Varenzin - CA 1 (Molidustat) Oral Suspension 25mg/mL, 27mL

Varenzin - CA1 is indicated for the control of nonregenerative anemia associated with chronic kidney disease (CKD) in cats. Varenzin-CA1 is the first and only FDA conditionally approved option for the treatment of CKD-related anemia, setting the new standard of care ofr cats suffering from the debilitating effects of this disease.

Key Benefits:

• A first of its kind in veterinary medicine, Varenzin-CA1 stimulates a cat's body to create its own erythropoietin (EPO)
• Approve for convenient at-home treatment; no in-clinic injections needed
• Reasonable expectation of efficacy with minimal side effects
• No costly and inconvenient extra label use of erythropoietin stimulating agents (ESAs)

Shake well before use.

The dosage of Varenzin-CA1 is 2.3 mg/lb (5 mg/kg) body weight (bw) administered orally once daily for up to 28 consecutive days. Treatment may be repeated after a minimum 7-day pause (see Monitoring and repeating Treatment). Varenzin-CA1 should be administered using the dosing syringe provided in the pakage. The dosing syringe is marked in increments of 0.1 mL. The dose should be rounded up to the nearest 0.1 mL.

Dosing Information:

To ensure the correcct dose is administered, body weight shoul be determined prior to starting treatment.

Note: The syringe included with the Varenzin-CA1 product cannot be used to accurately dose cats weighing under 3.4 pounds. Cats greater than 13.2 lb bw should be treated with a dose of 2.3 mg/lb bw rounded up to the nearest 0.1 mL.

Administration:

Shake well before use. Remove screw cap. Use the enclosed syringe for each treatment. Place the syringe nozzle firmly into the opening of the bottle. Turn the bottle upside down and withdraw the necessary volume. Turn the bottl back into an upright position before removing the syringe. The product should be administered with the syringe into the cat's mouth. See illustrations 1 through 4 below for adminsitrations steps:

After administration, close bottle tightly with cap and store syringe in the carton together with the product. Do not disassemble or wash the syringe. The product should be given once daily for up to 28 consecutive days. If the cat vomits after consuming any portion of the dose, the cat should not be re-dosed and should be considered as dosed for the day.

Monitoring and Repeating Treatment

Treated cats should initially have their hematocrit (HCT) or packed cell volume (PCV) levels monitored weekly beginning about the 14th day of the 28-day treatment cycle to ensre HCT or PCV does not exceed the upper limit of the reference range.

After treatment cessation the hematocrit level should be periodically checked (for example, weekly, every 2 weeks or monthly). When the HCT or PCV level declines below the lower limit of the reference range, a new treatment cycle should be started The interval betwen treatment cycles will vary between cats and may change over time for an individual cat but should be at least 7 days. If a cat does not respond to treatment after 3 weeks (see Reasonable Expectation of Effectiveness), It is recommended to re-examine the animal for any other uderlying condition that may contribute to anemia, such as iron deficiency, inflammatory diseases or blodd loss. It is advised to treat the underlying condition before restarting treatmet with Varenzin-CA1.