SIVEXTRO (tedizolid), antibiotic of the oxazolidinone class

INFECTIOLOGY - NEW MEDICINAL PRODUCT
Opinions on drugs - Posted on Jan 18 2016

Reason for request

Inclusion

No clinical benefit demonstrated by comparison with linezolid.

A role in non-serious infections of staphylococcal aetiology that are resistant to methicillin

 

  • SIVEXTRO has Marketing Authorisation in the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults.
  • It does not provide any therapeutic benefit by comparison with linezolid, since:

-       its in-vitro activity profile, efficacy and safety are comparable with that of linezolid;

-       and considering the insufficient documentation of clinical efficacy and safety in severe skin infections and/or skin infections caused by multidrug-resistant bacteria.

  • It may be offered in infections regardless of severity for which a staphylococcal aetiology is proven or suspected (suppurative infections) and where resistance to methicillin is proven or strongly suspected.

Clinical Benefit

Substantial

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Clinical Added Value

no clinical added value

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Therapeutic use

-

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