Robenacoxib

ONSIOR tablets are indicated for the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration, in cats greaterThanEqualTo 5.5 lbs (2.5 kg) and greaterThanEqualTo 4 months of age; for up to a maximum of 3 days.

onsior® Tablets for Cats

ONSIOR (robenacoxib) injection is indicated for the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration in cats greaterThanEqualTo 4 months of age; for up to a maximum of 3 days.

onsior® injection

ONSIOR (robenacoxib) injection is indicated for the control of postoperative pain and inflammation associated with soft tissue surgery in dogs greaterThanEqualTo 4 months of age; for up to a maximum of 3 days.

onsior® injection

For the control of postoperative pain and inflammation associated with soft tissue surgery in dogs greater at least 5.5 lbs (2.5 kg) and at least 4 months of age; for up to a maximum of 3 days.

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

onsior™

ONSIOR tablets are indicated for the control of postoperative pain and inflammation 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.

onsior™ (robenacoxib) 6 mg Tablets for Cats

ONSIOR (robenacoxib) injection is indicated for the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration in cats ≥ 4 months of age; for up to a maximum of 3 days.

onsior™ (robenacoxib)

ONSIOR (robenacoxib) injection is indicated for the control of postoperative pain and inflammation associated with soft tissue surgery in dogs ≥ 4 months of age; for up to a maximum of 3 days.

onsior™ (robenacoxib)

Robenacoxib is a non-steroidal anti-inflammatory drug (NSAID) of the coxib class. Repeated subcutaneous administration is not associated with a bioaccumulation of robenacoxib. Although the bioaccumulation of robenacoxib metabolites has not been tested, radiolabeled studies suggest that the various unidentified metabolites are associated with a markedly longer elimination half-life (approximately 22 hours) as compared to that of the parent molecule. The activity of these metabolites has not been evaluated. The pharmacokinetics of robenacoxib injection does not differ between male and female dogs, and is linear over the range of 0.25-4 mg/kg in dogs. Absorption Peak blood concentrations of robenacoxib are attained rapidly after subcutaneous injection in dogs. After a dosage of 2 mg/kg, peak concentrations are generally achieved within 1-2 hours post-dose. After subcutaneous administration of 1 mg/kg to dogs, systemic bioavailability ranged from 67% to 100% (average = 89%). Distribution Robenacoxib has a relatively small volume of distribution (Vss of 174 to 336 mL/kg, average = 240 mL/kg), which is consistent with a drug that is extensively bound to plasma proteins. Based upon in vitro canine plasma samples, robenacoxib is approximately 98% bound to plasma proteins when spiked at concentrations ranging from 200 – 2000 ng/mL. The corresponding canine in vitro whole blood-plasma ratio in artificially spiked blood was 0.44. Biotransformation Robenacoxib is extensively metabolized by the liver in dogs. Apart from one lactam metabolite, the identity of other metabolites is not known in dogs. Robenacoxib is excreted predominately via the biliary route in dogs (approximately 65 %); therefore, the majority of the absorbed dose (parent drug and metabolites) is eliminated in the feces. The remainder of the administered dose is eliminated in urine via the kidneys. Elimination After intravenous administration to normal healthy dogs, robenacoxib is rapidly cleared from blood (CL of 0.61 to 1.13 L/kg/h, average = 0.81 L/kg/hr) with an elimination half-life ranging from 0.41 to 1.07 hrs. After subcutaneous administration to normal healthy dogs, the terminal half-life from blood was within 1 – 4 hrs.

onsior™ (robenacoxib)

