Bravecto: Product Information

BRAVECTO- fluralaner solution
Merck Sharp & Dohme Corp.

Caution

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

Description:

Each tube is formulated to provide a minimum dose of 11.4 mg/lb (25 mg/kg) body weight. Each milliliter contains 280 mg of fluralaner.

The chemical name of fluralaner is (±)-4-[5-(3,5-dichlorophenyl)-5-(trifluoromethyl)-4,5- dihydroisoxazol-3-yl]-2-methyl-N -[2-oxo-2-(2,2,2- trifluoroethylamino) ethyl]benzamide. Inactive ingredients: dimethylacetamide, glycofurol, diethyltoluamide, acetone

Indications:

Bravecto kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations [Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick), and Rhipicephalus sanguineus (brown dog tick)] for 12 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 pounds or greater.

Bravecto is also indicated for the treatment and control of Amblyomma americanum (lone star tick) infestations for 8 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 pounds or greater.

Dosage and Administration:

Bravecto should be administered topically as a single dose every 12 weeks according to the Dosage Schedule below to provide a minimum dose of 11.4 mg/lb (25 mg/kg) body weight.

Bravecto may be administered every 8 weeks in case of potential exposure to Amblyomma americanum ticks (see Effectiveness).

Dosage Schedule
Body Weight Ranges (lb)Fluralaner content(mg)/tubeTubes Administered
*
Dogs over 123.0 lb should be administered the appropriate combination of tubes
4.4 – 9.9112.5One
>9.9 – 22.0250One
>22.0 – 44.0500One
>44.0 – 88.01000One
>88.0 – 123.0*1400One

Step 1: Immediately before use, open the pouch and remove the tube. Hold the tube at the crimped end with the cap in an upright position (tip up). The cap should be rotated clockwise or counter clockwise one full turn. The cap is designed to stay on the tube for dosing and should not be removed. The tube is open and ready for application when a breaking of the seal is felt.

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Step 2: The dog should be standing or lying with its back horizontal during application. Part the fur at the administration site. Place the tube tip vertically against the skin between the shoulder blades of the dog.

Step 3: Squeeze the tube and gently apply Bravecto in one or more spots starting between the shoulder blades and continuing along the dog’s back. Avoid applying an excessive amount of solution in any one spot which may cause some solution to run or drip off of the dog.

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Bathing or water immersion 3 days after administration will not reduce the effectiveness of Bravecto against fleas and Ixodes ricinus ticks (see Effectiveness).

Treatment with Bravecto may begin at any time of the year and can continue year round without interruption.

Contraindications:

There are no known contraindications for the use of the product.

WARNINGS

Human Warnings:

Not for human use. Keep this and all drugs out of the reach of children.

Do not contact or allow children to contact the application site until dry.

Keep the product in the original packaging until use in order to prevent children from getting direct access to the product.

Do not eat, drink or smoke while handling the product. Avoid contact with skin and eyes. If contact with eyes occurs, then flush eyes slowly and gently with water. Wash hands and contacted skin thoroughly with soap and water immediately after use of the product.

The product is highly flammable. Keep away from heat, sparks, open flame or other sources of ignition.

Precautions:

For topical use only. Avoid oral ingestion. (see Animal Safety).

Fluralaner 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.

Bravecto has not been shown to be effective for 12-weeks duration in puppies less than 6 months of age. Bravecto is not effective against Amblyomma americanum ticks beyond 8 weeks after dosing (see Effectiveness).

Adverse Reactions:

In a well-controlled U.S. field study, which included a total of 165 households and 321 treated dogs (221 with fluralaner and 100 with a topical active control), there were no serious adverse reactions.

Percentage of Dogs with Adverse Reactions in the Field Study
Adverse Reaction (AR) Bravecto Group: Percent of Dogs with the AR During the 105-Day Study(n= 221 dogs) Active Control Group: Percent of Dogs with the AR During the 84-Day Study(n= 100 dogs)
Vomiting 6.3 % 6.0 %
Alopecia 4.1 % 2.0 %
Diarrhea 2.7 % 11.0 %
Lethargy 2.7 % 2.0 %
Decreased Appetite 1.4 % 0.0 %
Moist Dermatitis/Rash 0.9 % 0.0 %

In the field study, two dogs treated with Bravecto with no prior history of seizures each experienced a seizure. One dog had two seizures a day apart about 18 days after its first dose. The dog was started on antiepileptic medication and had no additional seizures during the study. A second dog had a seizure 76 days after its first dose and 3 days after starting fluoxetine for separation anxiety. The fluoxetine was discontinued and the dog experienced no additional seizures during the study. One dog treated with Bravecto was observed by the owner to be off balance for about 30 minutes five days after its first dose and had no similar observations after the second dose. One dog with a history of seizures had a seizure the day after the second dose of the active control.

In two well-controlled laboratory dose confirmation studies, one dog developed mild to moderate redness, flaking, crusts/scabs and alopecia at the treatment site from Day 1 through 14 after application of Bravecto on Day 0, and one dog developed self-limiting generalized erythema (possible allergic reaction) one day after treatment with Bravecto.

In a European field study in cats, there were three reports of facial dermatitis in humans after close contact with the application site which occurred within 4 days of application.

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