Target species
Cats
Indications for use for each target species
For the treatment of non-regenerative anaemia associated with chronic kidney disease (CKD) in cats.
Contraindications
Do not use in cases of hypersensitivity to the active substance, or to any of the excipients.
Special warnings
None.
Special precautions for use
Special precautions for safe use in the target species:
The safety of the veterinary medicinal product has not been evaluated in cats less than 1 year of age or weighing less than 2 kg bodyweight.
Hypoxia-inducible factor (HIF) -prolyl hydroxylase (PH) inhibitors have been associated with thromboembolic disease. Use with caution in cats that may be predisposed to thromboembolic disease.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Accidental ingestion may cause flushing of the skin and/or orthostatic effects such as dizziness. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Target species: Cats
Common (1 to 10 animals/ 100 animals treated): | Vomiting |
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy, lactation or for breeding cats.
Interaction with other medicinal products and other forms of interaction
The use of the veterinary medicinal product administered concurrently with other erythropoiesis- stimulating agents, including recombinant erythropoietin drugs, has not been studied.
Phosphate binders or other products containing multivalent cations such as calcium, iron, magnesium or aluminium have been shown to chelate with other HIF-PH inhibitors.
Based on information in humans consider staggered administration of Varenzin and phosphate binders or iron supplements (at least 1 hour apart), to prevent potentially decreased absorption of molidustat. The veterinarian should consider monitoring iron levels.
Administration routes and dosage
For oral use.
To ensure a correct dosage, body weight should be determined as accurately as possible prior to starting treatment.
The veterinary medicinal product should be administered in accordance with the following table to ensure a dose of 5.0 mg/kg, equivalent to 0.2 ml/kg:
Weight Range in kilograms (kg) | Volume (ml) |
2 | 0.4 |
2.1 to 2.5 | 0.5 |
2.6 to 3.0 | 0.6 |
3.1 to 3.5 | 0.7 |
3.6 to 4.0 | 0.8 |
4.1 to 4.5 | 0.9 |
4.6 to 5.0 | 1.0 |
5.1 to 5.5 | 1.1 |
5.6 to 6.0 | 1.2 |
For treating cats with a bodyweight greater than 6.0 kg, calculate the dose using 0.2 ml/kg bodyweight and round up to the nearest 0.1 ml.
Shake the bottle well before use and remove the screw cap. Place the syringe nozzle firmly into the opening of the bottle. Turn the bottle upside down and withdraw the required volume of the veterinary medicinal product into the syringe. Turn the bottle back into an upright position before removing the syringe from the bottle. Administer the contents of the syringe into the cat’s mouth. See illustrations 1 through to 4 below for administration steps:
Step 1:
Step 2:
Step 3:
Step 4:
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 veterinary medicinal 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 Repeated Treatment:
Treated cats should initially have their haematocrit (HCT) or packed cell volume (PCV) levels monitored weekly beginning about the 14th day of the 28-day treatment cycle to ensure HCT or PCV does not exceed the upper limit of the reference range. Discontinue treatment if HCT or PCV exceeds the upper limit of the reference range.
After treatment cessation the haematocrit level should be periodically checked. When the HCT or PCV level declines below the lower limit of the reference range, a new treatment cycle should be started.
If a cat does not respond to treatment after 3 weeks, it is recommended to re-examine the animal for any other underlying condition that may contribute to anaemia, such as iron deficiency, inflammatory diseases or blood loss. It is advised to treat the underlying condition before restarting treatment.
In a clinical field trial, 75 cats were evaluated for effectiveness (40 received Varenzin and 35 received a control product), 68% of cats receiving Varenzin achieved treatment success after 28 days of treatment, compared to 17% in the placebo group. Treatment success was defined as an increase of ≥4% points in haematocrit observed on Study Day 28 and/or an overall 25% increase in haematocrit from baseline (Study Day 0).
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
None known.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
Withdrawal periods
Not applicable.