Egaten (triclabendazole)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved February 2019

Specific Treatments:

fascioliasis (liver fluke infestation)

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General Information

Egaten (triclabendazole) is an anthelmintic against Fasciola species.

Egaten is specifically indicated for the treatment of fascioliasis in patients 6 years of age and older.

Egaten is supplied as a tablet for oral administration. The recommended dose is 2 doses of 10 mg/kg given 12 hours apart in patients 6 years of age and older. The 250 mg tablets are functionally scored and divisible into two equal halves of 125 mg. If the dosage cannot be adjusted exactly, round the dose upwards. Take Egaten orally with food. The tablets can be swallowed whole or divided in half and taken with water or crushed and administered with applesauce. The crushed tablet mixed with applesauce is stable for up to 4 hours.

Clinical Results

FDA Approval

The FDA approval of Egaten was based on the following:

An open label, randomized trial, conducted in Vietnam compared the efficacy of triclabendazole (two 10 mg/kg doses given 12 hours apart with food) to oral artesunate (4 mg/kg, given once daily for 10 days). One hundred patients (age range: 9-74 years) with acute symptomatic fascioliasis were randomized, 50 in each treatment group. At 3 months after treatment, 92% and 76% of patients in the triclabendazole and artesunate arms respectively, reported no clinical symptoms.

The clinical development program of triclabendazole for the treatment of fascioliasis included 6 nonrandomized, open label studies performed in Cuba, Bolivia, Peru, Chile, and Iran in a total of 245 adult and pediatric patients with stool-confirmed fascioliasis. All studies were similar in design. The studied triclabendazole doses ranged from 5 mg/kg to 20 mg/kg administered on days 1-3. Cure was defined as absence of Fasciola eggs in the stool based on the Kato-Katz method at Day 60 in patients who were positive at baseline. Across these studies, there was a finding of a dose response. Specifically, the Day 60 cure rate was highest for the 20 mg/kg dose, which was given in 2 divided doses, followed by cure rates of 88%, 80% and 50% in the 15 mg/kg, 10 mg/kg, and 5 mg/kg dose groups, respectively. The 5 mg/kg, 10 mg/kg, and 15 mg/kg dosing regimens are not approved.

Side Effects

Adverse effects associated with the use of Egaten may include, but are not limited to, the following:

abdominal pain

hyperhidrosis

nausea

decreased appetite

headache

urticaria

diarrhea

vomiting

musculoskeletal chest pain

pruritus

Mechanism of Action

Egaten (triclabendazole) is an anthelmintic against Fasciola species. It is designated chemically as benzimidazole derivative. 

Additional Information

For additional information regarding Egaten or fascioliasis, please visit https://www.novartis.com/