ANTHRASIL Solution for infusion Ref.[9986] Active ingredients: Anthrax immunoglobulin

For intravenous use only.

2.1 Dose

Table 1. ANTHRASIL Dosing Guide and Intravenous Infusion Rate:

^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.

Table 2. Pediatric Dosing Guide for ANTHRASIL:

^a The pediatric dosing is derived from allometric scaling based on observed adult exposure to ANTHRASIL at 420 units by Toxin Neutralization Assay (TNA) dose.
^b Select initial dose based on clinical severity. Dose may be doubled for severe cases in patients >5 kg.

The initial dose of ANTHRASIL for the treatment of inhalational anthrax in adults in combination with appropriate antimicrobial therapy is 420 units (seven vials). Data in animal models suggest that administration of higher doses may result in improved survival [See 13.2 Animal Toxicology and/or Pharmacology]. An initial dose of 840 units (14 vials) may be considered, depending on the clinical status of the patient.

Depending on the severity of symptoms and the response to treatment, consider an initial dose of 840 units (14 vials) and repeat dosing especially in patients experiencing substantial hemorrhage as reflected in large transfusion requirements, patients with significant compartmental fluid losses such as from large volume and/or repeated therapeutic thoracentesis and/or abdominal paracentesis, and in patients whose own immune response may be impaired/delayed. Take the magnitude of ongoing blood and fluid losses and the clinical status of the patient into account in determining the time interval between doses when repeat doses are administered. Repeated dosing and single doses greater than 840 units in humans have not been studied. Without substantially delaying therapy, give consideration to performing therapeutic thoracentesis and/or abdominal paracentesis as indicated prior to or concurrently with administration of ANTHRASIL.

2.2 Preparation and Administration

Each vial of ANTHRASIL has a minimum potency of ≥60 units per vial [See 3 DOSAGE FORMS AND STRENGTHS].

• Bring ANTHRASIL vials to room temperature.
  • Thaw frozen vials rapidly for immediate use by placing at room temperature for one hour 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 to 8°C (36 to 46°F) until the vials are thawed (approximately 14 hours).
  • 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 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.
• Follow the steps below to prepare the ANTHRASIL infusion bag:
  • 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 of ANTHRASIL into a syringe, aseptically transfer into an appropriately sized intravenous 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. ANTHRASIL contains no preservative.
• Administer in an intravenous line with constant infusion pump. Use of an in-line filter is optional.
• If adverse reactions occur, such as flushing, headache, nausea, changes in pulse rate or blood pressure, slow the rate of infusion or temporarily stop the infusion.
• ANTHRASIL vials are for single use only. Discard any unused portion.

Store frozen at or below ≤-15°C (≤5°F) until required for use. Do not use after expiration date.

Once punctured, use the vial contents to prepare the infusion bag and infuse as soon as possible. ANTHRASIL contains no preservative.

Do not refreeze, reuse or save ANTHRASIL for future use.

Discard any partially used vials.