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ceftobiprole medocaril (Zevtera)

Advice

following a resubmission

ceftobiprole (Zevtera®) is accepted for restricted use within NHS Scotland.

Indication under review: Ceftobiprole is indicated for the treatment of the following infections in adults:
• Hospital-acquired pneumonia (HAP), excluding ventilator-associated pneumonia (VAP)
• Community-acquired pneumonia (CAP)
Consideration should be given to official guidance on the appropriate use of antibacterial agents.

SMC restriction: for use in the treatment of HAP (excluding VAP) when activity is required against suspected methicillin-resistant Staphylococcus aureus (MRSA) and Gram-negative pathogens (including Pseudomona aeruginosa, Escherichia coli and Klebsiella pneumoniae) and when combination treatment that includes vancomycin or teicoplanin is inappropriate or has not been tolerated, or when treatment modification is required, i.e. as an alternative to linezolid-based regimens.

In a randomised, double-blind phase III study of patients with HAP, the clinical cure rate  for empirical treatment with ceftobiprole was non-inferior to the rate associated with intravenous linezolid plus an anti-pseudomonal cephalosporin.

Drug Details

Drug Name: ceftobiprole medocaril (Zevtera)
SMC Drug ID: 943/14
Manufacturer: Basilea Pharmaceuticals Ltd
Indication: For the treatment of the following infections in adults: • Hospital-acquired pneumonia (HAP), excluding ventilator-associated pneumonia (VAP) • Community-acquired pneumonia (CAP) Consideration should be given to official guidance on the appropriate use of antibacterial agents.
BNF Category:
Sub Category: 5.1 Antibacterial drugs
Submission Type: Resubmission
Status: Restricted
Date Advice Published: 13 July 2015

Extra Notes

In February 2014, SMC reviewed ceftobiprole (Zevtera) for the treatment of hospital-acquired pneumonia (HAP), excluding ventilator-associated pneumonia (VAP) and community-acquired pneumonia (CAP)
The SMC Advice was withheld, in-confidence, pending confirmation of product availability. The company subsequently made a resubmission and this was reviewed by SMC in June 2015. Advice for the original submission was not issued as the product was made commercially available in April 2015 and close to the date of issue of the SMC advice for the resubmission. Therefore the advice for the resubmission only is published on the SMC website.

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