eravacycline

Common name: eravacycline

Trade name: Xerava

All names: eravacycline, Xerava, eravacycline

Suitable Indications:

XERAVA is a tetracycline antibacterial agent indicated for the treatment of complicated intra-abdominal infections in patients over 18 years of age

Restrictions on 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 only be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

Usage and Dosage:

Inject 1 mg/kg of XERAVA injection intravenously every 12 hours approximately 60 minutes for a total of 4 to 14 days.

Severe hepatic impairment (Pugh C in children): 1 mg/kg XERAVA every 12 hours starting on day 1, then 1 mg/kg XERAVA every 24 hours starting on day 2, for a total of 4 to 14 days.

Concomitant use of a potent inducer of cytochrome P450 isoenzyme (CYP) 3A: 1.5 mg/kg XERAVA every 12 hours for 4 to 14 days.

Specification:

50 mg/bottle

Adverse reactions:

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

Contraindications:

Known hypersensitivity to ravacycline, tetracycline antimicrobials, or any of the excipients in XERAVA.

Precautions:

Hypersensitivity reactions: Life-threatening hypersensitivity reactions (anaphylaxis) have been reported with tetracycline antibacterial drugs, including XERAVA. Avoid use in patients with known hypersensitivity to tetracyclines.

Tooth discoloration and enamel hypoplasia: Use of XERAVA during tooth development (the second half of pregnancy, infants, and children through 8 years of age) may cause permanent tooth discoloration (yellow-grey-brown) and enamel hypoplasia.

Inhibition of Bone Growth: Use of XERAVA during the second and third trimester of pregnancy, infancy, and children younger than 8 years of age may cause reversible inhibition of bone growth.

Clostridium difficile-associated diarrhea: Assess for the occurrence of diarrhea.

Storage:

XERAVA should be stored at 2°C to 8°C (36°F to 46°F) prior to reconstitution. Keep vial in carton until use.

Mechanism of action:

Eravacycline is a fluorocycline antibiotic in the tetracycline class of antibiotics. It disrupts bacterial protein synthesis by binding to the 30S ribosomal subunit, thereby preventing the incorporation of amino acid residues into the extended peptide chain. In general, eravacycline has bacteriostatic effects against Gram-positive bacteria (e.g., Staphylococcus aureus and Enterococcus faecalis); however, in vitro bactericidal activity has been demonstrated against certain strains of Escherichia coli and Klebsiella pneumoniae.

Safety and efficacy:

In clinical trials, eravacycline was well tolerated in patients with cIAI, had a high clinical cure rate, and was statistically non-inferior to two widely used contrast agents (ertapenem and meropenem).

Eravacycline has demonstrated a favorable safety profile in clinical trials and does not require dose adjustments in patients with renal impairment. This medication can also be used safely in people with penicillin allergies. This novel treatment may be of great benefit to patients with complicated intra-abdominal infections.