Anthim

ANTHIM^® is a monoclonal antibody directed against the protective antigen of

• ANTHIM should only be used for prophylaxis when its benefit for prevention of inhalational anthrax outweighs the risk of hypersensitivity and anaphylaxis. (
  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 ]

  .

  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 ]

  .

  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 ]

  .

  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.
  ,
  5.1 Hypersensitivity and Anaphylaxis

  Hypersensitivity reactions were the most common adverse reactions in the safety trials of ANTHIM, occurring in 34/320 healthy subjects (10.6%). Three (0.9%) cases of anaphylaxis occurred during or immediately after the infusion. In clinical trials, manifestations of anaphylaxis were rash/urticaria, cough, dyspnea, cyanosis, postural dizziness and chest discomfort. ANTHIM infusion was discontinued in 8 (2.5%) subjects due to hypersensitivity or anaphylaxis. The adverse reactions reported in these 8 subjects included urticaria, rash, cough, pruritus, dizziness, throat irritation, dysphonia, dyspnea and chest discomfort. The remaining subjects with hypersensitivity had predominantly skin-related symptoms such as pruritus and rash, and 6 subjects reported cough

  [see Adverse Reactions 6.1].

  Due to the risk of anaphylaxis, ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Patients should be monitored closely throughout the infusion period and for a period of time after administration

  [see Patient Counseling Information ].

  If anaphylaxis or hypersensitivity reactions occur, stop the infusion immediately and treat appropriately.

  Premedication with diphenhydramine is recommended prior to administration of ANTHIM

  [see Dosage and Administration and Adverse Reactions ]

  . Diphenhydramine premedication does not prevent anaphylaxis, and may mask or delay onset of symptoms of hypersensitivity.
  )
• The effectiveness of ANTHIM is based solely on efficacy studies in animal models of inhalational anthrax. (
  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 ]

  .

  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 ]

  .

  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 ]

  .

  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.
  ,
  14 CLINICAL STUDIES

  Overview

  Because it is not feasible or ethical to conduct controlled clinical trials in humans with inhalational anthrax, the efficacy of ANTHIM for the treatment of inhalational anthrax is based on efficacy studies in NZW rabbits and cynomolgus macaques. The animal efficacy studies are conducted under widely varying conditions, such that the survival rates observed in the animal studies cannot be directly compared between studies and may not reflect the rates observed in clinical practice.

  Types of Studies

  The efficacy of ANTHIM for treatment and prophylaxis of inhalational anthrax was studied in multiple studies in the cynomolgus macaque and NZW rabbit models of inhalational anthrax. These studies tested the efficacy of ANTHIM compared to placebo and the efficacy of ANTHIM in combination with antibacterial drugs relative to the antibacterial drugs alone.

  Study Design

  The animals were challenged with aerosolized

  B. anthracis

  spores (Ames strain) at approximately 200xLD₅₀to achieve 100% mortality if untreated. In prophylaxis studies of inhalational anthrax, animals were treated prior to the development of symptoms. In treatment studies, animals were administered treatment after exhibiting clinical signs or symptoms of systemic anthrax. Cynomolgus macaques were treated at the time of a positive serum electrochemiluminescence (ECL) assay for

  B. anthracis

  PA at a mean time of approximately 40 hours post-challenge with

  B. anthracis

  . In NZW rabbit treatment studies, animals were treated after a positive ECL assay for PA or sustained elevation of body temperature above baseline, at a mean time of approximately 30 hours post-challenge; the majority of animals triggered by temperature. In some of the treatment studies assessing the effect of ANTHIM in combination with antibacterial drugs, treatment was delayed to 72 to 96 hours post-challenge. Most study animals were bacteremic and had a positive ECL assay for PA prior to treatment. Survival was assessed at 28 days post-challenge with

  B. anthracis

  in most studies.

  Results

  NZW rabbit studies 1 and 2 and cynomolgus macaque studies 3 and 4 evaluated treatment with ANTHIM 16 mg/kg IV single dose compared to placebo in animals with systemic anthrax. Treatment with ANTHIM alone resulted in statistically significant improvement in survival relative to placebo .

  Table 4. Survival Proportions in Monotherapy Treatment Studies of 16 mg/kg IV, All Randomized Animals Positive for Bacteremia Prior to Treatment

  IV: intravenous, CI: Confidence Interval
  1Survival assessed 28 days after spore challenge
  2p-value is from 1-sided Boschloo Test (with Berger-Boos modification of gamma=0.001) compared to placebo
  3Exact 95% confidence interval of difference in survival rates
  4ANTHIM products manufactured at two different facilities were tested in two separate treatment arms
  	Proportion of Survival at Day 28 1 (# survived/n)		p-value 2	95% CI 3
  	Placebo	ANTHIM 16 mg/kg IV
  NZW Rabbits
  Study 1	0 (0/9)	93% (13/14)	0.0010	(0.59, 1.00)
  Study 2	0 (0/13)	62% (8/13)	0.0013	(0.29, 0.86)
  Cynomolgus Macaques
  Study 3	6% (1/16)	47% (7/15)	0.0068	(0.09, 0.68)
  Study 44	0 (0/17)	31% (5/16) 35% (6/17)	0.0085 0.0055	(0.08, 0.59) (0.11, 0.62)

  ANTHIM administered in combination with antibacterial drugs (levofloxacin, ciprofloxacin and doxycycline) for the treatment of systemic inhalational anthrax disease resulted in higher survival outcomes than antibacterial therapy alone in multiple studies where ANTHIM and antibacterial therapy was given at various doses and treatment times.

