NexGard Flea & Tick Chewables for Dogs

NexGard Chewables for Dogs is a monthly flea and tick control medication. It is a flavored chewable tablet that provides protection against fleas and ticks, including the American dog tick, the black-legged tick, and the Lone Star tick. NexGard is easy to administer and can be given with or without food. It starts killing fleas within 4 hours and ticks within 8 hours of administration, providing fast-acting and long-lasting protection for your dog. NexGard Chewables provide month-long protection against fleas and ticks. It is safe for use in dogs 8 weeks of age and older and weighing at least 4 pounds. Please note that NexGard is a prescription medication and should only be used under the guidance of a veterinarian.

Key Features:

1. Monthly Protection: NexGard Chewables provide month-long protection against fleas and ticks.
2. Fast-Acting: Starts killing fleas within 4 hours and ticks within 8 hours of administration.
3. Easy to Administer: Comes in a flavored chewable tablet that dogs love, making it easy to give to your pet.
4. Safe for Dogs: NexGard is safe for use in dogs 8 weeks of age and older and weighing at least 4 pounds.
5. Prescription Required: NexGard is a prescription medication and should only be used under the guidance of a veterinarian.

Indications:

1. Flea Infestations: NexGard is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) in dogs. It is highly effective in killing adult fleas before they can lay eggs, thus helping to break the flea life cycle.
2. Black-Legged (Deer) Ticks: NexGard provides effective control of black-legged ticks (Ixodes scapularis), commonly known as deer ticks. These ticks are known vectors of diseases such as Lyme disease and anaplasmosis in dogs.
3. American Dog Ticks: The medication is also effective against American dog ticks (Dermacentor variabilis), which can transmit diseases like Rocky Mountain spotted fever.
4. Lone Star Ticks: NexGard is indicated for the treatment and control of Lone Star ticks (Amblyomma americanum), which are found in certain regions of the United States and can transmit diseases.

It's essential to remember that NexGard is specifically formulated for dogs and should never be used on cats or other pets. Additionally, the dosage and administration should be in accordance with the veterinarian's instructions based on the dog's weight and health status.

How it works:

NexGard works by using the active ingredient afoxolaner, which belongs to the isoxazoline class of compounds. Afoxolaner is an insecticide and acaricide, meaning it targets and kills insects (like fleas) and acari (ticks). Here's how NexGard works:

1. Ingestion: When your dog ingests a NexGard chewable tablet, afoxolaner is absorbed into their bloodstream.
2. Neurological Effects: Afoxolaner works by interfering with the nervous system of fleas and ticks. It specifically targets receptors known as gamma-aminobutyric acid (GABA) and glutamate, which are important for nerve transmission in these parasites.
3. Paralysis and Death: By binding to these GABA and glutamate receptors, afoxolaner disrupts nerve signals, leading to overexcitation and uncontrolled activity in the nervous system of the fleas and ticks. This results in paralysis and ultimately leads to the death of the parasites.
4. Quick Action: NexGard is known for its rapid onset of action. It starts killing fleas within a few hours after administration, and its effectiveness lasts for up to one month. It also provides protection against various tick species, but the duration of tick protection may vary depending on the specific type of tick.
5. Continuous Administration: To maintain continuous protection against fleas and ticks, NexGard should be administered regularly according to your veterinarian's recommended schedule. Missing a dose could leave your dog vulnerable to infestations.

It's important to remember that NexGard is specifically formulated for dogs and should not be used on cats or other animals. Additionally, while NexGard is generally considered safe for most dogs, some dogs may experience side effects. If you notice any adverse reactions or have concerns about using NexGard for your dog, it's crucial to consult with your veterinarian for guidance. They can provide personalized recommendations based on your dog's specific health needs and circumstances.

Specifications:

• Active Ingredient: Afoxolaner
• Form: Chewable tablet
• Strength: Available in different strengths based on the weight of the dog
• Administration: Oral, once a month
• Flea Killing Activity: Starts within 4 hours
• Tick Killing Activity: Starts within 8 hours
• Duration of Action: One month
• Recommended for: Dogs and puppies 8 weeks of age and older, weighing at least 4 pounds
• Safety: Approved by the FDA for use in dogs
• Flavor: Beef-flavored chewable, making it easy to administer
• Packaging: Available in packs for different weight categories of dogs

View Nexgard Drug Facts Sheet.

