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warnings and cautions
5 WARNINGS AND PRECAUTIONS QT Prolongation : Prolongs QTc interval. Monitor electrocardiogram (ECG) in patients with a history of QTc prolongation or with electrolyte imbalance like hypokalemia or who are taking medications which prolong the QTc interval, or on CYP1A2 inhibitors, or have hepatic impairment. ( 5.1 ) 5.1 QT Prolongation EGATEN prolongs the QTc interval [see Clinical Pharmacology (12.2)] . The magnitude of QTc prolongation can increase with increasing treatment duration of EGATEN. Administration of EGATEN concurrently with CYP1A2 inhibitors and use in patients with hepatic impairment may result in increased exposures of triclabendazole and/or its metabolites, and, therefore, may increase the risk for QT prolongation. Monitor electrocardiogram (ECG) in patients with a history of prolongation of the QTc interval or a history of symptoms compatible with a long QT interval or with electrolyte imbalance like hypokalemia, or when EGATEN is used in patients who receive drugs that are known to prolong the QTc interval, or patients taking CYP1A2 inhibitors, or in patients with hepatic impairment. If signs of cardiac arrhythmia occur during treatment with EGATEN, stop the treatment and monitor ECG.
6 ADVERSE REACTIONS Most common adverse reactions (greater than 2%) with triclabendazole 20 mg/kg dose are abdominal pain, hyperhidrosis, nausea, decreased appetite, headache, urticaria, diarrhea, vomiting, musculoskeletal chest pain, and pruritus. ( 6.1 ) 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. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of triclabendazole was evaluated in 208 adult and pediatric patients 5 years of age and older who participated in 6 clinical trials for the treatment of fascioliasis and received 10 mg/kg or 20 mg/kg of triclabendazole; of these, 6 patients failed the 10 mg/kg dose and were retreated with 20 mg/kg. The 10 mg/kg dosing regimen is not approved [see Dosage and Administration (2)] . In these trials, 186 patients received a single dose of 10 mg/kg and 28 patients received a dose of 20 mg/kg as two divided doses. Pooled data for adverse reactions reported in more than 2% of the patients in these clinical trials for the 10 mg/kg and 20 mg/kg dosing regimens are presented in Table 1. Table 1: Adverse Reactions Occurring in >2% of Patients Who Received a Total of 10 mg/kg or 20 mg/kg Triclabendazole for Fascioliasis Treatment (Pooled Across 6 Studies) 1 Divided doses were given 6-48 hours apart. 2 Abdominal pain upper and abdominal pain. 3 Jaundice and ocular icterus. Adverse Reactions Triclabendazole 10 mg/kg N = 186, n (%) Triclabendazole 20 mg/kg in two divided doses 1 N = 28, n (%) Abdominal pain 2 105 (56) 26 (93) Hyperhidrosis 42 (23) 7 (25) Vertigo 16 (9) 0 Nausea 15 (8) 5 (18) Urticaria 12 (7) 3 (11) Vomiting 11 (6) 2 (7) Headache 11 (6) 4 (14) Dyspnea 9 (5) 0 Pruritus 8 (4) 1 (4) Asthenia 7 (4) 0 Musculoskeletal chest pain 7 (4) 1 (4) Cough 7 (4) 0 Decreased appetite 6 (3) 5 (18) Chest pain 6 (3) 0 Pyrexia 4 (2) 0 Jaundice 3 4 (2) 0 Chest discomfort 4 (2) 0 Diarrhea 0 2 (7) Adverse reactions reported in less than or equal to 2% of patients who received a total of 10 mg/kg of triclabendazole were constipation, biliary colic, arthralgia, back pain, spinal pain, and chromaturia. Some adverse reactions associated with triclabendazole treatment in fascioliasis, e.g., abdominal pain, biliary colic, and jaundice, could be secondary to the infection and may be more frequent and/or severe in patients with a heavy worm burden. The safety profile of triclabendazole 20 mg/kg in divided doses in a non-hepatic parasitic infection (N = 104) was generally similar to the safety profile in fascioliasis, except for a lower incidence of post-treatment abdominal pain. Liver Enzyme Elevations In clinical studies, up to one third of patients had liver enzyme elevations at baseline, which generally improved post-treatment. Of those with normal liver enzyme values at baseline, 6.8%, 4.5%, 4.2% and 3% of patients had post-treatment elevations in bilirubin, aspartate aminotransferase (AST), alkaline phosphatase (ALP) and alanine aminotransferase (ALT), respectively. Transient increases in liver enzymes and total bilirubin in fascioliasis patients receiving triclabendazole are reported in the literature. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-marketing use of EGATEN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Resistance to triclabendazole has been reported [see Microbiology (12.4)] .