In an inflammation model in cats, robenacoxib had analgesic, anti-inflammatory and anti-pyretic actions with a rapid onset of action (0.5 h). 1 In an in vitro whole blood assay in cats, robenacoxib demonstrated selective COX-2 inhibition. 2 The clinical relevance of this data has not been shown. Robenacoxib is an analog of diclofenac. Absorption Peak blood concentrations of robenacoxib are attained rapidly after subcutaneous injection in cats. After a dosage of 2 mg/kg, a Tmax of 1 hour, a Cmax of 1464 ng/ml and an AUC(0-inf) of 3128 ng.h/ml is obtained. The injection has a systemic bioavailability of 69%, which is higher than that observed after an equivalent oral dose. A slightly less than dose proportional increase in exposure was observed with an increase in dose (a 2X dose resulted in a 1.4X increase in drug exposure; a 3X increase in dose resulted in a 2.3X increase in drug exposure). Distribution Robenacoxib has a relatively small volume of distribution (mean Vss = 190 ml/kg) and is highly bound to plasma proteins (>99%). Robenacoxib persists longer in the inflammatory exudate of a tissue cage model than in blood. The median robenacoxib elimination half-life in exudate was about 27 hours versus 2.5 hours for blood. Metabolism Robenacoxib is extensively metabolized by the liver in cats. Apart from one lactam metabolite, the identity of other metabolites is not known. Elimination Robenacoxib is rapidly cleared from blood (mean clearance [CL] = 0.44 L/kg/h) with an elimination mean half-life (t1/2) of 1.1 hours after intravenous administration. After subcutaneous administration, the terminal half-life was 1.1 hour (range of estimated values was 0.9 hour to 1.6 hours). Repeated subcutaneous administration at dosages of 2-20 mg/kg produced no change in the blood profile, with neither bioaccumulation of robenacoxib nor enzyme induction. Elimination occurs predominantly through the biliary route (fecal and urinary excretion are 60 and 16.5% respectively). The pharmacokinetics of robenacoxib injection does not differ between male and female.

VETOneOstiRobeTM Injection(robenacoxib)

In an inflammation model in cats, robenacoxib had analgesic, anti-inflammatory and anti-pyretic actions with a rapid onset of action (0.5 h).1 In an in vitro whole blood assay in cats, robenacoxib demonstrated selective COX-2 inhibition.2 The clinical relevance of this data has not been shown. Robenacoxib is an analog of diclofenac.

onsior™ (robenacoxib) 6 mg Tablets for Cats

ONSIOR (robenacoxib) injection should not be used in cats that have a hypersensitivity to robenacoxib or known intolerance to NSAIDs.

onsior™ (robenacoxib)

ONSIOR tablets should not be used in cats that have a hypersensitivity to robenacoxib or known intolerance to NSAIDs.

onsior™ (robenacoxib) 6 mg Tablets for Cats

Not for use in humans. Keep this and all medications out of reach of children. Consult a physician in case of accidental exposure to humans. For subcutaneous use in dogs and cats only. See reverse side for instructions for use in cats. Do not administer robenacoxib injection or tablets in conjunction with any other oral or injectable NSAID or corticosteroid. Do not use for more than 3 days. Serious adverse events have been reported, including hepatopathy, with the long term use (28 day study) of robenacoxib tablets in dogs (See Adverse Reactions). Safety not demonstrated for longer than 3 days. All dogs 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).

VETOneOstiRobeTM Injection(robenacoxib)

Not for use in humans. Keep this and all medications out of reach of children. Consult a physician in case of accidental ingestion or injection by humans. For subcutaneous use in cats and dogs (see reverse side for instructions for use in dogs). 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). Do not administer robenacoxib injection or tablets in conjunction with any other oral or injectable NSAID or corticosteroid.

VETOneOstiRobeTM Injection(robenacoxib)

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 oral 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 or injection in conjunction with any other oral or injectable NSAID or corticosteroid.

