Companion Animal Product & Promotions Guide

GALLIPRANT ® (grapiprant tablets) For oral use in dogs only 20 mg, 60 mg and 100 mg flavored tablets A prostaglandin E 2 (PGE 2 ) EP4 receptor antagonist; a non-cyclooxygenase inhibiting, non-steroidal anti-inflammatory drug Caution: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Before using Galliprant, please consult the product insert, a summary of which follows: Indication: GALLIPRANT (grapiprant tablets) is indicated for the control of pain and inflammation associated with osteoarthritis in dogs. Dosage and Administration: Always provide "Information for Dog Owners" Sheet with prescription. Use the lowest effective dose for the shortest duration consistent with individual response. The dose of GALLIPRANT (grapiprant tablets) is 0.9 mg/lb (2 mg/kg) once daily. Only the 20 mg and 60 mg tablets of GALLIPRANT are scored. The dosage should be calculated in half tablet increments. Dogs less than 8 lbs. (3.6 kgs) cannot be accurately dosed. The 100 mg tablet is not scored and should not be broken in half. See product insert for complete dosing and administration information. Contraindications: GALLIPRANT should not be used in dogs that have a hypersensitivity to grapiprant. Warnings: Not for use in humans. Keep this and all medications out of reach of children and pets. Consult a physician in case of accidental ingestion by humans. For use in dogs only. Store GALLIPRANT out of reach of dogs and other pets in a secured location in order to prevent accidental ingestion or overdose. Precautions: The safe use of GALLIPRANT has not been evaluated in dogs younger than 9 months of age and less than 8 lbs (3.6 kg), dogs used for breeding, or in pregnant or lactating dogs. Adverse reactions in dogs receiving GALLIPRANT may include vomiting, diarrhea, decreased appetite, mucoid, watery or bloody stools, and decreases in serum albumin and total protein. If GALLIPRANT is used long term appropriate monitoring is recommended. Concurrent use with other anti-inflammatory drugs has not been studied. Concomitant use of GALLIPRANT with other anti-inflammatory drugs, such as COX-inhibiting NSAIDs or corticosteroids, should be avoided. If additional pain medication is needed after a daily dose of GALLIPRANT, a non-NSAID/ non-corticosteroid class of analgesic may be necessary. The concomitant use of protein-bound drugs with GALLIPRANT has not been studied. Commonly used protein-bound drugs include cardiac, anticonvulsant and behavioral medications. Drug compatibility should be monitored in patients requiring adjunctive therapy. Consider appropriate washout times when switching from one anti-inflammatory to another or when switching from corticosteroids or COX-inhibiting NSAIDs to GALLIPRANT use. The use of GALLIPRANT in dogs with cardiac disease has not been studied. It is not known whether dogs with a history of hypersensitivity to sulfonamide drugs will exhibit hypersensitivity to GALLIPRANT. GALLIPRANT is a methylbenzenesulfonamide. Adverse Reactions: In a controlled field study, 285 dogs were evaluated for safety when given either GALLIPRANT or a vehicle control (tablet minus grapiprant) at a dose of 2 mg/kg (0.9 mg/lb) once daily for 28 days. GALLIPRANT-treated dogs ranged in age from 2 yrs to 16.75 years. The following adverse reactions were observed: Table 1. Adverse reactions reported in the field study. GALLIPRANT Vehicle control Adverse reaction* (grapiprant tablets) (tablets minus N = 141 grapiprant) N = 144 Vomiting 24 9 Diarrhea, soft stool 17 13 Anorexia, inappetence 9 7 Lethargy 6 2 Buccal ulcer 1 0 Immune mediated hemolytic anemia 1 0 *Dogs may have experienced more than one type or occurrence during the study. GALLIPRANT was used safely during the field studies with other concurrent therapies, including antibiotics, parasiticides and vaccinations. To report suspected adverse drug events and/or to obtain a copy of the Safety Data Sheet (SDS) or for technical assistance, call 1-888-545-5973. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/AnimalVeterinary/SafetyHealth Information for Dog Owners: Owners should be advised of the potential for adverse reactions and be informed of the clinical signs associated with drug intolerance. Adverse reactions may include vomiting, diarrhea, decreased appetite, and decreasing albumin and total protein. Appetite and stools should be monitored and owners should be advised to consult with their veterinarian if appetite decreases or stools become abnormal. Effectiveness: Two hundred and eighty five (285) client-owned dogs were enrolled in the study and evaluated for field safety. GALLIPRANT-treated dogs ranging in age from 2 to 16.75 years and weighing between 4.1 and 59.6 kgs (9 – 131 lbs) with radiographic and clinical signs of osteoarthritis were enrolled in a placebo-controlled, masked field study. Dogs had a 7-day washout from NSAID or other current OA therapy. Two hundred and sixty two (262) of the 285 dogs were included in the effectiveness evaluation. Dogs were assessed for improvements in pain and function by the owners using the Canine Brief Pain Inventory (CBPI) scoring system. 7 A statistically significant difference in the proportion of treatment successes in the GALLIPRANT group (63/131 or 48.1%) was observed compared to the vehicle control group (41/131 or 31.3%). GALLIPRANT demonstrated statistically significant differences in owner assessed pain and function. The results of the field study demonstrate that GALLIPRANT, administered at 2 mg/kg (0.9 mg/pound) once daily for 28 days, was effective for the control of pain and inflammation associated with osteoarthritis. Storage Conditions: Store at or below 86° F (30° C) How Supplied: 20 mg, 60 mg and 100 mg flavored tablets in 7, 30 and 90 count bottles NADA 141-455, Approved by FDA Manufactured for: Elanco US Inc. Greenfield, IN 46140 Galliprant is the registered trademark of Aratana Therapeutics, Inc. Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. November 2018 PA101390X W2a

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