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  • CLASSES

    Antinematodal Agents

    DEA CLASS

    Rx

    DESCRIPTION

    Oral anthelmintic
    Used for fascioliasis
    Prolongs the QT interval

    COMMON BRAND NAMES

    Egaten

    HOW SUPPLIED

    Egaten Oral Tab: 250mg

    DOSAGE & INDICATIONS

    For the treatment of fascioliasis.
    Oral dosage
    Adults

    10 mg/kg/dose PO for 2 doses given 12 hours apart. The 250 mg tablets are scored and divisible into 2 equal halves; round the dose up if it cannot be adjusted exactly.[63962]

    Children and Adolescents 6 to 17 years

    10 mg/kg/dose PO for 2 doses given 12 hours apart. The 250 mg tablets are scored and divisible into 2 equal halves; round the dose up if it cannot be adjusted exactly.[63962]

    MAXIMUM DOSAGE

    Adults

    20 mg/kg/day PO.

    Geriatric

    20 mg/kg/day PO.

    Adolescents

    20 mg/kg/day PO.

    Children

    6 to 12 years: 20 mg/kg/day PO.
    1 to 5 years: Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

    Renal Impairment

    Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

    ADMINISTRATION

    Oral Administration
    Oral Solid Formulations

    Take with food.
    Tablets can be swallowed whole or divided in half and taken with water.
    Tablets may also be crushed and administered in applesauce. Crushed tablets mixed with applesauce are stable for up to 4 hours.[63962]

    STORAGE

    Egaten:
    - Store below 86 degrees F
    - Store in original container

    CONTRAINDICATIONS / PRECAUTIONS

    General Information

    Triclabendazole is contraindicated in patients with a known hypersensitivity to triclabendazole and/or to other benzimidazole derivatives.[63962]

    Apheresis, AV block, bradycardia, cardiomyopathy, celiac disease, females, fever, geriatric, heart failure, hepatic disease, human immunodeficiency virus (HIV) infection, hyperparathyroidism, hypocalcemia, hypokalemia, hypomagnesemia, hypothermia, hypothyroidism, long QT syndrome, myocardial infarction, pheochromocytoma, QT prolongation, rheumatoid arthritis, sickle cell disease, sleep deprivation, stroke, systemic lupus erythematosus (SLE)

    Triclabendazole prolongs the QTc interval. ECG monitoring is recommended in patients with a history of QT prolongation or symptoms compatible with a long QT interval and in patients with an electrolyte imbalance like hypokalemia, hepatic disease, or receiving other drugs that prolong the QT interval or those that inhibit CYP1A2. Concurrent use of CYP1A2 inhibitors and use in patients with hepatic impairment may increase exposure to triclabendazole and/or its metabolites, which may increase the risk of QT prolongation. Use triclabendazole with caution in patients with conditions that may increase the risk of QT prolongation including congenital long QT syndrome, bradycardia, AV block, heart failure, stress-related cardiomyopathy, myocardial infarction, stroke, hypomagnesemia, hypokalemia, hypocalcemia, or in patients receiving medications known to prolong the QT interval or cause electrolyte imbalances. Females, geriatric patients, patients with sleep deprivation, pheochromocytoma, sickle cell disease, hypothyroidism, hyperparathyroidism, hypothermia, systemic inflammation (e.g., human immunodeficiency virus (HIV) infection, fever, and some autoimmune diseases including rheumatoid arthritis, systemic lupus erythematosus (SLE), and celiac disease) and patients undergoing apheresis procedures (e.g., plasmapheresis [plasma exchange], cytapheresis) may also be at increased risk for QT prolongation.[28432] [28457] [56592] [63962]

    Pregnancy

    Caution is warranted with the use of triclabendazole during pregnancy. There are no available data on triclabendazole use in pregnant women to inform a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal studies have not shown a risk of increased fetal abnormalities with exposure to triclabendazole during organogenesis at doses of 0.3 to 1.6 times the maximum recommended human dose (MRHD) of 20 mg/kg/day.[63962]

    Breast-feeding

    Caution is warranted with the use of triclabendazole during breast-feeding. There are no data on the presence of triclabendazole in human breastmilk, the effects on the breastfed infant, or the effects on milk production. Limited animal studies indicate that triclabendazole is present in animal milk.[63962] Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested or administered drug, health care providers are encouraged to report the adverse effect to the FDA.

    ADVERSE REACTIONS

    Moderate

    hyperbilirubinemia / Delayed / 6.8-6.8
    dyspnea / Early / 5.0-5.0
    elevated hepatic enzymes / Delayed / 3.0-4.5
    chest pain (unspecified) / Early / 2.0-4.0
    constipation / Delayed / 0-2.0
    jaundice / Delayed / 2.0-2.0
    QT prolongation / Rapid / Incidence not known

    Mild

    abdominal pain / Early / 56.0-93.0
    hyperhidrosis / Delayed / 23.0-25.0
    nausea / Early / 8.0-18.0
    anorexia / Delayed / 3.0-18.0
    headache / Early / 6.0-14.0
    urticaria / Rapid / 7.0-11.0
    vertigo / Early / 9.0-9.0
    vomiting / Early / 6.0-7.0
    diarrhea / Early / 7.0-7.0
    pruritus / Rapid / 4.0-4.0
    asthenia / Delayed / 4.0-4.0
    cough / Delayed / 4.0-4.0
    fever / Early / 2.0-2.0
    arthralgia / Delayed / 0-2.0
    back pain / Delayed / 0-2.0
    urine discoloration / Early / 0-2.0

