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6 mg Tablets for Cats For Oral Use in Cats Only Caution: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Indication: ONSIOR tablets are indicated for the control of postoperative pain and infammation associated with orthopedic surgery, ovariohysterectomy and castration, in cats > 5.5 lbs (2.5 kg) and > 4 months of age; for up to a maximum of 3 days. Dosage and Administration: Always provide "Information for Cat Owners" Sheet with prescription. Carefully consider the potential benefts and risk of ONSIOR tablets and other treatment options before deciding to use ONSIOR tablets. Use the lowest efective dose for the shortest duration consistent with individual response. The dose of ONSIOR tablets is 0.45 mg/lb (1 mg/kg) orally once daily, for a maximum of 3 days. Dosage Directions: For oral use in cats ≥ 5.5 lbs and ≥ 4 months of age; for up to a maximum of 3 days. Tablets are not scored and should not be broken. The frst dose should be administered approximately 30 minutes prior to surgery, at the same time as the pre-anesthetic agents are given. ONSIOR tablets may be given with or without food. Contraindications: ONSIOR tablets should not be used in cats that have a hypersensitivity to robenacoxib or known intolerance to NSAIDs. Warnings: Not for use in humans. Keep this and all medications out of reach of children. Consult a physician in case of accidental ingestion by humans. For use in cats only. All cats should undergo a thorough history and physical examination before the initiation of NSAID therapy. Appropriate laboratory tests should be conducted to establish hematological and serum biochemical baseline data prior to administration of an NSAID. Owners should be advised to observe for signs of potential drug toxicity (see Adverse Reactions and Animal Safety) and be given an "Information for Cat Owners" Sheet about ONSIOR tablets. Do not administer ONSIOR tablets in conjunction with any other oral or injectable NSAID or corticosteroid. Precautions: Appetite should be monitored in cats receiving ONSIOR tablets. Stop administration of ONSIOR tablets if appetite decreases. The use of ONSIOR tablets has not been evaluated in cats younger than 4 months of age, cats weighing less than 5.5 lbs, cats used for breeding, or in pregnant or lactating cats. The use of ONSIOR tablets in cats with cardiac disease has not been studied. ONSIOR tablets have been shown to prolong the QT interval in a laboratory setting. As a class, cyclo-oxygenase inhibitory NSAIDs may be associated with gastrointestinal, renal, and hepatic toxicity. Sensitivity to drug-associated adverse events varies with the individual patient. Cats that have experienced adverse reactions from one NSAID may experience adverse reactions from another NSAID. Patients at greatest risk for adverse events are those that are dehydrated, on concomitant diuretic therapy, or those with existing renal, cardiovascular, and/ or hepatic dysfunction. Anesthetic drugs may afect renal perfusion; approach concomitant use of anesthetics and NSAIDs cautiously. Appropriate monitoring procedures (including ECG) should be employed during all surgical procedures. The use of parenteral fuids during surgery is recommended to decrease potential renal complications when using NSAIDs perioperatively. If additional pain medication is needed after a daily dose of ONSIOR tablets, a non-NSAID/non-corticosteroid class of analgesic may be necessary. Concurrent administration of potentially nephrotoxic drugs should be carefully approached and monitored. NSAIDs may inhibit prostaglandins which maintain normal homeostatic function. Such anti-prostaglandin efects may result in clinically signifcant disease in patients with underlying or pre-existing disease that has not been previously diagnosed. NSAIDs possess the potential to produce gastrointestinal ulcerations and/or gastrointestinal perforations. Do not use ONSIOR tablets concomitantly with other anti-infammatory drugs, such as NSAIDs or corticosteroids. Consider appropriate washout times when switching from one NSAID to another or when switching from corticosteroid use to NSAID use. The use of concomitantly protein-bound drugs with ONSIOR tablets has not been studied in cats. Commonly used protein-bound drugs include cardiac, anticonvulsant and behavioral medications. The infuence of concomitant drugs that may inhibit metabolism of ONSIOR tablets has not been evaluated. Drug compatibility should be monitored in patients requiring adjunctive therapy. Concurrent medications used during the feld study with ONSIOR tablets included antiparasiticides, anesthetics, pre-anesthetic medications, and antibiotics. The efect of cyclo-oxygenase