Raxibacumab (ABthrax) - Complete Drug Information

Raxibacumab is a recombinant human IgG1 lambda monoclonal antibody which binds and neutralizes free protective antigen (PA) component of Bacillus anthracis toxin

  • It is used in the treatment of inhalational anthrax following exposure to Bacillus anthracis

  • It is used  in combination with appropriate antimicrobial therapy

  • It is also used in prophylaxis of inhalational anthrax when alternative therapies are unavailable or not appropriate

Raxibacumab Dose in Adults

Dosage in the prophylaxis or treatment of Anthrax:

  • IV: 40 mg/kg as a single dose is given
  • Give diphenhydramine 25-50 mg (may administer oral or IV depending on the proximity to start of raxibacumab infusion) less than 1 hour prior to administration of raxibacumab to reduce the risk of infusion reactions.
  • It must be administered in combination with antimicrobial therapy.

Raxibacumab Dose in Childrens

  • Give diphenhydramine (oral or IV depending on the proximity to start of raxibacumab infusion) ≤1 hour prior to administration of raxibacumab to reduce the risk of infusion reactions.
  • It must be administered in combination with antimicrobial therapy.

Dosage in the prophylaxis or treatment of Anthrax:

  • Infants, Children, and Adolescents:
    • ≤15 kg:

      • 80 mg/kg is given as a single dose
    • >15 kg to 50 kg:

      • 60 mg/kg is given as a single dose
    • >50 kg:

      • 40 mg/kg is given as a single dose

Pregnancy Risk Factor B

  • Animal reproduction studies did not show any adverse events.
  • The guidelines for treatment and prophylaxis of inhalational Anthrax in pregnant and postpartum mothers exposed to Bacillus anthracis are generally the same as those in nonpregnant women.

Raxibacumab use during breastfeeding:

  • It is unknown if raxibacumab excreted in breastmilk.
  • Breast milk contains immunoglobulins.
  • While it is unlikely that breast milk will absorb a lot of nutrients, there are still unknown effects.
  • The guidelines for treatment and prophylaxis of inhalational Anthrax in Lactating Women are the same as those in nonpregnant women.

Raxibacumab Dose in Renal Disease:

  • No dosage adjustment given in manufacturer's labeling.
  • But, dosage adjustment unlikely as clearance is nonrenal.

Raxibacumab Dose in Liver Disease:

  • No dosage adjustment given in manufacturer's labeling

Common Side Effects of Raxibacumab Include:

  • Dermatologic:

    • Skin rash

Less Common Side Effects of Raxibacumab Include:

  • Central nervous system:

    • Pain
  • Dermatologic:

    • Pruritus

Contraindication to Raxibacumab Include:

The manufacturer's labeling does not list any contraindications.

Warnings and precautions

  • Infusion reactions
    • There have been instances of infusion-related reactions, such as rash, urticaria, and pruritus.
    • To reduce the risk, diphenhydramine can be used as a medication.
    • For monitoring adverse reactions, the administration rate is slowed for the first 20 minutes.
    • If adverse reactions, including infusion-related reactions, are observed, reduce the infusion rate or stop the injection.

Monitor:

None required

How to administer Raxibacumab?

  • Premedicate with diphenhydramine less than 1 hour prior to raxibacumab infusion.
  • Administer over 2 hours and 15 minutes intravenously.
  • administration rate should be slower in the first 20 minutes to monitor for adverse reactions
  • slow or interrupt infusion if adverse reactions (including infusion-related reactions) are seen.
  • Administer as follows:

Body weight ≥31 kg:

  • Infuse at 15 mL/hour for 20 minutes
  • then increase rate to 125 mL/hour for the remaining infusion

Mechanism of action of Raxibacumab (ABthrax):

  • Raxibacumab, a monoclonal recombinant human IgG1 Lambda monoclonal anti-Bacillus anthracis protective antibody (PA), is a recombinant IgG1 human IgG1 monoclonal antibody.
  • Therefore, PAmediated delivery is blocked of lethal and edema toxins via the anthrax receptor (ATR). This inhibits their infiltration into host cells.

Distribution: V :

  • 0.07 L/kg

Half-life elimination: Terminal: 20.44 ± 6.46 days

Excretion:  

  • Nonrenal

International Brands of Raxibacumab:

ABthrax

Raxibacumab Brands in Pakistan:

Raxibacumab is not available in Pakistan.

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