SIVEXTRO®

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

Patient Profiles

Profile of a Patient With ABSSSI (Cellulitis From a Severe Sunburn)

Not an actual patient

ABSSSI Cellulitis: Severe Sunburn

Patients like Lilly may be considered an appropriate candidate for SIVEXTRO 

Patient With ABSSSI, Cellulitis From a Severe Sunburn on the Back

Lilly is a 37-year-old female nurse who developed severe sunburn. This led to broken skin, which became infected just above her right shoulder blade on the back. She noticed redness, swelling, and area felt warm to the touch, so she suspected possible infection.

Reported Signs and Symptoms:
  • Above right shoulder blade on her back: pain that wouldn’t subside, burning sensation, and local increase in temperature
Other Medical Factors:
  • None
Clinical Examination:
  • BMI of 20.0 kg/m2
  • Vital Signs: Temp: 98.0°F; RR: 17 RPM; HR: 110 BPM; BP: 110/70 mm Hg
  • On her back: ~100 cm2 patch of erythematous, tender, warm skin
  • Some swelling, with no drainage
Lab Results:
  • WBC: 11 000 x 103 cells/mL

Diagnosis: ABSSSI (cellulitis)

Next Steps:
  • Initiate empiric antimicrobial therapy
Definitions

ABSSSI = acute bacterial skin and skin structure infections

BMI = body mass index

BP = blood pressure

BPM = beats per minute

HR = heart rate

RR = respiratory rate

RPM = respirations per minute

WBC = white blood cells

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 (7%), headache (5%), diarrhea (4%), vomiting (3%), and dizziness (2%). In 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%).

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.

US-SIV-0015108/19