studiedtriclabendazole doses ranged from 5 mg/kg to 20 mg/kg administered on Days 1-3. Cure was defined as absenceof Fasciola eggs in the stool based on the Kato-Katz method at Day 60 in patients who were positive atbaseline. Across these studies, there was a finding of a dose response. Specifically, the Day 60 cure rate washighest (95.5%; 95% CI [77%, 100%]) for the 20 mg/kg dose, which was given in 2 divided doses, followed bycure rates of 88% (95% CI [64%, 99%]), 80% (95% CI [73%, 86%]), and 50% (95% CI [27%, 73%]) in the 15mg/kg, 10 mg/kg, and 5 mg/kg dose groups, respectively. The 5 mg/kg, 10 mg/kg, and 15 mg/kg dosingregimens are not approved [see Dosage and Administration (2)]. These rates were significantly higher than thatestimated from patients receiving an inadequate, non-triclabendazole treatment in a separate study (22%; 95%CI [9.8, 38.2]).
16 HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
EGATEN (triclabendazole) tablets are supplied as pale red, speckled, capsule shaped, biconvex tablets, withimprint “EG EG” on one side and functionally scored on both sides. Each tablet contains 250 mg oftriclabendazole. 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).
17 PATIENT COUNSELING INFORMATION
Important Administration Instructions
Advise patients that EGATEN should be taken orally with food. The tablets can be swallowed whole or dividedin half and taken with water, or crushed and administered with applesauce. The crushed tablet mixed withapplesauce is stable for up to 4 hours [see Dosage and Administration (2)].
QT Prolongation
Advise patients with a history of prolongation of the QTc interval or a history of symptoms compatible with along QT interval or when EGATEN is used in patients who receive drugs that prolong the QT interval that theirECGs will need to be monitored [see Warnings and Precautions (5.1)].
https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/egaten.pdf
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