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1 Incredible. xng237353_techdetailer4thtick9x12_rsg.indd 1
2 xng237353_techdetailer4thtick9x12_rsg.indd 2
3 For dog owners who prefer to help protect their pets from fleas and ticks with an oral product that s easy to give. ORAL NexGard (afoxolaner) Soft, beef-flavored chew that dogs prefer 1, 2 Kills fleas and ticks Prevents infestations by killing fleas fast Prescription only Features anti-diversion technology monitored by Pinkerton Consulting & Investigations Available for dogs only Customer Satisfaction Guaranteed The first and only, prescription-only soft, beef-flavored chew that kills fleas AND ticks. IMPORTANT SAFETY INFORMATION: For use in dogs only. The most common adverse reaction is vomiting. Other adverse reactions reported are dry/flaky skin, diarrhea, lethargy, and anorexia. The safe use of NexGard in pregnant, breeding, or lactating dogs has not been evaluated. Use with caution in dogs with a history of seizures. 1 Data on File at Merial. 2 Data on File at Merial. xng237353_techdetailer4thtick9x12_rsg.indd 3
4 The next generation of flea and tick protection. Palatable protection. 3 NexGard (afoxolaner) is the first and only soft, beef-flavored chew that kills BOTH fleas and ticks. Combining a revolutionary active ingredient with an innovative form. NexGard is an FDA-approved prescription-only product that: Kills fleas fast Prevents flea infestations Comes in a soft, beef-flavored chewable Kills ticks We know dogs like NexGard. 3 We took steps to make sure you will, too. Revolutionary molecule, afoxolaner Soft chew that s easy to give Approved for puppies 8 weeks and older and at least 4 pounds Prescription-only Sold exclusively to veterinarians Anti-diversion technology monitored by Pinkerton Consulting & Investigations Lasts for a full month The future of flea and tick control is in your hands. NexGard is sold exclusively to veterinarians, and is available only with a veterinarian s prescription. In addition, NexGard features anti-diversion technology monitored by Pinkerton Consulting & Investigations. IMPORTANT SAFETY INFORMATION: For use in dogs only. The most common adverse reaction is vomiting. Other adverse reactions reported are dry/flaky skin, diarrhea, lethargy, and anorexia. The safe use of NexGard in pregnant, breeding, or lactating dogs has not been evaluated. Use with caution in dogs with a history of seizures. 3 Data on file at Merial. xng237353_techdetailer4thtick9x12_rsg.indd 4
5 PG 04 xng237353_techdetailer4thtick9x12_rsg.indd 5
6 Afoxolaner: Safe and effective all month long. The Active Ingredient Afoxolaner is a molecule developed specifically for the treatment of fleas and ticks that prey on dogs. 4 Afoxolaner binds to flea and tick nerve cell chloride channels activated by the neurotransmitter GABA (gamma-aminobutyric acid), which causes uncontrolled hyperexcitation of the central nervous system and death in fleas and ticks. Afoxolaner acts selectively on the nervous systems of fleas and ticks because the GABA-gated chloride channels of these pests are much more sensitive to afoxolaner than those of mammals. Afoxolaner in the dog 4 After oral administration of NexGard to dogs, afoxolaner: Is rapidly absorbed into the blood stream, reaching peak plasma levels in 2 to 4 hours Binds predominantly to plasma proteins while unbound afoxolaner is distributed throughout tissues Is slowly eliminated from the body through metabolism and biliary excretion Has a terminal half-life of approximately 15 days Afoxolaner sustains excellent ectoparasitic activity for a FULL month 4 The minimum monthly oral dose of 2.5 mg/kg maintains blood levels that are above the effective concentration that kills 90% of fleas in 24 hours and American dog ticks in 48 hours (EC 90 ). Mean Afoxolaner Plasma Concentration Versus Time 10,000 Afoxolaner in action Concentration (ng/ml) 1, D variabilis EC 90 C felis EC 90 Afoxolaner selectively binds to a distinct site within chloride channels of the nervous system of fleas and ticks. This leads to prolonged firing of neurons, nervous system hyperexcitation, uncontrolled activity of the central nervous system, and death of the fleas or ticks Days after treatment * EC 90 is the plasma afoxolaner concentration at which 90% of fleas were killed within 24 hours and ticks were killed within 48 hours after infestation on dogs. EC 90 for C. felis is 23 ng/ml and for D. variabilis is 110 ng/ml. 4 Letendre L, Huang R, Kvaternick V, et al. The intravenous and oral pharmacokinetics of afoxolaner, a novel isoxazoline, used as a monthly chewable antiparasitic for dogs. Vet Parasitol. 