Pregnancy

Risk Summary: 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. Reproductive studies in animals (rat and rabbits) have not shown a risk of increased fetal abnormalities with exposure to triclabendazole during organogenesis at doses approximately 0.3 to 1.6 times the maximum recommended human dose (MRHD) of 20 mg/kg based on body surface area comparison.(1)

The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.(1)

Animal Data: Embryo-fetal developmental toxicity studies revealed no malformations in rats and rabbits at doses up to 200 mg/kg/day and 20 mg/kg/day, respectively (approximately 1.6 times and 0.3 times the MRHD based on body surface area comparison, respectively). The animals were treated orally during organogenesis, starting on day 6 of the pregnancy until day 15 in rats and day 18 in rabbits. Maternal toxicity was noted at doses greater than or equal to 100 mg/kg per day in rats and 10 mg/kg per day in rabbits, which was associated with lower fetus weights and delayed ossification. These findings were considered indicative of delayed physiological growth that was secondary to maternal toxicity. No increase in malformation or other abnormalities was observed at any dose level in either species.(1)

Lactation

There are no data on the presence of triclabendazole in human milk, the effects on the breastfed infant, or the effects on milk production. Published animal data indicate that triclabendazole is detected in goat milk when administered as a single dose to one lactating animal. When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for triclabendazole and any potential adverse effects on the breastfed infant from triclabendazole or from the underlying maternal condition.(1)

Pediatric Use

Safety and effectiveness of triclabendazole has been established in pediatric patients aged 6 years and older.(1)

Safety and effectiveness of triclabendazole in pediatric patients below the age of 6 years have not been established.(1)

Geriatric Use

Clinical studies of triclabendazole did not include sufficient numbers of patients aged 65 and over to determine whether the elderly respond differently from younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.(1)

Renal Impairment

Triclabendazole has not been studied in patients with renal impairment.(1)

Hepatic Impairment

Triclabendazole has not been studied in patients with hepatic impairment.(1)