EGATEN

Clinical safety rating: caution

Comprehensive clinical and safety monograph for EGATEN (EGATEN).

How it works

Triclabendazole inhibits tubulin polymerization by binding to the colchicine binding site on beta-tubulin, leading to disruption of microtubule formation and paralysis/death of susceptible parasites, particularly Fasciola species.

What the body does with it

Metabolism	Primarily hepatic via CYP450 enzymes (CYP1A2, CYP2C9, CYP2E1, CYP3A4); major metabolite is triclabendazole sulfoxide (active) and sulfone (inactive).
Excretion	Primarily fecal (90% as metabolites); renal excretion of unchanged drug is negligible (<1%).
Half-life	Terminal elimination half-life: 4-6 hours in healthy adults; prolonged to 8-12 hours in severe hepatic impairment. Clinical context: supports once-daily dosing.
Protein binding	~95% bound to serum albumin.
Volume of Distribution	10.5 L/kg, indicating extensive tissue distribution (e.g., liver, spleen, bile).
Bioavailability	Oral: approximately 40% due to first-pass metabolism to active metabolite.
Onset of Action	Oral: 2-4 hours for schistosomicidal effect, due to time required for active metabolite formation and parasite uptake.
Duration of Action	Single oral dose provides clinical cure for schistosomiasis with >90% efficacy; duration of action corresponds to drug exposure over 12-24 hours. Repeat dosing at 2-4 weeks is standard.

Classification & Brands

Dosing & administration

10 mg/kg orally as a single dose, with food; for fascioliasis, 10 mg/kg orally three times daily for 3 days.

Dosage form	TABLET
Renal impairment	No dose adjustment required for mild-to-moderate renal impairment (CrCl ≥30 mL/min). For severe renal impairment (CrCl <30 mL/min), use with caution; no specific guidelines available.
Liver impairment	No dose adjustment required for mild-to-moderate hepatic impairment (Child-Pugh class A and B). For severe hepatic impairment (Child-Pugh class C), use with caution; no specific guidelines available.
Pediatric use	Children aged ≥6 years: 10 mg/kg orally as a single dose (for fascioliasis, 10 mg/kg orally three times daily for 3 days). Safety and efficacy in children <6 years not established.
Geriatric use	No specific dose adjustments recommended; use with caution due to potential age-related renal and hepatic function decline. Monitor for adverse effects.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for EGATEN (EGATEN).

Breastfeeding	No human data; M/P ratio unknown. Excretion in breast milk unknown. Caution advised.
Teratogenic Risk	Trimester 1: Limited human data; animal studies show no teratogenicity at therapeutic doses. Trimester 2-3: No known fetal risk; use if benefit outweighs risk.
Fetal Monitoring	Monitor hepatic function and CBC during therapy. Fetal ultrasound if used in pregnancy.

Warnings & precautions

■ FDA Black Box Warning

None.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Known hypersensitivity to triclabendazole or any excipient","Severe hepatic impairment (Child-Pugh class C)"]

Clinical Precautions

Precautions

["Do not use in patients with known hypersensitivity to triclabendazole or any component of the formulation.","Avoid use in patients with severe liver disease (e.g., decompensated cirrhosis) due to risk of drug accumulation.","Cautious use in patients with biliary obstruction, as drug may not reach the site of action.","Monitor for hepatotoxicity; liver function tests recommended before and during treatment.","Pregnancy category B: no adequate studies in pregnant women; use only if clearly needed.","Breastfeeding: unknown if excreted in human milk; caution advised."]

Food/Dietary

Take with a meal containing fat (e.g., whole milk, eggs, avocado) to increase bioavailability. Avoid grapefruit juice as it may affect drug metabolism. No other specific dietary restrictions.

Clinical Tips & Counseling

Drug interactions

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EGATEN

Clinical safety rating: caution

Comprehensive clinical and safety monograph for EGATEN (EGATEN).

How it works

What the body does with it

Metabolism	Primarily hepatic via CYP450 enzymes (CYP1A2, CYP2C9, CYP2E1, CYP3A4); major metabolite is triclabendazole sulfoxide (active) and sulfone (inactive).
Excretion	Primarily fecal (90% as metabolites); renal excretion of unchanged drug is negligible (<1%).
Half-life	Terminal elimination half-life: 4-6 hours in healthy adults; prolonged to 8-12 hours in severe hepatic impairment. Clinical context: supports once-daily dosing.
Protein binding	~95% bound to serum albumin.
Volume of Distribution	10.5 L/kg, indicating extensive tissue distribution (e.g., liver, spleen, bile).
Bioavailability	Oral: approximately 40% due to first-pass metabolism to active metabolite.
Onset of Action	Oral: 2-4 hours for schistosomicidal effect, due to time required for active metabolite formation and parasite uptake.
Duration of Action	Single oral dose provides clinical cure for schistosomiasis with >90% efficacy; duration of action corresponds to drug exposure over 12-24 hours. Repeat dosing at 2-4 weeks is standard.

Classification & Brands

Dosing & administration

10 mg/kg orally as a single dose, with food; for fascioliasis, 10 mg/kg orally three times daily for 3 days.

Dosage form	TABLET
Renal impairment	No dose adjustment required for mild-to-moderate renal impairment (CrCl ≥30 mL/min). For severe renal impairment (CrCl <30 mL/min), use with caution; no specific guidelines available.
Liver impairment	No dose adjustment required for mild-to-moderate hepatic impairment (Child-Pugh class A and B). For severe hepatic impairment (Child-Pugh class C), use with caution; no specific guidelines available.
Pediatric use	Children aged ≥6 years: 10 mg/kg orally as a single dose (for fascioliasis, 10 mg/kg orally three times daily for 3 days). Safety and efficacy in children <6 years not established.
Geriatric use	No specific dose adjustments recommended; use with caution due to potential age-related renal and hepatic function decline. Monitor for adverse effects.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for EGATEN (EGATEN).

Breastfeeding	No human data; M/P ratio unknown. Excretion in breast milk unknown. Caution advised.
Teratogenic Risk	Trimester 1: Limited human data; animal studies show no teratogenicity at therapeutic doses. Trimester 2-3: No known fetal risk; use if benefit outweighs risk.
Fetal Monitoring	Monitor hepatic function and CBC during therapy. Fetal ultrasound if used in pregnancy.

Warnings & precautions

■ FDA Black Box Warning

None.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Known hypersensitivity to triclabendazole or any excipient","Severe hepatic impairment (Child-Pugh class C)"]

Clinical Precautions

Precautions

Food/Dietary

Take with a meal containing fat (e.g., whole milk, eggs, avocado) to increase bioavailability. Avoid grapefruit juice as it may affect drug metabolism. No other specific dietary restrictions.

Clinical Tips & Counseling

Drug interactions

Loading safety data…

Clinical Pearls	EGATEN (triclabendazole) is a benzimidazole anthelmintic indicated for fascioliasis. It is not effective against nematodes or cestodes. Administer with food to enhance absorption. Monitor for biliary obstruction due to dead flukes. Use with caution in patients with hepatic impairment. Pregnancy category C.
Patient Advice	Take tablets with food to improve absorption. · Complete the full 2-day course even if symptoms improve. · May cause abdominal pain, nausea, or diarrhea; report severe symptoms. · Avoid alcohol during treatment and for 48 hours after last dose. · Inform your doctor if you are pregnant or breastfeeding. · Do not crush or chew tablets; swallow whole.