Bravecto 1-Month: Product Information

BRAVECTO 1-MONTH- fluralaner tablet, chewable
Merck Sharp & Dohme Corp.

Caution:

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

Description:

Bravecto 1-Month (fluralaner) is a flavored chew formulated to provide a minimum dose of 4.5 mg/lb (10 mg/kg) body weight 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.

Indications:

Bravecto 1-Month 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 one month in dogs and puppies 8 weeks of age and older, and weighing 4.4 pounds or greater.

Bravecto 1-Month is also indicated for the treatment and control of Amblyomma americanum (lone star tick) infestations for one month in dogs and puppies 6 months of age and older, and weighing 4.4 pounds or greater.

Dosage and Administration:

Bravecto 1-Month should be administered orally as a single dose monthly according to the Dosage Schedule below to provide a minimum dose of 4.5 mg/lb (10 mg/kg) fluralaner.

Bravecto 1-Month should be administered with food.

Dosage Schedule
Body Weight Ranges (lb) Fluralaner content (mg) Chews Administered
*
Dogs over 123.0 lb should be administered the appropriate combination of chews
4.4 – 9.9 45 One
>9.9 – 22.0 100 One
>22.0 – 44.0 200 One
>44.0 – 88.0 400 One
>88.0 – 123.0* 560 One

Treatment with Bravecto 1-Month 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:

Not for human use. Keep this and all drugs out of the reach of children. 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. Wash hands thoroughly with soap and water immediately after use of the product.

Keep Bravecto 1-Month in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

Precautions:

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 1-Month is not effective against A. americanum in puppies less than 6 months of age (see Effectiveness).

The safety of Bravecto 1-Month has not been evaluated in breeding, pregnant and lactating dogs (see Animal Safety).

Adverse Reactions:

In a well-controlled U.S. field study, which included 271 dogs (201 dogs were administered Bravecto 1-Month every 30 days and 70 dogs were administered an oral active control [an isoxazoline] every 30 days), there were no serious adverse reactions associated with treatment. Over the 90-day study period, all observations of potential adverse reactions were recorded.

Dogs with Adverse Reactions in the Field Study
Adverse Reaction (AR) Fluralaner Group: Percentage of Dogs with the AR during the 90-Day Study (n= 201 dogs) Active Control Group: Percentage of Dogs with the AR during the 90-Day Study (n= 70 dogs)
*
Alanine aminotransferase (ALT); alkaline phosphatase (ALP)
Pruritus 7.0% 10.0%
Diarrhea 3.0% 4.3%
Vomiting 3.0% 4.3%
Decreased Appetite 3.0% 0.0%
Liver enzymes (serum ALT or ALP) greater than twice the upper reference range * 1.0% 1.4%
Lethargy 1.0% 1.4%
Weight loss (>15%) 0.5% 0.0%

One dog in the Bravecto 1-Month group with a history of seizures managed with anticonvulsant medication had seizure activity 28 days after its first dose; the dog received its second dose later the same day. No additional seizures occurred during the study. One dog in the control group with no history of seizures had seizure activity 12 days after its second dose. The dog was started on anticonvulsant medication and no additional seizures occurred during the study.

During the palatability assessment, four dogs coughed within 1 hour of dosing with Bravecto 1-Month. Palatability was not assessed in the control group.

In well-controlled laboratory effectiveness studies, one dog and three puppies administered Bravecto 1-Month had diarrhea (with or without blood).

Post Approval Experience (2019):

The following adverse events are based on post-approval adverse drug experience reporting for fluralaner. Not all adverse events are reported to FDA/CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data.

The following adverse events reported for dogs are listed in decreasing order of reporting frequency:

Vomiting, lethargy, diarrhea (with and without blood), anorexia, pruritus, polydipsia, seizure, allergic reactions (including hives, swelling, erythema), dermatitis (including crusts, pustules, rash), tremors and ataxia.

To report suspected adverse events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Merck Animal Health at 1-800-224-5318. Additional information can be found at www.bravecto.com. 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/reportanimalae.

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