    DRUG INTERACTIONS

    Alfuzosin: (Moderate) Monitor ECGs in patients receiving triclabendazole with alfuzosin. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Based on electrophysiology studies performed by the manufacturer, alfuzosin may prolong the QT interval in a dose-dependent manner.
    Amiodarone: (Major) Avoid coadministration of amiodarone and triclabendazole due to the risk of additive QT prolongation. If coadministration is necessary, monitor ECGs for QT prolongation. Amiodarone, a Class III antiarrhythmic agent, is associated with a well-established risk of QT prolongation and torsade de pointes (TdP). Although the frequency of TdP is less with amiodarone than with other Class III agents, amiodarone is still associated with a risk of TdP. Due to the extremely long half-life of amiodarone, a drug interaction is possible for days to weeks after discontinuation of amiodarone. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Amisulpride: (Major) Monitor ECGs in patients receiving triclabendazole with amisulpride. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Amisulpride causes dose- and concentration- dependent QT prolongation.
    Amoxicillin; Clarithromycin; Omeprazole: (Major) Monitor ECGs in patients receiving triclabendazole with clarithromycin. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Clarithromycin is associated with an established risk for QT prolongation and torsade de pointes.
    Anagrelide: (Major) Do not use anagrelide with other drugs that prolong the QT interval, such as triclabendazole. Torsade de pointes and ventricular tachycardia have been reported with anagrelide; dose-related increases in mean QTc and heart rate were observed in healthy subjects. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Apomorphine: (Moderate) Monitor ECGs in patients receiving triclabendazole with apomorphine as concurrent use may increase the risk of QT prolongation. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Dose-related QTc prolongation is associated with therapeutic apomorphine exposure.
    Aripiprazole: (Moderate) Monitor ECGs in patients receiving triclabendazole with aripiprazole. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. QT prolongation has occurred during therapeutic use of aripiprazole and following overdose.
    Arsenic Trioxide: (Major) Avoid coadministration of triclabendazole and arsenic trioxide due to the potential for additive QT prolongation; discontinue or select an alternative drug that does not prolong the QT interval prior to starting arsenic trioxide therapy. Monitor ECG frequently if coadministration is required. QT interval prolongation, torsade de pointes, and complete atrioventricular block have been reported with arsenic trioxide use. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Artemether; Lumefantrine: (Major) Avoid coadministration of triclabendazole and artemether; lumefantrine due to the potential for additive QT prolongation. Monitor ECG for QT prolongation if coadministration is required. Artemether; lumefantrine is associated with QT interval prolongation. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Asenapine: (Major) Avoid coadministration of triclabendazole and asenapine due to the potential for additive QT prolongation. Asenapine has been associated with QT prolongation. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Atomoxetine: (Moderate) Monitor ECGs in patients receiving triclabendazole with atomoxetine as concurrent use may increase the risk of QT prolongation. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. QT prolongation has occurred during therapeutic use of atomoxetine and following overdose.
    Azithromycin: (Major) Avoid coadministration of azithromycin with triclabendazole due to the increased risk of QT prolongation. If use together is necessary, obtain an ECG at baseline to assess initial QT interval and determine frequency of subsequent ECG monitoring, avoid any non-essential QT prolonging drugs, and correct electrolyte imbalances. QT prolongation and torsade de pointes (TdP) have been spontaneously reported during azithromycin postmarketing surveillance. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Bedaquiline: (Major) Monitor ECGs for QT prolongation when triclabendazole is administered with bedaquiline. Bedaquiline has been reported to prolong the QT interval. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Belladonna Alkaloids; Ergotamine; Phenobarbital: (Moderate) Monitor phenobarbital concentrations if triclabendazole is initiated or discontinued in a patient taking phenobarbital; phenobarbital dose adjustments may be needed. Coadministration of triclabendazole and phenobarbital may result in increased phenobarbital concentrations; however, this elevation may be transient due to the short treatment duration of triclabendazole. Triclabendazole is an inhibitor of CYP2C19 in vitro and phenobarbital is partially metabolized by CYP2C19.
    Belzutifan: (Moderate) Monitor for anemia and hypoxia if concomitant use of triclabendazole with belzutifan is necessary due to increased plasma exposure of belzutifan which may increase the incidence and severity of adverse reactions. Reduce the dose of belzutifan as recommended if anemia or hypoxia occur. Belzutifan is a CYP2C19 substrate and triclabendazole is a CYP2C19 inhibitor.
    Bismuth Subcitrate Potassium; Metronidazole; Tetracycline: (Moderate) Concomitant use of metronidazole and triclabendazole may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP.
    Bismuth Subsalicylate; Metronidazole; Tetracycline: (Moderate) Concomitant use of metronidazole and triclabendazole may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP.
    Buprenorphine: (Major) Monitor ECGs in patients receiving triclabendazole with buprenorphine. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Buprenorphine has been associated with QT prolongation and has a possible risk of torsade de pointes. FDA-approved labeling for some buprenorphine products recommend avoiding use with Class 1A and Class III antiarrhythmic medications while other labels recommend avoiding use with any drug that has the potential to prolong the QT interval.
    Buprenorphine; Naloxone: (Major) Monitor ECGs in patients receiving triclabendazole with buprenorphine. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Buprenorphine has been associated with QT prolongation and has a possible risk of torsade de pointes. FDA-approved labeling for some buprenorphine products recommend avoiding use with Class 1A and Class III antiarrhythmic medications while other labels recommend avoiding use with any drug that has the potential to prolong the QT interval.
    Cabotegravir; Rilpivirine: (Moderate) Monitor ECGs in patients receiving triclabendazole with rilpivirine as concurrent use may increase the risk of QT prolongation. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Supratherapeutic doses of rilpivirine (75 to 300 mg/day) have caused QT prolongation.
    Ceritinib: (Major) Avoid coadministration of ceritinib with triclabendazole if possible due to the risk of QT prolongation. If concomitant use is unavoidable, monitor ECGs and electrolytes; an interruption of ceritinib therapy, dose reduction, or discontinuation of therapy may be necessary if QT prolongation occurs. Ceritinib causes concentration-dependent QT prolongation. Transient prolongation of the mean QTc interval was also noted on the ECG recordings in dogs administered triclabendazole.
    Chloroquine: (Major) Avoid coadministration of chloroquine with triclabendazole due to the increased risk of QT prolongation. If use together is necessary, obtain an ECG at baseline to assess initial QT interval and determine frequency of subsequent ECG monitoring, avoid any non-essential QT prolonging drugs, and correct electrolyte imbalances. Chloroquine is associated with an increased risk of QT prolongation and torsade de pointes (TdP); the risk of QT prolongation is increased with higher chloroquine doses. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Chlorpromazine: (Major) Monitor ECGs in patients receiving triclabendazole with chlorpromazine. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Chlorpromazine, a phenothiazine, is associated with an established risk of QT prolongation and torsade de pointes.
    Ciprofloxacin: (Moderate) Monitor ECGs in patients receiving triclabendazole with ciprofloxacin. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Rare cases of QT prolongation and torsade de pointes have been reported with ciprofloxacin during postmarketing surveillance.
    Cisapride: (Contraindicated) Coadministration of cisapride with triclabendazole is contraindicated due to the risk of additive QT prolongation. QT prolongation and ventricular arrhythmias, including torsade de pointes and death, have been reported with cisapride. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Citalopram: (Major) Avoid coadministration of triclabendazole and citalopram due to the potential for additive QT prolongation. Monitor ECG for QT prolongation if coadministration is required. Citalopram causes dose-dependent QT interval prolongation. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Clarithromycin: (Major) Monitor ECGs in patients receiving triclabendazole with clarithromycin. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Clarithromycin is associated with an established risk for QT prolongation and torsade de pointes.
    Clofazimine: (Major) Monitor ECGs in patients receiving triclabendazole with clofazimine. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. QT prolongation and torsade de pointes have been reported in patients receiving clofazimine in combination with QT prolonging medications.
    Clozapine: (Moderate) Monitor ECGs in patients receiving triclabendazole with clozapine as concurrent use may increase the risk of QT prolongation. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Treatment with clozapine has been associated with QT prolongation, torsade de pointes, cardiac arrest, and sudden death.