onsior™ (robenacoxib) 6 mg Tablets for Cats

20 mg/mL For Subcutaneous Use in Dogs

Robenacoxib Injection

The controlled field study (see Effectiveness) included a total of 349 healthy male and female cats in the field safety analysis. Robenacoxib injection treated cats represented 7 breeds, 4 months to 7 years old, weighing 5.5-13.2 lbs. The following table shows the number of cats exhibiting each observation. Adverse Reactions in the Postoperative Pain Field Study Adverse Reaction* Robenacoxib N = 174** Control (0.9% physiologic saline) N =175 Incision site infection,dehiscence 9 0 Increased incision site bleeding 6 4 Vomiting 5 0 Decreased appetite 4 3 Lethargy (after day of surgery) 4 2 UTI 2 0 Coughing 1 0 Fever 1 0 Semiconscious*** 1 0 Soft stool, diarrhea 0 2 *Cats may have experienced more than one type or occurrence of an event during the study. **One robenacoxib cat suffered an anesthetic-related death. ***Semiconscious cat fully recovered. The most commonly reported adverse reactions in cats treated with robenacoxib injection were infected incision sites, increased incision site bleeding, vomiting, inappetence, and lethargy. Changes in the clinical pathology values were not considered clinically significant. An additional study was conducted in client-owned cats to evaluate robenacoxib injection at a dose of 2 mg/kg administered once daily for the control of postoperative pain and inflammation associated with an onychectomy (forelimbs only) and OVH or castration. The study was a masked, negative controlled, multi-center field study in which 187 cats were enrolled in a 2:1 ratio into two groups (127 cats treated with robenacoxib injection and 60 cats treated with saline). Adverse Reactions from Additional Field Study Adverse Reaction* Robenacoxib N = 127 Control (0.9% physiologic saline) N = 60 Surgical or venipuncture site bleeding 9 3 Leukocytosis 9 2 Fever 8 11 Lethargy (after day of surgery) 7 0 Vomiting 6 0 Anorexia/ decreased appetite 6 3 Infected/drainage surgical site(s), infection 5 2 Dehiscence 1 0 Diarrhea 1 3 Bloody stool 1 0 Hypersalivation 1 2 UTI 0 1 *Cats may have experienced more than one type or occurrence of an event during the study. The mean WBC count in the robenacoxib group was 13.8 ± 5.64 103/μL (ranging from 4.4- 36.8) and the mean WBC count in the control group was 12.7 ± 5.41 103/μL (with values ranging from 2.9 - 30.1) at the end of the study. There were 6 robenacoxib cases with elevated ALT post-treatment compared to 1 control case. There were 4 robenacoxib cases with elevated AST post-treatment compared to 1 control case. The most commonly reported adverse reactions in cats treated with robenacoxib were increased incision site bleeding, leukocytosis, fever, inappetence, infected incision sites, vomiting, and lethargy. The results of the field study demonstrate that robenacoxib injection, when administered for a maximum of 3 days, is well-tolerated for the control of postoperative pain associated with onychectomy, ovariohysterectomy, and castration in cats.

VETOneOstiRobeTM Injection(robenacoxib)

The controlled field study (see Effectiveness ) included a total of 349 healthy male and female cats in the field safety analysis. ONSIOR (robenacoxib) injection treated cats represented 7 breeds, 4 months to 7 years old, weighing 5.5-13.2 lbs. The following table shows the number of cats exhibiting each observation. Adverse Reactions in the Postoperative Pain Field Study *Cats may have experienced more than one type or occurrence of an event during the study. **One ONSIOR cat suffered an anesthetic-related death. ***Semiconscious cat fully recovered. Adverse Reaction* ONSIOR N = 174** Control (0.9% physiologic saline) N = 175 Incision site infection, dehiscence 9 0 Increased incision site bleeding 6 4 Vomiting 5 0 Decreased appetite 4 3 Lethargy (after day of surgery) 4 2 UTI 2 0 Coughing 1 0 Fever 1 0 Semiconscious*** 1 0 Soft stool, diarrhea 0 2 The most commonly reported adverse reactions in cats treated with ONSIOR (robenacoxib) injection were infected incision sites, increased incision site bleeding, vomiting, inappetence, and lethargy. Changes in the clinical pathology values were not considered clinically significant. An additional study was conducted in client-owned cats to evaluate ONSIOR (robenacoxib) injection at a dose of 2 mg/kg administered once daily for the control of postoperative pain and inflammation associated with an onychectomy (forelimbs only) and OVH or castration. The study was a masked, negative controlled, multi-center field study in which 187 cats were enrolled in a 2:1 ratio into two groups (127 cats treated with robenacoxib injection and 60 cats treated with saline). Adverse Reactions from Additional Field Study *Cats may have experienced more than one type or occurrence of an event during the study. Adverse Reaction* ONSIOR N = 127 Control (0.9% physiologic saline N = 60 Surgical or venipuncture site bleeding 9 3 Leukocytosis 9 2 Fever 8 11 Lethargy (after day of surgery) 7 0 Vomiting 6 0 Anorexia/ decreased appetite 6 3 Infected/drainage surgical site(s), infection 5 2 Dehiscence 1 0 Diarrhea 1 3 Bloody stool 1 0 Hypersalivation 1 2 UTI 0 1 The mean WBC count in the ONSIOR group was 13.8 ± 5.64 103/μL (ranging from 4.4 – 36.8) and the mean WBC count in the control group was 12.7 ± 5.41 103/μL (with values ranging from 2.9 – 30.1) at the end of the study. There were 6 ONSIOR cases with elevated ALT post-treatment compared to 1 control case. There were 4 ONSIOR cases with elevated AST post-treatment compared to 1 control case. The most commonly reported adverse reactions in cats treated with ONSIOR were increased incision site bleeding, leukocytosis, fever, inappetence, infected incision sites, vomiting, and lethargy. The results of the field study demonstrate that ONSIOR injection, when administered for a maximum of 3 days, is well-tolerated for the control of postoperative pain associated with onychectomy, ovariohysterectomy, and castration in cats.

