SIVEXTRO® (tedizolid phosphate) 200 mg injection / 200 mg tablet
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Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Wound Infection: Postsurgical Wound

Profile of a Patient With ABSSSI (Wound Infection From a Postsurgical Wound)

Not an actual patient

Christina is a 45-year-old female high school teacher who is on her feet all day. She had a corn on her left foot, which was excised 10 days ago. But the surgical wound and surrounding area has become red, swollen, warm, and painful over the past few days.

Postsurgical Wound From the Base of Toe to Top of Foot

Reported signs and symptoms:

  • From base of toe to top of foot: swelling, tenderness, and redness

Clinical examination:

  • BMI of 23.0 kg/m2
  • Vital Signs: Temp: 100.0°F; RR: 15 RPM; HR: 120 BPM;
    BP: 130/80 mm Hg
  • From base of toe to top of foot: ~110 cm2 area of swelling, erythema, and warmth
  • No evidence of drainage

Lab results:

  • WBC: 13,000 x 103 cells/mL

Diagnosis: ABSSSI (wound infection)

Other medical factors:

  • Hypertension

Next steps:

  • Initiate empiric antimicrobial therapy
  • Incision and drainage

Patients like Christina may be considered an appropriate candidate for SIVEXTRO

Indication

SIVEXTRO is an oxazolidinone-class antibacterial indicated in adults and pediatric patients 12 years of age and older for the treatment of 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.

 

Clostridioides 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 antibacterial drug 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 (≥2%) in adults for SIVEXTRO are nausea (7%), headache (5%), diarrhea (4%), vomiting (3%), and dizziness (2%).

 

In adult patients receiving SIVEXTRO intravenously, infusion- or injection-related adverse reactions including but not limited to: phlebitis, injection- or infusion-site pain or swelling, injection-site reaction, erythema, or induration, and infusion-related reaction occurred (4%).

 

The most common adverse reactions (>2%) in pediatric patients 12 years of age and older are phlebitis (3%) and increased hepatic transaminases (3%).

 

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.

Indication

SIVEXTRO is an oxazolidinone-class antibacterial indicated in adults and pediatric patients 12 years of age and older for the treatment of 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.

SIVEXTRO is an oxazolidinone-class antibacterial indicated in

SIVEXTRO is an oxazolidinone-class antibacterial indicated in adults and pediatric patients 12 years of age and older for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms

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.

 

Clostridioides 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 antibacterial drug 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 (≥2%) in adults for SIVEXTRO are nausea (7%), headache (5%), diarrhea (4%), vomiting (3%), and dizziness (2%).

 

In adult patients receiving SIVEXTRO intravenously, infusion- or injection-related adverse reactions including but not limited to: phlebitis, injection- or infusion-site pain or swelling, injection-site reaction, erythema, or induration, and infusion-related reaction occurred (4%).

 

The most common adverse reactions (>2%) in pediatric patients 12 years of age and older are phlebitis (3%) and increased hepatic transaminases (3%).

 

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.

Patients with neutropenia: The safety and efficacy of SIVEXTRO

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