Drug updated on 4/16/2024
| 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.
Summary
- Tedizolid phosphate (Sivextro) is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults and pediatric patients 12 years of age and older, caused by designated susceptible bacteria. It exhibits a broad spectrum of activity against Gram-positive pathogens, including methicillin-resistant Staphylococcus aureus (MRSA).
- Five studies were reviewed to gather information about Sivextro's safety, efficacy, cost-effectiveness, and its utility in different infections, as well as its comparison with other drugs.
- When compared to Linezolid for ABSSSI treatment, tedizolid did not show a significant difference in therapeutic effects but exhibited significantly lower incidence rates for gastrointestinal adverse events and blood/lymphatic system disorders. This suggests that tedizolid may be better tolerated than linezolid.
- In vitro studies showed tedizolid possesses potent activity against MRSA isolates; however, it had higher MIC values compared to Dalbavancin, Oritavancin, or Telavancin, indicating somewhat diminished potency. The practical implications require clinical correlation to fully understand their significance on treatment outcomes.
- For complicated skin and soft structure infections (cSSSI), tedizolid demonstrated similar efficacy levels as vancomycin, without any significant differences regarding safety or total adverse events. However, within an American context where cost-effectiveness analyses are considered important factors during selection processes, Linezolid was preferred over vancomycin especially when treating hospital-acquired or ventilator-associated pneumonia cases (HAP/VAP).
- Populations such as adults versus pediatrics aged 12 years old and above, along with patient subgroups within indications like cellulitis/erysipelas, major cutaneous abscess, and wound infection, have been found safe using this medication, particularly those infected by MRSA due to its favorable microbiological response rate. This further enhances its value as a treatment option against ABSSSI and MRSA infections.
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 |