NexGard COMBO: Product Information (Page 2 of 3)

Precautions:

Do not administer orally. Cats may salivate excessively if NexGard® COMBO is accidentally administered orally or is ingested through licking/grooming the application site (see Target Animal Safety). Esafoxolaner, one of the ingredients in NexGard® COMBO, is a member of the isoxazoline class. This class has been associated with neurologic adverse reactions including tremors, ataxia, and seizures. Seizures have been reported in cats receiving isoxazoline class drugs, even in cats without a history of seizures. Use with caution in cats with a history of seizures or neurologic disorders.

The safety of NexGard® COMBO has not been tested in breeding, pregnant, or lactating cats.

The safety of NexGard® COMBO has not been tested in kittens less than 8 weeks of age or weighing less than 1.8 lbs (0.8 kg).

Adverse Reactions:

In a field safety and effectiveness study, which included a total of 201 households and 380 treated cats (244 cats treated with NexGard® COMBO, 136 cats treated with an active control), the safety of NexGard® COMBO was evaluated over a 90-day period through in-clinic physical examinations or through reporting of abnormalities by the owner. The most frequently reported reactions in the NexGard® COMBO and active control groups are presented in the following table.

Adverse Reactions by Treatment Group

EVENT
Treatment Group
NEXGARD® COMBO
Active Control
n1
% (n=244)
n2
% (n=136)
Vomiting
16
6.56
8

5.88

Application Site Hair Change

9
3.69
0

0.00

Anorexia
7
2.87
4

2.94

Lethargy
6
2.46
5

3.68

Bacterial skin infection
4
1.64
1

0.74

Itching
4
1.64
0

0.00

Sneezing
4
1.64
5

3.68

Skin Peeling
3
1.23
2

1.47

Diarrhea
3
1.23
3

2.21

Epiphora
3
1.23
1

0.74

Hypersalivation
3
1.23
0

0.00

Hyperthermia
3
1.23
0

0.00

Alopecia
2
0.82
0

0.00

Dermal thickening
2
0.82
0

0.00

Ear Pruritus
2
0.82
1

0.74

Application Site Redness
2
0.82
0

0.00

Conjunctivitis
1
0.41
1

0.74

1 Number of cats treated with NexGard® COMBO with the identified abnormality.

2 Number of cats treated with Active Control with the identified abnormality.

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