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Onsior (tablets for cats) (Canada)

This page contains information on Onsior (tablets for cats) for veterinary use.
The information provided typically includes the following:
  • Onsior (tablets for cats) Indications
  • Warnings and cautions for Onsior (tablets for cats)
  • Direction and dosage information for Onsior (tablets for cats)

Onsior (tablets for cats)

This treatment applies to the following species:
Manufacturer: Elanco (Novartis)

(robenacoxib)

6mg tablets for cats

Non-Steroidal Anti-Inflammatory

FOR VETERINARY USE ONLY

For use in cats only.

Description

ONSIOR™ (robenacoxib) is a non-steroidal anti-inflammatory drug (NSAID) belonging to the coxib class. The flavoured tablets are round, beige to brown in colour and are not scored.

Onsior (tablets for cats) Indications

ONSIOR (robenacoxib) is indicated for:

1. 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.

Dosage and Administration

Give orally without food or with a very small quantity of food (see Pharmacology, Biotransformation).

The recommended dosage of ONSIOR is 1 mg/kg body weight with a range 1-2.4 mg/kg in cats. Use the lowest effective dose for the shortest duration consistent with individual response. For relief of acute pain and inflammation associated with cat bites and scratches with and without abscesses and musculoskeletal injuries, administer once per day for a maximum of 6 days according to the table below. As an adjunctive medication, in the control of postoperative pain and inflammation associated with onychectomy, ovariohysterectomy and castration in cats, administer once per day for a maximum of 3 days according to the table below. The first dose should be administered approximately 30 minutes (without food) prior to surgery at the same time that the pre-anesthetic agents are given. After surgery, once daily treatment may be continued for up to two days. If necessary, additional analgesic treatment with opioids is recommended.

Body weight (kg)

Number of 6 mg Tablets / Frequency of Dosing

2.5 to less than 6

1 tablet once daily

6 to less than 12

2 tablets once daily

Contraindications

As with all non-steroidal anti-inflammatory drugs (NSAIDs), administration of this drug is contraindicated in the following circumstances:

● cats with gastrointestinal ulcers;

● cats that are dehydrated, hypovolemic, hypoproteinemic or hypotensive;

● cats with impaired cardiac, renal or hepatic function, or coagulation abnormalities;

● a known hypersensitivity to robenacoxib or its excipients;

● concurrent use of other NSAIDs or corticosteroids;

● in breeding, pregnant or lactating cats because the safety of robenacoxib has not been established in these animals.

CAUTIONS:

The safety of robenacoxib tablets has not been established in cats weighing less than 2.5 kg or under 6 months of age.

All cats should undergo a thorough history and physical exam before the initiation of NSAID therapy. Appropriate laboratory tests should be conducted to establish hematological and biochemical baseline data before the administration of any NSAID.

ONSIOR should be used with caution in cats with a known hypersensitivity to other NSAIDs.

ONSIOR should not be given to animals with impaired hydration status, cardiac or renal insufficiency or where subsequent blood loss or decrease in blood pressure during surgery may decrease renal or gut perfusion. Anesthetic and non-steroidal anti-inflammatory drugs may affect renal perfusion. The use of parenteral fluids during surgery is recommended to decrease potential renal complications when using NSAIDs perioperatively.

If gastrointestinal side effects occur, treatment should be discontinued.

Pretreatment with other anti-inflammatory drugs may result in additional or increased adverse effects and accordingly a treatment-free period with such substances should be observed.

The treatment-free period should take into account the pharmacokinetic properties of the products used previously.

Concomitant treatment with drugs which affect renal flow, e.g. anesthetics, should be subject to clinical monitoring. Concurrent administration of potentially nephrotoxic medicines should be avoided as there might be an increase of renal toxicity. The use of concomitantly protein-bound drugs with ONSIOR Tablets for Cats has not been studied in cats. Drug compatibility should be monitored closely in patients requiring additional therapy.

ONSIOR was administered concurrently with pre-anesthetic (opioid) and a metacarpal four point ring block using a longer acting local anesthetic medication, during the field study assessing the effect of ONSIOR on post-operative pain control. Level of analgesia should be monitored post-operatively to assess if additional pain control is needed. If necessary, additional analgesic treatment with opioids is recommended. NSAID drugs and corticosteroids should not be used.

The use of ONSIOR in cats with cardiac disease has not been studied. ONSIOR has been shown to prolong the QT interval in a laboratory setting. The associated risk of developing a 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 QT interval include antihistamines and prokinetic drugs. Appropriate monitoring procedures including ECG should be employed during all surgical procedures.

