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Xerava Approval History

Reviewed by J.Stewart B.Pharm Last updated on Aug 31, 2018.

FDA Approved: Yes (First approved August 27, 2018)
Brand name: Xerava
Generic name: eravacycline
Dosage form: Injection
Company: Tetraphase Pharmaceuticals, Inc.
Treatment for: Intraabdominal Infection

Xerava (eravacycline) is a fluorocycline antibiotic indicated for the treatment of complicated intra-abdominal infections.

Administration of Xerava

  • Xerava is administered via intravenous infusion over approximately 60 minutes every 12 hours for a total duration of 4 to 14 days.

Warnings and Precautions

  • Serious Allergic Reactions: Life-threatening allergic reactions (anaphylactic reactions) have been reported with tetracycline antibacterial drugs, including Xerava. Serious allergic reactions require immediate treatment. Use of Xerava is contraindicated in patients with known hypersensitivity to eravacycline, tetracycline-class antibacterial drugs, or any of the excipients in Xerava.
  • Tooth Discoloration and Inhibition of Bone Growth: Xerava, like other tetracycline-class drugs, may cause permanent tooth discoloration (yellow-gray-brown), enamel hypoplasia, and reversible inhibition of bone growth when administered during the second and third trimesters of pregnancy, infancy, or childhood up to the age of 8 years. Patients should tell their healthcare provider right away if they become pregnant during treatment.
  • Lactation: Women should not breastfeed during treatment with Xerava and for four days after the last dose.
  • Diarrhea: Diarrhea is a common problem caused by antibacterial drugs, including Xerava, which usually ends when the antibacterial drug is discontinued. Sometimes after starting treatment with an antibacterial drug, patients can develop watery and bloody stools (with or without stomach cramps and fever) as late as two or more months after receiving the last dose. This may be a sign of a more serious intestinal infection called Clostridium difficile infection, and patients should contact their healthcare provider as soon as possible if diarrhea occurs.
  • 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 infections that are proven or strongly suspected to be caused by susceptible bacteria.

Adverse Reactions
The most common adverse reactions (incidence ≥ 3%) include infusion site reactions, nausea, and vomiting.

Development History and FDA Approval Process for Xerava

DateArticle
Aug 27, 2018Approval Tetraphase Pharmaceuticals Announces FDA Approval of Xerava (eravacycline) for Complicated Intra-Abdominal Infections (cIAI)
Feb 27, 2018Tetraphase Pharmaceuticals Announces FDA Acceptance for Filing of its NDA Submission for Eravacycline for the Treatment of Complicated Intra-Abdominal Infections
Jan  2, 2018Tetraphase Pharmaceuticals Announces Submission of New Drug Application to FDA for Eravacycline for the Treatment of Complicated Intra-Abdominal Infections (cIAI)
Sep 11, 2017Tetraphase Pharmaceuticals Completes Enrollment of IGNITE3 Phase 3 Clinical Trial of Eravacycline in Complicated Urinary Tract Infections
Apr  3, 2017Tetraphase Pharmaceuticals Completes Enrollment of Ignite4 Phase 3 Clinical Trial of Eravacycline in Complicated Intra-Abdominal Infections
Jan 17, 2017Tetraphase Pharmaceuticals Doses First Patient In IGNITE3 Phase 3 Clinical Trial of Once-Daily IV Eravacycline in cUTI
Nov 17, 2016Tetraphase Publishes Phase 3 IGNITE1 Eravacycline Data in JAMA Surgery
Oct 14, 2016Tetraphase Pharmaceuticals Doses First Patient in IGNITE4 Phase 3 Clinical Trial Of Eravacycline in cIAI
May 12, 2016Tetraphase Pharmaceuticals Provides Update on Eravacycline Regulatory and Development Status
Sep  8, 2015Tetraphase Announces Top-Line Results From IGNITE2 Phase 3 Clinical Trial of Eravacycline in cUTI
Dec 17, 2014Tetraphase Announces Positive Top-line Results from Phase 3 IGNITE 1 Clinical Trial of Eravacycline in Complicated Intra-abdominal Infections
Jul 28, 2014Tetraphase Pharmaceuticals Completes Enrollment of IGNITE 1 Eravacycline Phase 3 Clinical Trial
Jun 19, 2014Tetraphase Pharmaceuticals Completes Enrollment in Lead-in Portion of IGNITE 2 Eravacycline Phase 3 Clinical Trial in cUTI

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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