  ANTHIM administered as prophylaxis resulted in higher survival outcomes compared to placebo in multiple studies where treatment was given at various doses and treatment times. In one study, cynomolgus macaques were administered ANTHIM 16 mg/kg at 18 hours, 24 hours or 36 hours after exposure. Survival was 6/6 (100%) at 18 hours, 5/6 (83%) at 24 hours, and 3/6 (50%) at 36 hours. Another cynomolgus macaque study evaluated ANTHIM 16 mg/kg administered 72, 48 or 24 hours prior to exposure. Survival was 100% at all three time points (14/14, 14/14, 15/15, respectively) at day 56 (end of study).
  )
• There have been no studies of the safety or pharmacokinetics (PK) of ANTHIM in the pediatric population. Dosing in pediatric patients was derived using a population PK approach. (
  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 ]

  .

  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 ]

  .

  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 ]

  .

  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.
  ,
  8.4 Pediatric Use

  As in adults, the effectiveness of ANTHIM in pediatric patients is based solely on efficacy studies in animal models of inhalational anthrax. As exposure of healthy children to ANTHIM is not ethical, a population PK approach was used to derive intravenous dosing regimens that are predicted to provide pediatric patients with exposure comparable to the observed exposure in adults receiving 16 mg/kg. The dose for pediatric patients is based on weight

  [see Dosage and Administration ]

  .

  There have been no studies of safety or PK of ANTHIM in the pediatric population.
  )
• ANTHIM does not have direct antibacterial activity. ANTHIM should be used in combination with appropriate antibacterial drugs. (
  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 ]

  .

  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 ]

  .

  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 ]

  .

  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.
  )
• ANTHIM is not expected to cross the blood-brain barrier and does not prevent or treat meningitis. (
  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 ]

  .

  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 ]

  .

  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 ]

  .

  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.
  )

• Pre-medicate with diphenhydramine. (
  2.1 Dosage for Adult Patients

  • Pre-medicate with diphenhydramine prior to administering ANTHIM
    [see Warnings and Precautions ]
    .
  • Dilute the injection in 0.9% Sodium Chloride Injection, USP, before administering as an intravenous infusion
    [see Dosage and Administration ]
    .
  • 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 ]
    .
  • For adult patients weighing less than 40 kg, see Table 1below.
  ,
  5.1 Hypersensitivity and Anaphylaxis

  Hypersensitivity reactions were the most common adverse reactions in the safety trials of ANTHIM, occurring in 34/320 healthy subjects (10.6%). Three (0.9%) cases of anaphylaxis occurred during or immediately after the infusion. In clinical trials, manifestations of anaphylaxis were rash/urticaria, cough, dyspnea, cyanosis, postural dizziness and chest discomfort. ANTHIM infusion was discontinued in 8 (2.5%) subjects due to hypersensitivity or anaphylaxis. The adverse reactions reported in these 8 subjects included urticaria, rash, cough, pruritus, dizziness, throat irritation, dysphonia, dyspnea and chest discomfort. The remaining subjects with hypersensitivity had predominantly skin-related symptoms such as pruritus and rash, and 6 subjects reported cough

  [see Adverse Reactions 6.1].

  Due to the risk of anaphylaxis, ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Patients should be monitored closely throughout the infusion period and for a period of time after administration

  [see Patient Counseling Information ].

  If anaphylaxis or hypersensitivity reactions occur, stop the infusion immediately and treat appropriately.

  Premedication with diphenhydramine is recommended prior to administration of ANTHIM

  [see Dosage and Administration and Adverse Reactions ]

  . Diphenhydramine premedication does not prevent anaphylaxis, and may mask or delay onset of symptoms of hypersensitivity.
  )
• Recommended Dosage of ANTHIM:
  • Adult Patients: 16 mg/kg. (
    2.1 Dosage for Adult Patients

    • Pre-medicate with diphenhydramine prior to administering ANTHIM
      [see Warnings and Precautions ]
      .
    • Dilute the injection in 0.9% Sodium Chloride Injection, USP, before administering as an intravenous infusion
      [see Dosage and Administration ]
      .
    • 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 ]
      .
    • For adult patients weighing less than 40 kg, see Table 1below.
    )
  • Pediatric Patients: (
    2.2 Dosage for Pediatric Patients

    • Pre-medicate with diphenhydramine prior to administering ANTHIM [see Warnings and Precautions ].
    • Dilute the injection in 0.9% Sodium Chloride Injection, USP, before administering as an intravenous infusion [see Dosage and Administration ].
    • The recommended dose for pediatric patients is based on weight as shown in Table 1below.

