Slentrol Oral Solution for Dogs

Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication.

Introduction

Company name: Pfizer Limited
Address: Ramsgate Road
Sandwich
Kent CT13 9NJ
Telephone: 0845 300 8034 (Out of hours: 01304 616161)
Fax: 01737 332521
Email: UKVetLine@pfizer.com
Website: www.pfizerah.co.uk

Presentation

Slentrol contains 5 mg/ml dirlotapide and is a colourless to pale yellow oral solution.

Uses

As an aid in the management of overweight and obesity in adult dogs. To be used as part of an overall weight management programme which also includes appropriate dietary changes and exercise practice.

Dosage and administration

Dogs should undergo a physical examination by a veterinary surgeon before starting treatment and a desired body weight or body condition score identified. To ensure correct dosing during the treatment period, the owner should seek advice from the responsible veterinary surgeon in connection to each monthly dosing adjustment.
Withdraw product from the bottle using the supplied dosing device and administer the product once daily directly into the mouth or on a small amount of food. Slentrol can be administered with or without food.
The recommended starting dose of Slentrol is 0.05 mg/kg initial body weight per day (0.01 ml/kg/day) by oral administration.
After two weeks of therapy, the initial dose volume should be doubled. Following these initial 4 weeks of therapy, dogs should be weighed monthly during treatment with the product and dose adjustments are made monthly according to effect as described below.
At the end of each month of therapy, the percentage of body weight loss should be determined. If the body weight loss since previous monthly weighing has been >3% body weight per month (equivalent to 0.1% body weight per day); the dose (number of ml administered) should be kept the same. If the bodyweight loss since previous monthly weighing has been <3% body weight per month, the dose should be increased without adjusting for the dog’s current body weight. The first time a conditional increase is required, the dose should be increased by 100% (doubled). In subsequent required conditional increases, the dose should be increased by 50% (increasing the dose volume to 1.5 times the volume administered in the previous month) up to a maximum dose of the product of 0.2 ml/kg current body weight. These adjustments should be continued until the weight targeted at the start of therapy is achieved.
Although not observed in clinical trials, in the case where body weight loss since previous monthly weighing has been >12% per month (equivalent to 0.4% body weight per day), the dose should be reduced by 25%.
According to clinical studies, a mean weight loss of about 18 to 20% after six months of weight loss therapy can be anticipated.
The duration of treatment with the product must not exceed 12 months and the dose of the product must not exceed a maximum of 0.2 ml/kg current body weight (1 mg/kg dirlotapide).

Contra-indications, warnings, etc

Do not use in dogs in the growth phase. Do not use in pregnant or lactating dogs. Do not use in animals with impaired liver function. Do not use in case of hypersensitivity to the active substance or excipient. Do not use in animals in which overweight or obesity is caused by a concomitant systemic disease such as hypothyroidism or hyperadrenocorticism. Do not use in cats due to the risk of development of hepatic lipidosis.
In clinical studies, vomiting, sometimes accompanied by signs of lethargy, anorexia or diarrhoea was observed during treatment with the product. These signs typically started during the first month of treatment (about 30% of dogs showed at least one vomiting event and up to 12% showed any of the other signs) and decreased continuously during the course of treatment. Some dogs (less than 10%) experienced repeated vomiting (i.e. more than once every 20 days on average).
If vomiting, diarrhoea or significantly reduced appetite or excessive weight loss occurs, treatment should be interrupted and the advice of a veterinary surgeon should be sought. Resolution of adverse reactions will occur shortly after the suspension of treatment. Dosing may be recommenced at the same or at a reduced dose volume (reduced by 25%) but if vomiting reoccurs, the product may need to be withdrawn.
Sporadic and mild ALT elevations up to 4 times the upper reference range and not associated with histopathological liver lesions or noticeable changes in other liver parameters may be observed in some dogs during the course of treatment.
User warnings:
In case of contact with the skin, wash off any product immediately with soap and water. Slentrol may cause eye-irritation. Avoid contact with eyes. If accidental eye exposure occurs, flush the eyes immediately with clean water.
When product is drawn into syringe, administer immediately.
Where the product has been administered on food, discard unconsumed food immediately to avoid unintentional ingestion by other animals or persons in the household. Slentrol ingestion can be harmful to children and pregnant women.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Pharmaceutical precautions

No special precautions for storage. Slentrol is light sensitive so the product should be stored in the original container. Shelf-life after first opening the container: 3 months.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Keep out of the reach and sight of children.
For animal treatment only.

