Just where it s needed.

Transcription

1 Relief. Just where it s needed. Tissue-selective 7,8 Strong safety profile 5,6,10,11 For dogs and cats

2 Onsior is available in a range of convenient and easy-to-dose formulations. Injectable solution for dogs and cats Injection (2 mg/kg for dogs and cats) subcutaneously: Dogs: For the relief of pain and inflammation associated with orthopedic or soft tissue surgery. Cats: As an adjunctive medication in the control of postoperative pain and inflammation associated with onychectomy, ovariohysterectomy and castration in cats. Palatable tablets for dogs Tablets (5 mg, 10 mg, 20 mg, 40 mg): For the relief of pain and inflammation associated with osteoarthritis in dogs. Palatable tablets for cats Tablets (6 mg): 1. For the relief of acute pain and inflammation associated with cat bites and scratches with and without abscesses and musculoskeletal injuries such as sprains and strains in cats. 2. As an adjunctive medication, in the control of postoperative pain and inflammation associated with onychectomy, ovariohysterectomy and castration in cats. Highly palatable tablets for both dogs and cats (shown at actual size). No pilling required! 159 out of 160 times, cats spontaneously accepted Onsior. 4 6 mg 5 mg 10 mg 20 mg 40 mg Cat Dog

3 Onsior is the ONLY pain relief that has proven tissue selectivity 7,8and COX-2 13,14selectivity. One tablet a day for the vast majority of dogs and cats. Dosing range ensures accurate dosing. Highly palatable tablets beef flavour for dogs, yeast flavour for cats. Onsior can be administered without food or with a small quantity of food which provides pet owners flexibility to administer medication. Onsior tablets for dogs 1 mg/kg with a dose range of 1-2 mg/kg: Body Number of Tablets Weight (kg) 5 mg 10 mg 20 mg 40 mg 2.5 to < 5 5 to < to < to < to 80 Note: Tablets not actual size. Onsior 6 mg tablets for cats 1 mg/kg with a dosing range of mg/kg: Body Weight (kg) 2.5 to < 6 6 to < 12 Number of Tablets A feline expert panel of the Feline Advisory Bureau (FAB) recognized Onsior with its Easy to Give Award. The award distinguishes products that are designed to be more palatable or easier to give to cats, which makes life better for vets, owners and feline patients alike. Note: Tablets not actual size.

4 Tissue selectivity: A key component of the strong safety profile of Onsior. 5,6,10,11 What does tissue selectivity mean? 1. Onsior is quickly absorbed from the gastrointestinal tract. Fast T max = 30 minutes 5,6 2. Onsior is eliminated from the blood quickly. * * Oral administration Short blood T 1/2 = 1.7 hours (cats) 5 and 1.2 hrs (dogs) 6 Concentrates at the site of inflammation. 7,8 3. Onsior has demonstrated tissue selectivity. 7,8 4. Onsior is effective with DAILY dosing. * 1,3 * Oral administration Effective for a full 24 hours. 1,3

5 How does tissue selectivity contribute to the strong safety profile? Onsior spares vulnerable organs and the GI tract from prolonged exposure to effective drug concentrations. 7,8 NSAIDs with short elimination half-lives like Onsior are rapidly cleared from the pharmacokinetic central compartment, which includes well-perfused organs such as the kidneys, liver, heart and blood vessels. 9 High COX-2 selectivity COX-1 enzymes produce prostaglandins that support kidney and platelet functions and protect the GI mucosa. The liver and kidneys are key destinations of cardiac blood. 12 COX-2 enzymes produce prostaglandins that lead to inflammation and pain. LIVER 25% cardiac output In cats, robenacoxib is 500x more selective for COX-2 than COX-1 13 KIDNEYS 20% cardiac output In dogs, robenacoxib is 140x more selective for COX-2 than COX-1 14

6 Onsior is in a class of its own. Onsior is the ONLY NSAID approved for dogs and cats with the benefit of both tissue selectivity and high COX-2 selectivity. YES Proven tissue selectivity * Lower COX-2 selectivity 15 carprofen deracoxib firocoxib Higher COX-2 selectivity 15 NO Proven tissue selectivity * * As defined by Brune. 9 How Onsior tablets for dogs compares: Onsior Tablets for Dogs 6 Onsior Injectable 16 Metacam Oral Suspension 17 Metacam Injectable 18 Active Ingredient robenacoxib robenacoxib T max 30 minutes 1 hour 7.5 hours 2.5 hours (SQ) T 1/2 1.2 hours 1.2 hours 24 hours 24 hours How Onsior tablets for cats compares: Onsior Tablets for Cats 9 Onsior Injectable 16 Metacam Oral Suspension for Cats 2 Metacam Injectable 11 Active Ingredient robenacoxib robenacoxib T max 30 minutes 1 hour 3 hours 1.5 hours T 1/2 1.7 hours 1.1 hours 24 hours 15 hours