    Codeine; Phenylephrine; Promethazine: (Moderate) Monitor ECGs in patients receiving triclabendazole with promethazine. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Promethazine, a phenothiazine, is associated with a possible risk for QT prolongation.
    Codeine; Promethazine: (Moderate) Monitor ECGs in patients receiving triclabendazole with promethazine. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Promethazine, a phenothiazine, is associated with a possible risk for QT prolongation.
    Crizotinib: (Major) Avoid coadministration of crizotinib with triclabendazole due to the risk of QT prolongation. If concomitant use is unavoidable, monitor ECGs for QT prolongation and monitor electrolytes. An interruption of therapy, dose reduction, or discontinuation of therapy may be necessary for crizotinib if QT prolongation occurs. Crizotinib can cause concentration-dependent QT prolongation. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Dasatinib: (Moderate) Monitor ECGs in patients receiving triclabendazole with dasatinib as concurrent use may increase the risk of QT prolongation. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. In vitro studies have shown that dasatinib has the potential to prolong the QT interval.
    Degarelix: (Moderate) Monitor ECGs in patients receiving triclabendazole with degarelix. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. QTc prolongation has been reported with the use of degarelix. Androgen deprivation therapy (i.e., degarelix) may prolong the QT/QTc interval.
    Desflurane: (Major) Monitor ECGs in patients receiving triclabendazole with halogenated anesthetics. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Halogenated anesthetics can prolong the QT interval.
    Deutetrabenazine: (Moderate) Monitor ECGs in patients receiving triclabendazole with deutetrabenazine. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Deutetrabenazine may prolong the QT interval, but the degree of QT prolongation is not clinically significant when deutetrabenazine is administered within the recommended dosage range.
    Dextromethorphan; Quinidine: (Major) Monitor ECGs in patients receiving triclabendazole with quinidine. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Quinidine administration is associated with QT prolongation and torsade de pointes.
    Disopyramide: (Major) Monitor ECGs in patients receiving triclabendazole with disopyramide. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Disopyramide administration is associated with QT prolongation and torsade de pointes.
    Dofetilide: (Major) Coadministration of dofetilide and triclabendazole is not recommended as concurrent use may increase the risk of QT prolongation. If coadministration cannot be avoided, monitor ECGs during treatment. Dofetilide, a Class III antiarrhythmic agent, is associated with a well-established risk of QT prolongation and torsade de pointes (TdP). Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Dolasetron: (Moderate) Monitor ECGs in patients receiving triclabendazole with dolasetron. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Dolasetron has been associated with a dose-dependent prolongation in the QT, PR, and QRS intervals on an electrocardiogram.
    Dolutegravir; Rilpivirine: (Moderate) Monitor ECGs in patients receiving triclabendazole with rilpivirine as concurrent use may increase the risk of QT prolongation. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Supratherapeutic doses of rilpivirine (75 to 300 mg/day) have caused QT prolongation.
    Donepezil: (Moderate) Monitor ECGs in patients receiving triclabendazole with donepezil. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Case reports indicate that QT prolongation and torsade de pointes can occur during donepezil therapy.
    Donepezil; Memantine: (Moderate) Monitor ECGs in patients receiving triclabendazole with donepezil. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Case reports indicate that QT prolongation and torsade de pointes can occur during donepezil therapy.
    Dronedarone: (Contraindicated) Coadministration of dronedarone with triclabendazole is contraindicated due to the risk of additive QT prolongation. Dronedarone administration is associated with a dose-related increase in the QTc interval. The increase in QTc is approximately 10 milliseconds at doses of 400 mg twice daily (the FDA-approved dose) and up to 25 milliseconds at doses of 1600 mg twice daily. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Droperidol: (Major) Droperidol should not be used in combination with any drug known to have potential to prolong the QT interval, such as triclabendazole. If concomitant use is unavoidable, use extreme caution; initiate droperidol at a low dose and increase the dose as needed to achieve the desired effect. Monitor ECGs for QT prolongation. Droperidol administration is associated with an established risk for QT prolongation and torsade de pointes. Some cases have occurred in patients with no known risk factors for QT prolongation and some cases have been fatal. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Efavirenz: (Moderate) Monitor ECGs in patients receiving triclabendazole with efavirenz as concurrent use may increase the risk of QT prolongation. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. QTc prolongation has been observed with the use of efavirenz.
    Efavirenz; Emtricitabine; Tenofovir: (Moderate) Monitor ECGs in patients receiving triclabendazole with efavirenz as concurrent use may increase the risk of QT prolongation. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. QTc prolongation has been observed with the use of efavirenz.
    Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate: (Moderate) Monitor ECGs in patients receiving triclabendazole with efavirenz as concurrent use may increase the risk of QT prolongation. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. QTc prolongation has been observed with the use of efavirenz.
    Eliglustat: (Major) Monitor ECGs in patients receiving triclabendazole with eliglustat. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Eliglustat is predicted to cause PR, QRS, and/or QT prolongation at significantly elevated plasma concentrations.
    Emtricitabine; Rilpivirine; Tenofovir alafenamide: (Moderate) Monitor ECGs in patients receiving triclabendazole with rilpivirine as concurrent use may increase the risk of QT prolongation. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Supratherapeutic doses of rilpivirine (75 to 300 mg/day) have caused QT prolongation.
    Emtricitabine; Rilpivirine; Tenofovir disoproxil fumarate: (Moderate) Monitor ECGs in patients receiving triclabendazole with rilpivirine as concurrent use may increase the risk of QT prolongation. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Supratherapeutic doses of rilpivirine (75 to 300 mg/day) have caused QT prolongation.
    Encorafenib: (Major) Avoid coadministration of encorafenib and triclabendazole due to QT prolongation. If concurrent use cannot be avoided, monitor ECGs for QT prolongation and monitor electrolytes; correct hypokalemia and hypomagnesemia prior to treatment. Encorafenib has been associated with dose-dependent QT prolongation. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Enflurane: (Major) Monitor ECGs in patients receiving triclabendazole with halogenated anesthetics. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Halogenated anesthetics can prolong the QT interval.
    Entrectinib: (Major) Avoid coadministration of entrectinib with triclabendazole due to the risk of QT prolongation. If coadministration is necessary, monitor ECGs during treatment. Entrectinib has been associated with QT prolongation. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Eribulin: (Major) Monitor ECGs in patients receiving triclabendazole with eribulin. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Eribulin has been associated with QT prolongation.
    Erythromycin: (Major) Monitor ECGs in patients receiving triclabendazole with erythromycin. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Erythromycin is associated with QT prolongation and torsade de pointes.
    Erythromycin; Sulfisoxazole: (Major) Monitor ECGs in patients receiving triclabendazole with erythromycin. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Erythromycin is associated with QT prolongation and torsade de pointes.
    Escitalopram: (Moderate) Monitor ECGs in patients receiving triclabendazole with escitalopram as concurrent use may increase the risk of QT prolongation. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Escitalopram has been associated with a risk of QT prolongation and torsade de pointes.
    Ezogabine: (Moderate) Monitor ECGs in patients receiving triclabendazole with ezogabine. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Ezogabine has been associated with QT prolongation.
    Fingolimod: (Moderate) Monitor ECGs in patients receiving triclabendazole with fingolimod as concurrent use may increase the risk of QT prolongation. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Fingolimod initiation results in decreased heart rate and may prolong the QT interval. Fingolimod has not been studied in patients treated with drugs that prolong the QT interval, but drugs that prolong the QT interval have been associated with cases of TdP in patients with bradycardia.
    Flecainide: (Major) Monitor ECGs in patients receiving triclabendazole with flecainide. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Flecainide is a Class IC antiarrhythmic associated with a possible risk for QT prolongation and/or torsade de pointes (TdP); flecainide increases the QT interval, but largely due to prolongation of the QRS interval. Although causality for TdP has not been established for flecainide, patients receiving concurrent drugs that have the potential for QT prolongation may have an increased risk of developing proarrhythmias.
    Fluconazole: (Moderate) Monitor ECGs in patients receiving triclabendazole with fluconazole as concurrent use may increase the risk of QT prolongation. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Fluconazole has been associated with QT prolongation and rare cases of torsade de pointes.
