Brand Name

Egaten

Generic Name
Triclabendazole
View Brand Information
FDA approval date: February 13, 2019
Classification: Anthelmintic
Form: Tablet

What is Egaten (Triclabendazole)?

In many parts of the world, eating raw or undercooked freshwater plants or fish is part of local tradition. However, for some people, these habits can lead to serious parasitic infections that affect the liver and bile ducts, causing long-lasting pain and illness. Egaten (triclabendazole) offers an effective and life-changing treatment for such infections, helping patients regain their health and quality of life. 

Egaten is an anthelmintic medication, a type of drug that kills or expels parasitic worms from the body. It belongs to the benzimidazole class of antiparasitic drugs and is primarily used to treat fascioliasis, an infection caused by Fasciola hepatica and Fasciola gigantica (commonly known as liver flukes). Egaten is manufactured by Novartis and is approved by the U.S. Food and Drug Administration (FDA) for human use. It is also listed by the World Health Organization (WHO) as an essential medicine for treating liver fluke disease, especially in regions where the infection is common. 

What does Egaten do? 

Egaten is used to treat fascioliasis, a parasitic infection that primarily affects the liver and bile ducts. People become infected when they eat contaminated water plants such as watercress or drink untreated water containing the parasite’s larval form. Once inside the body, the parasites migrate to the liver, where they cause inflammation, tissue damage, and symptoms such as abdominal pain, fever, nausea, and fatigue. 

By eliminating the parasites, Egaten helps relieve these symptoms, prevent complications like bile duct obstruction or liver fibrosis, and restore normal liver function. 

In clinical studies, triclabendazole has shown cure rates exceeding 90% for fascioliasis after a single treatment course (WHO, 2024). This high success rate makes it the first-line and only FDA-approved therapy specifically for this condition. Patients who respond well typically experience significant symptom relief within a few days to weeks after treatment, as the body clears the dead parasites and begins to heal. 

How does Egaten work? 

Egaten’s active ingredient, triclabendazole, works by directly targeting and killing the liver flukes that cause infection. 

In simple terms, triclabendazole disrupts the parasite’s energy metabolism and outer surface structure. The drug binds to the fluke’s tubulin, a protein vital for maintaining cell shape and nutrient absorption. This interference causes the worm’s cells to break down, leading to its death. Additionally, triclabendazole inhibits the parasite’s ability to produce energy, essentially starving it until it dies. 

This mechanism is unique because triclabendazole is effective against both immature and adult flukes, unlike many antiparasitic drugs that target only one life stage. Clinically, this broad action is crucial, it ensures the infection is completely cleared, preventing recurrence and complications. 

By helping the liver and bile ducts return to normal function, Egaten not only treats the infection but also supports long-term recovery and improved well-being. 

Egaten side effects 

Most people tolerate Egaten well, but as with any medication, some side effects may occur. These effects are often mild and temporary, resolving as the body processes the medication and eliminates the dead parasites. 

Common side effects may include: 

  • Mild abdominal pain or cramps 
     
  • Headache 
     
  • Nausea or vomiting 
     
  • Fatigue 
     
  • Fever or chills 

These symptoms are sometimes related to the body’s immune response to dying parasites rather than the drug itself. 

Less common but potentially serious side effects include: 

  • Allergic reactions such as rash, itching, or swelling 
     
  • Shortness of breath or chest tightness 
     
  • Signs of liver irritation (yellowing of the skin or eyes, dark urine) 

Patients should contact their doctor immediately if they experience severe abdominal pain, jaundice, or allergic symptoms. Avoid Egaten if allergic to triclabendazole or other benzimidazole drugs. Use with caution if you have severe liver disease.  

Pregnant or breastfeeding women should consult a doctor, though studies indicate Egaten is generally safe under medical guidance. (Mayo Clinic, 2024). 

Egaten dosage 

Egaten, an oral tablet, is taken with food, usually under healthcare supervision, as a short course (one or two doses). Liver function is monitored with blood tests before and after treatment, as the liver processes the drug. Patients must take Egaten exactly as prescribed. 

One treatment course is usually enough, but persistent symptoms may need follow-up testing and another dose to clear parasites. Older adults and those with liver conditions may need closer monitoring for side effects. 

Does Egaten have a generic version? 

Yes. Triclabendazole, the active ingredient in Egaten, is available as a generic medication in several countries. The FDA approved the generic version of Egaten in 2022, ensuring that it meets the same quality, safety, and effectiveness standards as the brand-name product. 

Generic triclabendazole is widely used in areas with common liver fluke infections, like parts of Asia, Africa, and South America, through national health programs and non-profit initiatives. Approved generic versions of Egaten are equally effective and more affordable, improving treatment access in low-resource settings. 

Conclusion 

Egaten (triclabendazole) represents a major advancement in the treatment of liver fluke infections, offering a safe, effective, and reliable cure for fascioliasis. By eliminating the parasites responsible for liver and bile duct damage, it helps patients recover their energy, appetite, and overall health. 

