Obiltoxaximab (Anthim) - Uses, MOA, Dose, Side effects

Obiltoxaximab is a monoclonal antibody used for the treatment of inhalational anthrax, which is a severe infectious disease caused by the bacterium Bacillus anthracis. This antibody works by targeting the protective antigen component of the anthrax toxin, thereby preventing the toxin from entering and damaging cells. Obiltoxaximab was approved by the U.S. Food and Drug Administration (FDA) in 2016 for use in combination with appropriate antibacterial drugs for the treatment of inhalational anthrax.

Obiltoxaximab (Anthim) is a high-affinity IgG1 monoclonal antibody that binds to B. Anthracis. It is used in the treatment and prophylaxis of inhalational anthrax.

Obiltoxaximab (Anthim) Uses:

  • Inhalational anthrax:
    • Treatment of Bacillus anthracis-caused inhalational anthrax in conjunction with appropriate antibiotics.
    • B. anthracis inhalational anthrax prophylaxis and prevention when alternate forms of therapy are unavailable or inappropriate
  • Limitations of use:
    • Only when the benefit of preventing inhalational anthrax outweighs the risk of hypersensitivity and anaphylaxis should be utilised for prophylaxis and preventive.

Obiltoxaximab Dose in Adults

Obiltoxaximab Dose in the treatment and prophylaxis of inhalational Anthrax: 

Note: Before giving the dose, it's recommended to give them diphenhydramine, which is a medication often used to prevent allergic reactions, as a premedication.

  • If they weigh less than 40 kilograms, they get 24 milligrams of Obiltoxaximab per kilogram of their weight as a single dose.
  • If they weigh more than 40 kilograms, they get 16 milligrams of Obiltoxaximab per kilogram of their weight as a single dose.

Obiltoxaximab Dose in Children

Obiltoxaximab Dose in the treatment and prophylaxis of Inhalational Anthrax:

For infants, children, and adolescents when given intravenously:

  • For those weighing up to 15 kilograms, the dose is 32 milligrams per kilogram as a single dose.
  • For those weighing more than 15 kilograms but up to 40 kilograms, the dose is 24 milligrams per kilogram as a single dose.
  • For those weighing over 40 kilograms, the dose is 16 milligrams per kilogram as a single dose.

Pregnancy Risk Factor B

  • Obiltoxaximab is classified as Pregnancy Risk Factor B, meaning it hasn't shown adverse effects in animal studies.
  • For pregnant and postpartum women exposed to Bacillus anthracis, guidelines for preventing or treating inhalational anthrax are similar to those for nonpregnant adults.
  • This suggests that Obiltoxaximab can be considered safe and effective in these situations, with its use guided by medical professionals following established protocols.

Obiltoxaximab use during breastfeeding:

  • It's uncertain whether Obiltoxaximab is excreted in breast milk.
  • While immunoglobulins like Obiltoxaximab can pass into breast milk, it's not expected to be significantly absorbed by the infant.
  • However, the potential effects on the baby are not fully understood.
  • Nevertheless, for lactating women exposed to Bacillus anthracis, the recommended guidelines for preventing or treating inhalational anthrax are the same as for nonpregnant adults.

Obiltoxaximab Dose in Kidney Disease:

  • The manufacturer's labeling for Obiltoxaximab does not specify any dosage adjustments for patient with kidney disease.

Obiltoxaximab Dose in Liver disease:

  • The manufacturer's labeling for Obiltoxaximab does not mention any dosage adjustments for patient with liver disease.

Side Effects of Obiltoxaximab (Anthim):

  • Central nervous system:
    • Headache
    • Dizziness
    • Fatigue
    • Voice Disorder
  • Miscellaneous:
    • Fever
    • Infusion Related Reaction
  • Dermatologic:
    • Pruritus
    • Skin Rash
    • Urticaria
  • Cardiovascular:
    • Chest Discomfort
    • Chest Pain
    • Palpitations
  • Gastrointestinal:
    • Vomiting
    • Xerostomia
  • Hypersensitivity:
    • Hypersensitivity Reaction
  • Immunologic:
    • Antibody Development
  • Hematologic & Oncologic:
    • Abnormal Lymphocyte Count
    • Change In Neutrophil Count
    • Decreased White Blood Cell Count​​
  • Local:
    • Infusion Site Reaction
    • Bruising At Injection Site
    • Local Discoloration
  • Neuromuscular & Skeletal:
    • Limb Pain
    • Musculoskeletal Pain
    • Increased Creatine Phosphokinase
    • Myalgia
  • Respiratory:
    • Oropharyngeal Pain
    • Sinus Congestion
    • Rhinorrhea
    • Nasal Congestion
    • Cough
    • Upper Respiratory Tract Infection
    • Throat Irritation
    • Cyanosis
    • Dyspnea

Contraindications to Obiltoxaximab (Anthim):

  • According to the manufacturer's labeling, there are no contraindications listed for Obiltoxaximab.