onsior™ (robenacoxib)

In a controlled field study (See Effectiveness ), a total of 317 male and female dogs representing various breeds were included in the field safety analysis. ONSIOR-treated dogs ranged in age from 6 months to 15 years and weighed between 2.5 and 53.8 kg. The following table shows the number of dogs exhibiting each observation. Table 1: Adverse reactions reported in the soft tissue surgery field study. * Dogs may have experienced more than one type or occurrence of an event during the study. **Most often occurred as a single event. Adverse Reaction* ONSIOR (robenacoxib) injection N = 159 Placebo (0.9% NaCl) N = 158 Pain on injection** 18 8 Diarrhea 15 8 Vomiting 10 6 Bradycardia 6 1 Decreased appetite 5 2 Hypotension 2 0 Facial edema, hypersensitivity 1 0 Increased incisional bleeding 1 0 Pain on injection, diarrhea and vomiting were the most commonly reported adverse reactions. Occurrences of hepatopathy, ataxia, skin lesions/urticaria, and anaphylaxis have been associated with the use of ONSIOR. In a month-long pilot study, 3 dogs that received ONSIOR developed hepatic toxicity. Two of these dogs were euthanized and a third dog recovered after prolonged hospitalization and supportive therapy. In foreign market experience, elevated liver enzymes, hepatic necrosis and death have been associated with the long term use of robenacoxib in dogs. Occurrences of liver failure, hepatitis, and cholangiohepatitis have been reported. In two other field studies, bradycardia, 2nd degree heart block in four dogs, and ventricular arrhythmia in one dog were noted in anesthetized dogs treated with ONSIOR injection. Injection site reactions (edema, necrosis, and abscesses), and anaphylactic reactions (panting, drooling, shock, pallor, dyspnea, tachypnea, ataxia) have been associated with the use of ONSIOR injection. Contact Information: For technical assistance or to report suspected adverse drug events, contact Elanco US Inc. at 1-888-545-5973. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae

onsior™ (robenacoxib)

In a controlled field study (See Effectiveness), a total of 317 male and female dogs representing various breeds were included in the field safety analysis. Robenacoxib-treated dogs ranged in age from 6 months to 15 years and weighed between 2.5 and 53.8 kg. The following table shows the number of dogs exhibiting each observation. Table 1: Adverse reactions reported in the soft tissue surgery field study. Adverse Reaction* Robenacoxib injection N=159 Placebo (0.9% NaCl) N = 158 Pain on injection** 18 8 Diarrhea 15 8 Vomiting 10 6 Bradycardia 6 1 Decreased appetite 5 2 Hypotension 2 0 Facial edema, hypersensitivity 1 0 Increased incisional bleeding 1 0 *Dogs may have experienced more than one type or occurrence of an event during the study. **Most often occurred as a single event. Pain on injection, diarrhea and vomiting were the most commonly reported adverse reactions. Occurrences of hepatopathy, ataxia, skin lesions/urticaria, and anaphylaxis have been associated with the use of robenacoxib. In a month-long pilot study, 3 dogs that received robenacoxib developed hepatic toxicity. Two of these dogs were euthanized and a third dog recovered after prolonged hospitalization and supportive therapy. In foreign market experience, elevated liver enzymes, hepatic necrosis and death have been associated with the long term use of robenacoxib in dogs. Occurrences of liver failure, hepatitis, and cholangiohepatitis have been reported. In two other field studies, bradycardia, 2nd degree heart block in four dogs, and ventricular arrhythmia in one dog were noted in anesthetized dogs treated with robenacoxib injection. Injection site reactions (edema, necrosis, and abscesses), and anaphylactic reactions (panting, drooling, shock, pallor, dyspnea, tachypnea, ataxia) have been associated with the use of robenacoxib injection.

