For: Complicated Intra-Abdominal Infections
Xerava (eravacycline) is a fluorocycline antibiotic indicated for the treatment of complicated intra-abdominal infections. 16.1 How Supplied
XERAVA for injection, 50 mg/vial, is a yellow to orange, sterile, preservative-free powder for reconstitution in single-dose 10-mL clear glass vials with a rubber stopper and an aluminum overseal. Each vial contains 50 mg of eravacycline (equivalent to 63.5 mg of eravacycline dihydrochloride). XERAVA is supplied in two packaging configurations:
Single-vial carton containing one 50 mg single-dose vial: NDC 71773-050-05.
Twelve-vial carton containing twelve 50 mg single-dose vial cartons: NDC 71773-050-12.
16.2 Storage and Handling
Prior to reconstitution, XERAVA should be stored at 2�C to 8�C (36�F to 46�F) [see Dosage and Administration 2.4]. Keep vial in carton until use. These highlights do not include all the information needed to use XERAVA safely and effectively. See full prescribing information for XERAVA.
XERAVA (eravacycline) for injection, for intravenous use
Initial U.S. Approval: 2018
RECENT MAJOR CHANGES
Dosage and Administration, Preparation (2.4) 10/2019
INDICATIONS AND USAGE
XERAVA is a tetracycline class antibacterial indicated for the treatment of complicated intra?abdominal infections in patients 18 years of age and older. (1.1)
Limitations of Use
XERAVA is not indicated for the treatment of complicated urinary tract infections (cUTI). (1.1)
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. (1.2)
DOSAGE AND ADMINISTRATION
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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. (2.1)
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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. (2.2)
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Concomitant Use of a Strong Cytochrome P450 Isoenzymes (CYP)3A Inducer: 1.5 mg/kg XERAVA every 12 hours for a total duration of 4 to 14 days. (2.3)
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See full prescribing information for the preparation of XERAVA (2.4)
DOSAGE FORMS AND STRENGTHS
For injection: 50 mg of eravacycline (equivalent to 63.5 mg eravacycline dihydrochloride) as a lyophilized powder in a single-dose vial for reconstitution and further dilution. (3)
CONTRAINDICATIONS
Known hypersensitivity to eravacycline, tetracycline-class antibacterial drugs, or any of the excipients in XERAVA (4, 5, 6)
WARNINGS AND PRECAUTIONS
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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. (5.1)
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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. (5.2, 8.1, 8.4)
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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 (5.3, 8.1, 8.4).
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Clostridium difficile-associated diarrhea: Evaluate if diarrhea occurs. (5.4)
ADVERSE REACTIONS
Most common adverse reactions (incidence ? 3%) are infusion site reactions, nausea, and vomiting. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Tetraphase Pharmaceuticals Inc., at 1-833-7-XERAVA (1-833-793-7282) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
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Concomitant use of strong CYP3A inducers decreases the exposure of eravacycline. Increase XERAVA dose with concomitant use of a strong CYP3A inducer (2.3, 7.1, 12.3)
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Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage (7.2)
USE IN SPECIFIC POPULATIONS
Lactation: Breastfeeding is not recommended during treatment with XERAVA. (8.2)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 10/2019