inhibition and the potential for thromboembolic occurrence or a hypercoagulable state has not been evaluated. It is unknown whether cats with a history of hypersensitivity to ß lactam drugs will exhibit hypersensitivity to ONSIOR tablets. Robenacoxib is poorly soluble in water and in acid solutions readily degrades to form γ-lactam. In cats, lactam is a metabolite of robenacoxib. Additionally, lactam is a degradation product that increases over the shelf-life of the tablets. Neurologic signs have been associated with the use of ß lactam drugs; it is unknown if the lactam in robenacoxib may cause similar neurologic signs (See Animal Safety). Robenacoxib may prolong the QT interval; the associated risk of developing ventricular arrhythmia is unknown. The use of robenacoxib with other drugs shown to prolong the QT interval is not recommended. Commonly used drugs that prolong the QT interval include antihistamines and prokinetic drugs. Adverse Reactions: In a controlled feld study, a total of 249 male and female cats representing 6 breeds, 6 months to 13 years old, weighing 5.5–15 lbs were included in the feld safety analysis. The following table shows the number of cats exhibiting each observation. Adverse Reactions in the Postoperative Pain Field Study 1 Clinical Sign ONSIOR 6 mg tablets for cats (robenacoxib) n = 167 Placebo (vehicle control) n = 82 Inappetance, weight loss 4 2 Incision site bleeding 7 1 Incision site infection 6 2 Decreased activity, lethargy 4 1 Cystitis, hematuria 3 0 Hair loss, excoriation, bruising 2 0 Vomiting 4 1 Hematachezia, diarrhea 3 1 Respiratory, cardiac arrest 1 0 Incoordination, weakness 1 1 Death 0 1 1 Cats may have experienced more than one of these signs during the study. The most commonly reported adverse reactions were surgical site bleeding, infected surgery sites, lethargy, vomiting and inappetance. Changes in the clinical pathology values were not considered clinically signifcant. To report suspected adverse drug events, contact Novartis Animal Health at 1-800-332-2761 or the FDA at 1-888-FDA-VETS or http://www.fda.gov/Animal Veterinary/SafetyHealth/ReportaProblem/ucm055305.htm. For technical assistance, contact Novartis Animal Health at 1-800-332-2761. Information for Cat Owners: ONSIOR tablets, like other drugs of its class, is not free from adverse reactions. 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, dark or tarry stools, increased water consumption, increased urination, anemia, yellowing of gums, skin or white of the eye due to jaundice, lethargy, incoordination, seizure, or behavioral changes. Serious adverse reactions associated with this drug class can occur without warning and in rare situations result in death (see Warnings and Adverse Reactions). Owners should be advised to discontinue ONSIOR tablets and contact their veterinarian immediately if signs of intolerance are observed. The vast majority of patients with drug related adverse reactions have recovered when the signs are recognized, the drug is withdrawn, and veterinary care, if appropriate, is initiated. Efectiveness: Efectiveness was demonstrated using ONSIOR tablets in a masked, placebo- controlled, multi-site feld study involving client-owned cats. In this study, 249 cats presenting for ovariohysterectomy or castration in conjunction with an onychectomy (forelimbs only) were randomly administered ONSIOR tablets, or a placebo. Drug was administered approximately 30 minutes prior to surgery along with pre-anesthetic medications and continued once daily for two additional treatments. Efectiveness was evaluated in 244 cats and feld safety was evaluated in 249 cats. A statistically signifcant diference in the proportion of treatment successes in the ONSIOR tablets treatment group (137/164 or 83.5%) compared to the placebo, vehicle control group (43/80 or 53.8%) was observed. Twenty-seven out of 164 robenacoxib cases (16.5%) and 37 out of 80 placebo cases (46.2%) were treatment failures. Statistically signifcant diferences for pain elicited on palpation at the spay or castration incision site, behavior following social interaction and posture score at various post-surgical time points were also observed. The results of the feld study demonstrate that ONSIOR tablets, when administered for a maximum of three days, are efective and well-tolerated for the control of postoperative pain associated with onychectomy, ovariohysterectomy and castration in cats. Manufactured for: Novartis Animal Health US, Inc. Greensboro, NC 27408 USA. NADA # 141-320, Approved by FDA © 2014 Novartis Animal Health US, Inc. ONSIOR is a registered trademark of Novartis AG NAH/ONS-FET/6mg/BS/1 3/13 TVP_2014-0506_FelinePainMgmt (Part 2).indd 30 5/23/2014 11:23:10 AM