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. 2018 Jul 13;11(1):409.
doi: 10.1186/s13071-018-2969-3.

Safety of lotilaner flavoured chewable tablets (CredelioTM) after oral administration in cats

Emmanuelle A Kuntz  1 , Srinivas Kammanadiminti  2
Affiliations

Safety of lotilaner flavoured chewable tablets (CredelioTM) after oral administration in cats

Emmanuelle A Kuntz et al. Parasit Vectors. .

Abstract

Background: Lotilaner is a new member of the isoxazoline class for treatment of flea and tick infestations in cats. This laboratory study with lotilaner vanilla-yeast flavoured chewable tablets (CredelioTM, Elanco) investigated the safety in healthy kittens starting at 8 weeks of age in a randomized, blinded, parallel-group design. Lotilaner tablets were given orally once a month over eight months at one, three and five times the upper level of the maximum recommended dose range (26 mg/kg).

Methods: The safety of lotilaner flavoured chewable tablets was assessed in healthy kittens when administered orally every 4 weeks for 8 months at the highest recommended dose rates, i.e. 1× (26 mg/kg) and at elevated dose rates, i.e. 3× (78 mg/kg) and 5× (130 mg/kg). Sixteen male and 16 female healthy 8-week-old kittens, with a mean body weight of 0.79 kg and 0.75 kg, respectively, were randomized to an untreated control group or lotilaner groups at dose rates of 26 mg/kg (1×), 78 mg/kg (3×), or 130 mg/kg (5×) every four weeks over eight months. The control group was sham-dosed. All animals were fed within 30 minutes prior to treatment. Safety assessment included general health observations, detailed clinical observations, complete physical/neurological examinations, including ophthalmological examinations, electrocardiographic (ECG) and clinical pathology evaluations (haematology, clinical chemistry and urinalysis), food and water consumption, body weight, pharmacokinetic blood collections, organ macroscopic and microscopic examinations.

Results: Systemic exposure to lotilaner was confirmed during the course of the study in all treated animals with the exception of the control group. No treatment-related effects were seen on daily clinical observations, food consumption (wet), ophthalmoscopic, physical/neurological and microscopic examinations. Statistically significant differences were recorded in some of the clinical pathology parameters, body weights, food consumption (dry), electrocardiograms, and organ weights, but none of the recorded observations was considered to be of clinical relevance.

Conclusions: Lotilaner, when administered once monthly over eight months at the highest recommended dose and overdoses of three- and five-fold, to 8-week-old healthy kittens, is well tolerated.

Keywords: Cat; Credelio™; Lotilaner; Oral; Safety.

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Conflict of interest statement

Ethics approval and consent to participate

The study was based on the guidelines for evaluating the target animal safety of new pharmaceuticals (VICH Guideline 43), and to recognized quality assurance standards (United States Food and Drug Administration (FDA) Good Laboratory Practice (GLP) Regulations, 21 Code of Federal Regulations (CFR) Part 58 and the Organization for Economic Cooperation and Development (OECD) Series on Principles of Good Laboratory Practice and Compliance Monitoring, Number 13) [–21]. The study protocol was reviewed and approved by the study site Ethics Committee (MPI Research, Institutional Animal Care & Use Committee, No 382-218, 02 January 2015) and the sponsor company’s Institutional Animal Care and Use Committee. This manuscript was prepared in compliance with the ARRIVE Guidelines Checklist for animal in vivo experiments [22].

Consent for publication

Not applicable.

Competing interests

EAK and SK are employees of Elanco Animal Health.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Mean lotilaner whole blood concentration-time profiles following eight consecutive monthly oral administrations of 26 (1×), 78 (3×), and 130 (5×) mg/kg
See this image and copyright information in PMC

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