Target species
Cats.
Indications for use for each target species
For the management of non-regenerative anaemia associated with chronic kidney disease (CKD) in cats, by increasing haematocrit/packed cell volume.
Contraindications Do not use in cases of hypersensitivity to the active substance, or to any of the excipients.
Treatment with molidustat should only be initiated once the haematocrit (HCT)/packed cell volume (PCV) is ≤28%. Under treatment, the HCT/PCV should be monitored on a regular basis and the treatment needs to be discontinued once the upper reference range is reached to avoid the risk of thrombosis.
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. Use according to the benefit-risk assessment by the responsible veterinarian in these cases.
Hypoxia-inducible factor (HIF) -prolyl hydroxylase (PH) inhibitors have been associated with thromboembolic disease.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
This veterinary medicinal product may cause increased erythropoietin levels, increased haemoglobin and haematocrit levels and dizziness after accidental oral ingestion. At higher dosages symptoms as increased heart rate, nausea, vomiting, headache and flushing may be possible.
Avoid accidental ingestion and contact with skin.
In order to prevent children getting access to a filled syringe, do not leave the filled syringe unattended and administer the veterinary medicinal product immediately after filling the syringe.
After administration return the unwashed syringe in the carton together with the veterinary medicinal product.
Wash hands after use.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
People with known hypersensitivity to molidustat sodium should avoid contact with the veterinary medicinal product.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Cats:
Common (1 to 10 animals/100 animals treated): | Vomiting |
Very rare (<1 animal/10,000 animals treated, including isolated reports): | Thrombosis1 |
1Thrombosis might be associated to a HIF-PH inhibitors class effect.
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 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. Use of the product during pregnancy and lactation, or in breeding cats is not recommended.
Laboratory studies in rats have shown at a dose of 30 mg/kg bodyweight maternotoxic effects including ocular malformations, decreased foetal weight and increased post implantation loss.
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 including iron supplements containing multivalent cations such as calcium, iron, magnesium, or aluminum may decrease molidustat sodium absorption.
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 mg molidustat sodium/kg, equivalent to 4.66 mg molidustat/kg and 0.2 ml suspension/kg once daily for up to 28 consecutive days:
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.
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. Prior to starting a new treatment cycle, it should be confirmed that the cat is anaemic (HCT/PCV <28%). If at the end of the current treatment cycle the cat remains anaemic, a new treatment cycle may be started without interruption in treatment.
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.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
Treatment in young, healthy, non-anaemic animals resulted in elevated HCT/PCV values, and an increase in total protein, potassium and calcium. Histopathologic abnormalities in these animals included congestion of the vasculature in multiple organs.
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.