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

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.

Precautions:

The safe use of NexGard in breeding, pregnant or lactating dogs has not been evaluated. Use with caution in dogs with a history of seizures (see Adverse Reactions).

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.

¹Number of dogs in the afoxolaner treatment group with the identified abnormality.

²Number of dogs in the control group with the identified abnormality.

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.

To report suspected adverse events, for technical assistance or to obtain a copy of the MSDS, contact Merial at 1-888-637-4251 or www.merial.com/nexgard. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/AnimalVeterinary/SafetyHealth.

Mode of Action:

Afoxolaner is a member of the isoxazoline family, shown to bind at a binding site to inhibit insect and acarine ligand-gated chloride channels, in particular those gated by the neurotransmitter gamma-aminobutyric acid (GABA), thereby blocking pre- and post-synaptic transfer of chloride ions across cell membranes. Prolonged afoxolaner-induced hyperexcitation results in uncontrolled activity of the central nervous system and death of insects and acarines. The selective toxicity of afoxolaner between insects and acarines and mammals may be inferred by the differential sensitivity of the insects and acarines' GABA receptors versus mammalian GABA receptors.

Effectiveness:

In a well-controlled laboratory study, NexGard began to kill fleas four hours after initial administration and demonstrated >99% effectiveness at eight hours. In a separate well-controlled laboratory study, NexGard demonstrated 100% effectiveness against adult fleas 24 hours post-infestation for 35 days, and was ≥93% effective at 12 hours post infestation through Day 21, and on Day 35. On Day 28, NexGard was 81.1% effective 12 hours post-infestation. Dogs in both the treated and control groups that were infested with fleas on Day 1 generated flea eggs at 12 and 24 hours post-treatment (0-11 eggs and 1-17 eggs in the NexGard treated dogs, and 4-90 eggs and 0-118 eggs in the control dogs, at 12 and 24-hours, respectively). At subsequent evaluations post infestation, fleas from dogs in the treated group were essentially unable to produce any eggs (0-1 eggs) while fleas from dogs in the control group continued to produce eggs (1-141 eggs).

In a 90-day US field study conducted in households with existing flea infestations of varying severity, the effectiveness of NexGard against fleas on the Day 30, 60 and 90 visits compared with baseline was 98.0%, 99.7%, and 99.9%, respectively.

Collectively, the data from the three studies (two laboratory and one field) demonstrate that NexGard kills fleas before they can lay eggs, thus preventing subsequent flea infestations after the start of treatment of existing flea infestations.

In well-controlled laboratory studies, NexGard demonstrated >97% effectiveness against Dermacentor variabilis, >94% effectiveness against Ixodes scapularis, and >93% effectiveness against Rhipicephalus sanguineus, 48 hours post-infestation for 30 days. At 72 hours post-infestation, NexGard demonstrated >97% effectiveness against Amblyomma americanum for 30 days.

Animal Safety:

In a margin of safety study, NexGard was administered orally to 8 to 9-week-old Beagle puppies at 1, 3, and 5 times the maximum exposure dose (6.3 mg/kg) for three treatments every 28 days, followed by three treatments every 14 days, for a total of six treatments. Dogs in the control group were sham-dosed. There were no clinically-relevant effects related to treatment on physical examination, body weight, food consumption, clinical pathology (hematology, clinical chemistries, or coagulation tests), gross pathology, histopathology or organ weights. Vomiting occurred throughout the study, with a similar incidence in the treated and control groups, including one dog in the 5x group that vomited four hours after treatment.

In a well-controlled field study, NexGard was used concomitantly with other medications, such as vaccines, anthelmintics, antibiotics (including topicals), steroids, NSAIDS, anesthetics, and antihistamines. No adverse reactions were observed from the concomitant use of NexGard with other medications.

Storage

Store at or below 30°C (86°F) with excursions permitted up to 40°C (104°F).