Indicated for:

Acute Bacterial Skin and Skin Structure Infections:

Indicated in adult 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.

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 or prevent infections that are proven or strongly suspected to be caused by bacteria.

SIVEXTRO for injection is incompatible with any solution containing divalent cations (e.g., Ca²⁺, Mg²⁺), including Lactated Ringer’s Injection and Hartmann’s Solution.

Limited data are available on the compatibility of SIVEXTRO for injection with other intravenous substances, additives or other medications and they should not be added to SIVEXTRO single-dose vials or infused simultaneously. If the same intravenous line is used for sequential infusion of several different drugs, the line should be flushed before and after infusion of SIVEXTRO with 0.9%Sodium Chloride Injection, USP.

The safety and efficacy of SIVEXTRO in patients with neutropenia (neutrophil counts <1000 cells/mm³) have not been adequately evaluated. Alternative therapies should be considered when treating patients with neutropenia and acute bacterial skin and skin structure infection. 

Clostridium difficile-associated diarrhea (CDAD) has been reported for nearly all systemic antibacterial agents including SIVEXTRO, with severity ranging from mild diarrhea to fatal colitis.

Peripheral and optic neuropathy have been described in patients treated with another member of the oxazolidinone class for longer than 28 days. No data are available for patients exposed to SIVEXTRO for longer than 6 days.

In postmarketing experience, thrombocytopenia has been reported in patients treated with SIVEXTRO.

Peripheral and optic neuropathy have been described in patients treated with another member of the oxazolidinone class for longer than 28 days.

Orally administered SIVEXTRO inhibits Breast Cancer Resistance Protein (BCRP) in the intestine, which can increase the plasma concentrations of orally administered BCRP substrates, and the potential for adverse reactions.

There are no adequate and well-controlled studies of SIVEXTRO in pregnant women. Based on animal reproduction studies, SIVEXTRO may cause fetal harm when administered to pregnant women. 

Tedizolid is excreted in the breast milk of rats. It is not known whether tedizolid is excreted in human milk.

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• Use in patients under 12 years of age. GoToSource

• Prosthetic joint infections. GoToSource

• Nosocomial pneumonia. GoToSource

• Diabetic foot, bone and joint infections. GoToSource

• Pulmonary tuberculosis. GoToSource

• Pulmonary mycobacterium avium complex. GoToSource

• Community-acquired bacterial pneumonia and bacteremia. GoToSource

• CNS infections. GoToSource

• Respiratory tract infections. GoToSource

Clostridium difficile-associated diarrhea. GoToSource

Elevated liver enzymes and low white blood cell count. GoToSource 

Bradycardia (slow heart rate). GoToSource

Thrombocytopenia (low blood platelet count), peripheral neuropathy (nerve damage) and optic neuropathy (optic nerve damage). GoToSource

Serotonin syndrome (potentially life-threatening drug reaction). GoToSource

No major injury lawsuits reported.