Xerava

ERAVACYCLINE

Manufacturer: Tetraphase Pharmaceuticals, Inc.

Score: 141.0

Quick Summary

Xerava (Eravacycline) is a tetracycline-class antibacterial drug used for the treatment of complicated intra-abdominal infections (cIAI) in patients 18 years of age and older. The recommended dose is 1 mg/kg every 12 hours for 4 to 14 days, with adjustments for severe hepatic impairment and concomitant use of strong CYP3A inducers. Key clinical findings include efficacy against a range of gram-positive and gram-negative bacteria. Important safety information includes warnings for hypersensitivity reactions, tooth discoloration, inhibition of bone growth, and Clostridium difficile-associated diarrhea. Contraindications include known hypersensitivity to eravacycline, tetracycline-class antibacterial drugs, or any of the excipients. Special population considerations include use during pregnancy, pediatric use, and geriatric use.

Key Clinical Findings and Indications

Treatment of complicated intra-abdominal infections (cIAI) in patients 18 years of age and older
Efficacy against gram-positive and gram-negative bacteria, including Escherichia coli, Klebsiella pneumoniae, and Staphylococcus aureus
Not indicated for the treatment of complicated urinary tract infections (cUTI)

Important Safety Information

Warning

Hypersensitivity reactions, tooth discoloration, inhibition of bone growth, and Clostridium difficile-associated diarrhea

Contraindications

Known hypersensitivity to eravacycline, tetracycline-class antibacterial drugs, or any of the excipients

Adverse Reactions

Infusion site reactions, nausea, vomiting, diarrhea, hypotension, and wound dehiscence

Dosing Recommendations

General Guidance

Adjustments for severe hepatic impairment and concomitant use of strong CYP3A inducers

Complicated intra-abdominal infections (cIAI)

Adult Dose

1 mg/kg every 12 hours for 4 to 14 days

Pediatric Dose

Not recommended for pediatric patients less than 8 years of age

Special Population Considerations

Pregnancy

May cause discoloration of deciduous teeth and reversible inhibition of bone growth when administered during the second and third trimester of pregnancy