Today's Veterinary Practice

MAY-JUN 2018

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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 this product, please consult the product insert, a summary of which follows: Indication: GALLIPRANT (grapiprant tablets) is indicated for the control of pain and inflammaƟon associated with osteoarthriƟs in dogs. Dosage and Administration: Always provide "InformaƟon for Dog Owners" Sheet with prescripƟon. Use the lowest effecƟve dose for the shortest duraƟon consistent with individual response. The dose of GALLIPRANT (grapiprant tablets) is 0.9 mg/lb (2 mg/kg) once daily. GALLIPRANT tablets are scored and dosage should be calculated in half tablet increments. Dogs less than 8 lbs (3.6 kgs) cannot be accurately dosed. See product insert for complete dosing and administraƟon informaƟon. Contraindications: GALLIPRANT should not be used in dogs that have a hypersensitivity to grapiprant. Warnings: Not for use in humans. Keep this and all medicaƟons out of reach of children and pets. Consult a physician in case of accidental ingesƟon by humans. For use in dogs only. Store GALLIPRANT out of reach of dogs and other pets in a secured locaƟon in order to prevent accidental ingesƟon 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 lactaƟng dogs. Adverse reacƟons in dogs receiving GALLIPRANT may include vomiƟng, diarrhea, decreased appeƟte, 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 anƟ-inflammatory drugs has not been studied. Concomitant use of GALLIPRANT with other anƟ-inflammatory drugs, such as COX-inhibiƟng NSAIDs or corƟcosteroids, should be avoided. If addiƟonal pain medicaƟon is needed aŌer a daily dose of GALLIPRANT, a non-NSAID/non-corƟcosteroid 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, anƟconvulsant and behavioral medicaƟons. Drug compaƟbility should be monitored in paƟents requiring adjuncƟve therapy. Consider appropriate washout Ɵmes when switching from one anƟ-inflammatory to another or when switching from corƟcosteroids or COX-inhibiƟng 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 hypersensiƟvity to sulfonamide drugs will exhibit hypersensiƟvity 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 galliprant) 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 reacƟons were observed: Adverse reaction* GALLIPRANT (grapiprant tablets) N = 141 Vehicle control (tablets minus grapiprant) N = 144 VomiƟng 24 9 Diarrhea, soŌ stool 17 13 Anorexia, inappe- tence 9 7 Lethargy 6 2 Buccal ulcer 1 0 Immune mediated hemolyƟc 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 anƟbioƟcs, parasiƟcides and vaccinaƟons. To report suspected adverse drug events and/or obtain a copy of the Safety Data Sheet (SDS) or for technical assistance, call 1-888-545-5973. For addiƟonal informaƟon about adverse drug experience reporƟng for animal drugs, contact FDA at 1-888-FDA-VETS or online at hƩp:// Information for Dog Owners: Owners should be advised of the potenƟal for adverse reacƟons and be informed of the clinical signs associated with drug intolerance. Adverse reacƟons may include vomiƟng, diarrhea, decreased appeƟte, and decreasing albumin and total protein. AppeƟte and stools should be monitored and owners should be advised to consult with their veterinarian if appeƟte 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 osteoarthriƟs 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 effecƟveness evaluaƟon. Dogs were assessed for improvements in pain and funcƟon by the owners using the Canine Brief Pain Inventory (CBPI) scoring system. 1 A staƟsƟcally significant difference in the proporƟon 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 staƟsƟcally significant differences in owner assessed pain and funcƟon. The results of the field study demonstrate that GALLIPRANT, administered at 2 mg/kg (0.9 mg/pound) once daily for 28 days was effecƟve for the control of pain and inflammaƟon associated with osteoarthriƟs. Storage Conditions: Store at or below 86° F (30° C) How Supplied: 20 mg, 60 mg, 100 mg flavored tablets in 7, 30 and 90 count boƩles. NADA 141-455, Approved by FDA US Patents: 6,710,054; 7,960,407; 9,265,756 Made in New Zealand Manufactured for: Aratana TherapeuƟcs, Inc., Leawood, KS 66211 Reference: 1. hƩp:// AddiƟonal informaƟon is available at 1-888-545-5973. GALLIPRANT is a trademark of Aratana TherapeuƟcs, Inc. © Aratana TherapeuƟcs, Inc. June 2016 Brief Summary: AT1-040-16 GALLIPRANT ® (grapiprant tablets) IMPOR TA N T SAFE T Y INFORMAT ION Not for use in humans. For use in dogs only. Keep this and all medications out of reach of children and pets. Store out of reach of dogs and other pets in a secured location in order to prevent accidental ingestion or overdose. Do not use in dogs that have a hypersensitivity to grapiprant. If Galliprant is used long term, appropriate monitoring is recommended. Concomitant use of Galliprant with other anti- inflammatory drugs, such as COX-inhibiting NSAIDs or corticosteroids, should be avoided. Concurrent use with other anti-inflammatory drugs or protein- bound drugs has not been studied. 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, pregnant or lactating dogs, or dogs with cardiac disease. The most common adverse reactions were vomiting, diarrhea, decreased appetite, and lethargy. Please see brief summary to the left for full prescribing information. 1. Kirkby Shaw, K., Rausch-Derra, L., and Rhodes, L. 2016. "Grapiprant: an EP4 prostaglandin receptor antagonist and novel therapy for pain and inflammation." Vet. Med. Sci. 2: 3-9. 2. Rausch-Derra, L., Huebner, M., and Rhodes, L. 2015. "Evaluation of the safety of long-term, daily oral administration of grapiprant, a novel drug for treatment of osteoarthritis pain and inflammation, in healthy dogs." Am. J. Vet. Res. 76.10: 853-859. 3. Rausch-Derra, L., Rhodes, L., Freshwater, L., et al. 2016. "Pharmacokinetic comparison of oral tablet and suspension formulations of grapiprant, a novel therapeutic for the pain and inflammation of osteoarthritis in dogs." J. Vet. Pharmacol. March 29. DOI: 10.1111/jvp.12306.

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