    Fluoxetine: (Moderate) Monitor ECGs in patients receiving triclabendazole with fluoxetine. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. QT prolongation and torsade de pointes have been reported in patients treated with fluoxetine.
    Fluphenazine: (Minor) Monitor ECGs in patients receiving triclabendazole with fluphenazine. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Fluphenazine is associated with a possible risk for QT prolongation.
    Fluvoxamine: (Minor) Monitor ECGs in patients receiving triclabendazole with fluvoxamine. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. QT prolongation and torsade de pointes have been reported during fluvoxamine postmarketing use.
    Foscarnet: (Major) Avoid coadministration of triclabendazole and foscarnet due to the potential for additive QT prolongation. Both QT prolongation and torsade de pointes have been reported during postmarketing use of foscarnet. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Fosphenytoin: (Moderate) Monitor phenytoin concentrations if triclabendazole is initiated or discontinued in a patient taking fosphenytoin; fosphenytoin dose adjustments may be needed. Coadministration of triclabendazole and fosphenytoin may result in increased phenytoin concentrations; however, this elevation may be transient due to the short treatment duration of triclabendazole. Triclabendazole is an inhibitor of CYP2C19 in vitro and phenytoin is partially metabolized by CYP2C19.
    Fostemsavir: (Moderate) Monitor ECGs in patients receiving triclabendazole with fostemsavir. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Supratherapeutic doses of fostemsavir (2,400 mg twice daily, four times the recommended daily dose) have been shown to cause QT prolongation. Fostemsavir causes dose-dependent QT prolongation.
    Gemifloxacin: (Moderate) Monitor ECGs in patients receiving triclabendazole with gemifloxacin as concurrent use may increase the risk of QT prolongation. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Gemifloxacin may prolong the QT interval in some patients. The maximal change in the QTc interval occurs approximately 5 to 10 hours following oral administration of gemifloxacin. The likelihood of QTc prolongation may increase with increasing dose of the drug; therefore, the recommended dose should not be exceeded especially in patients with renal or hepatic impairment where the Cmax and AUC are slightly higher.
    Gemtuzumab Ozogamicin: (Moderate) Monitor ECG and electrolytes if triclabendazole is coadministered with gemtuzumab due to the potential for additive QT prolongation. Although QT interval prolongation has not been reported with gemtuzumab, it has been reported with other drugs that contain calicheamicin. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Gilteritinib: (Moderate) Monitor ECGs in patients receiving triclabendazole with gilteritinib as concurrent use may increase the risk of QT prolongation. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Gilteritinib has also been associated with QT prolongation.
    Glasdegib: (Major) Avoid coadministration of glasdegib with triclabendazole due to the potential for additive QT prolongation. If coadministration cannot be avoided, monitor patients for increased risk of QT prolongation with increased frequency of ECG monitoring. Glasdegib therapy may result in QT prolongation and ventricular arrhythmias including ventricular fibrillation and ventricular tachycardia. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Goserelin: (Moderate) Monitor ECGs in patients receiving triclabendazole with goserelin. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
    Granisetron: (Moderate) Monitor ECGs in patients receiving triclabendazole with granisetron. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Granisetron has been associated with QT prolongation.
    Halogenated Anesthetics: (Major) Monitor ECGs in patients receiving triclabendazole with halogenated anesthetics. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Halogenated anesthetics can prolong the QT interval.
    Haloperidol: (Moderate) Monitor ECGs in patients receiving triclabendazole with haloperidol. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. QT prolongation and torsade de pointes have been observed during haloperidol treatment. Excessive doses (particularly in the overdose setting) or IV administration of haloperidol may be associated with a higher risk of QT prolongation.
    Halothane: (Major) Monitor ECGs in patients receiving triclabendazole with halogenated anesthetics. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Halogenated anesthetics can prolong the QT interval.
    Histrelin: (Moderate) Monitor ECGs in patients receiving triclabendazole with histrelin. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Androgen deprivation therapy (i.e., histrelin) may also prolong the QT/QTc interval.
    Hydroxychloroquine: (Major) Avoid coadministration of triclabendazole and hydroxychloroquine due to an increased risk of QT prolongation. If use together is necessary, obtain an ECG at baseline to assess initial QT interval and determine frequency of subsequent ECG monitoring, avoid any non-essential QT prolonging drugs, and correct electrolyte imbalances. Hydroxychloroquine prolongs the QT interval. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Hydroxyzine: (Moderate) Monitor ECGs in patients receiving triclabendazole with hydroxyzine. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Postmarketing data indicate that hydroxyzine causes QT prolongation and torsade de pointes.
    Ibutilide: (Major) Monitor ECGs in patients receiving triclabendazole with ibutilide. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Ibutilide administration can cause QT prolongation and torsade de pointes; proarrhythmic events should be anticipated. The potential for proarrhythmic events with ibutilide increases with the coadministration of other drugs that prolong the QT interval.
    Iloperidone: (Major) Avoid coadministration of triclabendazole and iloperidone due to the potential for additive QT prolongation. Iloperidone has been associated with QT prolongation. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Inotuzumab Ozogamicin: (Major) Avoid coadministration of inotuzumab with triclabendazole due to the potential for additive QT prolongation. If coadministration is unavoidable, obtain ECGs and prior to the start of treatment and periodically during treatment. Inotuzumab has been associated with QT interval prolongation. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Isoflurane: (Major) Monitor ECGs in patients receiving triclabendazole with halogenated anesthetics. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Halogenated anesthetics can prolong the QT interval.
    Itraconazole: (Moderate) Monitor ECGs in patients receiving triclabendazole with itraconazole as concurrent use may increase the risk of QT prolongation. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Itraconazole has been associated with prolongation of the QT interval.
    Ivosidenib: (Major) Avoid coadministration of ivosidenib with triclabendazole due to an increased risk of QT prolongation. If concomitant use is unavoidable, monitor ECGs for QTc prolongation and monitor electrolytes; correct any electrolyte abnormalities as clinically appropriate. An interruption of therapy and dose reduction of ivosidenib may be necessary if QT prolongation occurs. Prolongation of the QTc interval and ventricular arrhythmias have been reported in patients treated with ivosidenib. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Ketoconazole: (Moderate) Monitor ECGs in patients receiving triclabendazole with ketoconazole as concurrent use may increase the risk of QT prolongation. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Ketoconazole has been associated with prolongation of the QT interval.
    Lansoprazole; Amoxicillin; Clarithromycin: (Major) Monitor ECGs in patients receiving triclabendazole with clarithromycin. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Clarithromycin is associated with an established risk for QT prolongation and torsade de pointes.
    Lapatinib: (Moderate) Monitor ECGs in patients receiving triclabendazole with lapatinib. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Lapatinib has been associated with concentration-dependent QT prolongation; ventricular arrhythmias and torsade de pointes (TdP) have been reported in postmarketing experience with lapatinib.
    Lefamulin: (Major) Avoid coadministration of lefamulin with triclabendazole as concurrent use may increase the risk of QT prolongation. If coadministration cannot be avoided, monitor ECG during treatment. Lefamulin has a concentration dependent QTc prolongation effect. The pharmacodynamic interaction potential to prolong the QT interval of the electrocardiogram between lefamulin and other drugs that effect cardiac conduction is unknown. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Lenvatinib: (Major) Avoid coadministration of lenvatinib with triclabendazole due to the risk of QT prolongation. Prolongation of the QT interval has been reported with lenvatinib therapy. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Leuprolide: (Moderate) Monitor ECGs in patients receiving triclabendazole with leuprolide. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Androgen deprivation therapy (i.e., leuprolide) may also prolong the QT/QTc interval.
    Leuprolide; Norethindrone: (Moderate) Monitor ECGs in patients receiving triclabendazole with leuprolide. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Androgen deprivation therapy (i.e., leuprolide) may also prolong the QT/QTc interval.
    Levofloxacin: (Moderate) Monitor ECGs in patients receiving triclabendazole with levofloxacin. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Levofloxacin has been associated with a risk of QT prolongation and torsade de pointes (TdP). Although extremely rare, TdP has been reported during postmarketing surveillance of levofloxacin.
