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Contra-indications, warnings, etc
Do not use in animals under 12 months and/or under 2.5 kg body weight.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
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.
Do not use in animals intended for breeding.
Continuation of treatment should be based on the individual response of each animal. If a positive response is not observed, consider alternative treatments.
This veterinary medicinal product may induce transient or persistent anti-drug antibodies. The induction of such antibodies may reduce the efficacy of the product although this was not observed during the 84 days of the pivotal clinical trial. No information is available for longer duration treatment.
The safety and efficacy of this product has not been investigated in cats with kidney disease IRIS stages 3 and 4. Use of the product in such cases should be based on a benefit-risk assessment performed by the responsible veterinarian.
There are no safety data on the concurrent use of non-sterodal anti-inflammatory drugs (NSAIDs) and frunevetmab in the cat. 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) non-steroidal anti-inflammatory drugs (NSAIDs) concomitantly with an anti-NGF monoclonal antibody. Cats have no reported equivalent of human rapidly progressive osteoarthritis.
If a vaccine is to be administered at the same time as treatment with frunevetmab, the vaccine should be administered at a different site to that of frunevetmab administration to reduce any potential recruitment of immunogenicity (formation of anti-drug antibodies) to the mAb.
Do not mix with any other veterinary medicinal product.
Focal skin reactions (e.g. pruritus, dermatitis and alopecia) occurred commonly in studies.
Adverse reactions
Common (1 to 10 animals / 100 animals treated):
localised skin reaction (e.g. alopecia, dermatitis, puritus)
Rare (1 to 10 animals / 10,000 animals treated):
injection site reaction (e.g. pain and alopecia) 1
Very rare (<1 animal / 10,000 animals treated, including isolated reports):
1 Mild.
2 In case of such reactions, appropriate symptomatic treatment should be administered.
No adverse reactions were observed in laboratory overdose studies when Solensia was administered for 6 consecutive monthly doses at 5 times the maximum recommended dose.
In case of adverse clinical signs after an overdose the cat should be treated symptomatically.
User warnings
Hypersensitivity reactions, including anaphylaxis, could potentially occur in the case of accidental self-injection. Repeated self-administration may increase the risk of hypersensitivity reactions.
The importance of Nerve Growth Factor (NGF) 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.