Warnings and precautions

Hypersensitivity [US Boxed Warning]

  • Obiltoxaximab carries a US Boxed Warning regarding hypersensitivity reactions, including anaphylaxis, which can manifest as symptoms like rash, cough, difficulty breathing, chest discomfort, and dizziness.
  • Due to this risk, it's crucial to administer Obiltoxaximab in a monitored setting and closely observe patients for any signs of hypersensitivity during and after the infusion.
  • If a hypersensitivity reaction occurs, immediate discontinuation of the infusion is necessary, followed by appropriate treatment.
  • This highlights the importance of vigilance and preparedness in managing potential allergic reactions to Obiltoxaximab.

Monitoring parameters:

  • Patients should be closely monitored for any signs or symptoms of hypersensitivity both during and after receiving the infusion of Obiltoxaximab.

How to administer Obiltoxaximab (Anthim)?

Administration Guidelines for Obiltoxaximab (IV)

  • Premedication: It's recommended to premedicate patients with diphenhydramine before administering Obiltoxaximab intravenously.
  • Preparation: Administer the prepared solution (IV infusion bag or syringe) using a 0.22-micron inline filter.
  • Infusion Time: The infusion should be administered over 1 hour and 30 minutes to ensure a controlled rate of administration.
  • Post-Infusion: After the infusion is complete, flush the IV line with normal saline (NS) to ensure all medication has been delivered.

Following these guidelines helps ensure safe and effective administration of Obiltoxaximab intravenously.

Mechanism of action of Obiltoxaximab (Anthim):

  • Obiltoxaximab is a type of monoclonal antibody.
  • It works by targeting and binding to the protective antigen component of the anthrax toxin produced by Bacillus anthracis bacteria.
  • By doing so, it prevents the anthrax toxin from entering the cells of the body.
  • This action blocks the harmful effects of the anthrax toxin by inhibiting the intracellular entry of the anthrax lethal factor and edema factor, which are the enzymatic components responsible for the harmful effects of anthrax toxin.
  • In essence, Obiltoxaximab acts as a shield, neutralizing the damaging effects of the anthrax toxin and aiding in the body's defense against anthrax infection.

Distribution:

  • Obiltoxaximab has a distribution that extends beyond the plasma volume, indicating that it reaches tissues throughout the body.
  • This suggests that the medication is capable of distributing to various tissues where it can exert its therapeutic effects.

Excretion:

  • Obiltoxaximab is primarily eliminated from the body through minimal renal (kidney) elimination.
  • This means that only a small amount of the medication is excreted through the kidneys.
  • Most of the medication is likely eliminated through other routes, such as metabolism or possibly fecal elimination.

Obiltoxaximab International Brand Names:

  • Anthim
  • Anthrax antitoxin

Obiltoxaximab Brand Names in Pakistan:

No Brands are Available in Pakistan.

Obiltoxaximab is a monoclonal antibody used for the treatment of inhalational anthrax, which is a severe infectious disease caused by the bacterium Bacillus anthracis. This antibody works by targeting the protective antigen component of the anthrax toxin, thereby preventing the toxin from entering and damaging cells. Obiltoxaximab was approved by the U.S. Food and Drug Administration (FDA) in 2016 for use in combination with appropriate antibacterial drugs for the treatment of inhalational anthrax.

Obiltoxaximab (Anthim) is a high-affinity IgG1 monoclonal antibody that binds to B. Anthracis. It is used in the treatment and prophylaxis of inhalational anthrax.

Obiltoxaximab (Anthim) Uses:

  • Inhalational anthrax:
    • Treatment of Bacillus anthracis-caused inhalational anthrax in conjunction with appropriate antibiotics.
    • B. anthracis inhalational anthrax prophylaxis and prevention when alternate forms of therapy are unavailable or inappropriate
  • Limitations of use:
    • Only when the benefit of preventing inhalational anthrax outweighs the risk of hypersensitivity and anaphylaxis should be utilised for prophylaxis and preventive.

Obiltoxaximab Dose in Adults

Obiltoxaximab Dose in the treatment and prophylaxis of inhalational Anthrax: 

Note: Before giving the dose, it's recommended to give them diphenhydramine, which is a medication often used to prevent allergic reactions, as a premedication.

  • If they weigh less than 40 kilograms, they get 24 milligrams of Obiltoxaximab per kilogram of their weight as a single dose.
  • If they weigh more than 40 kilograms, they get 16 milligrams of Obiltoxaximab per kilogram of their weight as a single dose.

Obiltoxaximab Dose in Children

Obiltoxaximab Dose in the treatment and prophylaxis of Inhalational Anthrax:

For infants, children, and adolescents when given intravenously:

  • For those weighing up to 15 kilograms, the dose is 32 milligrams per kilogram as a single dose.
  • For those weighing more than 15 kilograms but up to 40 kilograms, the dose is 24 milligrams per kilogram as a single dose.
  • For those weighing over 40 kilograms, the dose is 16 milligrams per kilogram as a single dose.

Pregnancy Risk Factor B

  • Obiltoxaximab is classified as Pregnancy Risk Factor B, meaning it hasn't shown adverse effects in animal studies.
  • For pregnant and postpartum women exposed to Bacillus anthracis, guidelines for preventing or treating inhalational anthrax are similar to those for nonpregnant adults.
  • This suggests that Obiltoxaximab can be considered safe and effective in these situations, with its use guided by medical professionals following established protocols.