    Levoketoconazole: (Moderate) Monitor ECGs in patients receiving triclabendazole with ketoconazole as concurrent use may increase the risk of QT prolongation. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Ketoconazole has been associated with prolongation of the QT interval.
    Lithium: (Moderate) Monitor ECGs in patients receiving triclabendazole with lithium. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Lithium has been associated with QT prolongation.
    Lofexidine: (Moderate) Monitor ECGs in patients receiving triclabendazole with lofexidine. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Lofexidine prolongs the QT interval.
    Loperamide: (Moderate) Monitor ECGs in patients receiving triclabendazole with loperamide. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. At high doses, loperamide has been associated with serious cardiac toxicities, including syncope, ventricular tachycardia, QT prolongation, torsade de pointes, and cardiac arrest.
    Loperamide; Simethicone: (Moderate) Monitor ECGs in patients receiving triclabendazole with loperamide. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. At high doses, loperamide has been associated with serious cardiac toxicities, including syncope, ventricular tachycardia, QT prolongation, torsade de pointes, and cardiac arrest.
    Lopinavir; Ritonavir: (Major) Avoid coadministration of lopinavir with triclabendazole due to the potential for additive QT prolongation. If use together is necessary, obtain a baseline ECG to assess initial QT interval and determine frequency of subsequent ECG monitoring, avoid any non-essential QT prolonging drugs, and correct electrolyte imbalances. Lopinavir is associated with QT prolongation. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Macimorelin: (Major) Avoid concurrent administration of macimorelin with drugs that prolong the QT interval, such as triclabendazole. Use of these drugs together may increase the risk of developing torsade de pointes-type ventricular tachycardia. Sufficient washout time of drugs that are known to prolong the QT interval prior to administration of macimorelin is recommended. Treatment with macimorelin has been associated with an increase in the corrected QT (QTc) interval. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Maprotiline: (Major) Monitor ECGs in patients receiving triclabendazole with maprotiline. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Maprotiline has been reported to prolong the QT interval, particularly in overdose or with higher-dose prescription therapy (elevated serum concentrations). Cases of long QT syndrome and torsade de pointes tachycardia have been described with maprotiline use, but rarely occur when the drug is used alone in normal prescribed doses and in the absence of other known risk factors for QT prolongation. Limited data are available regarding the safety of maprotiline in combination with other QT-prolonging drugs.
    Mefloquine: (Moderate) Monitor ECGs in patients receiving triclabendazole with mefloquine as concurrent use may increase the risk of QT prolongation. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. There is evidence that the use of halofantrine after mefloquine causes a significant lengthening of the QTc interval. Mefloquine alone has not been reported to cause QT prolongation. However, due to the lack of clinical data, mefloquine should be used with caution in patients receiving drugs that prolong the QT interval.
    Meperidine; Promethazine: (Moderate) Monitor ECGs in patients receiving triclabendazole with promethazine. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Promethazine, a phenothiazine, is associated with a possible risk for QT prolongation.
    Methadone: (Major) Monitor ECGs in patients receiving triclabendazole with methadone. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Methadone is considered to be associated with an increased risk for QT prolongation and torsade de pointes, especially at higher doses (more than 200 mg/day but averaging approximately 400 mg/day in adult patients). Most cases involve patients being treated for pain with large, multiple daily doses of methadone, although cases have been reported in patients receiving doses commonly used for maintenance treatment of opioid addiction.
    Metronidazole: (Moderate) Concomitant use of metronidazole and triclabendazole may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP.
    Midostaurin: (Major) Monitor ECGs in patients receiving triclabendazole with midostaurin. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. QT prolongation was reported in patients who received midostaurin in clinical trials.
    Mifepristone: (Moderate) Monitor ECG and use the lowest effective dose of mifepristone if triclabendazole is coadministered due to the potential for additive QT prolongation. Mifepristone has been associated with dose-dependent prolongation of the QT interval. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Mirtazapine: (Moderate) Monitor ECGs in patients receiving triclabendazole with mirtazapine. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Mirtazapine has been associated with dose-dependent prolongation of the QT interval. Torsade de pointes has been reported postmarketing, primarily in overdose or in patients with other risk factors for QT prolongation.
    Mobocertinib: (Major) Concomitant use of mobocertinib and triclabendazole increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
    Moxifloxacin: (Major) Monitor ECGs in patients receiving triclabendazole with moxifloxacin. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Quinolones have been associated with a risk of QT prolongation and torsade de pointes (TdP). Although extremely rare, TdP has been reported during postmarketing surveillance of moxifloxacin. These reports generally involved patients with concurrent medical conditions or concomitant medications that may have been contributory.
    Nilotinib: (Major) Avoid the concomitant use of nilotinib and triclabendazole; significant prolongation of the QT interval may occur. Sudden death and QT prolongation have been reported in patients who received nilotinib therapy. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Octreotide: (Moderate) Monitor ECGs in patients receiving triclabendazole with octreotide. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Arrhythmias, sinus bradycardia, and conduction disturbances have occurred during octreotide therapy. Since bradycardia is a risk factor for development of torsade de pointes (TdP), the potential occurrence of bradycardia during octreotide administration could theoretically increase the risk of TdP in patients receiving drugs that prolong the QT interval.
    Ofloxacin: (Moderate) Monitor ECGs in patients receiving triclabendazole with ofloxacin as concurrent use may increase the risk of QT prolongation. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Quinolones have been associated with a risk of QT prolongation and torsade de pointes (TdP). Although extremely rare, TdP has been reported during postmarketing surveillance of ofloxacin. These reports generally involved patients with concurrent medical conditions or concomitant medications that may have been contributory.
    Olanzapine: (Moderate) Monitor ECGs in patients receiving triclabendazole with olanzapine. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Limited data, including some case reports, suggest that olanzapine may be associated with a significant prolongation of the QTc interval.
    Olanzapine; Fluoxetine: (Moderate) Monitor ECGs in patients receiving triclabendazole with fluoxetine. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. QT prolongation and torsade de pointes have been reported in patients treated with fluoxetine. (Moderate) Monitor ECGs in patients receiving triclabendazole with olanzapine. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Limited data, including some case reports, suggest that olanzapine may be associated with a significant prolongation of the QTc interval.
    Olanzapine; Samidorphan: (Moderate) Monitor ECGs in patients receiving triclabendazole with olanzapine. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Limited data, including some case reports, suggest that olanzapine may be associated with a significant prolongation of the QTc interval.
    Ondansetron: (Major) Monitor ECGs in patients receiving triclabendazole with ondansetron. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Ondansetron has been associated with a dose-related increase in the QT interval and postmarketing reports of torsade de pointes.
    Osilodrostat: (Moderate) Monitor ECGs in patients receiving triclabendazole with osilodrostat. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Osilodrostat is associated with dose-dependent QT prolongation.
    Osimertinib: (Major) Avoid coadministration of triclabendazole with osimertinib due to the risk of QT prolongation. If concomitant use is unavoidable, periodically monitor ECGs for QT prolongation and monitor electrolytes; an interruption of osimertinib therapy with dose reduction or discontinuation may be necessary if QT prolongation occurs. Concentration-dependent QTc prolongation occurred during clinical trials of osimertinib. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Oxaliplatin: (Major) Monitor ECG and electrolytes if triclabendazole is coadministered with oxaliplatin due to the potential for additive QT prolongation. Correct electrolyte abnormalities prior to administration of oxaliplatin. QT prolongation and ventricular arrhythmias including fatal torsade de pointes have been reported with oxaliplatin use in postmarketing experience. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Ozanimod: (Major) In general, do not initiate ozanimod in patients taking triclabendazole due to the risk of additive bradycardia, QT prolongation, and torsade de pointes (TdP). If concomitant use is necessary, monitor ECGs. Ozanimod initiation may result in a transient decrease in heart rate and atrioventricular conduction delays. Ozanimod has not been studied in patients taking concurrent QT prolonging drugs; however, QT prolonging drugs have been associated with TdP in patients with bradycardia. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Pacritinib: (Major) Concomitant use of pacritinib and triclabendazole increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
