Eravacycline

Eravacycline is an antibacterial drug [see Microbiology ( 12.4 )].

• XERAVA is a tetracycline class antibacterial indicated for the treatment of complicated intra‑abdominal infections in patients 18 years of age and older. ( 1.1 ) Limitations of Use XERAVA is not indicated for the treatment of complicated urinary tract infections (cUTI).ICD-10: N39.0

• XERAVA is contraindicated for use in patients with known hypersensitivity to eravacycline, tetracycline-class antibacterial drugs, or to any of the excipients [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )]. Known hypersensitivity to eravacycline, tetracycline-class antibacterial drugs, or any of the excipients in XERAVA.contraindicated

Administer XERAVA for injection 1 mg/kg by intravenous infusion over approximately 60 minutes every 12 hours for a total duration of 4 to 14 days. ( 2.1 ) Severe Hepatic Impairment (Child Pugh C): 1 mg/kg XERAVA every 12 hours on Day 1, then 1 mg/kg every 24 hours starting on Day 2 for a total duration of 4 to 14 days. ( 2.2 ) Concomitant Use of a Strong Cytochrome P450 (CYP) Isoenzyme 3A Inducer: 1.5 mg/kg XERAVA every 12 hours for a total duration of 4 to 14 days. ( 2.3 ) See full prescribing information for the preparation of XERAVA. ( 2.4 ) 2.1 Recommended Adult Dosage The recommended dose regimen of XERAVA is 1 mg/kg every 12 hours. Administer intravenous infusions of XERAVA over approximately 60 minutes every 12 hours. The recommended duration of treatment with XERAVA for cIAI is 4 to 14 days. The duration of therapy should be guided by the severity and location of infection and the patient's clinical response. 2.2 Dosage Modifications in Patients with Hepatic Impairment In patients with severe hepatic impairment (Child Pugh C), administer XERAVA 1 mg/kg every 12 hours on Day 1 followed by XERAVA 1 mg/kg every 24 hours starting on Day 2 for a total duration of 4 to 14 days. No dosage adjustment is warranted in patients with mild to moderate hepatic impairment (Child Pugh A and Child Pugh B) [see Use in Specific Populations ( 8.6 ) and Clinical Pharmacology ( 12.3 )].

Hypersensitivity Reactions : Life-threatening hypersensitivity (anaphylactic) reactions have been reported with tetracycline antibacterial drugs, including XERAVA. Avoid use in patients with known hypersensitivity to tetracyclines. ( 5.1 ) Tooth Discoloration and Enamel Hypoplasia : 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. ( 5.2 , 8.1 , 8.4 ) Inhibition of Bone Growth : 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. ( 5.3 , 8.1 , 8.4 ) Clostridioides difficile -Associated Diarrhea: Evaluate if diarrhea occurs. ( 5.4 ) 5.1 Hypersensitivity Reactions Life-threatening hypersensitivity (anaphylactic) reactions have been reported with XERAVA [see Adverse Reactions ( 6.1 )] . XERAVA is structurally similar to other tetracycline-class antibacterial drugs and should be avoided in patients with known hypersensitivity to tetracycline- class antibacterial drugs. Discontinue XERAVA if an allergic reaction occurs. 5.2 Tooth Discoloration and Enamel Hypoplasia 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-grey-brown). This adverse reaction is more common during long-term use of the tetracycline class drugs, but it has been observed following repeated short-term courses.

The following clinically significant adverse reactions are described in greater detail in the Warnings and Precautions section: Hypersensitivity Reactions [Warning and Precautions ( 5.1 )] Tooth Discoloration [ Warning and Precautions ( 5.2 )] Inhibition of Bone Growth [Warning and Precautions ( 5.3 )] Clostridioides difficile -Associated Diarrhea [Warning and Precautions ( 5.4 )] Tetracycline Class Adverse Reactions [Warning and Precautions ( 5.5 )] Most common adverse reactions (incidence ≥ 3%) are infusion site reactions, nausea, and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Tetraphase Pharmaceuticals, Inc., at 1-800-651-3861 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. XERAVA was evaluated in 3 active-controlled clinical trials (Trial 1, Trial 2, and Trial 3) in adults with cIAI. These trials included two Phase 3 trials (Trial 1 and Trial 2) and one Phase 2 trial (Trial 3, NCT01265784). The Phase 3 trials included 520 patients treated with XERAVA and 517 patients treated with comparator antibacterial drugs (ertapenem or meropenem). The median age of patients treated with XERAVA was 56 years, ranging between 18 and 93 years old; 30% were age 65 years and older. Patients treated with XERAVA were predominantly male (57%) and Caucasian (98%).

Lactation: Breastfeeding is not recommended during treatment with XERAVA. ( 8.2 ) 8.1 Pregnancy Risk Summary XERAVA, like other tetracycline-class antibacterial drugs, may cause discoloration of deciduous teeth and reversible inhibition of bone growth when administered during the second and third trimester of pregnancy [see Warnings and Precautions ( 5.1 , 5.2 ), Use in Specific Populations ( 8.4 )] . The limited available data with XERAVA use in pregnant women are insufficient to inform drug‑associated risk of major birth defects and miscarriages. Animal studies indicate that eravacycline crosses the placenta and is found in fetal plasma; doses greater than approximately 3- and 2.8- times the clinical exposure, based on AUC in rats and rabbits, respectively, administered during the period of organogenesis, were associated with decreased ossification, decreased fetal body weight, and/or increased post-implantation loss (see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Metabolism

Following single-dose intravenous administration, eravacycline AUC and Cmax increase approximately dose-proportionally over doses from 1 mg/kg to 3 mg/kg (3 times the approved dose). The mean exposure of eravacycline after single and multiple intravenous infusions (approximately 60 minutes) of 1 mg/kg administered to healthy adults every 12 hours is presented in Table 2.

