Description

PANOQUELL-CA1 Injection

Fuzapladib Sodium for Injection

Selective LFA-1 Activation Inhibitor | Management of Clinical Signs Associated with Acute-Onset Pancreatitis in Dogs

Manufactured for: Ishihara Sangyo Kaisha, Ltd., Osaka, Japan
Distributed by: Ceva Animal Health, LLC
Country of Origin: Japan
Dosage form: Sterile lyophilized powder for IV injection
Presentation: Two-vial system — 14 mg fuzapladib sodium lyophilized powder + 3.9 mL sterile diluent.

Ingredients & Composition

Lyophilized powder vial:

Fuzapladib sodium — 14 mg
D-mannitol — 52.5 mg
Tromethamine — 21 mg

Diluent vial:

3.9 mL bacteriostatic water for injection
Benzyl alcohol — 1.8% w/v
After reconstitution with 3.5 mL of the supplied diluent, each mL contains 4 mg fuzapladib sodium, 15 mg D-mannitol, 6 mg tromethamine and 18 mg benzyl alcohol. No other diluent should be used.

Description / Action

PANOQUELL-CA1 Injection contains fuzapladib sodium, a selective inhibitor of leukocyte function-associated antigen-1 (LFA-1). Inhibition of LFA-1 reduces inflammatory cell adhesion and migration into sites of tissue injury and inflammation.

Class

LFA-1 activation inhibitor / Anti-inflammatory agent

Indication / Uses

Management of clinical signs associated with acute onset of pancreatitis in dogs.

The FDA continues to list PANOQUELL-CA1 as a conditionally approved product for this indication.

Dosage and administration

0.4 mg/kg (0.1 mL/kg) IV bolus once daily for 3 consecutive days. Administer the IV bolus over 15 seconds to 1 minute.

Reconstitution / Pharmaceutical precautions

1. 1. Withdraw 5 mL of the supplied sterile diluent.
   2. Transfer slowly into the powder vial.
   3. Gently swirl until completely dissolved.
   4. Gently swirl before every use.
   5. Draw the required dose with a new sterile needle and syringe.
   6. Administer promptly after drawing into the syringe.
   7. Refrigerate the reconstituted product at 2–8°C and use within 28 days.

Store unopened vials at 15–25°C.

Overdose / Side effects / Contraindications / Warnings

Contraindication

Known hypersensitivity to fuzapladib sodium.

Important precautions

Safe use has not been evaluated in dogs with cardiac disease, hepatic failure or renal impairment.

Not evaluated in pregnant, lactating or breeding dogs.

Not evaluated in dogs under 6 months of age.

Fuzapladib is highly protein bound; concurrent use with other highly protein-bound drugs has not been studied.

Reported adverse reactions

Anorexia
Digestive tract disorders
Respiratory tract disorders
Hepatopathy/jaundice
Abnormal urine
Diarrhea
Arrhythmia
Cardiac arrest
Hyperthermia
Pruritus/urticaria
Hypersalivation
Injection-site swelling/bruising
Tremor/shivering/shaking
Hypertension
Anaphylaxis
Facial/tongue swelling, collapse and seizure were also reported voluntarily in foreign-market post-approval experience.

Safety: Age / Pregnancy / Withdrawal

Age: Safety has not been evaluated in dogs <6 months.
Pregnancy/Lactation/Breeding: Safety has not been evaluated.
Human pregnancy exposure: Pregnant, breastfeeding or pregnancy-planning individuals should avoid direct contact because limited teratogenicity data are available.
Withdrawal period: Not applicable for companion dogs.

Substitute

No direct therapeutic substitute with the same active ingredient/mechanism was identified. Fuzapladib sodium is a specific LFA-1 inhibitor developed for canine acute-onset pancreatitis.

Other pancreatitis therapies should not be presented as direct substitutes, because they have different mechanisms and treatment roles.