    Paliperidone: (Major) Avoid coadministration of triclabendazole and paliperidone due to the potential for additive QT prolongation. Monitor ECG if coadministration is necessary. Paliperidone has been associated with QT prolongation; torsade de pointes and ventricular fibrillation have been reported in the setting of overdose. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Panobinostat: (Major) Coadministration of triclabendazole and panobinostat is not recommended due to the potential for additive QT prolongation. Panobinostat can cause QT prolongation. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Pasireotide: (Moderate) Monitor ECGs in patients receiving triclabendazole with pasireotide as concurrent use may increase the risk of QT prolongation. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. QT prolongation has occurred with pasireotide at therapeutic and supra-therapeutic doses.
    Pazopanib: (Major) Coadministration of triclabendazole and pazopanib is not recommended due to the risk of additive QT prolongation. Monitor the ECG for QT prolongation if coadministration is required. Pazopanib is associated with QT interval prolongation. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Pentamidine: (Major) Monitor ECGs in patients receiving triclabendazole with pentamidine. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Systemic pentamidine has been associated with QT prolongation.
    Perphenazine: (Minor) Monitor ECGs in patients receiving triclabendazole with perphenazine. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Perphenazine is associated with a possible risk for QT prolongation.
    Perphenazine; Amitriptyline: (Minor) Monitor ECGs in patients receiving triclabendazole with perphenazine. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Perphenazine is associated with a possible risk for QT prolongation.
    Phenobarbital: (Moderate) Monitor phenobarbital concentrations if triclabendazole is initiated or discontinued in a patient taking phenobarbital; phenobarbital dose adjustments may be needed. Coadministration of triclabendazole and phenobarbital may result in increased phenobarbital concentrations; however, this elevation may be transient due to the short treatment duration of triclabendazole. Triclabendazole is an inhibitor of CYP2C19 in vitro and phenobarbital is partially metabolized by CYP2C19.
    Phenobarbital; Hyoscyamine; Atropine; Scopolamine: (Moderate) Monitor phenobarbital concentrations if triclabendazole is initiated or discontinued in a patient taking phenobarbital; phenobarbital dose adjustments may be needed. Coadministration of triclabendazole and phenobarbital may result in increased phenobarbital concentrations; however, this elevation may be transient due to the short treatment duration of triclabendazole. Triclabendazole is an inhibitor of CYP2C19 in vitro and phenobarbital is partially metabolized by CYP2C19.
    Phenytoin: (Moderate) Monitor phenytoin concentrations if triclabendazole is initiated or discontinued in a patient taking phenytoin; phenytoin dose adjustments may be needed. Coadministration of triclabendazole and phenytoin may result in increased phenytoin concentrations; however, this elevation may be transient due to the short treatment duration of triclabendazole. Triclabendazole is an inhibitor of CYP2C19 in vitro and phenytoin is partially metabolized by CYP2C19.
    Pimavanserin: (Major) Avoid coadministration of triclabendazole and pimavanserin due to the potential for additive QT prolongation. Pimavanserin may cause QT prolongation. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Pimozide: (Contraindicated) Coadministration of pimozide with triclabendazole is contraindicated due to the risk of additive QT prolongation. Pimozide is associated with a well-established risk of QT prolongation and torsade de pointes. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Pitolisant: (Major) Avoid coadministration of pitolisant with triclabendazole as concurrent use may increase the risk of QT prolongation. If concomitant use is necessary, monitor ECGs. Pitolisant prolongs the QT interval. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Ponesimod: (Major) In general, do not initiate ponesimod in patients taking triclabendazole due to the risk of additive bradycardia, QT prolongation, and torsade de pointes (TdP). If treatment initiation is considered, seek advice from a cardiologist. Ponesimod initiation may result in a transient decrease in heart rate and atrioventricular conduction delays. Ponesimod has not been studied in patients taking concurrent QT prolonging drugs; however, QT prolonging drugs have been associated with TdP in patients with bradycardia. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Posaconazole: (Moderate) Monitor ECGs in patients receiving triclabendazole with posaconazole as concurrent use may increase the risk of QT prolongation. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Posaconazole has been associated with prolongation of the QT interval as well as rare cases of torsade de pointes.
    Primaquine: (Moderate) Monitor ECGs in patients receiving triclabendazole with primaquine as concurrent use may increase the risk of QT prolongation. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Primaquine has the potential to prolong the QT interval.
    Primidone: (Moderate) Monitor primidone and phenobarbital concentrations if triclabendazole is initiated or discontinued in a patient taking primidone; primidone dose adjustments may be needed. Coadministration of triclabendazole and primidone may result in increased primidone and phenobarbital concentrations; however, this elevation may be transient due to the short treatment duration of triclabendazole. Triclabendazole is an inhibitor of CYP2C19 in vitro and phenobarbital is partially metabolized by CYP2C19.
    Procainamide: (Major) Monitor ECGs in patients receiving triclabendazole with procainamide. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Procainamide is associated with a well-established risk of QT prolongation and torsade de pointes.
    Prochlorperazine: (Minor) Monitor ECGs in patients receiving triclabendazole with prochlorperazine. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Prochlorperazine is associated with a possible risk for QT prolongation.
    Promethazine: (Moderate) Monitor ECGs in patients receiving triclabendazole with promethazine. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Promethazine, a phenothiazine, is associated with a possible risk for QT prolongation.
    Promethazine; Dextromethorphan: (Moderate) Monitor ECGs in patients receiving triclabendazole with promethazine. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Promethazine, a phenothiazine, is associated with a possible risk for QT prolongation.
    Promethazine; Phenylephrine: (Moderate) Monitor ECGs in patients receiving triclabendazole with promethazine. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Promethazine, a phenothiazine, is associated with a possible risk for QT prolongation.
    Propafenone: (Major) Monitor ECGs in patients receiving triclabendazole with propafenone. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Propafenone is a Class IC antiarrhythmic which increases the QT interval, but largely due to prolongation of the QRS interval.
    Quetiapine: (Major) Avoid coadministration of triclabendazole and quetiapine due to the potential for additive QT prolongation. Limited data, including some case reports, suggest that quetiapine may be associated with a significant prolongation of the QTc interval in rare instances. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Quinidine: (Major) Monitor ECGs in patients receiving triclabendazole with quinidine. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Quinidine administration is associated with QT prolongation and torsade de pointes.
    Quinine: (Major) Avoid coadministration of triclabendazole and quinine due to the potential for additive QT prolongation. Quinine has been associated with QT prolongation and rare cases of torsade de pointes. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Ranolazine: (Moderate) Monitor ECGs in patients receiving triclabendazole with ranolazine as concurrent use may increase the risk of QT prolongation. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Ranolazine is associated with dose- and plasma concentration-related increases in the QTc interval. Although there are no studies examining the effects of ranolazine in patients receiving other QT prolonging drugs, coadministration of such drugs may result in additive QT prolongation.
    Relugolix: (Moderate) Monitor ECGs in patients receiving triclabendazole with relugolix. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Androgen deprivation therapy (i.e., relugolix) may also prolong the QT/QTc interval.
    Relugolix; Estradiol; Norethindrone acetate: (Moderate) Monitor ECGs in patients receiving triclabendazole with relugolix. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Androgen deprivation therapy (i.e., relugolix) may also prolong the QT/QTc interval.
    Ribociclib: (Major) Avoid coadministration of triclabendazole and ribociclib due to the potential for additive QT prolongation. Ribociclib has also been shown to prolong the QT interval in a concentration-dependent manner. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Ribociclib; Letrozole: (Major) Avoid coadministration of triclabendazole and ribociclib due to the potential for additive QT prolongation. Ribociclib has also been shown to prolong the QT interval in a concentration-dependent manner. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Rilpivirine: (Moderate) Monitor ECGs in patients receiving triclabendazole with rilpivirine as concurrent use may increase the risk of QT prolongation. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Supratherapeutic doses of rilpivirine (75 to 300 mg/day) have caused QT prolongation.
