At Tetraphase, we are committed to fighting one of the most significant medical threats to humanity—antibiotic resistance—through the promise of our technology and the passion of our employees. We are dedicated to making novel antibiotics for serious and life-threatening infections available to patients in need. Our passionate and diligent pursuit to fight antibiotic resistance worldwide is what sets us apart.
Our proprietary chemistry technology has yielded multiple novel tetracycline-based antibiotics with activity against some of the most challenging Gram-negative, multidrug-resistant (MDR) bacteria. Through the dedication of our team—from our chemists and microbiologists to those executing our clinical development and future commercialization efforts—we have completed multiple clinical trials evaluating our lead product, XERAVA™ (eravacycline), approved for the treatment of complicated intra-abdominal infections (cIAI). Our pipeline of agents also holds great promise: TP-6076, which targets Gram-negative MDR infections, including Acinetobacter spp; and TP-271, an intravenous and oral antibiotic that targets respiratory disease caused by bacterial biothreats and antibiotic-resistant public health pathogens.
Our success is rooted in the talent and passion of our employees, who work daily to discover, develop, and commercialize our novel antibiotics. Being part of our nimble biotechnology company allows our team the opportunity to drive change within a growing company and to make an impact by coming together to create accessible, innovative treatments to address the global public health crisis of antibiotic resistance.
We are at a pivotal juncture in our trajectory, as we transition into a commercial-stage company and deliver XERAVA on a global level, while continuing to advance our earlier-stage pipeline assets. Thanks to our multidisciplinary collaborative team, the support of our shareholders, and clinicians and patients, we are on a strong path toward addressing a critical unmet need. We are optimistic about the next chapter for Tetraphase and what it means for the fight against antibiotic resistance.
We welcome and appreciate your interest in our company.
President and Chief Executive Officer
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).
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 at www.XERAVA.com.