Fuzapladib

Indications

PANOQUELL ® -CA1 is indicated for the management of clinical signs associated with acute onset of pancreatitis in dogs.

Dosage and Administration

Prior to use, the sterile lyophilized powder should be reconstituted (see Reconstitution Procedures ) using the sterile diluent provided, resulting in a 4 mg/mL solution of PANOQUELL ® -CA1. Once reconstituted, swirl the bottle gently before every use to ensure a uniform solution. The reconstituted product is administered at a dosage of 0.4 mg (0.1 mL) per kg body weight once daily for three consecutive days by intravenous (IV) bolus injection over 15 seconds to 1 minute. Reconstitution Procedures: The items needed for reconstitution are: Sterile PANOQUELL ® -CA1 lyophilized powder Sterile diluent Sterile 5 mL syringe for transfer of diluent Sterile needle Steps for reconstitution: Using a sterile needle and syringe, withdraw 3.5 mL of the sterile diluent from the vial and slowly transfer the sterile diluent into the vial containing the sterile PANOQUELL ® -CA1 lyophilized powder through the stopper. There is more sterile diluent supplied than the 3.5 mL needed for reconstitution. Once the sterile diluent has been added to the powder vial, remove the needle and syringe from the vial. Discard unused sterile diluent, syringe, and needle. Gently swirl the vial until the powder is fully reconstituted into solution, leaving no visible residue or undissolved material. Before each use, gently swirl to ensure a uniform solution. Draw up the appropriate dose using a new sterile needle and syringe. Administer the dose promptly after drawing into the dosing syringe. Store any remaining reconstituted product at refrigerated conditions, 36˚ to 46˚F (2˚ to 8˚C). Reconstituted product remains stable under refrigeration for 28 days.

Contraindications

Do not use in dogs with a known hypersensitivity to fuzapladib sodium.

Warnings

User Safety Warnings: Not for use in humans. Keep this medication out of reach of children. In case of accidental self-injection: Seek medical advice immediately and show the package insert or label to the physician. In case of accidental skin contact: Wash the exposed skin with water for at least 15 minutes. If redness and swelling occur, seek medical advice immediately and show the package insert or label to the physician. In case of accidental eye exposure: Wash the eyes with water for at least 15 minutes. If wearing contact lenses, rinse the eyes first, then remove contacts and continue to rinse with water. If redness and swelling occur, seek medical advice immediately and show the package insert or label to the physician. In case of accidental ingestion: Rinse the mouth out with water. Do not induce vomiting unless directed to do so by medical personnel. Seek medical advice immediately and show the package insert or label to the physician. Limited data is available on the potential teratogenic effects of fuzapladib sodium. Therefore, anyone who is pregnant, breast feeding, or planning to become pregnant should avoid direct contact with PANOQUELL ® -CA1. Anyone with known hypersensitivity to fuzapladib sodium or to any of the excipients should avoid contact with PANOQUELL ® -CA1. To obtain a Safety Data Sheet, contact Ceva Animal Health, LLC, at 1-800-999-0297 or www.ceva.com.

Precautions

PANOQUELL ® -CA1 is highly protein bound. Use with caution with other medications that are highly protein bound. The concomitant use of PANOQUELL ® -CA1 with other protein bound drugs has not been studied in dogs. Commonly used protein bound drugs include non-steroidal anti-inflammatory drugs (NSAIDs), anti-emetics, antibiotics, diuretics, and behavioral medications. Drug compatibility should be monitored in patients requiring adjunctive therapy. Concurrent medications used during the pilot effectiveness study with fuzapladib sodium included, but were not limited to, pain medications (excluding NSAIDs), antiemetics, parasiticides, vaccinations, and medications used to treat well-controlled pre-existing conditions. The safe use of PANOQUELL ® -CA1 has not been evaluated in dogs with cardiac disease, hepatic failure, or renal impairment. The safe use of PANOQUELL ® -CA1 has not been evaluated in dogs that are pregnant, lactating, or intended for breeding. The safe use of PANOQUELL ® -CA1 has not been evaluated in dogs less than 6 months of age.

Adverse Reactions

In a well-controlled pilot field study to assess the effectiveness and safety of fuzapladib sodium (not commercial formulation) in client-owned dogs diagnosed with acute onset of pancreatitis (see REASONABLE EXPECTATION OF EFFECTIVENESS ), 31 dogs administered fuzapladib sodium and 30 dogs administered vehicle control were evaluated for safety. The vehicle control was excipient sterile lyophilized powder solubilized in 1 mL of Sterile Water for Injection, USP. The adverse reactions observed in the study and the number of dogs experiencing each adverse reaction is summarized in Table 1. In Table 1, digestive tract disorders included regurgitation (1 fuzapladib, 2 vehicle control), vomiting (1 fuzapladib, 1 vehicle control), flatulence (1 fuzapladib), nausea (1 fuzapladib), and enteritis (1 fuzapladib). Respiratory tract disorders included pneumonia (2 fuzapladib, 1 vehicle control), inspiratory crackles (1 fuzapladib, 2 vehicle control), tachypnea (2 fuzapladib), and dyspnea (1 fuzapladib). Abnormal urine included proteinuria (2 fuzapladib, 2 vehicle control), hematuria (2 vehicle control), and malodorous urine (1 fuzapladib). Some of these dogs were reported with more than one abnormality. Note: Some dogs experienced an adverse reaction on more than one occasion but are only presented once in the table above for each reported adverse reaction. Five out of the 61 enrolled dogs died during the study: four in the fuzapladib sodium group and one in the vehicle control group. Two additional dogs in the vehicle control group were euthanized shortly after completion of the study. Of the seven dogs that died or were euthanized during or after the study, three deaths could be attributed to complications from severe acute onset of pancreatitis: two in the fuzapladib sodium group and one in the vehicle control group. One dog in the fuzapladib sodium group was suspected to have aspiration pneumonia and died after experiencing cardiac arrest. One dog in the vehicle control group was euthanized because of a poor prognosis. Two deaths could be attributed to causes other than acute onset of pancreatitis: one dog in the fuzapladib sodium group had intestinal lymphoma and one vehicle control group dog had a cranial thromboembolic event and a pheochromocytoma. Foreign Market Experience The following adverse events were reported voluntarily during post-approval use of the product in dogs in foreign markets: facial and tongue swelling, collapse, and seizure. These adverse events occurred within 24 hours of administration.

Description

PANOQUELL ® -CA1 (fuzapladib sodium for injection) is a selective inhibitor of LFA-1. Fuzapladib sodium is the non-proprietary designation for N-[2-((ethylsulfonyl)amino)-5-(trifluoromethyl)-3-pyridinyl] cyclohexanecarboxamide monosodium. PANOQUELL ® -CA1 has a molecular weight of 401.38 and the following structural formula: PANOQUELL ® -CA1 consists of two separate vials. One vial contains 14 mg of fuzapladib sodium, 52.5 mg of D-mannitol, and 21 mg of tromethamine as sterile lyophilized powder. The second vial of 3.9 mL sterile diluent (bacteriostatic water for injection), containing 1.8% w/v benzyl alcohol, is for reconstituting the sterile lyophilized powder prior to use. No other diluent should be used. When reconstituted with 3.5 mL of the provided Bacteriostatic Water for Injection, each milliliter of reconstituted drug product contains 4 mg fuzapladib sodium, 15 mg D-mannitol, 6 mg tromethamine, and 18 mg benzyl alcohol. The pH was adjusted with hydrochloric acid or sodium hydroxide. chemical structure

FDA adverse event reports

The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming fuzapladib as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.

These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.