    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 ]
      .

    There have been no studies of the safety or PK of ANTHIM conducted in the pediatric population. The dosing recommendations in Table 1are 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 ]

    .
    )
    • ➢ 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
• Dilute the injection in 0.9% Sodium Chloride Injection, USP, before administering as an intravenous (IV) infusion over 1 hour and 30 minutes. (
  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 ]
    .
  • 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

  • Calculate the milligrams of ANTHIM injection needed by multiplying the recommended mg/kg dose in Table 2by the patient weight in kilograms.
  • 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.
  • 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.
  • 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).
  • Transfer the required volume of ANTHIM injection to the selected infusion bag.
  • Gently invert the bag to mix the solution. Do not shake.
  • 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

  • Calculate lunused product.
  )
• Administer ANTHIM in a monitored setting equipped to manage anaphylaxis. (
  2.4 Administration

  • Administer ANTHIM in appropriately monitored settings which are equipped to manage anaphylaxis
    [see Warnings and Precautions ]
    .
  • Dilute ANTHIM injection
    [see Dosage and Administration ]
    before administering ANTHIM intravenously using the bag or syringe for infusion.
  • After preparation of the bag or syringe for infusion administer the infusion solution using a 0.22 micron inline filter with the infusion rate described in Table 2
    [see Dosage and Administration ]
    .
  • Administer diluted ANTHIM intravenous infusion over 1 hour and 30 minutes. Monitor patients closely for signs and symptoms of hypersensitivity throughout the infusion and for a period of time after administration
    [see Warnings and Precautions ]
    .
  • Stop the infusion immediately and treat appropriately, if hypersensitivity or anaphylaxis occurs
    [see Warnings and Precautions ]
    .
  • Flush the line with 0.9% Sodium Chloride Injection, USP at the end of the intravenous infusion.
  ,
  5.1 Hypersensitivity and Anaphylaxis

  Hypersensitivity reactions were the most common adverse reactions in the safety trials of ANTHIM, occurring in 34/320 healthy subjects (10.6%). Three (0.9%) cases of anaphylaxis occurred during or immediately after the infusion. In clinical trials, manifestations of anaphylaxis were rash/urticaria, cough, dyspnea, cyanosis, postural dizziness and chest discomfort. ANTHIM infusion was discontinued in 8 (2.5%) subjects due to hypersensitivity or anaphylaxis. The adverse reactions reported in these 8 subjects included urticaria, rash, cough, pruritus, dizziness, throat irritation, dysphonia, dyspnea and chest discomfort. The remaining subjects with hypersensitivity had predominantly skin-related symptoms such as pruritus and rash, and 6 subjects reported cough

  [see Adverse Reactions 6.1].

  Due to the risk of anaphylaxis, ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Patients should be monitored closely throughout the infusion period and for a period of time after administration

  [see Patient Counseling Information ].

  If anaphylaxis or hypersensitivity reactions occur, stop the infusion immediately and treat appropriately.

  Premedication with diphenhydramine is recommended prior to administration of ANTHIM

  [see Dosage and Administration and Adverse Reactions ]

  . Diphenhydramine premedication does not prevent anaphylaxis, and may mask or delay onset of symptoms of hypersensitivity.
  )
• See Full Prescribing Information for instructions on preparation, dilution and administration of ANTHIM injection. (
  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 ]
    .
  • 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

  • Calculate the milligrams of ANTHIM injection needed by multiplying the recommended mg/kg dose in Table 2by the patient weight in kilograms.
  • 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.
  • 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.
  • 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).
  • Transfer the required volume of ANTHIM injection to the selected infusion bag.
  • Gently invert the bag to mix the solution. Do not shake.
  • 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

  • Calculate lunused product.
  ,
  2.4 Administration

  • Administer ANTHIM in appropriately monitored settings which are equipped to manage anaphylaxis
    [see Warnings and Precautions ]
    .
  • Dilute ANTHIM injection
    [see Dosage and Administration ]
    before administering ANTHIM intravenously using the bag or syringe for infusion.
  • After preparation of the bag or syringe for infusion administer the infusion solution using a 0.22 micron inline filter with the infusion rate described in Table 2
    [see Dosage and Administration ]
    .
  • Administer diluted ANTHIM intravenous infusion over 1 hour and 30 minutes. Monitor patients closely for signs and symptoms of hypersensitivity throughout the infusion and for a period of time after administration
    [see Warnings and Precautions ]
    .
  • Stop the infusion immediately and treat appropriately, if hypersensitivity or anaphylaxis occurs
    [see Warnings and Precautions ]
    .
  • Flush the line with 0.9% Sodium Chloride Injection, USP at the end of the intravenous infusion.
  )

Injection: 600 mg/6 mL (100 mg/mL) in a single-dose vial.

ANTHIM is a clear to opalescent, colorless to pale yellow to pale brownish-yellow solution and may contain few translucent-to-white proteinaceous particulates.

Pediatric Use: There have been no studies of the safety or PK of ANTHIM in the pediatric population. (