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How does PANOQUELL®-CA1 (fuzapladib sodium for injection) work?

Fuzapladib is a Leukocyte Function Associated Antigen-1 (LFA-1) activation inhibitor. PANOQUELL®-CA1 inhibits activation of LFA-1, which results in anti-inflammatory effects. LFA-1 inhibition prevents 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 multi-organ failure.

What part does LFA-1 play in acute canine pancreatitis (ACP)?

Infiltration of neutrophils is a hallmark of ACP. When LFA-1, is inhibited, the neutrophils cannot extravasate into the pancreas and cause inflammation.

Can you administer PANOQUELL®‑CA1 with other medications?

Yes, all dogs enrolled in the efficacy study for conditional approval received the standard of care for acute onset of pancreatitis: including fluids, nutritional support, pain medications (excluding NSAIDs), anti-emetics and medications used to treat well-controlled pre-existing conditions. Some dogs also received parasiticides and vaccinations. 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.

What are the common adverse reactions of PANOQUELL®‑CA1?

From the pilot efficacy study for conditional approval, the most common adverse reactions were anorexia, digestive tract disorders, respiratory tract disorders, hepatopathy and jaundice.

What are the contraindications of PANOQUELL®‑CA1?

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

Is an intravenous (IV) catheter required for administration of PANOQUELL®‑CA1?

PANOQUELL®-CA1 is labeled to be given intravenously. Administration can be accomplished via peripheral IV catheter, butterfly catheter or directly with a syringe over 15 seconds to one minute. Do not dilute into IV fluid bag for administration.

Are specific diagnostic test results required before administration of PANOQUELL®‑CA1?

No, a confirmation test for pancreatitis is not needed. PANOQUELL®-CA1 is indicated for the management of clinical signs associated with acute onset of pancreatitis in dogs.

What is MCAI-7?

Modified Canine Activity Index (MCAI). MCAI-7 score includes seven areas of clinical relevance to dogs with acute onset of pancreatitis: decreased activity, decreased appetite, vomiting, cranial abdominal pain, dehydration, stool consistency and blood in the stool. MCAI-7 is an objective measurement tool for assessing the severity for intestinal diseases such as pancreatitis and inflammatory bowel disease. Click here to read more.

What is the dosage for the canine patient?

PANOQUELL®-CA1 dosage is 0.4 mg/kg (0.1 mL/kg) body weight once daily for three consecutive days by intravenous (IV) bolus injection over 15 seconds to 1 minute. The reconstituted product contains 4 mg/mL of fuzapladib sodium. Dosage and vial chart coming soon.

How do you store and reconstitute PANOQUELL®‑CA1?

Store unopened vials at room temperature, 59°-77° F (15°-25° C). After reconstitution, store remaining product at refrigerated conditions, 36°-46° F (2°-8° C). After puncturing the stopper, the product remains stable under refrigeration for 28 days. Each vial contains 14 mg fuzapladib sodium, 4 mg/mL when reconstituted. When reconstituting, do not use a transfer needle. Click here to view the product insert for reconstitution instructions.

What does 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.

Click here to learn more on conditional approval.

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