SIVEXTRO®

(tedizolid phosphate) 200 mg injection, for intravenous use; 200 mg tablet, for oral use

Patient Profiles

Profile of a Patient With ABSSSI (Infected Puncture Wound).

Not an actual patient

ABSSSI Wound infection: Puncture wound

Patients like Jack may be considered an appropriate candidate for SIVEXTRO 

ABSSSI Patient With Infected Puncture Wound on the Foot.

Diagnosis: ABSSSI (wound infection)

39-year-old male with wound on bottom of foot from stepping on glass at beach

Patient profile:

  • 39-year-old white male
  • 5'8", 174 lbs, BMI of 26.5 kg/m2

Medical history:

  • No significant medical history

Drug allergies:

  • Sulfa medications

Current presentation:

  • Penetration wound on bottom of right foot from stepping on glass on the beach
  • Redness and drainage at the infection site

Relevant acute findings

Vital signs:

  • Temp: 100.0°F; RR: 17; HR: 82

Physical examination:

  • Lesion surface area involving right foot that measures 80 cm2
  • Spontaneous purulent drainage, surrounding erythema extending 6 cm from wound margin
  • Local lymph node tenderness

Laboratory test results:

  • WBC count: 10,000 x 103/mL with left shift

Diagnosis:

  • ABSSSI—wound infection

Next steps

  • Send specimen for culture and for pathogen identification, susceptibility, and sensitivity
  • Initiate empiric antimicrobial therapy

Indication

Indication: SIVEXTRO is an oxazolidinone-class antibacterial indicated for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-resistant [MRSA] and methicillin-susceptible [MSSA] isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius and Streptococcus constellatus), and Enterococcus faecalis.

Usage: To reduce the development of drug-resistant bacteria and maintain the effectiveness of SIVEXTRO and other antibacterial drugs, SIVEXTRO should be used only to treat ABSSSI that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Selected Safety Information

Patients with neutropenia: The safety and efficacy of SIVEXTRO in patients with neutropenia (neutrophil counts <1000 cells/mm3) have not been adequately evaluated. In an animal model of infection, the antibacterial activity of SIVEXTRO was reduced in the absence of granulocytes. Alternative therapies should be considered when treating patients with neutropenia.

Clostridium difficile–associated diarrhea (CDAD), ranging from mild diarrhea to fatal colitis, has been reported with nearly all systemic antibacterial agents, including SIVEXTRO. Evaluate all patients who present with diarrhea following antibiotic use. Careful medical history is necessary because CDAD has been reported to occur more than two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, antibacterial use not directed against C. difficile should be discontinued, if possible.

Development of drug-resistant bacteria: Prescribing SIVEXTRO in the absence of a proven or strongly suspected bacterial infection or prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Adverse reactions: The most common adverse reactions for SIVEXTRO are nausea (8%), headache (6%), diarrhea (4%), vomiting (3%), and dizziness (2%). Infusion site reactions (phlebitis) have been reported (3.1%) in patients receiving SIVEXTRO (when administered intravenously), particularly among Asian patients.

Drug interactions with BCRP substrates: SIVEXTRO (when administered orally) can increase the plasma concentrations of orally administered Breast Cancer Resistance Protein (BCRP) substrates and the potential for adverse reactions. Monitor for adverse reactions related to the concomitant BCRP substrates if coadministration cannot be avoided.

Before prescribing SIVEXTRO, please read the accompanying Prescribing Information. The Patient Information also is available.

AINF-1180496-000404/18