Prevention of recurrence of Clostridioides difficile infection (CDI)

Active Ingredient: Bezlotoxumab

Indication for Bezlotoxumab

Population group: only children (1 year - 12 years old) , adolescents (12 years - 18 years old) , adults (18 years old or older)
Therapeutic intent: Preventive action

Bezlotoxumab is indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in adult and paediatric patients 1 year of age and older at high risk for recurrence of CDI.

For this indication, competent medicine agencies globally authorize below treatments:

10 mg/kg once

For:

Dosage regimens

Intravenous, 10 milligrams bezlotoxumab per kilogram of body weight, one dose.

Detailed description

Bezlotoxumab should be administered during the course of antibacterial therapy for CDI.

Bezlotoxumab should be administered as a single intravenous infusion of 10 mg/kg.

The experience with bezlotoxumab in patients is limited to a single CDI episode and single administration.

Dosage considerations

  • Administer the diluted solution for infusion intravenously over 60 minutes using a sterile, non-pyrogenic, low-protein binding 0.2 micron to 5 micron in-line or add-on filter. Bezlotoxumab should not be administered as an intravenous push or bolus.
  • The diluted solution can be infused via a central line or peripheral catheter.
  • Bezlotoxumab must not be co-administered with other medicinal products simultaneously through the same infusion line.

Active ingredient

Bezlotoxumab

Bezlotoxumab is a human monoclonal antitoxin antibody that binds with high affinity to C. difficile toxin B and neutralizes its activity. Bezlotoxumab prevents CDI recurrence by providing passive immunity against toxin produced by the outgrowth of persistent or newly-acquired C. difficile spores.

Read more about Bezlotoxumab

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