do not exceed recommended infusion rate. Monitor for infusion reactions; slow infusion rate or interrupt if occur. High doses (>2g/kg given as single dose or over several days), non-O blood group, or underlying inflammatory state; monitor for hemolysis. Consider measuring hemoglobin/hematocrit prior to infusion, within ~36–96hrs, and again ~7–10 days post-infusion. Perform neurological exam if signs/symptoms of aseptic meningitis syndrome develop (including CSF studies). Monitor for pulmonary adverse reactions; if transfusion-related acute lung injury (TRALI) suspected, perform appropriate tests. Contains human plasma; monitor for possible viral disease and variant Creutzfeldt-Jakob disease transmission. Pregnancy. Nursing mothers.

Anthrasil Pharmacokinetics

See Literature

Anthrasil Interactions

Interactions

May falsely elevate glucose readings due to maltose content; use systems that are glucose-specific to test or monitor levels. May interfere with serological tests (eg, Coombs' test). May impair efficacy of live attenuated vaccines (eg, measles, rubella, mumps, varicella); defer until ~3 months after Anthrasil administration; revaccinate if Anthrasil was received shortly after live virus vaccination 3 months after Anthrasil administration.

Anthrasil Adverse Reactions

Adverse Reactions

Headache, infusion site pain and swelling, nausea, back pain; thrombosis, acute renal dysfunction/failure, hemolysis, aseptic meningitis syndrome.

Anthrasil Clinical Trials

See Literature

Anthrasil Note

Not Applicable

Anthrasil Patient Counseling

See Literature