2014;201: xng237353_techdetailer4thtick9x12_rsg.indd 6
7 PG 06 IMPORTANT SAFETY INFORMATION: For use in dogs only. The most common adverse reaction is vomiting. Other adverse reactions reported are dry/flaky skin, diarrhea, lethargy, and anorexia. The safe use of NexGard in pregnant, breeding, or lactating dogs has not been evaluated. Use with caution in dogs with a history of seizures. Kills fleas fast In a study designed to evaluate the speed of kill, NexGard: Started killing fleas just four hours after being consumed Killed 99.5% of existing fleas within eight hours after treatment Killed of fleas within 12 hours after treatment 100 Effectiveness of treatment against an existing flea infestation. 5 The FDA has approved NexGard for use in puppies 8 weeks of age or older weighing at least 4 pounds % 99.5% (P = 0.064) (P < 0.001) (P < 0.001) (P < 0.001) 4 HRS 8 HRS 12 HRS 24 HRS AFTER TREATMENT 5 Kunkle BN, Drag M, Chester TS, Larsen DL. Assessment of the onset of action of afoxolaner against existing adult flea (Ctenocephalides felis) infestations on dogs. Vet Parasitol. 2014;201(3-4): xng237353_techdetailer4thtick9x12_rsg.indd 7
8 Kill existing fleas with ease, keep infestations from coming back. NexGard is easy to give and has the speed it In a study, NexGard killed >99% of existing fleas within 8 hours after treatment 5 takes to kill fleas before they can lay eggs. In addition to being effective and convenient, it s consistent too. NexGard remains effective all month long so that your clients don t have to worry about infestations coming back. Kills EXISTING fleas before they can lay eggs 6 Kills NEW fleas before they can lay eggs 7 In a study, dogs were pre-infested with approximately 100 fleas the day before treatment Dogs were treated with NexGard on Day 0, then infested with fleas on Days 7, 14, 21, 28 and 35 Zero eggs were found on Days 8, 22, 29 and 36 Only 1 egg collected from 1 dog, on Day 15 C. felis Egg Count Reduction for Pre-infested Dogs 12 hours After Treatment Percent Efficacy* Flea Egg Reduction for Treated Dogs at 24 Hours Post-Infestation % % HRS AFTER TREATMENT DAY 8 DAY 15 DAY 22 DAY 29 DAY 36 AFTER TREATMENT 6 Freedom of Information Summary, NADA (09/14/2013), NexGard. 7 Hunter JS 3rd, Dumont P, Chester TS, et al. Evaluation of the curative and preventive efficacy of a single oral administration of afoxolaner against cat flea (Ctenocephalides felis) infestations on dogs. Vet Parasitol. 2014;201: * Percent efficacy = 100 [(C T)/C], where T and C are the appropriate means of treated and control groups, respectively. xng237353_techdetailer4thtick9x12_rsg.indd 8
9 PG 08 Kill NEW fleas fast all month long. For the entire month, NexGard maintains blood levels of afoxolaner that provide sustained, excellent efficacy against fleas. Kills NEW fleas all month long 7 In a study, NexGard killed of fleas within 24 hours NexGard has staying power: In a study, NexGard killed of fleas 24 hours after infestation for a full month. 7 Dogs were given NexGard on Day 0 Dogs were then infested with roughly 100 (+/- 5) Ctenocephalides felis fleas on Days 7, 14, 21, 28 and 35 NexGard efficacy was through day Percent Efficacy* Against Adult Fleas 24 Hours After Treatment or Flea Reinfestation DAY 1 DAY 8 DAY 15 DAY 22 AFTER TREATMENT DAY 29 DAY 36 IMPORTANT SAFETY INFORMATION: For use in dogs only. The most common adverse reaction is vomiting. Other adverse reactions reported are dry/flaky skin, diarrhea, lethargy, and anorexia. The safe use of NexGard in pregnant, breeding, or lactating dogs has not been evaluated. Use with caution in dogs with a history of seizures. xng237353_techdetailer4thtick9x12_rsg.indd 9
