Target species
Dogs.
Indications for use, specifying the target species
For the treatment of pain associated with mild to moderate osteoarthritis in dogs.
Contraindications
Do not use in case of hypersensitivity to the active substance or any of the excipients. Do not use in pregnant, lactating or breeding animals, see section below.
Special warnings for each target species
The majority of clinical cases assessed in the clinical field studies suffered from mild to moderate osteoarthritis based on the veterinary assessment. To achieve a substantiated response to treatment, use the veterinary medicinal product only in mild and moderate cases of osteoarthritis.
From the two clinical field studies, the overall success rates based on CBPI (Canine Brief Pain Inventory, as completed by the owner) at 28 days after the start of the treatment, were 51.3% (120/235) for Galliprant and 35.5% (82/231) for the placebo group. This difference in favour of Galliprant was statistically significant (p-value= 0.0008).
A clinical response to treatment is usually seen within 7 days. If no clinical improvement is apparent after 14 days, treatment with Galliprant should be iscontinued and different treatment options should be explored in consultation with the veterinarian.
Special precautions for use
Special precautions for use in animals
Grapiprant is a methylbenzenesulfonamide. It is not known whether dogs with a history of hypersensitivity to sulphonamides will exhibit hypersensitivity to grapiprant. If signs of sulphonamide hypersensitivity occur, treatment should be discontinued.
Use with caution in dogs suffering from pre-existing liver, cardiovascular or renal dysfunctions or from gastrointestinal disease.
The concurrent use of grapiprant with other anti-inflammatory agents has not been studied and should be avoided.
The safety of the veterinary medicinal product has not been established in dogs under 9 months of age and in dogs weighing less than 3.6 kg.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Wash hands after handling of the veterinary medicinal product.
In case of accidental ingestion by children, mild and reversible gastrointestinal signs and nausea may be observed. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Special precautions for the protection of the environment
Not applicable
Adverse reactions (frequency and seriousness)
Target species: Dogs
| |
Very common (>1 animal / 10 animals treated): | Vomiting |
Common (1 to 10 animals / 100 animals treated): | Loose stool, Diarrhoea Inappetance |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Haematemesis, Haemorrhagic diarrhoea Pancreatitis Elevated blood urea nitrogen (BUN), Elevated creatinine, Elevated liver enzymes, Hypoalbuminaemia1, Hypoproteinaemia1 |
1These signs were not associated with any clinically significant observations or events.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See section 'Contact details' of the package insert.
Use during pregnancy, lactation or lay
Do not use in pregnant, lactating or breeding animals as the safety of grapiprant has not been established during pregnancy and lactation or in dogs used for breeding.
Interaction with other medicinal products and other forms of interaction
Prior treatment with other anti-inflammatory substances may result in additional or increased severity of adverse effects and accordingly a treatment-free period with such veterinary medicinal products should be observed before the commencement of treatment with this veterinary medicinal product. The treatment-free period should take into account the pharmacokinetic properties of the products used previously.
The concomitant use of protein-bound veterinary medicinal products with grapiprant has not been studied. Commonly used protein-bound veterinary medicinal products include cardiac, anticonvulsant and behavioural medications.
Veterinary medicinal product compatability should be monitored in animals requiring adjunctive therapy.
Amounts to be administered and administration route
For oral use.
Administer this veterinary medicinal product on an empty stomach (e.g. in the morning) and at least one hour before the next meal, once daily at a target dose of 2 mg per kg body weight (bw).
Duration of treatment will depend on the response observed to treatment. As field studies were limited to 28 days, longer-term treatment should be considered carefully and regular monitoring undertaken by the veterinarian.
Since clinical signs of canine osteoarthritis wax-and-wane, intermittent treatment may be beneficial in some dogs.
The following number of tablets should be given once daily:
Body weight (kg) | 20 mg tablet | 60 mg tablet | 100 mg tablet | Dose range (mg/kg bw) |
3.6 - 6.8 | 0.5 | | | 1.5 - 2.7 |
6.9 - 13.6 | 1 | | | 1.5 - 2.9 |
13.7 - 20.4 | | 0.5 | | 1.5 - 2.2 |
20.5 - 34.0 | | 1 | | 1.8 - 2.9 |
34.1 - 68.0 | | | 1 | 1.5 - 2.9 |
68.1 - 100.0 | | | 2 | 2.0 - 2.9 |
Overdose (symptoms, emergency procedures, antidotes), if necessary
In healthy dogs treated with grapiprant for 9 consecutive months, mild and transient soft-formed or mucous faeces, occasionally bloody, and vomiting were observed at daily overdoses of approximately 2.5x and 15x the recommended dose. Grapiprant did not produce any signs of kidney or liver toxicity at daily overdoses of up to 15x the recommended dose.
In case of overdose, symptomatic treatment should be initiated.
Withdrawal period(s)
Not applicable.