A gamma lactam (γ-lactam) metabolite of robenacoxib is formed in the cat. In addition, this γ-lactam is a degradation product that increases over the shelf life of the tablets and can be decreased by refrigeration. Neurological signs have been associated with the use of β lactam drugs; it is unknown if this γ-lactam may cause similar neurological signs.

Warnings

KEEP OUT OF REACH OF CHILDREN. In case of accidental ingestion, seek medical advice immediately and show the package insert or the label to the physician.

Adverse Reactions

In the pivotal clinical trial to evaluate acute pain and inflammation associated with musculoskeletal disorders, where 56 cats were treated with ONSIOR, diarrhea, emesis, lethargy, hyperactivity and polydipsia were reported at the following frequencies:

Adverse Event

ONSIOR (56 Cats)

Positive Control (48 Cats)

Diarrhea

4/56 (7%)

1/48 (2%)

Emesis

3/56 (5%)

0/48 (0%)

Lethargy

3/56 (5%)

1/48 (2%)

Hyperactivity

2/56 (4%)

0/48 (0%)

Polydipsia

1/56 (2%)

0/48 (0%)

In a controlled post-operative pain field study associated with ovariohysterectomy, castration and onychectomy, 249 male and female cats of various breeds, 6 months to 13 years old weighing 2.5 to 7.5 kg, the most commonly reported adverse reactions were surgical site bleeding, infected surgery sites, lethargy, vomiting and inappetance.

Adverse Reactions in the Postoperative Pain Field Study1.

Clinical Sign

ONSIOR

(167 cats)

Control Group

(82 cats)

Incision site bleeding

7/167 (4%)

1/82 (1%)

Incision site infection

6/167 (4%)

2/82 (2%)

Inappetance, weight loss

4/167 (2%)

2/82 (2%)

Decreased activity, lethargy

4/167 (2%)

1/82 (1%)

Vomiting

4/167 (2%)

1/82 (1%)

Cystitis, hematuria

3/167 (2%)

0/82 (0%)

Hematochezia diarrhea

3/167 (2%)

1/82 (1%)

Hair loss, excoriation, bruising

2/167 (1%)

0/82 (0%)

Respiratory, cardiac arrest

1/167 (1%)

0/82 (0%)

Incoordination, weakness

1/167 (1%)

1/82 (1%)

Death

0/167 (0%)

1/82 (1%)

1.Cats may have experienced more than one of these signs during the study

One cat was reported to have vomiting, diarrhea, incoordination, tachypnea, weakness, and tachycardia approximately 24 hours following the second administration of ONSIOR. On physical examination, the cat was described as very weak and uncoordinated, which was attributed to hypoxia. With treatment, the cat gradually recovered the same day. Blood work was within normal limits.

While pain was not reported as an adverse event, the most common reasons associated with “rescue due to pain” as identified by investigators were tenderness of surgical sites, aggressive/guarding behaviour, vocalizing, and agitated, purposeful avoidance of painful stimulus, hunched position, trembling/shaking, little or no social response, and tachycardia/tachypnea. (See efficacy section)

INFORMATION FOR CAT OWNERS:

ONSIOR is the product your veterinarian has chosen to treat your cat’s pain and inflammation. It belongs to a class of drugs called “non-steroidal anti-inflammatory” or NSAIDs. These drugs must be used according to your veterinarian’s directions. Occasionally, NSAIDs can cause side effects. If your cat stops eating, is depressed, vomits or has diarrhea stop the drug immediately and contact your veterinarian. In most cases the side effects will disappear when the drug is stopped but in rare cases it may be serious. For this reason, it is important to consult with your veterinarian. If you notice any serious side effects or others not mentioned in this insert, please inform your veterinarian.

Pharmacology

Mode of Action

Robenacoxib is an NSAID of the coxib class. It is a highly potent and selective inhibitor of the cyclooxygenase 2 enzyme (COX-2). The cyclooxygenase enzyme (COX) is present in two forms. COX-1 is the “constitutive” form of the enzyme and has protective functions including in the gastrointestinal tract and kidney. COX-2 is the “inducible” form of the enzyme and is responsible for the production of mediators including PGE2 which induce pain, inflammation or fever.

Pharmacokinetics

Absorption: In a feline pharmacokinetic study, estimates for PK parameters in fasted cats included Cmax 1158.9 ng/ml, Tmax 0.5 h, AUC (0-) 1337 ng.h/ml, terminal half-life 1.9 hours and mean residence time 1.4 hours. Co-administration with the normal diet (1/3 of daily ration) produced no change in Cmax, Tmax or AUC (0-). Co-administration with the entire daily ration of food produced no change in Tmax but a 20% reduction in AUC (0-) and a 40.3% reduction in Cmax of robenacoxib.

The systemic bioavailability of non-flavoured robenacoxib tablets was 49% without food.