10 It s not just lab tested. It s real-world proven. Before releasing NexGard to the veterinary community, its efficacy and safety was studied and evaluated in a 90-day, multicenter clinical field study. In the efficacy portion of the study 6 : Dogs from 186 households were treated with NexGard These households had varying levels of active flea infestations Many homes had multiple pets Dogs were brought in for a flea count on their first visit, then given NexGard They returned to their homes where they were continually exposed to the fleas there Dogs then returned to their veterinarian for two more doses over the next two months Dogs were evaluated 30 days after the last dose was administered NexGard was proven safe and effective in a field study that featured clientowned dogs in their natural flea-infested environments during a 3-month period. Dogs from 186 households were treated with NexGard Homes had active flea infestations Visit 0: 26.5 AVERAGE PRE-TREATMENT FLEA COUNT for dogs that would be treated with NexGard xng237353_techdetailer4thtick9x12_rsg.indd 10
11 IMPORTANT SAFETY INFORMATION: For use in dogs only. The most common adverse reaction is vomiting. Other adverse reactions reported are dry/flaky skin, diarrhea, lethargy, and anorexia. The safe use of NexGard in pregnant, breeding, or lactating dogs has not been evaluated. Use with caution in dogs with a history of seizures. The Future of Flea and Tick Control. RESULTS Visit 1: 98.0% FLEA REDUCTION 30 days after first NexGard Visit 2: 99.7% FLEA REDUCTION 30 days after second NexGard Visit 3: 99.9% FLEA REDUCTION 30 days after third NexGard xng237353_techdetailer4thtick9x12_rsg.indd 11
12 Designed to be safe, proven to be safe. Powerful protection, safe science The safety portion of the extensive field study featured 615 treated dogs of these dogs were administered NexGard and 200 an active control. Over the course of the study, no serious adverse reactions were observed with NexGard. Concurrent use: NexGard was used concurrently with other medications, such as vaccines, anthelmintics, antibiotics (including topicals), steroids, NSAIDs, anesthetics, and antihistamines. No adverse reactions were observed from the concomitant use of NexGard with other medications. Adverse reactions: Vomiting was the most commonly reported adverse reaction. Two dogs with a history of seizures experienced seizure activity during this study. The most frequent reactions reported within any of the three months of observations are presented in the table below. Animal Safety Before NexGard was tested in pet owner homes, a margin of safety study was completed. Veterinarians and pet owners can be confident that NexGard is safe to give at the recommended dose. Dose tolerance: In a margin of safety study, 8 NexGard was administered orally to 8- to 9-week-old Beagle puppies at 1, 3, and 5 times the maximum exposure dose (6.3 mg/kg) for three treatments every 28 days, followed by three treatments every 14 days, for a total of six treatments. There were no clinically-relevant effects related to treatment. NexGard was demonstrated to be well tolerated in dogs as young as 8 weeks of age. Dogs with Adverse Reactions TREATMENT GROUP REACTION Vomiting (with and without blood) Dry/Flaky Skin Diarrhea (with and without blood) Lethargy Anorexia Afoxolaner 4.1% 3.1% 3.1% 1.7% 1.2% Oral Active Control 12.5% 1.0% 3.5% 2.0% 4.5% 8 Drag M, Saik J, Harriman J, Larsen D. Safety evaluation of orally administered afoxolaner in 8-week-old dogs. Vet Parasitol. 2014;201: xng237353_techdetailer4thtick9x12_rsg.indd 12
