Animal Health Solutions

Text in this ad is too close to the trim Don't wait for weight loss. Stimulate appetite early to help treat the whole picture. Add ENTYCE ® (capromorelin oral solution) at the first sign of decreased eating as part of your overall treatment plan. Proven to effectively stimulate appetite to help improve food consumption The ONLY FDA-approved appetite stimulant for dogs Convenient, once-daily oral solution Take a closer look at EntyceForDogs.com INDICATION: For appetite stimulation in dogs. IMPORTANT SAFETY INFORMATION: For use in dogs only. Do not use in dogs that have a hypersensitivity to capromorelin. Use with caution in dogs with hepatic dysfunction or renal insufficiency. The safe use of Entyce has not been evaluated in breeding, pregnant or lactating dogs. The most common adverse reactions included diarrhea, vomiting, elevated blood urea nitrogen, polydipsia, and hypersalivation. Please see the brief summary of the full prescribing information below for more detail. ©2020 Elanco. Entyce, Elanco and the diagonal bar are trademarks of Elanco or its affiliates. PM-US-20-1317 W1a PA102553X 30 mg/mL For oral use in dogs only Appetite Stimulant Caution: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Before using Entyce, please consult the product insert, a summary of which follows: Indication: ENTYCE (capromorelin oral solution) is indicated for appetite stimulation in dogs. Dosage and Administration: Administer ENTYCE orally at a dose of 3 mg/kg (1.4 mg/lb) body weight once daily. To administer ENTYCE, gently shake the bottle, and then withdraw the appropriate amount of solution using the provided syringe. Rinse syringe between treatment doses. The effectiveness of ENTYCE has not been evaluated beyond 4 days of treatment in the clinical field study (See Effectiveness). See product insert for complete dosing and administration information. Contraindications: ENTYCE should not be used in dogs that have a hypersensitivity to capromorelin. Warnings: Not for use in humans. Keep this and all medications out of reach of children and pets. Consult a physician in case of accidental ingestion by humans. For use in dogs only Precautions: Use with caution in dogs with hepatic dysfunction. ENTYCE is metabolized by CYP3A4 and CYP3A5 enzymes (See Clinical Pharmacology). Use with caution in dogs with renal insufficiency. ENTYCE is excreted approximately 37% in urine and 62% in feces (See Adverse Reactions and Clinical Pharmacology). The safe use of ENTYCE has not been evaluated in dogs used for breeding or pregnant or lactating bitches. Adverse Reactions: In a controlled field study, 244 dogs were evaluated for safety when administered either ENTYCE or a vehicle control (solution minus capromorelin) at a dose of 3 mg/kg once daily for 4 days. Enrolled dogs had a reduced or absent appetite for a minimum of 2 days prior to day 0 and had various medical conditions: arthritis (40); gastrointestinal disease (24); allergy (22); dental disease (22); cardiovascular disease (16); renal disease (13); and others. Some dogs may have experienced more than one of the adverse reactions during the study. The following adverse reactions were observed: The following adverse reactions were reported in < 1% of dogs administered ENTYCE: hyperactivity, increase fecal volume, increase gut sounds, and polyuria. Effectiveness: Laboratory Effectiveness Study: Twenty four healthy Beagle dogs (6 dogs per sex in each group) with normal appetite were randomized into two groups and dosed daily with ENTYCE (capromorelin oral solution) at 3 mg/kg/day or vehicle control (solution minus capromorelin) to compare food intake over a 4-day period. The dogs were 13 months of age and weighed between 6.5 and 12.5 kg at the time of randomization. Six dogs administered ENTYCE repeatedly exhibited salivation post dosing and two dogs administered vehicle control exhibited salivation only one time on study day 0. Emesis was observed in one dog administered ENTYCE on study day 1. Dogs administered ENTYCE at a dose of 3 