Safety of fluralaner chewable tablets (BravectoTM), a novel systemic antiparasitic drug, in dogs after oral administration

Abstract

BackgroundFluralaner is a novel systemic insecticide and acaricide that provides long acting efficacy in dogs after a single oral treatment. This study investigated the safety of oral administration of fluralaner in chewable tablets to dogs at the highest recommended treatment dose and at multiples of this dose.MethodsThirty-two (16 male and 16 female) healthy 8-week old Beagle dogs weighing 2.0 - 3.6 kg at first administration were included in the study. Fluralaner was administered on three occasions at 8-week intervals at doses of up to 56, 168, and 280 mg fluralaner/kg body weight, equivalent to 1, 3, and 5 times the highest recommended treatment dose of fluralaner; sham dosed dogs served as controls.During the study, all dogs were clinically observed, and their health was carefully monitored including body weight development, food consumption and measurement of hematology, coagulation, clinical chemistry (including measurement of levels of ACTH and C-reactive protein) and urinalysis. Following euthanasia of the dogs, complete gross post mortem examination, including organ weight determination, and histopathological examination of multiple tissues were conducted.ResultsThere were no clinical findings related to fluralaner treatment. Statistically significant differences between the treated groups and the control group were observed for some clinical pathology parameters and organ weights; none of these findings were considered to be of clinical relevance.ConclusionsOral administration of fluralaner at the highest recommended treatment dose (56 mg/kg) at 8-week intervals is well tolerated and has a safety margin of more than five in healthy dogs eight weeks of age or older and weighing at least 2 kg.

Safety of the concurrent treatment of dogs with Bravecto™ (fluralaner) and Scalibor™ protectorband (deltamethrin)

“…These observations are not unexpected in dogs wearing collars and are consistent with the product leaflet [2]; none of the collars needed to be removed. Such findings have not been reported in studies where only Bravecto™ was administered [1,6]. No other clinical findings related to the use of either product alone, or to the concurrent use of Bravecto™ and Scalibor™ Protectorband were observed.…”

Uso do fluralaner no tratamento da demodicidose canina juvenil generalizada: relato de caso

“…Esse fármaco tem ação inseticida, a qual combate pulgas e carrapatos, além de ação acaricida descoberta recentemente (Fourie et al, 2015). É uma substância que apresenta uma adequada segurança, pois não demonstra potencial de intoxicação mesmo quando administrada em quantidade cinco vezes acima da dose máxima terapêutica recomendada para cães (Walther et al, 2014a). Essas características encorajaram a utilização do fluralaner como uma opção prática e resguardada para o tratamento da DG nos indivíduos explicitados.…”

Fluralaner, a novel isoxazoline, prevents flea (Ctenocephalides felis) reproduction in vitro and in a simulated home environment

“…Fluralaner has high selectivity for arthropods and a very favorable safety profile in vertebrates including dogs [3]. Oral fluralaner administration (Bravecto™) provides 12 weeks efficacy against tick and flea infestations on dogs [4,5].…”