13 PG 14 IMPORTANT SAFETY INFORMATION: For use in dogs only. The most common adverse reaction is vomiting. Other adverse reactions reported are dry/flaky skin, diarrhea, lethargy, and anorexia. The safe use of NexGard in pregnant, breeding, or lactating dogs has not been evaluated. Use with caution in dogs with a history of seizures. In a well-controlled field study, NexGard was used concomitantly with other medications, such as vaccines, anthelmintics, antibiotics (including topicals), steroids, NSAIDs, anesthetics, and antihistamines. No adverse reactions were observed from the concomitant use of NexGard with other medications. xng237353_techdetailer4thtick9x12_rsg.indd 13
14 The Tick Threat. Take Out Ticks Ticks now pose a greater threat to dogs across the country than ever before. 9 Several species of ticks and the diseases that they can transmit are now commonly found in parts of the country where they previously did not exist. Black-legged (deer) ticks 10 Ixodes scapularis Associated with 11 : Lyme disease Anaplasmosis American dog ticks 10 Dermacentor variabilis Associated with 11 : Rocky Mountain spotted fever Tick paralysis Tularemia Lone star ticks 10 Amblyomma americanum Associated with 11 : Ehrlichiosis Tularemia Brown dog ticks 10 Rhipicephalus sanguineus Associated with 11 : Rocky Mountain spotted fever Ehrlichiosis 9 Dryden MW. Flea and tick control in the 21st century, challenges and opportunities. Vet Derm. 2009;20: Center for Disease Control - Tick Geographic Distribution. Accessed February 5, Blagburn BL, et al. Biology, treatment and control of flea and tick infestations. Vet Clin Small Anim. 2009;39: Freedom of Information Summary Supplement, NADA (05/15/2014), NexGard. 13 Mitchell EB, Dorr P, Everett WR, et al. Efficacy of afoxolaner against Dermacentor variabilis ticks in dogs. Vet Parasitol. 2014;201: Freedom of Information Summary Supplement, NADA (02/15/2015), NexGard. xng237353_techdetailer4thtick9x12_rsg.indd 14
15 PG 14 Percent Efficacy* Against Ixodes scapularis 48 Hours After Treatment or Reinfestation 12 Percent Efficacy* Against Amblyomma americanum 48 Hours After Treatment and 72 Hours After Reinfestation Black-legged (deer) tick (Ixodes scapularis) % DAY % DAY % DAY % DAY 30 Lone star tick (Amblyomma americanum) DAY % DAY 10 DAY 17 DAY % DAY 31 Percent Efficacy* Against Dermacentor variabilis 48 Hours After Treatment or Reinfestation 13 Percent Efficacy* Against Rhipicephalus sanguineus 48 Hours After Treatment or Reinfestation American dog tick (Dermacentor variabilis) DAY 2 DAY 9 DAY % DAY % DAY 30 Brown dog tick (Rhipicephalus sanguineus) DAY % DAY % DAY % DAY % DAY 30 IMPORTANT SAFETY INFORMATION: For use in dogs only. The most common adverse reaction is vomiting. Other adverse reactions reported are dry/flaky skin, diarrhea, lethargy, and anorexia. The safe use of NexGard in pregnant, breeding, or lactating dogs has not been evaluated. Use with caution in dogs with a history of seizures. NexGard kills fleas and ticks all month long. * Percent effectiveness of the treated group with respect to the control group was calculated using the formula [(C T)/C] x 100, where C = geometric mean live tick count for the control group and T = geometric mean live tick count for the treated group for each time point. Efficacy against Lone star ticks was evaluated 48 hours after treatment (day 2) -- and 72 hours post-infestation for the remainder of the month (days 10-31) xng237353_techdetailer4thtick9x12_rsg.indd 15
16 Protection in a form patients will favor. 3 NexGard soft chews are designed for ease of administration. Created with soy proteins and braised beef flavoring, NexGard features a chewy texture, rich brown color, and beefy aroma that makes it easy to give. 3 NexGard is a vegetable-based, meatless, beef-flavored chew that may be a suitable option for dogs with beef allergies. No Dinner Required Studies showed that there is no significant difference in plasma concentrations of afoxolaner between fed and fasted dogs 4. You can send it home with your clients, or you can give it right in your exam room to: Offer immediate treatment to an existing flea or tick problem Demonstrate how easy it is to give Since it doesn t have to be administered with food, that means no worries about efficacy being affected because of a dose being administered without a meal. And, since it s so palatable, 3 your clients won t have to go to the trouble of hiding NexGard in their dog s food, either. IMPORTANT SAFETY INFORMATION: For use in dogs only. The most common adverse reaction is vomiting. Other adverse reactions reported are dry/flaky skin, diarrhea, lethargy, and anorexia. The safe use of NexGard in pregnant, breeding, or lactating dogs has not been evaluated. Use with caution in dogs with a history of seizures. xng237353_techdetailer4thtick9x12_rsg.indd 16
