Safety

Dog study results

Extended-release bupivacaine has been studied in dog models as part of the development for human use. These studies were centered on the local and systemic safety and tolerability of the suspension in a dog model of inguinal hernia repair and reported similar macroscopic and microscopic findings in control and bupivacaine liposome injectable suspension-treated animals at day 15. There were no significant adverse effects on wound healing using bupivacaine liposome injectable suspension at doses higher than recommended with clinical use in dogs.

Under the same group of investigators, the effects of repeated doses of bupivacaine liposome injectable suspension in dogs was evaluated. Dogs were injected twice weekly for a total of eight injections

with bupivacaine liposome injectable suspension (at doses higher than clinically recommended), bupivacaine HCl, or saline, administered into the subcutaneous tissue over the scapulae. There were no observed clinical signs consistent with CNS toxicity and no ECG abnormalities. In the bupivacaine liposome injectable suspension group, the only difference observed as compared to the other groups was macroscopic and microscopic indications of mild-to-moderate granulomatous inflammation. These observations were considered a normal response to the liposomes.

See chart below for additional adverse events observed as part of the clinical field study in dogs

NOCITA safety information

Now Approved For Cats

NOCITA is now FDA-approved for use in cats as a peripheral nerve block to provide regional post-operative analgesia following onychectomy. Please see the full Prescribing Information for more detail.

Cat study results

The safety of NOCITA® (bupivacaine liposome injectable suspension) was evaluated in 120 NOCITA treated cats and 121 saline (placebo) treated cats as part of the clinical field study in cats undergoing onychectomy. NOCITA was administered as a 4-point peripheral nerve block at a dose of 5.3 mg/kg per forelimb (0.4 mL/kg per forelimb, for a total dose of 10.6 mg/kg/cat). The most common adverse events observed were elevated body temperature, infection or chewing/licking at the surgical site. The results of this study showed that NOCITA was well-tolerated by cats.

Separately, in a 22 day laboratory study, 40 healthy cats were randomized to receive 10.6, 21.2, or 31.8 mg/kg of NOCITA, 5.3 mg/kg bupivacaine HCl, or saline control by injection adjacent to the femoral nerve on days 0, 9, and 18. The NOCITA doses correspond to 1x, 2x and 3x the maximum labeled total dose of 10.6 mg/kg/cat, representing 2x, 4x and 6x the maximum labeled dose of 5.3 mg/kg/forelimb. There were no clinically relevant effects of NOCITA on clinical pathology findings, body weights, electrocardiography parameters, or organ weights. Results showed NOCITA did not produce systemic toxicity and had an acceptable margin of safety in cats, even when administered at up to 6 times the therapeutic dose. 

Clinical References

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Experience the Difference

“We began using Nocita on canine patients undergoing cranial cruciate ligament stabilization surgeries and have been very pleased with the results.  The product is intuitive to use and we have observed nothing but positive effects for our patients post-operatively.  Specifically, these patients appear to bear more significant weight immediately post-op than usually expected, require very little rescue analgesia, and are willing to eat early in the recovery period which has allowed easy transition to oral medications.  Nocita has quickly become standard protocol for analgesia on our canine cruciate ligament stabilization procedures.” 

Veterinary Surgeon

Milwaukee WI

DOG INDICATION: For single-dose infiltration into the surgical site to provide local post-operative analgesia for cranial cruciate ligament surgery in dogs.

IMPORTANT SAFETY INFORMATION: NOCITA® (bupivacaine liposome injectable suspension) is for local infiltration injection in dogs only. Do not use in dogs younger than 5 months of age, that are pregnant, lactating or intended for breeding. Do not administer by intravenous or intra‐arterial injection. Adverse reactions in dogs may include discharge from incision, incisional inflammation and vomiting. Avoid concurrent use with bupivacaine HCl, lidocaine or other amide local anesthetics. Please see the full Prescribing Information for more detail.

CAT INDICATION: For use as a peripheral nerve block to provide regional post-operative analgesia following onychectomy in cats.

IMPORTANT SAFETY INFORMATION: NOCITA® (bupivacaine liposome injectable suspension) is for use as a peripheral nerve block in cats only. Do not use in cats younger than 5 months of age, that are pregnant, lactating, or intended for breeding. Do not administer by intravenous or intra‐arterial injection. Adverse reactions in cats may include elevated body temperature, infection or chewing/licking at the surgical site. Avoid concurrent use with bupivacaine HCl, lidocaine or other amide local anesthetics. Please see the full Prescribing Information for more detail.

Other therapeutics from Aratana

ENTYCE logo

Finally, appetite stimulation is in your control.

ENTYCE® (capromorelin oral solution) is the ONLY FDA-approved veterinary therapeutic designed to safely and effectively stimulate appetite in dogs. Administered orally once a day, ENTYCE is appropriate for treating inappetence caused by chronic and acute conditions.

VIEW WEBSITE

IMPORTANT SAFETY INFORMATION: ENTYCE® (capromorelin oral solution) is for use in dogs only. Do not use in breeding, pregnant or lactating dogs. Use with caution in dogs with hepatic dysfunction or renal insufficiency. Adverse reactions in dogs may include diarrhea, vomiting, polydipsia, and hypersalivation. Should not be used in dogs that have a hypersensitivity to capromorelin. Please see the full Prescribing Information for more detail.