mg/kg/day for 4 consecutive days had statistically significantly increased food consumption compared to the vehicle control group (p < 0.001). Clinical Field Study: Effectiveness was evaluated in 177 dogs (121 dogs in the ENTYCE group and 56 dogs in the vehicle control group) in a double-masked, vehicle controlled field study. Dogs with a reduced appetite or no appetite, with various medical conditions, for a minimum of 2 days prior to day 0 were enrolled in the study. The dogs ranged in age from 4 months to 18 years. Dogs were randomized to treatment group and dosed once daily for 4 days with ENTYCE at 3 mg/kg or vehicle control. Dogs were assessed for appetite by owners on day 0 and day 3 ± 1 using an "increased", "no change" or "decreased" scoring system. Dogs were classified as a treatment success if the owner scored their dog's appetite as "increased" on day 3 ± 1. The success rates of the two groups were significantly different (p = 0.0078); 68.6% (n = 83) of dogs administered ENTYCE were successes, compared to 44.6% (n = 25) of the dogs in the vehicle control group. Storage Conditions: Store at or below 86° F (30° C) How Supplied: 30 mg/mL flavored solution in 10 mL, 15 mL and 30 mL bottles with measuring syringe Approved by FDA under NADA # 141-457 Manufactured for: Elanco US Inc. Greenfield, IN 46140, USA Revised: February 2020 ENTYCE, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. Table 1: Adverse Reactions reported in dogs administered ENTYCE oral solution compared to vehicle control Adverse Reactions ENTYCE (n = 171) Vehicle Control (n = 73) n (%) n (%) GASTROINTESTINAL Diarrhea 12 (7.0 %) 5 (6.8 %) Vomiting 11 (6.4 %) 4 (5.5 %) Hypersalivation 4 (2.3 %) 0 (0.0 %) Abdominal discomfort 2 (1.2 %) 0 (0.0 %) Flatulence 2 (1.2 %) 0 (0.0 %) Nausea 2 (1.2 %) 0 (0.0 %) CLINICAL PATHOLOGY Elevated blood urea nitrogen 7 (4.1 %) 2 (2.7 %) Elevated phosphorus 4 (2.3 %) 1 (1.4 %) Elevated creatinine 1 (0.6 %) 1 (1.4 %) OTHER Polydipsia 7 (4.1 %) 1 (1.4 %) Lethargy/depression 2 (1.2 %) 0 (0.0 %) Don't wait for weight loss. Stimulate appetite early to help treat the whole picture. Add ENTYCE ® (capromorelin oral solution) at the first sign of decreased eating as part of your overall treatment plan. Proven to effectively stimulate appetite to help improve food consumption The ONLY FDA-approved appetite stimulant for dogs Convenient, once-daily oral solution Take a closer look at EntyceForDogs.com INDICATION: For appetite stimulation in dogs. IMPORTANT SAFETY INFORMATION: For use in dogs only. Do not use in dogs that have a hypersensitivity to capromorelin. Use with caution in dogs with hepatic dysfunction or renal insufficiency. The safe use of Entyce has not been evaluated in breeding, pregnant or lactating dogs. The most common adverse reactions included diarrhea, vomiting, elevated blood urea nitrogen, polydipsia, and hypersalivation. Please see the brief summary of the full prescribing information below for more detail. ©2020 Elanco. Entyce, Elanco and the diagonal bar are trademarks of Elanco or its affiliates. PM-US-20-1317 W1a PA102553X 30 mg/mL For oral use in dogs only Appetite Stimulant Caution: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Before using Entyce, please consult the product insert, a summary of which follows: Indication: ENTYCE (capromorelin oral solution) is indicated for appetite stimulation in dogs. Dosage and Administration: Administer ENTYCE orally at a dose of 3 mg/kg (1.4 mg/lb) body weight once daily. To administer ENTYCE, gently shake the bottle, and then withdraw the appropriate amount of solution using the provided syringe. Rinse syringe between treatment doses. The effectiveness of ENTYCE has not been evaluated beyond 4 days of treatment in the clinical field study (See Effectiveness). See product insert for complete dosing and administration information. Contraindications: ENTYCE should not be used in dogs that have a hypersensitivity to capromorelin. Warnings: Not for use in humans. Keep this and all medications out of reach of children and