Animal Health Solutions

(fluralaner) Chews for Dogs BRIEF SUMMARY (For full Prescribing Information, see package insert) Caution: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. 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. Contraindications: There are no known contraindications for the use of this product. WARNINGS Human 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. The safety of Bravecto 1-Month has not been evaluated in breeding, pregnant and lactating dogs. 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 *Alanine aminotransferase (ALT); alkaline phosphatase (ALP) 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 or without blood), anorexia, pruritus, polydipsia, seizure, allergic reactions (including hives, swelling, erythema), dermatitis (including crusts, pustules, rash), tremors and ataxia. Contact Information: 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. How Supplied: Bravecto 1-Month is available in five strengths (45, 100, 200, 400, and 560 mg fluralaner per chew). Each chew is packaged individually into aluminum foil blister packs sealed with a peelable paper backed foil lid stock. Product may be packaged in 1, 3, or 4 chews per package. Copyright © 2020 Intervet Inc, a subsidiary of Merck & Company Inc. All rights reserved Rev: 03/20 Approved by FDA under NADA # 141-532 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) 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% (fluralaner) flavored chew for dogs BRIEF SUMMARY (For full Prescribing Information, see package insert) Caution: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. 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. 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. 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 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 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. Adverse Reactions: In a well-controlled U.S. field study, which included 294 dogs (224 dogs were administered Bravecto every 12 weeks and 70 dogs were administered an oral active control every 4 weeks and were provided with a tick collar); there were no serious adverse reactions. All potential adverse reactions were recorded in dogs treated with Bravecto over a 182-day period and in dogs treated with the active control over an 84-day period. The most frequently reported adverse reaction in dogs in the Bravecto and active control groups was vomiting. Percentage of Dogs with Adverse Reactions in the Field Study In a well-controlled laboratory dose confirmation study, one dog developed edema and hyperemia of the upper lips within one hour of receiving Bravecto. The edema improved progressively through the day and had resolved without medical intervention by the next morning. Post-Approval Experience (2019): The following adverse events are based on post-approval adverse drug experience reporting. 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 for fluralaner: Vomiting, lethargy, diarrhea (with and without blood), anorexia, pruritis, polydipsia, seizure, allergic reactions (including hives, swelling, erythema), dermatitis (including crusts, pustules, rash), tremors and ataxia. Contact Information: For a copy of the Safety Data Sheet (SDS) or to report suspected adverse drug events, 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 http://www.fda.gov/AnimalVeterinary/SafetyHealth. How Supplied: Bravecto is available in five strengths for use in dogs (112.5, 250, 500, 1000, and 1400 mg fluralaner per chew). Each chew is packaged individually into aluminum foil blister packs sealed with a peelable paper backed foil lid stock. Product may be packaged in 1, 2, or 4 chews per package. Distributed by: Intervet, Inc., (d/b/a Merck Animal Health), Madison, NJ 07940 Fluralaner (active ingred.) Made in Japan. Formulated in Austria Copyright © 2014, 2019 Intervet Inc, a subsidiary of Merck & Company Inc. All rights reserved. Rev. 04/19 356271 R3 (fluralaner topical solution) BRIEF SUMMARY (For full Caution: Federal (USA) law restricts this Indications: Bravecto kills adult fleas and is tations (Ctenocephalides felis) and scapularis (black-legged tick), Dermacentor sanguineus (brown dog tick)] for older, and weighing 4.4 pounds Bravecto is also indicated for the star tick) infestations for 8 weeks weighing 4.4 pounds or greater. Contraindications: There are no known contraindications WARNINGS Human Warnings: Not for human use. Keep this or allow children to contact the original packaging until use the product. Do not eat, drink skin and eyes. If contact with eyes Wash hands and contacted ately after use of the product. The product is highly flammable. sources of ignition. Precautions: For topical use only. Avoid oral This class has been associated ataxia, and seizures. Seizures have drugs, even in dogs without a of seizures or neurologic disorders. Bravecto has not been shown 6 months of age. Bravecto is not weeks after dosing. Adverse Reactions: In a well-controlled U.S. field study, treated dogs (221 with fluralaner serious adverse reactions. Percentage of Dogs with In the field study, two dogs treated experienced a seizure. One dog dose. The dog was started on during the study. A second dog starting fluoxetine for separation experienced no additional seizures observed by the owner to be off and had no similar observations had a seizure the day after the In two well-controlled laboratory moderate redness, flaking, crusts/scabs through 14 after application of generalized erythema (possible In a European field study in cats, after close contact with the application Contact Information: For a copy of the Safety Data Sheet contact Merck Animal Health at www.bravecto.com. For additional information about contact FDA at 1-888-FDA-VETS How Supplied: Bravecto is available in five strengths fluralaner per tube). Each tube supplied in 1 or 2 tubes per carton. Distributed by: Intervet, Inc., (d/b/a Merck Animal Fluralaner (active ingred.) Made Formulated in USA Copyright © 2016, 2019 Intervet reserved. Rev. 04/19 188575 R3 Adverse Reaction (AR) Bravecto Group: Percent of Dogs with the AR During the 182-Day Study (n=224 dogs) Active Control Group: Percent of Dogs with the AR During the 84- Day Study (n=70 dogs) Vomiting 7.1 14.3 Decreased Appetite 6.7 0.0 Diarrhea 4.9 2.9 Lethargy 5.4 7.1 Polydipsia 1.8 4.3 Flatulence 1.3 0.0 Adverse Reaction (AR) Vomiting Alopecia Diarrhea Lethargy Decreased Appetite Moist Dermatitis/Rash Approved by FDA under NADA # 141-426 Approved by FDA under NADA

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