SIVEXTRO®

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

Patient Profiles

Profile of a Patient With ABSSSI (Cellulitis on the Leg).

Not an actual patient

ABSSSI Cellulitis: Infection site on leg

Patients like Rich may be considered an appropriate candidate for SIVEXTRO

ABSSSI Patient With Cellulitis/Erysipelas Infection Site on the Lower Leg.

Diagnosis: ABSSSI (cellulitis)

45-year-old male with infection site on lower leg

Patient profile:

  • 45-year-old white male
  • 5'5", 220 lbs, BMI of 36.6 kg/m2

Medical history:

  • Type 2 diabetes, obesity

Drug allergies:

  • None reported

Current presentation:

  • Redness, swelling, and tenderness at the infection site on left lower leg

Relevant acute findings

Vital signs:

  • Temperature: 98.6°F; RR: 15; HR: 80

Physical examination:

  • Lesion surface area involving left lower leg that measures 276 cm2 with localized warmth, tenderness, edema, and erythema that is well-demarcated
  • No evidence of drainage
  • Local lymph node tenderness

Laboratory test results:

  • WBC count: 12,000 x 103/mL with left shift

Diagnosis:

  • ABSSSI—diffuse cellulitis

Next steps

  • 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