    Risperidone: (Moderate) Monitor ECGs in patients receiving triclabendazole with risperidone. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Risperidone has been associated with a possible risk for QT prolongation and/or TdP, primarily in the overdose setting.
    Romidepsin: (Moderate) Monitor ECG and electrolytes if triclabendazole is coadministered with romidepsin due to the potential for additive QT prolongation as concurrent use may increase the risk of QT prolongation. Romidepsin has been reported to prolong the QT interval. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Saquinavir: (Major) Avoid coadministration of triclabendazole and saquinavir boosted with ritonavir due to the potential for additive QT prolongation. Monitor ECG at baseline and during therapy if coadministration cannot be avoided. Saquinavir boosted with ritonavir increases the QT interval in a dose-dependent fashion, which may increase the risk for serious arrhythmias such as torsade de pointes. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Selpercatinib: (Major) Monitor ECGs more frequently for QT prolongation if coadministration of selpercatinib with triclabendazole is necessary due to the risk of additive QT prolongation. Concentration-dependent QT prolongation has been observed with selpercatinib therapy. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Sertraline: (Moderate) Monitor ECGs in patients receiving triclabendazole with sertraline. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Sertraline's FDA-approved labeling recommends avoiding concomitant use with drugs known to prolong the QTc interval; however, the risk of sertraline-induced QT prolongation is generally considered to be low in clinical practice. Its effect on QTc interval is minimal (typically less than 5 msec), and the drug has been used safely in patients with cardiac disease (e.g., recent myocardial infarction, unstable angina, chronic heart failure).
    Sevoflurane: (Major) Monitor ECGs in patients receiving triclabendazole with halogenated anesthetics. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Halogenated anesthetics can prolong the QT interval.
    Siponimod: (Major) In general, do not initiate treatment with siponimod in patients receiving triclabendazole due to the potential for QT prolongation. Consult a cardiologist regarding appropriate monitoring if siponimod use is required. Siponimod therapy prolonged the QT interval at recommended doses in a clinical study. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Solifenacin: (Moderate) Monitor ECGs in patients receiving triclabendazole with solifenacin. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Solifenacin has been associated with dose-dependent prolongation of the QT interval. Torsade de pointes has been reported with postmarketing use, although causality was not determined.
    Sorafenib: (Major) Avoid coadministration of sorafenib with triclabendazole due to the risk of additive QT prolongation. If concomitant use is unavoidable, monitor electrocardiograms and correct electrolyte abnormalities. An interruption or discontinuation of sorafenib therapy may be necessary if QT prolongation occurs. Sorafenib is associated with QTc prolongation. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Sotalol: (Major) Monitor ECGs in patients receiving triclabendazole with sotalol. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Sotalol administration is associated with QT prolongation and torsade de pointes. Proarrhythmic events should be anticipated after initiation of therapy and after each upward dosage adjustment.
    Sunitinib: (Moderate) Monitor ECGs in patients receiving triclabendazole with sunitinib. Sunitinib can prolong the QT interval. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Tacrolimus: (Moderate) Monitor ECGs and serum electrolytes in patients receiving triclabendazole with tacrolimus. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Tacrolimus may also prolong the QT interval and cause torsade de pointes.
    Tamoxifen: (Moderate) Monitor ECGs in patients receiving triclabendazole with tamoxifen. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Tamoxifen has been reported to prolong the QT interval, usually in overdose or when used in high doses. Rare case reports of QT prolongation have also been described when tamoxifen is used at lower doses.
    Telavancin: (Moderate) Monitor ECGs in patients receiving triclabendazole with telavancin as concurrent use may increase the risk of QT prolongation. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Telavancin has been associated with QT prolongation.
    Telithromycin: (Moderate) Monitor ECGs in patients receiving triclabendazole with telithromycin. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Telithromycin is associated with QT prolongation and torsade de pointes.
    Tetrabenazine: (Major) Avoid coadministration of triclabendazole with tetrabenazine due to the potential for additive QT prolongation. Tetrabenazine causes a small increase in the corrected QT interval (QTc). Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Thioridazine: (Contraindicated) Coadministration of thioridazine with triclabendazole is contraindicated due to the risk of additive QT prolongation. Thioridazine is associated with a well-established risk of QT prolongation and torsade de pointes. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Tolterodine: (Moderate) Monitor ECGs in patients receiving triclabendazole with tolterodine. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Tolterodine has been associated with dose-dependent prolongation of the QT interval, especially in poor CYP2D6 metabolizers.
    Toremifene: (Major) Avoid coadministration of triclabendazole with toremifene due to the risk of additive QT prolongation. If concomitant use is unavoidable, closely monitor ECGs for QT prolongation and monitor electrolytes. Toremifene has been shown to prolong the QTc interval in a dose- and concentration-related manner. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Trazodone: (Major) Avoid coadministration of triclabendazole with trazodone due to the potential for additive QT prolongation. Trazodone can prolong the QT/QTc interval at therapeutic doses. In addition, there are postmarketing reports of torsade de pointes. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Trifluoperazine: (Minor) Monitor ECGs in patients receiving triclabendazole with trifluoperazine. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Trifluoperazine is associated with a possible risk for QT prolongation.
    Triptorelin: (Moderate) Monitor ECGs in patients receiving triclabendazole with triptorelin. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Androgen deprivation therapy (i.e., triptorelin) may also prolong the QT/QTc interval.
    Vandetanib: (Major) Avoid coadministration of vandetanib with triclabendazole due to an increased risk of QT prolongation. If concomitant use is unavoidable, monitor ECGs for QT prolongation and monitor electrolytes; correct hypocalcemia, hypomagnesemia, and/or hypomagnesemia prior to vandetanib administration. An interruption of vandetanib therapy or dose reduction may be necessary for QT prolongation. Vandetanib can prolong the QT interval in a concentration-dependent manner; torsade de pointes and sudden death have been reported in patients receiving vandetanib. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Vardenafil: (Moderate) Monitor ECGs in patients receiving triclabendazole with vardenafil as concurrent use may increase the risk of QT prolongation. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Vardenafil is associated with QT prolongation. Both therapeutic and supratherapeutic doses of vardenafil produce an increase in QTc interval.
    Vemurafenib: (Major) Monitor ECGs in patients receiving triclabendazole with vemurafenib. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Vemurafenib has been associated with QT prolongation and torsade de pointes.
    Venlafaxine: (Moderate) Monitor ECGs in patients receiving triclabendazole with venlafaxine. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Venlafaxine administration is associated with a possible risk of QT prolongation; torsade de pointes has been reported with postmarketing use.
    Voclosporin: (Moderate) Concomitant use of voclosporin and triclabendazole may increase the risk of QT prolongation. Consider interventions to minimize the risk of progression to torsades de pointes (TdP), such as ECG monitoring and correcting electrolyte abnormalities, particularly in patients with additional risk factors for TdP. Voclosporin has been associated with QT prolongation at supratherapeutic doses. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.
    Voriconazole: (Moderate) Monitor ECGs in patients receiving triclabendazole with voriconazole as concurrent use may increase the risk of QT prolongation. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Voriconazole has been associated with QT prolongation and rare cases of torsade de pointes.
    Vorinostat: (Moderate) Monitor ECGs in patients receiving triclabendazole with vorinostat. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole. Vorinostat therapy is associated with a risk of QT prolongation.
    Warfarin: (Moderate) Monitor PT/INR if triclabendazole is initiated or discontinued in a patient taking warfarin; warfarin dose adjustments may be needed. Coadministration of triclabendazole and warfarin may result in increased warfarin concentrations; however, this elevation may be transient due to the short treatment duration of triclabendazole. Triclabendazole is an inhibitor of CYP2C19 in vitro and warfarin is partially metabolized by CYP2C19.
    Ziprasidone: (Major) Avoid coadministration of triclabendazole with ziprasidone due to the potential for additive QT prolongation. Clinical trial data indicate that ziprasidone causes QT prolongation; there are postmarketing reports of torsade de pointes in patients with multiple confounding factors. Transient prolongation of the mean QTc interval was noted on the ECG recordings in dogs administered triclabendazole.

