Tedizolid Indications
Tedizolid (Sivextro) is FDA-approved for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria in adults and pediatric patients 12 years of age and older. 1
FDA-Approved Indication
Tedizolid is indicated specifically for ABSSSI caused by designated susceptible bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), methicillin-susceptible S. aureus (MSSA), Streptococcus pyogenes, Streptococcus agalactiae, and Streptococcus anginosus group. 1
The approved dosing regimen is 200 mg administered once daily (oral or intravenous) for 6 days in patients 12 years and older. 1
Clinical Context for Use
Tedizolid represents an effective treatment option for moderate to severe purulent and nonpurulent SSTIs, particularly when MRSA coverage is required. 2
When to Consider Tedizolid:
For purulent SSTIs with systemic signs of infection (temperature >38°C, tachycardia >90 bpm, tachypnea >24 breaths/min, or abnormal WBC count) where MRSA is suspected or confirmed. 2
For severe nonpurulent cellulitis/erysipelas in patients who have failed oral antibiotics, have systemic signs of infection, are immunocompromised, or have clinical signs of deeper infection (bullae, skin sloughing, hypotension, organ dysfunction). 2
As an alternative to linezolid or vancomycin for hospitalized patients requiring intravenous MRSA coverage, with the advantage of once-daily dosing and shorter treatment duration. 2
For oral step-down therapy after initial intravenous treatment, given its 91% oral bioavailability allowing seamless IV-to-oral transition. 3, 4
Comparative Efficacy
Tedizolid 200 mg once daily for 6 days demonstrated non-inferior efficacy to linezolid 600 mg twice daily for 10 days in two Phase III trials (ESTABLISH-1 and ESTABLISH-2) for ABSSSI treatment. 2, 3
Tedizolid showed superior clinical response compared to vancomycin at both end of therapy and post-therapy evaluation in network meta-analysis. 5
Tedizolid has a lower incidence of thrombocytopenia (3.2% vs 5.6%) and fewer gastrointestinal adverse effects compared to linezolid. 6, 7
Important Caveats
Tedizolid should not be used in neutropenic patients (neutrophil counts <1000 cells/mm³), as safety and efficacy have not been adequately evaluated in this population, and animal studies showed reduced antibacterial activity in the absence of granulocytes. 1
Consider alternative therapies for neutropenic patients with ABSSSI requiring MRSA coverage. 1
Tedizolid has activity against certain linezolid-resistant strains harboring the cfr gene (in the absence of specific ribosomal mutations), making it a potential option when linezolid resistance is suspected. 7
When administered orally, tedizolid can increase plasma concentrations of BCRP substrates, requiring monitoring for adverse reactions if coadministration cannot be avoided. 1
Evaluate for Clostridioides difficile-associated diarrhea if diarrhea develops during or after treatment. 1