Xerava (Eravacycline) | CIAIs | HongKong DengYue Medicine

  • Generic Name/Brand Name: ​Eravacycline/XERAVA
  • Indications: CIAIs (Antibiotics)
  • Dosage Form: ​Injection, lyophilized powder for solution
  • Specification: 50mg x 1 vial
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Eravacycline Application Scope

Intravenous treatment of complicated intra-abdominal infections (cIAIs) in adults caused by susceptible organisms (e.g., E. coli, K. pneumoniae, Enterococcus spp., S. aureus, Bacteroides spp., etc.)

eravacycline
eravacycline

 

 Characteristics

  • Ingredients: 50 mg eravacycline (equivalent to 63.5 mg eravacycline dihydrochloride) per single-dose vial (lyophilized powder)

  • Properties: Fully synthetic fluorocycline (tetracycline class), with broad-spectrum activity including many MDR Gram-negative, Gram-positive, and anaerobic bacteria

  • Packaging Specification: Single-dose lyophilized powder vial containing 50 mg eravacycline

  • Storage: See prescribing info for optimal storage; generally stored at controlled room temperature before reconstitution

  • Expiry Date: Per vial label (usually 2–3 years from manufacture; check package insert)

  • Executive Standard: Complies with FDA/EMA prescribing standards as defined in XERAVA’s label

  • Approval Number: FDA-approved on August 27, 2018 for cIAI

  • Date of Revision: See latest FDA label (2018; check your package information for updated revision dates)

  • Manufacturer: Marketed by Innoviva Specialty Therapeutics on behalf of Tetraphase Pharmaceuticals

Guidelines for the Use of Eravacycline

  • Dosage and Administration:

    • Reconstitute vial and administer as IV infusion over ~60 minutes, every 12 hours

    • Recommended dose: 1 mg/kg IV every 12 hours for 4–14 days, based on infection severity and clinical response

    • Compatible with 0.9% sodium chloride; do not mix with other drugs

  • Adverse Reactions:

    • Common (≥3%): Infusion site reactions (≈7.7%), nausea (≈6.5%), vomiting (≈3.7%)

    • Others: Hives, difficulty breathing, diarrhea (including up to 2 months post-treatment), severe headaches, pancreatitis, photosensitivity, pseudotumor cerebri, elevated liver enzymes, BUN, and azotemia

  • Contraindications: Hypersensitivity to eravacycline, tetracycline-class antibiotics, or any excipient

  • Precautions:

    • Allergic reactions: Risk of anaphylaxis—discontinue use if symptoms occur

    • Tooth discoloration & enamel hypoplasia: Avoid during tooth development (pregnancy 2nd–3rd trimester, infants, children ≤8 years)

    • Bone growth inhibition: Possible reversible effects on bone growth in young children/pregnant women

    • Clostridioides difficile–associated diarrhea: Monitor for diarrhea during and up to 2 months post-therapy

    • Photosensitivity, pseudotumor cerebri, liver/kidney function changes, pancreatitis: Monitor and discontinue if suspected

    • Superinfection risk: May lead to fungal or resistant bacterial overgrowth; monitor and treat accordingly

Interactions

  • Drug Interactions:​
  • CYP3A inducers: e.g., rifampin—may reduce eravacycline exposure; dose adjustments may be needed

  • Anticoagulants: Additive effect—monitor INR and adjust dose as needed

  • General tetracycline-like interactions: Avoid coadministration with antacids, iron, calcium-rich foods that inhibit absorption (if/when oral formulation used)

 

Note:

  • If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
  • It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.
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