Target species
Cats.
Indications for use for each target species
For the alleviation of pain associated with osteoarthritis in cats.
Contraindications
Do not use in animals under 12 months of age.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in animals intended for breeding.
Do not use in pregnant or lactating animals.
Special warnings
This veterinary medicinal product may induce transient or persistent anti-drug antibodies (immunogenicity), including neutralising anti-drug antibodies.
In clinical studies, a small proportion of cats developed anti‑drug antibodies after one or multiple doses. At the proposed commercial dose (0.5 mg relfovetmab per kg body weight), the incidence of anti‑drug antibodies ranged from approximately
2% to 4%.
Due to the limited number of animals developing anti‑drug antibodies, the impact of immunogenicity on safety or efficacy could not be determined. No adverse events directly attributable to anti‑drug antibodies were identified. No information is available for treatment periods longer than 9 months.
Immunogenicity has not been investigated in cats previously treated with other anti-NGF monoclonal antibodies. Continuation of treatment should be based on the individual response of each animal. If a positive response is not observed, consider alternative treatments.
Special precautions for use
Special precautions for safe use in the target species:
As the following conditions were not studied in clinical trials, the safety of relfovetmab has not been established in cats with intervertebral disc disease, recent injuries resulting in neurologic deficit(s) or lameness due to neoplasia, primary neurologic or immunologic disorders, infection, recent joint trauma, non‑healed fractures, or ligament ruptures within six months.
In the clinical trials, joint radiographs were only taken at screening. Therefore, potential negative effects on the progression of the osteoarthritis have not been investigated radiographically.
The efficacy and safety of the veterinary medicinal product have not been studied in cats weighing less than 2.5 kg or more than 13.7 kg.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Hypersensitivity reactions, including anaphylaxis, could potentially occur in the case of accidental self-injection. Repeated accidental self-injection may increase the risk of hypersensitivity reactions.
In humans, minor and reversible peripheral neurologic signs (for example, paraesthesia, dysesthesia, hypoesthesia) have been reported in a small subset of patients receiving therapeutic doses of human anti-NGF monoclonal antibodies. The frequency of these events is dependent on factors such as dose level and duration of dosing. These events were transitory and reversible upon discontinuation of treatment.
The importance of nerve growth factor in ensuring normal foetal nervous system development is well-established and laboratory studies conducted on non-human primates with human anti-NGF antibodies have shown evidence of reproductive and developmental toxicity. Pregnant women, women trying to conceive, and breastfeeding women should take extreme care to avoid accidental self-injection.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
This veterinary medicinal product may cause eye irritation. Avoid contact with the eyes. In case of accidental contact with eyes, rinse thoroughly with water. If irritation persists, seek medical advice and show package leaflet or the label to the physician.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Cats:
Very common (>1 animal / 10 animals treated): | Immediate pain upon injection |
Common (1 to 10 animals / 100 animals treated): | Dermatitis |
Uncommon (1 to 10 animals / 1 000 animals treated): | Pruritus Skin scabs |
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 and lactation or in breeding cats. Laboratory studies with human anti-NGF antibodies in cynomolgus monkeys have shown evidence of teratogenic and foetotoxic effects.
Pregnancy and lactation:
Do not use in pregnant or lactating animals.
Fertility:
Do not use in breeding animals.
Interaction with other medicinal products and other forms of interaction
There are no safety data on the concurrent long-term use of non-steroidal anti-inflammatory drugs (NSAIDs) and relfovetmab in cats. In clinical trials in humans, rapidly progressive osteoarthritis has been reported in patients receiving humanised anti-NGF monoclonal antibody therapy. The incidence of these events increased with high doses and in those human patients that received long-term (more than 90 days) NSAIDs concomitantly with an anti-NGF monoclonal antibody.
Cats have no reported equivalent of human rapidly progressive osteoarthritis.
No interactions were observed in clinical trials where this veterinary medicinal product was administered concomitantly with veterinary medicinal products including anaesthetics, systemic antimicrobials, endectocides, psycholeptics, anti-inflammatory medications and ectoparasiticides. No laboratory studies on the safety of concomitant administration of this veterinary medicinal product with other veterinary medicinal products have been conducted.
If a vaccine(s) is to be administered at the same time as treatment with the veterinary medicinal product , the vaccine(s) should be administered at a different site to that of the veterinary medicinal product administration.
Administration routes and dosage
Subcutaneous use.
To ensure a correct dosage, body weight should be determined as accurately as
possible.
Dosage and treatment schedule:
The recommended dose is 0.5-1.25 mg/kg body weight, once every three months.
Dose according to the dosing chart below.
Body weight (kg) of cat | Portela number of vials to be administered 2.5 mg | Portela number of vials to be administered 6.4 mg |
2.5 - 5.0 | 1 | - |
5.1 - 12.8 | - | 1 |
For cats between 12.9 kg and 13.7 kg, the contents of one 2.5 mg vial and one 6.4 mg vial are required to administer a single dose. In those cases, withdraw the content from each required vial into the same syringe and administer as a single subcutaneous injection.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
Relfovetmab was evaluated in laboratory-based safety studies where the product was dosed up to 5-fold the maximum recommended dose once every three months over a six-month period in one study, and up to 23-fold the maximum recommended dose, dosed monthly (3-fold increased dosing frequency compared to the clinical dosing schedule), for seven consecutive doses in a separate six-month study. Relfovetmab exposure increased in proportion to the dose administered in both studies. These studies identified focal skin reactions (pruritus, abrasions, alopecia, or scabs mostly around the face, base of ears, and neck) that were generally found to increase in incidence with increasing dose.
In case of adverse clinical signs after an overdose, the cat should be treated symptomatically.
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.