HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use BENZNIDAZOLE TABLETS safely and effectively. See full prescribing information for BENZNIDAZOLE TABLETS.
BENZNIDAZOLE tablets, for oral use
Initial U.S. Approval: 2017
INDICATIONS AND USAGE
Benznidazole Tablets, a nitroimidazole antimicrobial, is indicated in pediatric patients 2 to 12 years of age for the treatment of Chagas disease (American trypanosomiasis), caused by Trypanosoma cruzi (1).
This indication is approved under accelerated approval based on the number of treated patients who became Immunoglobulin G (IgG) antibody negative against the recombinant antigens of T. cruzi. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials (1, 14).
DOSAGE AND ADMINISTRATION
•Pediatric patients 2 to 12 years of age: The total daily dose is 5 mg/kg to 8 mg/kg orally administered in two divided doses separated by approximately 12 hours for a duration of 60 days ( 2.2).
•See Full Prescribing Information for important administration instructions ( 2.1, 2.3, 2.4).
DOSAGE FORMS AND STRENGTHS
•Tablets: 100 mg (functionally scored) ( 3).
•Tablets: 12.5 mg ( 3).
CONTRAINDICATIONS
•History of hypersensitivity reaction to benznidazole or other nitroimidazole derivatives ( 4.1).
•Disulfiram usage within the last two weeks ( 4.2).
•Alcoholic beverage consumption during and for at least three days after therapy ( 4.3).
WARNINGS AND PRECAUTIONS
•Potential Risk for Genotoxicity and Carcinogenicity ( 5.1).
•Embryo-Fetal Toxicity: Can cause fetal harm. Pregnancy testing is recommended for females of reproductive potential. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception ( 2.3, 5.2, 8.1, 8.3).
•Hypersensitivity skin reactions have been reported with benznidazole. In case of skin reactions, presenting with additional symptoms of systemic involvement such as lymphadenopathy, fever and/or purpura, discontinuation of treatment is recommended ( 5.3).
•Treatment with Benznidazole Tablets can potentially cause paresthesia or symptoms of peripheral neuropathy. In cases where neurological symptoms occur, immediate discontinuation of treatment is recommended ( 5.4).
•There have been hematological manifestations of bone marrow depression, such as neutropenia, thrombocytopenia, anemia, and leukopenia ( 5.5).
ADVERSE REACTIONS
Most common adverse reactions observed were abdominal pain, rash, decreased weight, headache, nausea, vomiting, neutropenia, urticaria, pruritis, eosinophilia, decreased appetite (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact Exeltis USA, Inc. at 1-877-324-9349 or FDA at 1-800-FDA-1088 or WWW.FDA.GOV/MEDWATCH.
USE IN SPECIFIC POPULATIONS
Lactation: Breastfeeding is not recommended (8.2).
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 8/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Important Administration Instructions
2.2 Recommended Dosage in Pediatric Patients (2 to 12 Years of Age)
2.3 Assessment Prior to Initiating Benznidazole Tablets
2.4 Preparation of Slurry as an Alternative Method of Admi