Mild, temporary side effects may occur, but regular medical follow-up ensures safe and successful treatment. As the only FDA-approved medication for fascioliasis, Egaten is crucial for global public health, especially in rural and agricultural areas where parasitic infections are prevalent. When properly administered, Egaten allows patients to recover and live infection-free. 

References 

  1. World Health Organization (WHO). (2024). Fascioliasis and triclabendazole use in human treatment. Retrieved from https://www.who.int 
     
  1. U.S. Food and Drug Administration (FDA). (2024). Egaten (triclabendazole) prescribing information. Retrieved from https://www.accessdata.fda.gov 
     
  1. MedlinePlus. (2024). Triclabendazole: Drug information and use. National Library of Medicine. Retrieved from https://medlineplus.gov 
     
  1. Mayo Clinic. (2024). Triclabendazole (oral route) – precautions and side effects. Retrieved from https://www.mayoclinic.org 

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Related Clinical Trials

A Phase IV, Multi-center, Open-label Study to Determine the Safety, Tolerability and Clinical Outcomes Following Oral Administration of EGATEN™ (Triclabendazole) in Patients (6 Years of Age or Older) With Fascioliasis.

Summary: This is a multicenter, open label, non-comparative, single arm multi-country study in approximately 300 adult and pediatric subjects (≥ 6 years of age) with fascioliasis. The study population consists of male and female adult and pediatric patients (≥ 6 years of age). The study will enroll approximately 300 subjects with acute (minimum 15% of overall study population) or chronic fascioliasis. Enro...

Brand Information

EGATEN (triclabendazole)
1INDICATIONS AND USAGE
EGATEN
2DOSAGE AND ADMINISTRATION
The recommended dose of EGATEN 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. EGATEN 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.
3DOSAGE FORMS AND STRENGTHS
EGATEN (triclabendazole) tablet: 250 mg pale red, speckled, capsule shaped, biconvex with “EG ⅁Ǝ” debossed on one side and functionally scored on both sides.
4CONTRAINDICATIONS
EGATEN is contraindicated in patients with known hypersensitivity to triclabendazole and/or to other benzimidazole derivatives or to any of the excipients in EGATEN.
5OVERDOSAGE
The reported symptom of overdosage following ingestion of approximately 54 mg/kg of EGATEN (approximately 2.7 times the recommended dose) was nausea. The patient recovered following osmotic diuresis. In the event of overdose, monitor ECG and institute symptomatic treatment.
6DESCRIPTION
EGATEN (triclabendazole) tablet is an orally administered anthelmintic for immediate release. Triclabendazole is designated chemically as benzimidazole derivative, 6-chloro-5-(2, 3-dichlorophenoxy)-2-(methylthio)-1H-benzimidazole (triclabendazole). The molecular formula for triclabendazole is C
The chemical structure of triclabendazole is a white or almost white, crystalline powder.
Triclabendazole is a white or almost white, crystalline powder.
EGATEN tablets are pale red, speckled, capsule shaped, biconvex tablets, with “EG ⅁Ǝ” debossed on one side and functionally scored on both sides. Each tablet contains 250 mg of triclabendazole.
Inactive Ingredients: colloidal silicon dioxide, iron oxide red, lactose monohydrate, maize starch, magnesium stearate, methylhydroxyethylcellulose.
7CLINICAL STUDIES
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% (difference 16%; 95% CI [1.7, 30.8], p = 0.035) 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 non-randomized, 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
8HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
EGATEN (triclabendazole) tablets are supplied as pale red, speckled, capsule shaped, biconvex tablets with “EG ⅁Ǝ” debossed on one side and functionally scored on both sides. Each tablet contains 250 mg of triclabendazole. EGATEN (triclabendazole) tablets are available as:
Blister packs of 4 tablets (NDC 0078-0937-91).
Storage
Store in the original container. Store below 30°C (86°F).
9PATIENT COUNSELING INFORMATION
Important Administration Instructions
Advise patients that EGATEN should be taken 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
QT Prolongation
Advise patients with a history of prolongation of the QTc interval or a history of symptoms compatible with a long QT interval or with electrolyte imbalance like hypokalemia or when EGATEN is used in patients who receive drugs that are known to prolong the QTc interval or on CYP1A2 inhibitors or have hepatic impairment that their ECGs will need to be monitored
Distributed by:
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936
For more information on EGATEN, call 1-888-669-6682.
© Novartis
T2022-10
10PRINCIPAL DISPLAY PANEL
Egaten
(triclabendazole)
250 mg per tablet
NDC 0078-0937-91
Rx only
4 scored tablets
Novartis
PRINCIPAL DISPLAY PANEL
									Egaten®
									(triclabendazole)
									Tablets
									250 mg per tablet
									NDC 0078-0937-91
									Rx only
									4 scored tablets
									Novartis