Distribution: Robenacoxib has a relatively small volume of distribution (Vss 190 ml/kg) and is highly bound to plasma proteins (>98%).

Biotransformation: Robenacoxib is extensively metabolized by the liver in cats. The systemic exposure of the γ-lactam metabolite is about 25% of robenacoxib exposure following oral administration to fed cats. Further, the systemic exposure to lactam appears to be two-fold greater in fed cats than in fasted cats (see Cautions). Apart from the one γ-lactam metabolite, the identity and activity of the other metabolites is not known in cats.

Elimination: Robenacoxib is rapidly cleared from blood (CL 0.44 L/kg/h) with a mean elimination half-life 1.1 h after intravenous administration. After oral administration of tablets, the mean terminal half-life from blood was 1.7 h, and elimination is predominantly through the biliary route (fecal and urinary excretion are 60 and 16.5% respectively).

The pharmacokinetics of robenacoxib do not differ between male and female cats.

Safety Studies

Animal Safety:

21 Day Target Animal Safety Study:

In a 21-day laboratory tolerance study, 8 month-old healthy, DSH cats (4/sex/group) were administered robenacoxib at a dose of 0 mg/kg (control group) or 24 mg/kg/day (10X the maximum exposure based on the single, 6 mg tablet size). All cats survived to study termination. Vomiting and decreased activity was noted in some of the treated cats. Two cats in the 10X group exhibited abnormal rear limb neurologic function. One of these cats also exhibited a head tilt and nystagmus at the end of the study. Mean food consumption was less in the 10X group. The mean kidney weights were lower in the 10X group compared to the control group; and the mean thymus weights were also lower in the 10X group compared to the controls. Two cats in the 10X group had chronic interstitial nephritis on histopathology; this finding was correlated with a renal mass observed on gross necropsy in one cat. One 10X cat had a focal cecal/large intestinal erosion. One 10X cat and one control cat had periportal, multifocal necrosis in one lobe of the liver. There were four 10X cats and 2 control cats with renal tubular degeneration. Under the conditions of this study, robenacoxib was well tolerated when administered at 24 mg/kg/day for 21 days, except for 2 cats in the 10X group with neurologic signs.

42 Day Target Animal Safety Study:

In a 42 day study, 8 month-old, healthy cats were administered robenacoxib at 0, 2, 6 or 10 mg/kg/twice daily. Small thymuses were noted in all robenacoxib-treated groups with corresponding organ weight decreases and/or atrophic changes on histopathology. There was a decrease in the kidney weights in the 10 mg/kg/twice daily-group compared to the controls. Vomiting was the most common adverse reaction noted in the treated cats. An adequate safety margin was demonstrated for ONSIOR when administered under the conditions of this 42-day study.

6 Month Target Animal Safety Study:

In a 6 month study, 8 month old, healthy cats (4/sex/group) were administered robenacoxib at 0, 1X (2.4 mg/kg), 3X (7.2 mg/kg) or 5X (12 mg/kg) once daily. One 5X cat had clonic seizures on Day 115 and was ataxic on Day 175. One 5X cat had skin cold to the touch on Day 106. One cat in the 1X group experienced urethral obstruction/FLUTD. Vomiting, decreased activity, injected sclera and soft stools were the most common adverse reactions observed in the treated groups. Soft stools and injected sclera were also observed in the control group.

The mean body weights in the 1X and 3X groups were lower than the controls from Day 21 - Day 182; and lower in the 5X group from Day 28 - Day 182. There was a clear dose-related and possibly time-related increase in the QTc interval at Day 41 and Day 175, particularly in the 3X and 5X groups, no other ECG abnormalities were noted.

There was no obvious accumulation in Cmax or AUC between Days 1, 31 and 171, and there was no apparent difference in parameters between males and females. The following parameters were calculated for the 1X dosage: Tmax was 0.5 h (median), the dose-normalized mean Cmax was 668 ng/mL and the dose-normalized mean area under the curve (AUC(0-inf)) was 902 h*ng/mL. Similarly, the following parameters were calculated for the 3X dosage: Tmax was 0.5 h (median), the dose normalized mean Cmax was 1019 ng/mL and the dose-normalized mean area under the curve (AUC(0-inf)) was 1394 h*ng/mL. For the 5X dosage the following parameters were calculated: Tmax was 1.0 h (median), the dose-normalized mean Cmax was 1198 ng/mL and the dose-normalized mean area under the curve (AUC(0-inf)) was 1884 h*ng/mL. A post hoc analysis of PK parameters revealed that dose normalized Cmax and AUC were greater than dose proportional.

