Sponsored by Ceva Animal Health, LLC
*This is a conceptual track for the average case of acute pancreatitis in dogs. Diagnostic and therapeutic interventions and monitoring parameters should be chosen based on individual case factors.
PANOQUELL®-CA1 (Fuzapladib Sodium for Injection) for the Management of Clinical Signs Associated with Acute Canine Pancreatitis
PANOQUELL®-CA1 is a leukocyte function-associated antigen-1 (LFA-1) activation inhibitor. LFA-1 activation inhibition results in anti-inflammatory effects through prevention of inflammatory cell adhesion and migration into sites of tissue injury and inflammation. These anti-inflammatory properties are thought to limit pancreatic lesion expansion and help prevent complications such as multiorgan failure.
PANOQUELL®-CA1 is administered at 0.4 mg/kg once daily for 3 consecutive days by IV bolus in either an inpatient or outpatient setting.
PANOQUELL®-CA1 has been shown to be safe to use in conjunction with fluid therapy, pain control, antiemetics, parasiticides, and standard supportive care for patients with clinical signs associated with acute pancreatitis.
PANOQUELL®-CA1 comes in a multiuse vial that, when reconstituted, is stable in the refrigerator for 28 days.
PANOQUELL®-CA1 (fuzapladib sodium for injection) is indicated for the management of clinical signs associated with acute onset of pancreatitis in dogs.
Important Safety Information
The safe use of PANOQUELL®-CA1 has not been evaluated in dogs with cardiac disease, hepatic failure, renal impairment, dogs that are pregnant, lactating, intended for breeding or puppies under 6 months of age. PANOQUELL®-CA1 should not be used in dogs with a known hypersensitivity to fuzapladib sodium. PANOQUELL®-CA1 is a highly protein bound drug and its use with other highly protein bound medications have not been studied. The most common side effects in the pilot field study were anorexia, digestive tract disorders, respiratory tract disorders and jaundice. PANOQUELL®-CA1 is not for use in humans. 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. For additional information on the use of PANOQUELL®-CA1, please refer to the product insert.
Conditionally approved by the FDA pending a full demonstration of effectiveness under application number 141-567. Based on the data submitted by the sponsor for the conditional approval of PANOQUELL®-CA1, the FDA has determined that the drug is safe and has a reasonable expectation of effectiveness when used according to the labeling. It is a violation of Federal law to use this product other than as directed in the labeling.
What Does FDA Conditional Approval Mean?
Conditional approval may be granted for a veterinary drug when it is shown to be safe and when used according to the label. In addition, the drug must also demonstrate a “reasonable expectation of effectiveness,” but has not yet been proven to meet the “substantial evidence” standard of effectiveness required for full approval. Conditionally approved drugs may not be used for any off-label indications.
PANOQUELL® is a registered trademark of Ishihara Sangyo Kaisha, Ltd.