Legal category

POM-V

Packaging Quantities

Slentrol oral solution for dogs is supplied in bottles with child-resistant closures containing 20, 50 or 150 ml. Each bottle comes with two dosing devices of 1, 3 or 10 ml respectively.

Further information

In the absence of compatibility studies, Slentrol should not be physically mixed with other veterinary medicinal products. Interactions with other drug types have not been specifically investigated. Therefore, for dogs receiving treatments in addition to Slentrol, drug interactions should be monitored closely.
Oral dosing devices may be cleaned with water but must be dried before re-use. The product is not miscible with water.
Overdose up to 10 times the maximum dose of 1 mg/kg current body weight may produce vomiting, diarrhoea or increased ALT/AST levels. These signs will resolve spontaneously following discontinuation of product administration.
Fertility studies have not been conducted in the target species. Use in dogs intended for breeding should be subject to a risk-benefit analysis by the attending veterinary surgeon. MTP inhibitors (microsomal triglyceride transfer protein inhibitors) as a class have the potential to disrupt yolk sac development and laboratory studies on rats and rabbits have shown evidence of embryolethality, teratogenicity, and developmental toxicity.
In clinical trials, treated animals rapidly regained weight following cessation of treatment when diet was not restricted. In order to avoid this rebound weight gain, it is necessary to feed the animals to maintenance energy requirements. Thus, during treatment or at the end of treatment at the latest, an appropriate feeding and exercise regimen should be implemented in order to ensure long term maintenance of the body weight.
During treatment, because food intake is reduced as when using a traditional non-medical calorie restriction method, care must be taken to ensure that protein, vitamins, essential fatty acids and minerals supplied by the daily food ration meet minimal recommended requirements in order to ensure a complete and balanced nutritional supply.
The liver function of dogs suspected of suffering from a liver disease or dysfunction should be evaluated, before commencing treatment with the product.
Any clinical suspicion of liver disease or dysfunction during treatment should be investigated through the evaluation of liver function. Any indication of progressive liver damage or of dysfunction should result in the discontinuation of the treatment. Sporadic and mild serum ALT elevations up to 4 times the upper reference range are not a reason for discontinuing therapy in the absence of any indication of liver dysfunction.
Dirlotapide is a potent selective inhibitor of the microsomal triglyceride transfer protein (MTP). The microsomal triglyceride transfer protein (MTP) is pivotal for the absorption and distribution of fat. The inhibition of intestinal and hepatic MTP reduces plasma cholesterol and triglyceride concentration. The selective inhibition of intestinal MTP also reduces intestinal fat absorption.
Clinical and pharmacodynamic data strongly suggest that the efficacy of dirlotapide results from a primary local action in the gut after oral administration. This is consistent with in vivo data generated in mice which shows that dirlotapide has selectivity for intestinal MTP. The effect is mainly mediated indirectly due to reduced feed intake during therapy.
As a consequence of reducing intestinal fat absorption, dirlotapide reduces food intake in dogs in a dose dependent manner. This food inhibitory effect of dirlotapide results from a primary local effect on the gastrointestinal tract following oral administration, and is not a result of systemic exposure.
The efficacy of dirlotapide has been demonstrated with various types of diets, representing the whole range of fat contents available in commercial diets.
In a radiolabeled metabolism study, the primary route for excretion was via the faeces with minimal excretion via urine (<1%). Additionally, dirlotapide is highly protein bound (>99%) in dog plasma.

Marketing authorisation number

EU/2/07/071/1-3.