7 Onsior : Proven safety profile studied over wide margins. Dogs 6,10,16 Maximum margin of safety studied Duration of study Tablets Up to 5X daily dose (study tested up to 10 mg/kg) 6 6 months Up to 20X daily dose (study tested up to 40 mg/kg) days Injectable Up to 10X daily dose (study tested up to 20 mg/kg) 16 6 weeks Cats 5,11,16 Maximum margin of safety studied Duration of study Tablets Up to 4X daily dose (study tested up to 10 mg/kg) 28 days 5, 11 Up to 8X daily dose (study tested up to 10mg/kg twice daily) 42 days to 5X daily dose (study tested up to 12 mg/kg) 5 6 months Up to 10x daily dose (study tested up to 24mg/kg) 5 21 days Tablets + Injectable* Up to 5X daily dose days * Interchangeable use was evaluated by alternating three 7-day oral tablet/3-day subcutaneous injection cycles followed by one final 7-day oral tablet dosing cycle. As with all drugs in this class side effects can occur, please consult the package insert for a full list of side effects. These are normally mild, but may be serious. Pet owners should discontinue therapy and contact their veterinarian immediately if side effects occur. Evaluation for pre-existing conditions and regular monitoring are recommended for pets on any medication, including Onsior. Use with other NSAIDs or corticosteroids should be avoided.

8 Make Onsior part of your practice. Onsior is the ONLY tissue-selective and highly COX-2 selective NSAID for dogs and cats. Tissue-selective Short blood half-life minimizes exposure to vulnerable organs, but persists much longer in inflamed tissues 7,8 Palatable Easy daily dosing for dogs and cats Convenient Available as flavour tablets or injection References 1. Giraudel JM et al. Evaluation of orally administered robenacoxib versus ketoprofen for treatment of acute pain and inflammation associated with musculoskeletal disorders in cats. Am J Vet Res. 2010;71: Canadian Metacam Oral Suspension for Cats product insert. 3. Reymond, N, Speranza C, Gruet P, et al. Robenacoxib vs carprofen for the treatment of canine osteoarthritis; a randomized, noninferiority clinical trial. J Vet Pharmacal Ther. 35 (2): NAH Internal Study - NAH CRA09-79-Sept Canadian Onsior Tablets for Cats product insert. 6. Canadian Onsior Tablets for Dogs product insert. 7. Pelligand L et al. Pharmacokinetic and pharmacodynamic modelling of robenacoxib in a feline tissue cage model of inflammation. J Vet Pharmacol Ther. 2012;35(1): Silber HE, Burgener C, Letellier IM, et al. Population pharmacokinetic analysis of blood and joint synovial fluid concentrations of robenacoxib from healthy dogs and dogs with osteoarthritis. Pharm Res Dec;27(12): Brune K et al. Combining enzyme specificity and tissue selectivity of cyclooxygenase inhibitors: towards better tolerability? Rheumatology (Oxford) 2007;46(6): King JN, Arnaud JP, Goldenthal El, et al. Robenacoxib in the dog: target species safety in relation to extent and duration of inhibition of COX-1 and COX-2. J Vet Pharmacol Ther Jun;34(3): King JN, Hotz R, Reagan EL, et al. Safety of oral robenacoxib in the cat J Vet Pharmacol Ther Jun;35(3): Pinakatt T et al. Distribution of cardiac output in dogs. Am J Physiol 1967;213(4): Giraudel JM, Toutain PL, King JN, Lees P. Differential inhibition of cyclooxygenase isoenzymes in the cat by the NSAID robenacoxib. J Vet Pharmacol Ther. 2009, Feb;32(1): King JN, Rudaz C, Borer L, Jung M, Seewald W, Lees P. In vitro and ex vivo inhibition of canine cyclooxygenase isoforms by robenacoxib: a comparative study. Res Vet Sci, 2010 Jun;88(3): Lees P, Landoni M.F., Giraudel J et al. Pharmacodynamics and pharmacokinetics of nonsteroidal anti-inflammatory drugs in species of veterinary interest. J Vet Pharmacol Ther. 2004;27, Canadian Onsior Injectable product insert. 17. Veterinary Medicine Expert Committee. USP Veterinary Pharmaceutical Information Monographs - Anti-inflammatory. Journal of Pharmacology and Therapeutics. 2004; 27, Canadian Metacam 0.5% injection product insert. Elanco, Onsior and the diagonal bar are trademarks owned by or licensed to Eli Lilly and Company, its affiliates or subsidiaries. All other product and company names are trademarks of their respective owners Eli Lilly and Company, or its affiliates. CACAHONS00040