sivextro ™ (tedizolid phosphate) manufacturer: cubist pharmaceuticals fda approval date: june 20,...
TRANSCRIPT
Sivextro™
(tedizolid phosphate)
Manufacturer: Cubist Pharmaceuticals
FDA Approval Date: June 20, 2014
• Indications: • Acute bacterial skin and skin structure
infections
• Susceptible Gram-positive organisms
• Place in therapy:• First line against gram positives?
• Think good antimicrobial stewardship
Sivextro™ - tedizolid phosphate
Clinical Application
Sivextro™ - tedizolid phosphate
Clinical Application
• Contraindications:• None
• Warnings and Precautions:• Neutropenia (<1000 cells/mm3)
• Bacterial or Fungal Super-infections
Sivextro™ - tedizolid phosphate
Clinical Application
• Pregnancy:• Category C
• Adverse event noted in animal studies
• Lactation:• Not known if it enters breast milk
Sivextro™ - tedizolid phosphate
Drug Facts
• Pharmacology:• Prodrug (tedizolid phosphate tedizolid)
• Binds to the 50S bacterial ribosomal subunit
• Bacteriostatic against
• Enterococci• Staphylococci• Streptococci
Sivextro™ - tedizolid phosphate
Drug Facts
Sivextro™ - tedizolid phosphate
Drug Interactions
• Drug Interactions – Object Drugs: • No known drug interactions
• Drug interactions – Precipitant Drugs:• No known drug interactions
Sivextro™ - tedizolid phosphate
Adverse Effects
Sivextro™ - tedizolid phosphate
Monitoring Parameters
• Efficacy Monitoring:• Signs of clinical improvement
• Toxicity Monitoring:• Reduction in circulation RBCs, WBCs,
and platelets
Sivextro™ - tedizolid phosphate
Prescription Information
• Dosing:• 200 mg Oral or Intravenous
• Infusion time 1 hour• Daily for six days
• IV to oral – no dose adjustment
Sivextro™ - tedizolid phosphate
Prescription Information
• Cost:
Brand (generic) Dose(s) Cost
Sivextro (tedizolid phosphate)
Oral – 200 mg tablets #6
$2124.00
IV – 200 mg vial #10 $2820.00
Lexi-Comp via UpToDate; Accessed 10/16/2014
Sivextro™ - tedizolid phosphate
Literature 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
Sivextro™ - tedizolid phosphate
Literature 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
Sivextro™ - tedizolid phosphate
Literature Review
Prokocimer et al., JAMA. 2013;309(6):559-569
Tedizolid Phosphate(n = 332)
Linezolid(n = 335)
Absolute difference(95% CI)
48- to 72-h assessment (ITT) No. (%) [95% CI]
264 (79.5)[74.8 to 83.7]
266 (79.4)[74.7 to 83.6]
0.1 (-6.1 to 6.2)
Sustained at EOT assessment (ITT)No. (%) [95% CI]
230 (69.3)[64.0 to 74.2]
241 (71.9)[66.8 to 76.7]
-2.6 (-9.6 to 4.2)
Sivextro™ - tedizolid phosphate
Summary
• 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.
• 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
Sivextro™ - tedizolid phosphate
References