    PREGNANCY AND LACTATION

    Pregnancy

    Caution is warranted with the use of triclabendazole during pregnancy. There are no available data on triclabendazole use in pregnant women to inform a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal studies have not shown a risk of increased fetal abnormalities with exposure to triclabendazole during organogenesis at doses of 0.3 to 1.6 times the maximum recommended human dose (MRHD) of 20 mg/kg/day.[63962]

    Caution is warranted with the use of triclabendazole during breast-feeding. There are no data on the presence of triclabendazole in human breastmilk, the effects on the breastfed infant, or the effects on milk production. Limited animal studies indicate that triclabendazole is present in animal milk.[63962] Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested or administered drug, health care providers are encouraged to report the adverse effect to the FDA.

    MECHANISM OF ACTION

    Triclabendazole is an anthelmintic against Fasciola species. Triclabendazole and its metabolites are active against the immature and mature worms of Fasciola hepatica and Fasciola gigantica. The mechanism by which it exhibits its effect is not fully elucidated. In vitro and animal studies suggest that triclabendazole and its active metabolites (sulfoxide and sulfone) are absorbed by the tegument of the immature and mature worms, leading to a decrease of the resting membrane potential and inhibition of tubulin function as well as protein and enzyme synthesis. These metabolic disturbances are associated with inhibition of motility and disruption of the surface and ultrastructure that includes inhibition of spermatogenesis and vitelline cells.[63962]
     
    The mechanism of resistance for triclabendazole may be multifactorial and include changes in the drug uptake/efflux mechanisms, the target molecules, and altered metabolism. The clinical significance of resistance in humans is not established.[63962]

    PHARMACOKINETICS

    Triclabendazole is administered orally. Protein binding of triclabendazole, the sulfoxide metabolite, and the sulfone metabolite in human plasma is 96.7%, 98.4%, and 98.8%, respectively. The apparent volume of distribution of the sulfoxide metabolite in fed patients is approximately 1 L/kg. Triclabendazole is metabolized to an active sulfoxide metabolite which is further metabolized to an active sulfone metabolite. No excretion data are available in humans; however, in animals, triclabendazole and its metabolites are largely excreted via the biliary tract in the feces (90%). Less than 10% of the oral dose is excreted in the urine. The plasma half-life of triclabendazole, the sulfoxide metabolite, and the sulfone metabolite in humans is approximately 8, 14, and 11 hours, respectively.[63962]
     
    Affected cytochrome P450 isoenzymes and drug transporters: CYP1A2, CYP2C9, CYP2C19
    Based on in vitro studies, triclabendazole is primarily metabolized by CYP1A2 (approximately 64%) into its active sulfoxide metabolite and to a lesser extent by CYP2C9, CYP2C19, CYP2D6, CYP3A, and FMO. The sulfoxide metabolite is further metabolized primarily by CYP2C9 to the active sulfone metabolite and to a lesser extent by CYP1A1, CYP1A2, CYP1B1, CYP2C19, CYP2D6, and CYP3A4, in vitro. Triclabendazole and its metabolites have the potential to inhibit CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A at clinically relevant plasma concentrations, with the highest potential of inhibition on CYP2C19.[63962]

    Oral Route

    After oral administration of a single dose of triclabendazole at 10 mg/kg with a 560-kcal meal, the median Tmax for the parent compound and the sulfoxide metabolite was 3 to 4 hours. The mean Cmax for triclabendazole, the sulfoxide metabolite, and the sulfone metabolite was 1.16, 38.6, and 2.29 micromoles/L, respectively. The AUC for triclabendazole, the sulfoxide metabolite, and the sulfone metabolite was 5.72, 386, and 30.5 micromoles x hour/L, respectively. The Cmax and AUC of triclabendazole and the sulfoxide metabolite increased approximately 3-fold and 2-fold, respectively, when triclabendazole was administered with a meal containing a total of 560 kcal. In addition, the sulfoxide metabolite Tmax increased from 2 hours in the fasted state to 4 hours in the fed state.[63962]