SIVEXTRO®

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

Patient Profiles

Profile of a Patient With ABSSSI (Erysipelas From Insect Bites)

Not an actual patient

ABSSSI Erysipelas: Insect Bites

Patients like Robert may be considered an appropriate candidate for SIVEXTRO

Patient With ABSSSI, Erysipelas Infection From Insect Bites on the Calf

Robert, a 63-year-old male, just returned from a vacation to discover multiple mosquito bites on his legs. His excessive scratching has led to broken skin and the appearance of a growing, painful, red rash on his left calf.

Reported Signs and Symptoms:
  • Over left upper calf: painful, red patch of skin
Other Medical Factors:
  • Hypertension and mild arrhythmia
Clinical Examination:
  • BMI of 34.0 kg/m2
  • Vital Signs: Temp: 99.0°F; RR: 17 RPM; HR: 110 BPM; BP: 130/75 mm Hg
  • Over left lateral leg: ~150 cm2 patch of tender, intensely red, shiny skin; red streaking
  • Sharply raised edges, distinctly demarcated from adjacent skin; no drainage
Lab Results:
  • WBC: 13 500 x 103 cells/mL, ESR: 40 mm/h

Diagnosis: ABSSSI (erysipelas)

Next Steps:
  • Initiate empiric antimicrobial therapy
  • Manage localized pain
Definitions

ABSSSI = acute bacterial skin and skin structure infections

BMI = body mass index

BP = blood pressure

BPM = beats per minute

ESR = erythrocyte sedimentation rate

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 (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.

US-SIV-0002202/19