VETOneOstiRobeTM Injection(robenacoxib)

In a controlled field 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 field safety analysis. The following table shows the number of cats exhibiting each observation. 1 Cats may have experienced more than one of these signs during the study. Adverse Reactions in the Postoperative Pain Field Study1 ONSIOR 6 mg Tablets for Cats Placebo Adverse Reaction (robenacoxib) n = 167 (vehicle control) n = 82 Incision site bleeding 7 1 Incision site infection 6 2 Inappetance, weight loss 4 2 Decreased activity, lethargy 4 1 Vomiting 4 1 Cystitis, hematuria 3 0 Hematachezia, diarrhea 3 1 Hair loss, excoriation, bruising 2 0 Respiratory, cardiac arrest 1 0 Incoordination, weakness 1 1 Death 0 1 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 significant.

onsior™ (robenacoxib) 6 mg Tablets for Cats

For subcutaneous injection in cats greaterThanEqualTo 4 months of age; for up to a maximum of 3 days. To ensure accuracy of dosing, the use of a 1 mL graduated syringe is recommended. The first dose should be administered approximately 30 minutes prior to surgery, at the same time as the pre-anesthetic agents are given. Subsequent doses can be given via subcutaneous injection, or interchanged with the oral tablet in cats greaterThanEqualTo 5.5 lbs and greaterThanEqualTo 4 months of age, for a maximum of 3 total ONSIOR doses over 3 days, not to exceed one dose per day (see Animal Safety and ONSIOR tablet product insert).

Subcutaneous

onsior® injection

Administer 0.91 mg per pound (2 mg/kg) by subcutaneous injection, once daily, for a maximum of 3 days.

Subcutaneous

Robenacoxib Injection

The dose of ONSIOR tablets is 0.45 mg/lb (1 mg/kg) orally once daily, for a maximum of 3 days.

Oral

onsior® Tablets for Cats

Administer 0.45 mg/lb (1 mg/kg) orally, once daily, for a maximum of 3 days.

Oral

Robenacoxib

For subcutaneous injection in dogs greaterThanEqualTo 4 months of age; for up to a maximum of 3 days. The first dose should be administered approximately 45 minutes prior to surgery, at the same time as the pre-anesthetic agents are given. Subsequent doses can be given via subcutaneous injection, or interchanged with the oral tablet in dogs greaterThanEqualTo 5.5 lbs and greaterThanEqualTo 4 months of age, for a maximum of 3 total ONSIOR doses over 3 days, not to exceed one dose per day (see Animal Safety and ONSIOR tablet product insert). If subsequent doses are given by subcutaneous injection, different sites for each injection should be used (See Adverse Reactions).

Subcutaneous

onsior® injection

Administer 0.91 mg per pound (2 mg/kilogram (kg)) by subcutaneous injection, once daily, for a maximum of 3 days. After the initial subcutaneous dose, subsequent doses can be given by subcutaneous injection or as the oral tablet in dogs weighing at least 5.5 pounds (2.5 kg) and at least 4 months of age, for a maximum of 3 total doses over 3 days, not to exceed 1 dose per day.

Subcutaneous

Robenacoxib Injection

0.91 mg/lb (2mg/kg) orally once daily, for a maximum of three days.

Oral

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

onsior™

Always provide “Information for Cat Owners” Sheet with prescription. Carefully consider the potential benefits and risks of ONSIOR tablets and other treatment options before deciding to use ONSIOR tablets. Use the lowest effective 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. See dosing chart for dosage directions. 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. Body weight 6 mg ONSIOR (robenacoxib) Tablet 5.5 to 13.2 lbs (2.5 to 6 kg) 1 whole tablet once daily 13.3 to 26.4 lbs (6.1 to 12 kg) 2 whole tablets once daily Do not use in cats weighing less than 5.5 lbs, as cats less than 5.5 lbs cannot be accurately dosed. The first 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. In cats ≥ 5.5 lbs and ≥ 4 months of age, subsequent doses can be given via the oral tablet, or interchanged with subcutaneous injection for a maximum of 3 total ONSIOR doses over 3 days, not to exceed one dose per day (see Animal Safety and the ONSIOR injection package insert). Note the dose of ONSIOR tablets and ONSIOR injection are different. If a second and third tablet dose is dispensed to the client to administer at home, doses should be dispensed in the dispensing envelope with the attached Information for Owner Sheet intact. Do not remove Information for Cat Owner Sheet. Record when the first dose was administered on the dispensing envelope. Cats weighing ≥ 13.3 lbs may require two blister cards, each dispensed in an individual dispensing envelope.

