Product label updates: Solensia, Nexgard Chewables for Dogs, and Nexgard Spectra Chewables for dogs
Published on 11 July 2024
The product labels for the registered products Solensia, Nexgard Chewables for Dogs, and Nexgard Spectra Chewables for dogs have recently been updated as a result of pharmacovigilance investigations. The adverse event section of some registered veterinary medicine product labels have been updated to reflect reports based on New Zealand +/- international field experience. A copy of the full currently approved label can be accessed via the individual product record on MPI’s ACVM Product Register. Note that it may take up to a year for product released to the marketplace to incorporate new labels with the revised statement.
The changes most recently actioned are:
| ACVM Number | Product Trade Name | Current Statement | New/Revised Statement |
Date Approved |
| A011914 | Solensia | Mild, focal skin reactions (dermatitis, alopecia and pruritus) were observed commonly in field trials (i.e. between 1 and 10 animals in every 100 animals treated). Mild reactions at the injection site (e.g. pain and/or immediate pain upon injection, alopecia) may be observed rarely. |
Focal skin reactions (dermatitis, alopecia and pruritus) have been reported commonly (1 to 10 animals / 100 animals treated). Administer symptomatic treatment if required. Mild reactions at the injection site (e.g. pain and/or immediate pain upon injection, alopecia) have been reported rarely (1 to 10 animals / 10000 animals treated). Anaphylaxis (severe allergic reaction) has been reported very rarely (<1 animal/ 10000 animals treated). In case of such reactions, appropriate symptomatic treatment should be administered. |
Jun-24 |
| A011040 | Nexgard Chewables for Dogs | Afoxolaner is part of the isoxazoline family of chemicals. Adverse reactions to this family of chemicals are rarely observed but may include vomiting, diarrhoea, lack of energy, decreased appetite, itching and very rarely, neurological signs including seizure and tremor. Most adverse reactions are generally short-lived and resolve spontaneously. If you have any concerns, please speak to your veterinarian. | Afoxolaner is part of the isoxazoline family of chemicals. Adverse reactions to this family of chemicals are rarely observed but may include vomiting, diarrhoea, lack of energy, decreased appetite, itching and very rarely, neurological signs including seizure and tremor. Most adverse reactions are generally short-lived and resolve spontaneously. If you have any concerns, please speak to your veterinarian. Pruritus (itching) is very rarely reported (less than 1 animal in 10,000 treated) following product administration. Based on post- registration experience in New Zealand, itching is generally mild and of short duration (median 2 days) but may be severe or of longer duration in isolated cases. |
Jul-24 |
| A011184 | Nexgard Spectra Chewables for Dogs | Afoxolaner is part of the isoxazoline family of chemicals. Adverse reactions to this family of chemicals are rarely observed but may include vomiting, diarrhoea, lack of energy, decreased appetite, itching and very rarely, neurological signs including seizure and tremor. Most adverse reactions are generally short-lived and resolve spontaneously. If you have any concerns, please speak to your veterinarian. | Afoxolaner is part of the isoxazoline family of chemicals. Adverse reactions to this family of chemicals are rarely observed but may include vomiting, diarrhoea, lack of energy, decreased appetite, itching and very rarely, neurological signs including seizure and tremor. Most adverse reactions are generally short-lived and resolve spontaneously. If you have any concerns, please speak to your veterinarian. Pruritus (itching) is very rarely reported (less than 1 animal in 10,000 treated) following product administration. Based on post- registration experience in New Zealand, itching may range from mild to severe, and is generally of short duration (median 2 days) but may be of longer duration in isolated cases. |
Jul-24 |