Obiltoxaximab use during breastfeeding:

  • It's uncertain whether Obiltoxaximab is excreted in breast milk.
  • While immunoglobulins like Obiltoxaximab can pass into breast milk, it's not expected to be significantly absorbed by the infant.
  • However, the potential effects on the baby are not fully understood.
  • Nevertheless, for lactating women exposed to Bacillus anthracis, the recommended guidelines for preventing or treating inhalational anthrax are the same as for nonpregnant adults.

Obiltoxaximab Dose in Kidney Disease:

  • The manufacturer's labeling for Obiltoxaximab does not specify any dosage adjustments for patient with kidney disease.

Obiltoxaximab Dose in Liver disease:

  • The manufacturer's labeling for Obiltoxaximab does not mention any dosage adjustments for patient with liver disease.

Side Effects of Obiltoxaximab (Anthim):

  • Central nervous system:
    • Headache
    • Dizziness
    • Fatigue
    • Voice Disorder
  • Miscellaneous:
    • Fever
    • Infusion Related Reaction
  • Dermatologic:
    • Pruritus
    • Skin Rash
    • Urticaria
  • Cardiovascular:
    • Chest Discomfort
    • Chest Pain
    • Palpitations
  • Gastrointestinal:
    • Vomiting
    • Xerostomia
  • Hypersensitivity:
    • Hypersensitivity Reaction
  • Immunologic:
    • Antibody Development
  • Hematologic & Oncologic:
    • Abnormal Lymphocyte Count
    • Change In Neutrophil Count
    • Decreased White Blood Cell Count​​
  • Local:
    • Infusion Site Reaction
    • Bruising At Injection Site
    • Local Discoloration
  • Neuromuscular & Skeletal:
    • Limb Pain
    • Musculoskeletal Pain
    • Increased Creatine Phosphokinase
    • Myalgia
  • Respiratory:
    • Oropharyngeal Pain
    • Sinus Congestion
    • Rhinorrhea
    • Nasal Congestion
    • Cough
    • Upper Respiratory Tract Infection
    • Throat Irritation
    • Cyanosis
    • Dyspnea

Contraindications to Obiltoxaximab (Anthim):

  • According to the manufacturer's labeling, there are no contraindications listed for Obiltoxaximab.

Warnings and precautions

Hypersensitivity [US Boxed Warning]

  • Obiltoxaximab carries a US Boxed Warning regarding hypersensitivity reactions, including anaphylaxis, which can manifest as symptoms like rash, cough, difficulty breathing, chest discomfort, and dizziness.
  • Due to this risk, it's crucial to administer Obiltoxaximab in a monitored setting and closely observe patients for any signs of hypersensitivity during and after the infusion.
  • If a hypersensitivity reaction occurs, immediate discontinuation of the infusion is necessary, followed by appropriate treatment.
  • This highlights the importance of vigilance and preparedness in managing potential allergic reactions to Obiltoxaximab.

Monitoring parameters:

  • Patients should be closely monitored for any signs or symptoms of hypersensitivity both during and after receiving the infusion of Obiltoxaximab.

How to administer Obiltoxaximab (Anthim)?

Administration Guidelines for Obiltoxaximab (IV)

  • Premedication: It's recommended to premedicate patients with diphenhydramine before administering Obiltoxaximab intravenously.
  • Preparation: Administer the prepared solution (IV infusion bag or syringe) using a 0.22-micron inline filter.
  • Infusion Time: The infusion should be administered over 1 hour and 30 minutes to ensure a controlled rate of administration.
  • Post-Infusion: After the infusion is complete, flush the IV line with normal saline (NS) to ensure all medication has been delivered.

Following these guidelines helps ensure safe and effective administration of Obiltoxaximab intravenously.

Mechanism of action of Obiltoxaximab (Anthim):

  • Obiltoxaximab is a type of monoclonal antibody.
  • It works by targeting and binding to the protective antigen component of the anthrax toxin produced by Bacillus anthracis bacteria.
  • By doing so, it prevents the anthrax toxin from entering the cells of the body.
  • This action blocks the harmful effects of the anthrax toxin by inhibiting the intracellular entry of the anthrax lethal factor and edema factor, which are the enzymatic components responsible for the harmful effects of anthrax toxin.
  • In essence, Obiltoxaximab acts as a shield, neutralizing the damaging effects of the anthrax toxin and aiding in the body's defense against anthrax infection.

Distribution:

  • Obiltoxaximab has a distribution that extends beyond the plasma volume, indicating that it reaches tissues throughout the body.
  • This suggests that the medication is capable of distributing to various tissues where it can exert its therapeutic effects.

Excretion:

  • Obiltoxaximab is primarily eliminated from the body through minimal renal (kidney) elimination.
  • This means that only a small amount of the medication is excreted through the kidneys.
  • Most of the medication is likely eliminated through other routes, such as metabolism or possibly fecal elimination.

Obiltoxaximab International Brand Names:

  • Anthim
  • Anthrax antitoxin

Obiltoxaximab Brand Names in Pakistan:

No Brands are Available in Pakistan.