NexGard: Product Information

NEXGARD- afoxolaner tablet, chewable
Frontline Vet Labs

CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

Description:

NexGard^® (afoxolaner) is available in four sizes of beef-flavored, soft chewables for oral administration to dogs and puppies according to their weight. Each chewable is formulated to provide a minimum afoxolaner dosage of 1.14 mg/lb (2.5 mg/kg). Afoxolaner has the chemical composition 1-Naphthalenecarboxamide, 4-[5-[3-chloro-5-(trifluoromethyl)-phenyl]-4,5-dihydro-5-(trifluoromethyl)-3-isoxazolyl]-N-[2-oxo-2-[(2,2,2-trifluoroethyl)amino]ethyl.

Indications:

NexGard kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) , and the treatment and control of Black-legged tick (Ixodes scapularis) , American Dog tick (Dermacentor variabilis) , Lone Star tick (Amblyomma americanum), and Brown dog tick (Rhipicephalus sanguineus) infestations in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body weight or greater, for one month. NexGard is indicated for the prevention of Borrelia burgdorferi infections as a direct result of killing lxodes scapularis vector ticks.

Dosage and Administration:

NexGard is given orally once a month, at the minimum dosage of 1.14 mg/lb (2.5 mg/kg).

Dosing Schedule:

Body Weight	Afoxolaner Per Chewable (mg)	Chewables Administered
4.0 to 10.0 lbs.	11.3	One
10.1 to 24.0 lbs.	28.3	One
24.1 to 60.0 lbs.	68	One
60.1 to 121.0 lbs.	136	One
Over 121.0 lbs.	Administer the appropriate combination of chewables

NexGard can be administered with or without food. Care should be taken that the dog consumes the complete dose, and treated animals should be observed for a few minutes to ensure that part of the dose is not lost or refused. If it is suspected that any of the dose has been lost or if vomiting occurs within two hours of administration, redose with another full dose. If a dose is missed, administer NexGard and resume a monthly dosing schedule.

Flea Treatment and Prevention:

Treatment with NexGard may begin at any time of the year. In areas where fleas are common year-round, monthly treatment with NexGard should continue the entire year without interruption.

To minimize the likelihood of flea reinfestation, it is important to treat all animals within a household with an approved flea control product.

Tick Treatment and Control:

Treatment with NexGard may begin at any time of the year (see Effectiveness).

Contraindications:

There are no known contraindications for the use of NexGard.

Warnings:

Not for use in humans. Keep this and all drugs out of the reach of children. In case of accidental ingestion, contact a physician immediately.

Keep NexGard in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

Precautions:

Afoxolaner 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 dogs receiving isoxazoline class drugs, even in dogs without a history of seizures. Use with caution in dogs with a history of seizures or neurologic disorders.

The safe use of NexGard in breeding, pregnant or lactating dogs has not been evaluated.

Adverse Reactions:

In a well-controlled US field study, which included a total of 333 households and 615 treated dogs (415 administered afoxolaner; 200 administered active control), no serious adverse reactions were observed with NexGard.

Over the 90-day study period, all observations of potential adverse reactions were recorded. The most frequent reactions reported at an incidence of > 1% within any of the three months of observations are presented in the following table. The most frequently reported adverse reaction was vomiting. The occurrence of vomiting was generally self-limiting and of short duration and tended to decrease with subsequent doses in both groups. Five treated dogs experienced anorexia during the study, and two of those dogs experienced anorexia with the first dose but not subsequent doses.

Table 1: Dogs With Adverse Reactions.

	Treatment Group
	Afoxolaner		Oral active control
	N *	% (n=415)	N †	% (n=200)
* Number of dogs in the afoxolaner treatment group with the identified abnormality. † Number of dogs in the control group with the identified abnormality.
Vomiting (with and without blood)	17	4.1	25	12.5
Dry/Flaky Skin	13	3.1	2	1.0
Diarrhea (with and without blood)	13	3.1	7	3.5
Lethargy	7	1.7	4	2.0
Anorexia	5	1.2	9	4.5

In the US field study, one dog with a history of seizures experienced a seizure on the same day after receiving the first dose and on the same day after receiving the second dose of NexGard. This dog experienced a third seizure one week after receiving the third dose. The dog remained enrolled and completed the study. Another dog with a history of seizures had a seizure 19 days after the third dose of NexGard. The dog remained enrolled and completed the study. A third dog with a history of seizures received NexGard and experienced no seizures throughout the study.