pets. Consult a physician in case of accidental ingestion by humans. For use in dogs only Precautions: Use with caution in dogs with hepatic dysfunction. ENTYCE is metabolized by CYP3A4 and CYP3A5 enzymes (See Clinical Pharmacology). Use with caution in dogs with renal insufficiency. ENTYCE is excreted approximately 37% in urine and 62% in feces (See Adverse Reactions and Clinical Pharmacology). The safe use of ENTYCE has not been evaluated in dogs used for breeding or pregnant or lactating bitches. Adverse Reactions: In a controlled field study, 244 dogs were evaluated for safety when administered either ENTYCE or a vehicle control (solution minus capromorelin) at a dose of 3 mg/kg once daily for 4 days. Enrolled dogs had a reduced or absent appetite for a minimum of 2 days prior to day 0 and had various medical conditions: arthritis (40); gastrointestinal disease (24); allergy (22); dental disease (22); cardiovascular disease (16); renal disease (13); and others. Some dogs may have experienced more than one of the adverse reactions during the study. The following adverse reactions were observed: The following adverse reactions were reported in < 1% of dogs administered ENTYCE: hyperactivity, increase fecal volume, increase gut sounds, and polyuria. Effectiveness: Laboratory Effectiveness Study: Twenty four healthy Beagle dogs (6 dogs per sex in each group) with normal appetite were randomized into two groups and dosed daily with ENTYCE (capromorelin oral solution) at 3 mg/kg/day or vehicle control (solution minus capromorelin) to compare food intake over a 4-day period. The dogs were 13 months of age and weighed between 6.5 and 12.5 kg at the time of randomization. Six dogs administered ENTYCE repeatedly exhibited salivation post dosing and two dogs administered vehicle control exhibited salivation only one time on study day 0. Emesis was observed in one dog administered ENTYCE on study day 1. Dogs administered ENTYCE at a dose of 3 mg/kg/day for 4 consecutive days had statistically significantly increased food consumption compared to the vehicle control group (p < 0.001). Clinical Field Study: Effectiveness was evaluated in 177 dogs (121 dogs in the ENTYCE group and 56 dogs in the vehicle control group) in a double-masked, vehicle controlled field study. Dogs with a reduced appetite or no appetite, with various medical conditions, for a minimum of 2 days prior to day 0 were enrolled in the study. The dogs ranged in age from 4 months to 18 years. Dogs were randomized to treatment group and dosed once daily for 4 days with ENTYCE at 3 mg/kg or vehicle control. Dogs were assessed for appetite by owners on day 0 and day 3 ± 1 using an "increased", "no change" or "decreased" scoring system. Dogs were classified as a treatment success if the owner scored their dog's appetite as "increased" on day 3 ± 1. The success rates of the two groups were significantly different (p = 0.0078); 68.6% (n = 83) of dogs administered ENTYCE were successes, compared to 44.6% (n = 25) of the dogs in the vehicle control group. Storage Conditions: Store at or below 86° F (30° C) How Supplied: 30 mg/mL flavored solution in 10 mL, 15 mL and 30 mL bottles with measuring syringe Approved by FDA under NADA # 141-457 Manufactured for: Elanco US Inc. Greenfield, IN 46140, USA Revised: February 2020 ENTYCE, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. Table 1: Adverse Reactions reported in dogs administered ENTYCE oral solution compared to vehicle control Adverse Reactions ENTYCE (n = 171) Vehicle Control (n = 73) n (%) n (%) GASTROINTESTINAL Diarrhea 12 (7.0 %) 5 (6.8 %) Vomiting 11 (6.4 %) 4 (5.5 %) Hypersalivation 4 (2.3 %) 0 (0.0 %) Abdominal discomfort 2 (1.2 %) 0 (0.0 %) Flatulence 2 (1.2 %) 0 (0.0 %) Nausea 2 (1.2 %) 0 (0.0 %) CLINICAL PATHOLOGY Elevated blood urea nitrogen 7 (4.1 %) 2 (2.7 %) Elevated phosphorus 4 (2.3 %) 1 (1.4 %) Elevated creatinine 1 (0.6 %) 1 (1.4 %) OTHER Polydipsia 7 (4.1 %) 1 (1.4 %) Lethargy/depression 2 (1.2 %) 0 (0.0 %)

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