No reports of overdose were reported in clinical trials. In the case of suspected overdose, XERAVA should be discontinued and the patient monitored for adverse reactions. Hemodialysis is not expected to remove significant quantities of XERAVA [see Clinical Pharmacology ( 12.3 )].

• Aug 27, 2018NDANDA211109Tetraphase Pharms

1. 1Off Label Use6429%
2. 2Drug Ineffective2813%
3. 3Blood Fibrinogen Decreased167.3%
4. 4Nausea156.8%
5. 5Thrombocytopenia156.8%
6. 6Multiple Organ Dysfunction Syndrome146.4%
7. 7Product Use In Unapproved Indication146.4%
8. 8Lactic Acidosis115.0%
9. 9Hypertransaminasaemia104.5%
10. 10Diarrhoea94.1%
11. 11Drug Intolerance83.6%
12. 12Pancreatitis83.6%
13. 13Enterococcal Infection73.2%
14. 14Acute Respiratory Distress Syndrome62.7%
15. 15Condition Aggravated62.7%

The 10 most recently updated of 19 ClinicalTrials.gov registrations naming Eravacycline as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study to Evaluate the Safety and Tolerability of Eravacycline in Pediatric Patients Aged 8 to 17 With Complicated Intra-abdominal Infections (cIAI)
  Recruiting · Phase 2 · Interventional · 35 enrolled · Tetraphase Pharmaceuticals, Inc
  NCT06794541updated 2026-05-05
• Prospective Evaluation of Xerava Prophylaxis in Hematological Malignancy Patients With Prolonged Neutropenia
  Recruiting · Phase 2 · Interventional · 55 enrolled · West Virginia University
  NCT05537896updated 2026-04-16
• Therapeutic Options for CRAB
  Recruiting · Phase 4 · Interventional · 108 enrolled · Clinical Hospital Centre Zagreb
  NCT06440304updated 2026-01-21
• The Efficacy and Adverse Reactions of Neotetracycline in the Treatment of GNB Infections
  Enrolling by invitation · Observational · 300 enrolled · The First Affiliated Hospital with Nanjing Medical University
  NCT06990126updated 2026-01-06
• Optimising TREATment for Severe Gram-Negative Bacterial Infections
  Recruiting · Phase 4 · Interventional · 600 enrolled · National University of Singapore
  NCT07004049updated 2025-06-04
• Real-World Pharmacokinetic/Pharmacodynamic Study of Eravacycline in Critically III Patients
  Not yet recruiting · Observational · 100 enrolled · Sichuan Provincial People's Hospital
  NCT06666998updated 2024-11-04
• A Study on the Combination Therapy of Eravacycline for Treating Carbapenem-Resistant Acinetobacter Baumannii Pneumonia
  Not yet recruiting · Observational · 50 enrolled · Peking University Third Hospital
  NCT06670872updated 2024-11-01
• Eravacycline Combination Therapy for MRAB
  Unknown · Observational · 20 enrolled · Fujian Medical University Union Hospital
  NCT06282835updated 2024-02-28
• Efficacy and Safety of the Combination Therapy Based on Eravacycline in Immunocompromised Hosts With MDROS Infection
  Unknown · Observational · 100 enrolled · Sichuan Provincial People's Hospital
  NCT06223100updated 2024-01-25
• Efficacy and Safety Study of Eravacycline Compared With Levofloxacin in Complicated Urinary Tract Infections
  Completed · Phase 3 · Interventional · 908 enrolled · Tetraphase Pharmaceuticals, Inc
  NCT01978938updated 2022-01-11

Frequently asked questions

How does Eravacycline work?

Eravacycline is an antibacterial drug [see Microbiology ( 12.4 )].

What is Eravacycline used for?

According to FDA labeling, Eravacycline carries indications including: XERAVA is a tetracycline class antibacterial indicated for the treatment of complicated intra‑abdominal infections in patients 18 years of age and older. ( 1.1 ) Limitations of Use XERAVA is not indicated for the treatment of complicated urinary tract infections (cUTI).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Eravacycline?

Eravacycline is classified as Tetracyclines, Tetracycline-class Antibacterial, Protein Synthesis Inhibitors, Decreased Protein Synthesis.

What are the brand names for Eravacycline?

Eravacycline is marketed under brand names including Xerava.

What are the contraindications for Eravacycline?

Eravacycline labeling lists contraindications including: XERAVA is contraindicated for use in patients with known hypersensitivity to eravacycline, tetracycline-class antibacterial drugs, or to any of the excipients [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )]. Known hypersensitivity to eravacycline, tetracycline-class antibacterial drugs, or any of the excipients in XERAVA.. Always consult the full prescribing information and a clinician.