ORAL

onsior™ (robenacoxib) 6 mg Tablets for Cats

Carefully consider the potential benefits and risks of Robenacoxib Injection and other treatment options before deciding to use Robenacoxib Injection. Use the lowest effective dose for the shortest duration consistent with individual response. It is recommended as good aseptic practice to clean stopper surface with isopropyl alcohol before and after each insertion of a needle. The dose of Robenacoxib Injection is 0.91 mg/lb (2 mg/kg) subcutaneously once daily, for a maximum of 3 days (See Warnings, Precautions and Adverse Reactions). Dosage Directions: For subcutaneous injection in dogs ≥ 4 months of age; for up to a maximum of 3 days. The first dose should be administered approximately 45 minutes prior to surgery, at the same time as the pre-anesthetic agents are given. Subsequent doses can be given via subcutaneous injection, or interchanged with the oral tablet in dogs ≥ 5.5 lbs and ≥ 4 months of age, for a maximum of 3 total robenacoxib doses over 3 days, not to exceed one dose per day (see Animal Safety and robenacoxib tablet product insert). If subsequent doses are given by subcutaneous injection, different sites for each injection should be used (See Adverse Reactions).

SUBCUTANEOUS

Robenacoxib Injection

Carefully consider the potential benefits and risks of Robenacoxib Injection and other treatment options before deciding to use Robenacoxib Injection. Use the lowest effective dose for the shortest duration consistent with individual response. It is recommended as good aseptic practice to clean stopper surface with isopropyl alcohol before and after each insertion of a needle. The dose of Robenacoxib Injection is 0.91 mg/lb (2 mg/kg) subcutaneously once daily, for a maximum of 3 days. Dosage Directions: Far subcutaneous injection in cats ≥ 4 months of age; for up to a maximum of 3 days. To ensure accuracy of dosing, the use of a 1 mL graduated syringe is recommended. The first dose should be administered approximately 30 minutes prior to surgery, at the same time as the pre-anesthetic agents are given. Subsequent doses can be given via subcutaneous injection, or interchanged with the oral tablet in cats ≥ 5.5 lbs and ≥ 4 months of age, for a maximum of 3 total robenacoxib doses over 3 days, not to exceed one dose per day (see Animal Safety and robenacoxib tablet product insert). Note: In cats, the dose of robenacoxib tablets and Robenacoxib Injection are different.

SUBCUTANEOUS

Robenacoxib Injection

Carefully consider the potential benefits and risks of ONSIOR and other treatment options before deciding to use ONSIOR (robenacoxib) injection. Use the lowest effective dose for the shortest duration consistent with individual response. It is recommended as good aseptic practice to clean stopper surface with isopropyl alcohol before and after each insertion of a needle. The dose of ONSIOR (robenacoxib) injection is 0.91 mg/lb (2 mg/kg) subcutaneously once daily, for a maximum of 3 days. Dosage Directions: For subcutaneous injection in cats ≥ 4 months of age; for up to a maximum of 3 days. To ensure accuracy of dosing, the use of a 1 mL graduated syringe is recommended. The first dose should be administered approximately 30 minutes prior to surgery, at the same time as the pre-anesthetic agents are given. Subsequent doses can be given via subcutaneous injection, or interchanged with the oral tablet in cats ≥ 5.5 lbs and ≥ 4 months of age, for a maximum of 3 total ONSIOR doses over 3 days, not to exceed one dose per day (see Animal Safety and ONSIOR tablet product insert). Note: In cats, the dose of ONSIOR tablets and ONSIOR injection are different.

SUBCUTANEOUS

onsior™ (robenacoxib)