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Sivextro ™ (tedizolid phosphate)

Sivextro ™ (tedizolid phosphate). Manufacturer: Cubist Pharmaceuticals FDA Approval Date: June 20, 2014. Sivextro ™ - tedizolid phosphate Clinical Application. Indications: Acute bacterial skin and skin structure infections Susceptible Gram-positive organisms Place in therapy:

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Sivextro ™ (tedizolid phosphate)

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  1. Sivextro™(tedizolid phosphate) Manufacturer: Cubist Pharmaceuticals FDA Approval Date: June 20, 2014

  2. Sivextro™ - tedizolid phosphateClinical Application • Indications: • Acute bacterial skin and skin structure infections • Susceptible Gram-positive organisms • Place in therapy: • First line against gram positives? • Think good antimicrobial stewardship

  3. Sivextro™ - tedizolid phosphateClinical Application • Contraindications: • None • Warnings and Precautions: • Neutropenia (<1000 cells/mm3) • Bacterial or Fungal Super-infections

  4. Sivextro™ - tedizolid phosphateClinical Application • Pregnancy: • Category C • Adverse event noted in animal studies • Lactation: • Not known if it enters breast milk

  5. Sivextro™ - tedizolid phosphateDrug Facts • Pharmacology: • Prodrug (tedizolid phosphate  tedizolid) • Binds to the 50S bacterial ribosomal subunit • Bacteriostatic against • Enterococci • Staphylococci • Streptococci

  6. Sivextro™ - tedizolid phosphateDrug Facts

  7. Sivextro™ - tedizolid phosphateDrug Interactions • Drug Interactions – Object Drugs: • No known drug interactions • Drug interactions – Precipitant Drugs: • No known drug interactions

  8. Sivextro™ - tedizolid phosphateAdverse Effects

  9. Sivextro™ - tedizolid phosphateMonitoring Parameters • Efficacy Monitoring: • Signs of clinical improvement • Toxicity Monitoring: • Reduction in circulation RBCs, WBCs, and platelets

  10. Sivextro™ - tedizolid phosphatePrescription Information • Dosing: • 200 mg Oral or Intravenous • Infusion time 1 hour • Daily for six days • IV to oral – no dose adjustment

  11. Sivextro™ - tedizolid phosphatePrescription Information • Cost: Lexi-Comp via UpToDate; Accessed 10/16/2014

  12. Sivextro™ - tedizolid phosphateLiterature Review • Study Design (ESTABLISH-1) • Phase 3, randomized, double blind, double dummy, non-inferiority trial • 81 study centers from North America, Latin American and Europe • Interventions • Tedizolid 200 mg daily for 6 days • Linezolid 600 mg twice daily for 10 days Prokocimer et al., JAMA. 2013;309(6):559-569

  13. Sivextro™ - tedizolid phosphateLiterature Review • Endpoints • Primary • Early clinical response (48-72hr) • Temp ≤ 37.6°C • Cessation of primary lesion spread • Classified as responders, non-responders, and indeterminate Prokocimer et al., JAMA. 2013;309(6):559-569

  14. Sivextro™ - tedizolid phosphateLiterature Review Prokocimer et al., JAMA. 2013;309(6):559-569

  15. Sivextro™ - tedizolid phosphateSummary • Sivextro is a new oxazolidinone for acute bacterial skin and skin structure infections for gram positive organisms. • IV or oral 200 mg once daily dosing. • It has a simple metabolism and does not interfere with other medications • Sivextro should be used as a second line medication for ABSSSI. More uses could become available.

  16. Sivextro™ - tedizolid phosphateReferences • http://sivextro.com/. 10/14. • Sivextro package insert. Cubist. October 2014. • Prokocimer et al., Tedizolid Phosphate vs Linezolid for Treatment of Acute Bacterial Skin and Skin Structure Infections. JAMA. 2013;309(6):559-569

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