Eravacycline

XERAVA is a tetracycline class antibacterial indicated for the treatment of complicated intra‑abdominal infections in patients 18 years of age and older. Limitations of 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 be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

Eravacycline is an antibacterial drug.

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. 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. 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. See full prescribing information for the preparation of XERAVA.

XERAVA is contraindicated for use in patients with known hypersensitivity to eravacycline, tetracycline-class antibacterial drugs, or to any of the excipients. Known hypersensitivity to eravacycline, tetracycline-class antibacterial drugs, or any of the excipients in XERAVA.

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. 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. 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. Clostridioides difficile -Associated Diarrhea: Evaluate if diarrhea occurs.

The following clinically significant adverse reactions are described in greater detail in the Warnings and Precautions section: Hypersensitivity Reactions [Warning and Precautions ] Tooth Discoloration [ Warning and Precautions ] Inhibition of Bone Growth [Warning and Precautions ] Clostridioides difficile -Associated Diarrhea [Warning and Precautions ] Tetracycline Class Adverse Reactions [Warning and Precautions ] Most common adverse reactions (incidence ≥ 3%) are infusion site reactions, nausea, and vomiting.

Strong CYP 3A Inducers: Co-administration decreases the exposure of eravacycline, increase XERAVA dose with concomitant use. Anticoagulant Drugs: Downward adjustment of anticoagulant dosage may be required.

Prior to reconstitution, XERAVA should be stored at 2°C to 8°C (36°F to 46°F).