Anthim

ANTHIM — obiltoxaximab solution
Elusys Therapeutics, Inc.

WARNING: HYPERSENSITIVITY and ANAPHYLAXIS

Hypersensitivity and anaphylaxis have been reported during the intravenous infusion of ANTHIM. Due to the risk of hypersensitivity and anaphylaxis, ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Monitor individuals who receive ANTHIM closely for signs and symptoms of hypersensitivity reactions throughout the infusion and for a period of time after administration. Stop ANTHIM infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs [see Indications and Usage (1.2), Dosage and Administration (2.4) and Warnings and Precautions (5.1)].

1 INDICATIONS AND USAGE

1.1 Inhalational Anthrax

ANTHIM is indicated in adult and pediatric patients for the treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs.

ANTHIM is indicated for prophylaxis of inhalational anthrax due to B. anthracis when alternative therapies are not available or not appropriate [see Indications and Usage (1.2)].

1.2 Limitations of Use

ANTHIM should only be used for prophylaxis when its benefit for prevention of inhalational anthrax outweighs the risk of hypersensitivity and anaphylaxis [see Warnings and Precautions (5.1)].

The effectiveness of ANTHIM is based solely on efficacy studies in animal models of inhalational anthrax. It is not ethical or feasible to conduct controlled clinical trials with intentional exposure of humans to anthrax [see Clinical Studies (14)].

Safety and PK of ANTHIM have been studied in adult healthy volunteers. There have been no studies of safety or PK of ANTHIM in the pediatric population. A population PK approach was used to derive intravenous infusion dosing regimens that are predicted to provide pediatric patients with exposure comparable to the observed exposure in adults [see Use in Specific Populations (8.4)].

ANTHIM binds to the protective antigen (PA) component of B. anthracis toxin; it does not have direct antibacterial activity. ANTHIM is not expected to cross the blood-brain barrier and does not prevent or treat meningitis. ANTHIM should be used in combination with appropriate antibacterial drugs.

2 DOSAGE AND ADMINISTRATION

2.1 Dosage for Adult Patients

  • Pre-medicate with diphenhydramine prior to administering ANTHIM [see Warnings and Precautions (5.1)].
  • Dilute the injection in 0.9% Sodium Chloride Injection, USP, before administering as an intravenous infusion [see Dosage and Administration (2.3)].
  • The recommended dosage of ANTHIM in adult patients is a single dose of 16 mg/kg administered intravenously over 90 minutes (1 hour and 30 minutes) [see Dosage and Administration (2.4)].
  • For adult patients weighing less than 40 kg, see Table 1 below.

2.2 Dosage for Pediatric Patients

  • Pre-medicate with diphenhydramine prior to administering ANTHIM [see Warnings and Precautions (5.1)].
  • Dilute the injection in 0.9% Sodium Chloride Injection, USP, before administering as an intravenous infusion [see Dosage and Administration (2.3)].
  • The recommended dose for pediatric patients is based on weight as shown in Table 1 below.
Table 1. Recommended Pediatric Dose of ANTHIM (weight-based dosing)
Body Weight Dose
Greater than 40 kg 16 mg/kg
Greater than 15 kg to 40 kg 24 mg/kg
Less than or equal to 15 kg 32 mg/kg
  • Administer the recommended dose of ANTHIM intravenously over 90 minutes (1 hour and 30 minutes) [see Dosage and Administration (2.4)].

There have been no studies of the safety or PK of ANTHIM conducted in the pediatric population. The dosing recommendations in Table 1 are derived from simulations using a population PK approach designed to match the observed adult exposure to ANTHIM at a 16 mg/kg dose [see Use in Specific Populations (8.4)].

2.3 Preparation and Dilution for Administration

Important Preparation Instructions

  • Keep vials in their cartons prior to preparation of an infusion solution to protect ANTHIM from light. ANTHIM vials contain no preservative.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
  • Discard the vial if the solution is discolored or contains extraneous particles other than a few translucent-to- white, proteinaceous particles [see Description (11)].
  • Do not shake the vial.
Table 2. ANTHIM Dose, Total Infusion Volume and Infusion Rate by Body Weight
Body Weight (weight-based dosing) Total Infusion Volume Infusion Rate
Greater than 40 kg or adult (16 mg/kg)
Greater than 40 kg 250 mL 167 mL/hr
Greater than 15 kg to 40 kg (24 mg/kg)
31 kg to 40 kg 250 mL 167 mL/hr
16 kg to 30 kg 100 mL 67 mL/hr
15 kg or less (32 mg/kg)
11 kg to 15 kg 100 mL 67 mL/hr
5 kg to 10 kg 50 mL 33.3 mL/hr
3.1 kg to 4.9 kg 25 mL 17 mL/hr
2.1 kg to 3 kg 20 mL 13.3 mL/hr
1.1 kg to 2 kg 15 mL 10 mL/hr
1 kg or less 7 mL 4.7 mL/hr

Preparation and Dilution in Bag for Infusion

  1. Calculate the milligrams of ANTHIM injection needed by multiplying the recommended mg/kg dose in Table 2 by the patient weight in kilograms.
  2. Calculate the required volume in milliliters of ANTHIM injection and number of vials needed for the dose by dividing the calculated dose in milligrams (step 1) by the concentration, 100 mg/mL. Each single vial allows delivery of 6 mL of ANTHIM.
  3. Select an appropriate size bag of 0.9% Sodium Chloride Injection, USP. Withdraw a volume of solution from the bag equal to the calculated volume in milliliters of ANTHIM in step 2 above. Discard the solution that was withdrawn from the bag.
  4. Withdraw the required volume of ANTHIM injection (calculated from step 2) from the ANTHIM vial(s). Discard any unused portion remaining in the ANTHIM vial(s).
  5. Transfer the required volume of ANTHIM injection to the selected infusion bag.
  6. Gently invert the bag to mix the solution. Do not shake.
  7. The prepared solution is stable for 8 hours stored at room temperature 20°C to 25°C (68°F to 77°F) or 8 hours stored in the refrigerator at 2°C to 8°C (36°F to 46°F).

Preparation and Dilution in Syringe for Infusion

  1. Calculate the milligrams of ANTHIM injection needed by multiplying the recommended mg/kg dose in Table 2 by the patient weight in kilograms.
  2. Calculate the required volume in milliliters of ANTHIM injection and number of vials needed for the dose by dividing the calculated dose in milligrams (step 1) by the concentration, 100 mg/mL. Each single vial allows delivery of 6 mL of ANTHIM.
  3. Select an appropriate size syringe for the total volume of infusion to be administered.
  4. Using the selected syringe, withdraw the required volume of ANTHIM injection (calculated from step 2). Discard any unused portion remaining in the ANTHIM vial(s).
  5. Withdraw an appropriate amount of 0.9% Sodium Chloride Injection, USP to prepare the total infusion volume specified in Table 2.
  6. Gently mix the solution. Do not shake.
  7. Once a diluted solution of ANTHIM has been prepared, administer immediately. Do not store solution in syringe. Discard unused product.

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