Trial Design

Phase 3 ABSSSI Trial Design

Both randomized, multicenter, multinational, double-blind, noninferiority ESTABLISH trials compared SIVEXTRO 200 mg once daily for 6 days to linezolid 600 mg every 12 hours for 10 days. Patients with cellulitis/erysipelas, major cutaneous abscess, or wound infection were enrolled in the trials. Patients with wound infections could have received aztreonam and/or metronidazole as adjunctive therapy for Gram-negative bacterial coverage, if needed. In the ESTABLISH 2 trial, patients taking SIVEXTRO received at least 1 day of IV treatment. For the secondary endpoint of post-therapy evaluation, clinical success was defined as resolution or near resolution of disease-specific signs and symptoms, absence or near resolution of systemic signs of infection if present at baseline (lymphadenopathy, fever, >10% immature neutrophils, abnormal white blood cell count), and no further antibiotic treatment required for the treatment of the primary ABSSSI lesion.

IV=intravenous.

Indication

SIVEXTRO® (tedizolid phosphate) 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 Important Safety Information

Patients with neutropenia: The safety and efficacy of SIVEXTRO® (tedizolid phosphate) 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%).

Before prescribing SIVEXTRO, please read the accompanying Prescribing Information.

MULT-1044371-0307 07/15

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Selected Important Safety Information

Patients with neutropenia: The safety and efficacy of SIVEXTRO® (tedizolid phosphate) 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%).

Before prescribing SIVEXTRO, please read the accompanying Prescribing Information.