17 PG 16 NexGard is the ONLY soft, beef-flavored chew that kills fleas AND ticks. Dogs prefer NexGard over COMFORTIS (spinosad ). In two studies, dogs that showed a preference preferred NexGard 18-1 over COMFORTIS. 1 18* DOGS DOG * to 1. xng237353_techdetailer4thtick9x12_rsg.indd 17
18 Innovative protection for dogs, unmatched support for you. NexGard is a prescription-only product sold only to veterinarians. But that s not the only support for your practice that comes with NexGard. As part of the Merial family of flea and tick control, NexGard comes with full support for you and your clients: Practice Support Anti-Diversion Technology NexGard incorporates anti-diversion technology monitored by Pinkerton Consulting & Investigations. Pinkerton is one of the country s original investigative and security firms CLIENT CONNECTION TM Plus Merial is proud to include NexGard in our popular CLIENT CONNECTION Plus program. CLIENT CONNECTION Plus helps drive pet owners into your practice by mailing out educational materials and high value coupons to your clients All mailings to your clients appear to come directly from your practice Client Support Customer Satisfaction Guaranteed Merial guarantees customer satisfaction and your clients can reach Merial Customer Care at PLUS ( ). For full terms and conditions, including the SATISFACTION PLUS GUARANTEE, visit NexGardForDogs.com Consumer Promotion Merial is investing heavily in consumer advertising to drive pet owners into veterinary practices to get the flea and tick protection their dog deserves. NexGard promotion will include television, print and online advertising All advertising directs pet owners to their veterinarian xng237353_techdetailer4thtick9x12_rsg.indd 18 4/6/15 3:58 PM
19 PG 18 IMPORTANT SAFETY INFORMATION: For use in dogs only. The most common adverse reaction is vomiting. Other adverse reactions reported are dry/flaky skin, diarrhea, lethargy, and anorexia. The safe use of NexGard in pregnant, breeding, or lactating dogs has not been evaluated. Use with caution in dogs with a history of seizures. NexGard comes with full support for you and your clients: Quick Reference Report NexGard Diversion Consumer Education All veterinarians who carry NexGard are eligible to receive informative materials to promote the importance of flea and tick control to their clients. Educational materials include posters, coupons, displays and more If you see NexGard being sold by a non-veterinarian: Call , Option 1 NexGardInvestigation@pinkerton.com Fill out a report on MERIALconnect.com SM CLIENT CONNECTION Plus Enroll at MerialClientConnectionPlus.com Customer Satisfaction Guaranteed Have your clients report any issues to PLUS ( ). xng237353_techdetailer4thtick9x12_rsg.indd 19 4/6/15 3:58 PM
20 Easy to give, easy to stock. NexGard is available in 4 sizes (both 3 packs and 6 packs): Small Dog: lbs Medium Dog: lbs Actual Size of Soft Beef-Flavored Chew Actual Size of Soft Beef-Flavored Chew Large Dog: lbs Extra Large Dog: lbs Actual Size of Soft Beef-Flavored Chew Actual Size of Soft Beef-Flavored Chew IMPORTANT SAFETY INFORMATION: For use in dogs only. The most common adverse reaction is vomiting. Other adverse reactions reported are dry/flaky skin, diarrhea, lethargy, and anorexia. The safe use of NexGard in pregnant, breeding, or lactating dogs has not been evaluated. Use with caution in dogs with a history of seizures. xng237353_techdetailer4thtick9x12_rsg.indd 20 4/6/15 3:58 PM
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