Drug updated on 9/4/2024
| Dosage Form | Injection (intravenous: 200 mg); Tablet (oral: 200 mg) |
| Drug Class | Oxazolidinone antibacterials |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for treatment in adult and pediatric patients 12 years of age and older for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria.
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Summary
- Sivextro (tedizolid phosphate) is indicated for treatment in adult and pediatric patients 12 years of age and older for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria.
- This summary is based on the review of five systematic review(s)/meta-analysis(es). [1-5]
- Tedizolid demonstrated non-inferior effectiveness to linezolid in the early clinical response for ABSSSI, with response rates of 79.6% for tedizolid and 80.5% for linezolid (OR = 0.96, 95% CI = 0.77-1.19), and similar microbiological response rates for MRSA (Tedizolid: 95.2%, Linezolid: 94%; OR = 1.19, 95% CI = 0.49-2.90).
- Tedizolid was significantly less effective than linezolid in the treatment of pneumonia, with no specific numerical data provided.
- Tedizolid showed potent in vitro activity against MRSA with MIC50 and MIC90 values of 0.25 and 0.5 μg/mL, respectively, although telavancin, dalbavancin, and oritavancin exhibited lower MIC values, indicating higher in vitro potency.
- Tedizolid was associated with a significantly lower incidence of gastrointestinal adverse events and blood/lymphatic system disorders compared to linezolid, including a lower risk of nausea, vomiting, and abnormal neutrophil count.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Sivextro (tedizolid phosphate) prescribing information. | 2023 | Nabriva Therapeutics US, Inc., Fort Washington, PA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Target therapeutic ranges of anti-MRSA drugs, linezolid, tedizolid and daptomycin, and the necessity of TDM. | 2022 | Biological & Pharmaceutical Bulletin |
| Antibacterial activity of recently approved antibiotics against methicillin-resistant Staphylococcus aureus (MRSA) strains: A systematic review and meta-analysis. | 2022 | Annals of Clinical Microbiology and Antimicrobials |
| Tedizolid versus linezolid for the treatment of acute bacterial skin and skin structure infection: A systematic review and meta-analysis. | 2019 | Antibiotics |
| Antibacterial activity of tedizolid, a novel oxazolidinone against methicillin-resistant staphylococcus aureus: A systematic review and meta-analysis. | 2019 | Microbial Drug Resistance |
| Network meta-analysis and pharmacoeconomic evaluation of antibiotics for the treatment of patients infected with complicated skin and soft structure infection and hospital-acquired or ventilator-associated pneumonia. | 2019 | Antimicrobial Resistance and Infection Control |