XERAVA: BROAD ACTIVITY AGAINST IMPORTANT RESISTANT PATHOGENS1

Provides the broad coverage needed in a polymicrobial infection, such as cIAI, including resistant strains found in patients at risk1

  • Covers many Gram-negative, Gram-positive, and anaerobic bacteria relevant to cIAI, including many resistant strains1
    • Active against ESBL-producing Enterobacteriaceae such as E coli and K pneumoniae, which are identified as high-priority pathogens by the CDC and WHO2,3
    • Active against B fragilis1

B fragilis, Bacteroides fragilis; CDC, Centers for Disease Control and Prevention; cIAI, complicated intra-abdominal infection; C difficile, Clostridium difficile; C freundii, Citrobacter freundii; C perfringens, Clostridium perfringens; E cloacae, Enterobacter cloacae; E coli, Escherichia coli; E faecalis VRE, Enterococcus faecalis vancomycin-resistant enterococci; E faecalis VSE, Enterococcus faecalis vancomycin-sensitive enterococci; E faecium VRE, Enterococcus faecium vancomycin-resistant enterococci; E faecium VSE, Enterococcus faecium vancomycin-sensitive enterococci; ESBL, extended-spectrum beta-lactamase; K oxytoca, Klebsiella oxytoca; K pneumoniae, Klebsiella pneumoniae; MDR, multidrug-resistant; MIC, minimum inhibitory concentration; MRSA, methicillin-resistant Staphylococcus aureus; MSSA, methicillin-susceptible Staphylococcus aureus; P distasonis, Parabacteroides distasonis; S anginosus, Streptococcus anginosus; VRE, vancomycin-resistant enterococci; VSE, vancomycin-susceptible enterococci; WHO, World Health Organization.

References: 1. XERAVA [prescribing information]. Watertown, MA: Tetraphase Pharmaceuticals, Inc.; 2018. 2. Antibiotic resistance threats in the United States, 2013. Centers for Disease Control and Prevention website. https://www.cdc.gov/drugresistance/pdf/ar-threats-2013-508.pdf. Accessed July 26, 2018. 3. Tacconelli E, Magrini N. Global priority list of antibiotic-resistant bacteria to guide research, discovery, and development of new antibiotics. World Health Organization website. http://www.who.int/medicines/publications/WHO-PPL-Short_Summary_ 25Feb-ET_NM_WHO.pdf. Accessed July 23, 2018. 4. Data on file. Watertown, MA: Tetraphase Pharmaceuticals, Inc.; 2018.

Indications and Usage; Important Safety Information

EXPAND COLLAPSE

Indications and Usage

XERAVA is indicated for the treatment of complicated intra-abdominal infections (cIAI) caused by susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii, Enterobacter cloacae, Klebsiella oxytoca, Enterococcus faecalis, Enterococcus faecium, Staphylococcus aureus, Streptococcus anginosus group, Clostridium perfringens, Bacteroides species, and Parabacteroides distasonis in patients 18 years or older.

Limitations of Use

XERAVA is not indicated for the treatment of complicated urinary tract infections (cUTI).

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of XERAVA and other antibacterial drugs, XERAVA should be used only to treat or prevent infections 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.

Important Safety Information

XERAVA is contraindicated for use in patients with known hypersensitivity to eravacycline, tetracycline-class antibacterial drugs, or to any of the excipients. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with XERAVA.

The use of XERAVA during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.

The use of XERAVA during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, and may range in severity from mild diarrhea to fatal colitis.

The most common adverse reactions observed in clinical trials (incidence ≥3%) were infusion site reactions (7.7%), nausea (6.5%), and vomiting (3.7%).

XERAVA is structurally similar to tetracycline-class antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri, and anti-anabolic action which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline-class antibacterial drugs, and may occur with XERAVA. Discontinue XERAVA if any of these adverse reactions are suspected.

To report SUSPECTED ADVERSE REACTIONS, contact Tetraphase Pharmaceuticals Inc., at 1-833-7-XERAVA (1-833-793-7282) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information for XERAVA.

Indications and Usage

XERAVA is indicated for the treatment of complicated intra-abdominal infections (cIAI) caused by susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii, Enterobacter cloacae, Klebsiella oxytoca, Enterococcus faecalis, Enterococcus faecium, Staphylococcus aureus, Streptococcus anginosus group, Clostridium perfringens, Bacteroides species, and Parabacteroides distasonis in patients 18 years or older.

Limitations of Use

XERAVA is not indicated for the treatment of complicated urinary tract infections (cUTI).

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of XERAVA and other antibacterial drugs, XERAVA should be used only to treat or prevent infections 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.

Important Safety Information

XERAVA is contraindicated for use in patients with known hypersensitivity to eravacycline, tetracycline-class antibacterial drugs, or to any of the excipients. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with XERAVA.

The use of XERAVA during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.

The use of XERAVA during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, and may range in severity from mild diarrhea to fatal colitis.

The most common adverse reactions observed in clinical trials (incidence ≥3%) were infusion site reactions (7.7%), nausea (6.5%), and vomiting (3.7%).

XERAVA is structurally similar to tetracycline-class antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri, and anti-anabolic action which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline-class antibacterial drugs, and may occur with XERAVA. Discontinue XERAVA if any of these adverse reactions are suspected.

To report SUSPECTED ADVERSE REACTIONS, contact Tetraphase Pharmaceuticals Inc., at 1-833-7-XERAVA (1-833-793-7282) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information for XERAVA.