The mean kidney weights were lower in all robenacoxib-treated groups. One 5X cat with decreased kidney weight and size also had transient increases in BUN and creatinine. There were transient increases in AST, amylase, and ALT in the 3X and 5X cats from Day 30 - Day 183. There was an increased severity of the tubular degeneration/regeneration in the kidneys of two 1X and two 5X cats with inflammation, papillary necrosis and papillary mineralization. An increased incidence of minimal to mild Kupffer cell pigmentation was observed in the livers of all robenacoxib-treated cats; however, no hepatocellular damage was noted on histopathology. One 5X cat had a focal, minimal ulcer of the gastric fundus (peptic and parietal cells).

This 6 month safety study supports the safe use of ONSIOR 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 for a maximum of 6 days.

EFFICACY STUDY

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.

Efficacy was demonstrated using ONSIOR in a blinded, positive controlled, multi-site field study conducted in France and the United Kingdom involving client owned cats. In this study cats with signs of acute musculoskeletal pain and inflammation caused by injury or a bite with or without an abscess were randomly assigned to receive 5 or 6 days of treatment with ONSIOR Tablets for Cats or the positive control article. There were 56 cats in the ONSIOR Tablets for Cats group and 48 cats in the positive control group. The primary endpoint was a global investigator score, a composite score of pain on palpation, inflammation and mobility. Non-inferiority was demonstrated for the primary endpoint. 63% of cats had concomitant treatments of antibiotics, lancing and draining of abscesses. The results of the study demonstrated the efficacy of ONSIOR Tablets for Cats was non-inferior to the positive control treatment.

2. For the control of postoperative pain and inflammation associated with onychectomy, ovariohysterectomy, and castration in cats.

Efficacy was demonstrated using ONSIOR in a masked, controlled, multi-site field study. In this study, 249 cats presenting for ovariohysterectomy or castration in conjunction with an onychectomy (forelimbs only) were randomly administered ONSIOR in the active treatment group, or a placebo in the control treatment group. There were 167 cats in the ONSIOR group and 82 cats in the control group. Cats treated with ONSIOR, butorphanol and a metacarpal 4 point ring block using bupivacaine were compared to cats treated with a placebo tablet, butorphanol and a metacarpal 4 point ring block using bupivacaine on the need to provide rescue medication to control postoperative pain. The cats were assessed at extubation, and at 30 minutes, 1h, 3h, 5h, 8h, 24h, 28h, 32h, 48h and 52 hours post extubation. The drug was administered approximately 30 minutes prior to surgery along with pre-anesthetic medications and continued once daily for two additional treatments. Effectiveness was evaluated in 244 cats and field safety was evaluated in 249 cats. A statistically significant difference in the proportion of treatment successes in the ONSIOR treatment group (137/164 or 83.5%) compared to the control treatment group (43/80 or 53.8%) was observed. Twenty-seven out of 164 ONSIOR cases (16.5%) and 37 out of 80 control treatment cases (46.2%) were treatment failures. The most common reasons checked by investigators for rescue were tenderness of surgical sites, aggressive/guarding behaviour, vocalizing, and agitated, purposeful avoidance of painful stimulus, hunched position, trembling/shaking, little or no social response, and tachycardia/tachypnea.

Statistically significant differences for pain elicited on palpation at the spay or castration incision site, behaviour following social interaction and posture score at various post-surgical time points were also observed. The results of the field study demonstrate that ONSIOR, when administered for a maximum of three days, is effective and well-tolerated as an adjunctive medication in the control of postoperative pain associated with onychectomy, ovariohysterectomy, and castration in cats.

PRESENTATION:

ONSIOR is available in 6 mg tablet strength for oral administration.

STORAGE CONDITIONS:

ONSIOR should be stored between 5°C and 25 °C.

Elanco Canada Limited, 150 Research Lane, Suite 120, Guelph, Ontario N1G 4T2

Date: February 2016

Elanco, Onsior and the diagonal bar are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries or affiliates.

26Feb2016

CPN: 1231105.2

ELANCO CANADA LIMITED
Distributed by ELANCO, Division Eli Lilly Canada Inc. & ELANCO CANADA LIMITED (successor to Novartis Animal Health Canada Inc.)
RESEARCH PARK CENTRE, 150 RESEARCH LANE, SUITE 120, GUELPH, ON, N1G 4T2
Telephone:   519-821-0277
Order Desk:   800-773-7603
Fax:   519-821-7831
Elanco Canada Limited Customer Service Telephone:   800-387-6325
Elanco Canada Limited Customer Service Fax:   800-827-5782
Website:   www.Elanco.ca
Every effort has been made to ensure the accuracy of the Onsior (tablets for cats) information published above. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the Canadian product label or package insert.

Copyright © 2016 North American Compendiums. Updated: 2016-10-31

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