HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use EGATEN safely and effectively. See full prescribing information for EGATEN.
EGATEN(triclabendazole)tablets, for oral use
Initial U.S. Approval: 2019
INDICATIONS AND USAGE
EGATEN™ tablet is an anthelmintic indicated for the treatment of fascioliasisin patients 6 years of age and older.
DOSAGE AND ADMINISTRATION
The recommended dose of EGATEN is 2 doses of 10 mg/kg given 12 hoursapart in patients 6 years of age and older.
Take orally with food.
Swallow tablets whole or divide in half and take with water, or crush andadminister with applesauce.
If the dosage cannot be adjusted exactly, round dose upwards.
DOSAGE FORMS AND STRENGTHS
Tablets: 250 mg, functionally scored.
CONTRAINDICATIONS
Patients with known hypersensitivity to triclabendazole, other benzimidazolederivatives or any of the excipients in EGATEN.
WARNINGS AND PRECAUTIONS
QT Prolongation: May prolong QT interval. Monitor ECG in patients with ahistory of QT prolongation or who are taking medications which prolong theQT interval.
ADVERSE REACTIONS
Most common adverse reactions (greater than 2%) with triclabendazole 20mg/kg dose are abdominal pain, hyperhidrosis, nausea, decreased appetite,headache, urticaria, diarrhea, vomiting, musculoskeletal chest pain, andpruritus.
To report SUSPECTED ADVERSE REACTIONS, contact Novartis
Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
CYP2C19 Substrates: Re-check the plasma concentration of concomitantlyadministered CYP2C19 substrates after cessation of EGATEN therapy, if theplasma concentrations of the CYP2C19 substrates are elevated duringadministration of EGATEN.
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 2/2019
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 QT Prolongation
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Effect of EGATEN on CYP2C19 Substrates
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
12.4 Microbiology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing information are notlisted.

FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
EGATEN™ is indicated for the treatment of fascioliasis in patients 6 years of age and older.
2 DOSAGE AND ADMINISTRATION
The recommended dose of EGATEN is 2 doses of 10 mg/kg given 12 hours apart in patients 6 years of age andolder. The 250 mg tablets are functionally scored and divisible into two equal halves of 125 mg. If the dosagecannot be adjusted exactly, round the dose upwards.
Take EGATEN orally with food. EGATEN tablets can be swallowed whole or divi