Today's Veterinary Practice

TVP_JUL-AUG2018

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NADA 141-459, Approved by FDA (fluralaner topical solution) 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. 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. Use with caution in dogs with a history of seizures. Seizures have been reported in dogs receiving fluralaner, even in dogs without a history of seizures. 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 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) 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. For technical assistance or to report a suspected adverse drug reaction, 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/AnimalVeterinary/SafetyHealth. How Supplied: Bravecto is available in five strengths for use in dogs (112.5, 250, 500, 1000, and 1400 mg fluralaner per tube). Each tube is packaged individually in a pouch. Product may be supplied in 1 or 2 tubes per carton. Distributed by: Intervet Inc (d/b/a Merck Animal Health) Madison, NJ 07940 Made in the USA. Rev. 9/16 Copyright © 2016 Intervet Inc, a subsidiary of Merck & Company Inc. All rights reserved 155586 R4 NADA 141-426, Approved by FDA Flavored 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 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: 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. Precautions: 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 Adverse Reaction (AR) Bravecto Group: Percentage of Dogs with the AR During the 182-Day Study (n=224 dogs) Active Control Group: Percentage 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 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. For technical assistance or to report a suspected adverse drug reaction, 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/AnimalVeterinary/SafetyHealth. How Supplied: Bravecto is available in five strengths (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 Made in Austria Copyright © 2014 Intervet Inc, a subsidiary of Merck & Company Inc. All rights reserved 154545 R1 NADA 141-459, Approved by FDA (fluralaner topical solution) for Cats 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 Ixodes scapularis (black-legged tick) infestations for 12 weeks in cats and kittens 6 months of age and older, and weighing 2.6 pounds or greater. Bravecto is also indicated for the treatment and control of Dermacentor variabilis (American dog tick) infestations for 8 weeks in cats and kittens 6 months of age and older, and weighing 2.6 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. 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. Use with caution in cats with a history of neurologic abnormalities. Neurologic abnormalities have been reported in cats receiving Bravecto, even in cats without a history of neurologic abnormalities. Bravecto has not been shown to be effective for 12-weeks duration in kittens less than 6 months of age. Bravecto is not effective against Dermacentor variabilis ticks beyond 8 weeks after dosing. The safety of Bravecto has not been established in breeding, pregnant and lactating cats. Adverse Reactions: In a well-controlled U.S. field study, which included a total of 161 households and 311 treated cats (224 with fluralaner and 87 with a topical active control), there were no serious adverse reactions. Percentage of Cats with Adverse Reactions (AR) in the Field Study Adverse Reaction (AR) Bravecto Group: Percent of Cats with the AR During the 105-Day Study (n=224 cats) Control Group: Percent of Cats with the AR During the 84-Day Study (n=87 cats) Vomiting 7.6% 6.9% Pruritus 5.4% 11.5% Diarrhea 4.9% 1.1% Alopecia 4.9% 4.6% Decreased Appetite 3.6% 0.0% Lethargy 3.1% 2.3% Scabs/Ulcerated Lesions 2.2% 3.4% In the field study, two cats treated with fluralaner topical solution experienced ataxia. One cat became ataxic with a right head tilt 34 days after the first dose. The cat improved within one week of starting antibiotics. The ataxia and right head tilt, along with lateral recumbency, reoccurred 82 days after administration of the first dose. The cat recovered with antibiotics and was redosed with fluralaner topical solution 92 days after administration of the first dose, with no further abnormalities during the study. A second cat became ataxic 15 days after receiving its first dose and recovered the next day. The cat was redosed with fluralaner topical solution 82 days after administration of the first dose, with no further abnormalities during the study. In a European field study, two cats from the same household experienced tremors, lethargy, and anorexia within one day of administration. The signs resolved in both cats within 48-72 hours. In a European field study, there were three reports of facial dermatitis in humans after close contact with the application site which occurred within 4 days of application. For technical assistance or to report a suspected adverse drug reaction, 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/ AnimalVeterinary/SafetyHealth. How Supplied: Bravecto is available in three strengths for use in cats (112.5, 250, and 500 mg fluralaner per tube). Each tube is packaged individually in a pouch. Product may be supplied in 1 or 2 tubes per carton. Distributed by: Intervet Inc (d/b/a Merck Animal Health) Madison, NJ 07940 Made in the USA. Rev. 9/16 Copyright © 2016 Intervet Inc, a subsidiary of Merck & Company Inc. All rights reserved 159363 R3

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