ZINPLAVA (bezlotoxumab), anti-toxin B monoclonal antibody of Clostridium difficile
INFECTIOUS DISEASES - New medicinal product
Opinions on drugs -
Posted on
Sep 07 2017
Reason for request
Inclusion
Minor improvement in the prevention of recurrent Clostridium difficile infection in adults at high risk for recurrences
- ZINPLAVA has Marketing Authorisation in the prevention of recurrent Clostridium difficile infection (CDI) in adults at high risk for recurrent CDI.
- Its efficacy has been demonstrated in combination with metronidazole and vancomycin.
- There is no robust efficacy data, in combination with fidaxomicin, or in more severe forms and/or with multiple recurrent infections (history of more than one episode of CDI). Its safety profile is overall satisfactory, with a reservation about use in patients with underlying congestive heart failure.
» The therapeutic decision must be made with the assistance of an antibiotics specialist.
Clinical Benefit
Substantial |
- |
Clinical Added Value
minor |
- |
Therapeutic use
- |
English version
Contact Us
Évaluation des médicaments