Today's Veterinary Practice

JUL-AUG 2015

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Today's VeTerinary PracTice | May/June 2015 | tvpjournal.com Today's VeTerinary news 14 nEXgarD rEcEIVEs 2015 BEsT nEw proDucT awarD froM BetteR Homes and GaRdens MagazInE Merial has announced that NexGard (afoxolaner) has been awarded the Best New Flea & Tick Control Product for Dogs by Better Homes and Gardens. More than 70,000 consumers participated in helping select the annual award winners. The Better Homes and Gardens Best New Product Awards recognize the most appealing and innovative beauty, food and beverage, health and personal care, household, and kid products. For more information, visit bhg.com/better-homes-and-garden-magazine/ best-new-product-awards/best-new-product-award-household. gEnErIc MIcrochIps prEVEnTIng pETs froM gETTIng hoME Generic microchips with a 900 manufacturing code are creating challenges for shelters and rescues across the U.S. This issue is receiving national attention because several companies continue to manufacture these chips. Established microchip suppliers have dedicated prefx numbers, such as 981 (Datamars Companion Animal ID, datamars.com) and 985 (HomeAgain Pet Microchip, public.homeagain.com). When a pet is located but its microchip does not have the owner information registered with it, the company that sold the chip can be contacted for the "trackback" information, which identifes the facility—generally a veterinary practice or shelter—that purchased and implanted the microchip. In turn, that facility can usually provide the needed information, reuniting the pet and owner. However, more than 6 companies sell microchips that start with the 900 code, making it very diffcult to track down the specifc company that sold the chip. Therefore, if the owner information is not registered along with the chip number, shelters and rescues hit an immediate dead end—the generic number does not provide any way to locate the company associated with the chip. This has led to situations in which pets have not been reunited with their owners, such as lost pets with microchips being adopted by new owners. "Veterinarians need to be warned about the use of these microchips and their registration services. Pet owners need to know that these chips may not get their pets home if ever lost and what they need to do so their pets have a better chance of getting home," said Steve Wilcox, Datamars, Inc. He added that Datamars is educating veterinarians, shelters, and pet owners about the risks of using these generic chips. For more information on the chips used in your practice, contact your supplier to ask whether they have a designated 3-digit code. Learn more about pet microchipping by reading The Importance of Microchipping, a The Back Page interview with AVMA's Dr. Kimberly May in the May/June 2015 issue, available at tvpjournal.com. aaVM c p roVIDEs nEws aggrEgaT or for LaTE s T upDaTE s In acaDEMIc VETErInary MEDIcInE On their News & Media Resources page, the Association of American Veterinary Medical Colleges (AAVMC) is providing a compilation of news stories and press releases that member institutions promote via RSS feeds to help inform the media and public about the latest news in academic veterinary medicine, including comparative medicine. The AAVMC has designed this resource to help spread the word about the important work occurring in academic veterinary medicine around the world. If you are a member institution with an RSS feed and would like to be included in this page, please email jjohnson@aavmc.org. For more information, visit aavmc.org/NewsAggregator.aspx. N 1 % (n=415) N 2 % (n=200) Vomiting (with and without blood) 17 4.1 25 12.5 Dry/Flaky Skin 13 3.1 2 1.0 Diarrhea (with and without blood) 13 3.1 7 3.5 Lethargy 7 1.7 4 2.0 Anorexia 5 1.2 9 4.5 Treatment Group Afoxolaner Oral active control Body Afoxolaner Per Chewables Weight Chewable (mg) Administered 4.0 to 10.0 lbs. 11.3 One 10.1 to 24.0 lbs. 28.3 One 24.1 to 60.0 lbs. 68 One 60.1 to 121.0 lbs. 136 One Over 121.0 lbs. Administer the appropriate combination of chewables CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Description: NexGard ® (afoxolaner) is available in four sizes of beef-favored, soft chewables for oral administration to dogs and puppies according to their weight. Each chewable is formulated to provide a minimum afoxolaner dosage of 1.14 mg/lb (2.5 mg/ kg). Afoxolaner has the chemical composition 1-Naphthalenecarboxamide, 4-[5- [3-chloro-5-(trifuoromethyl)-phenyl]-4, 5-dihydro-5-(trifuoromethyl)-3-isoxazolyl]-N-[2-oxo-2-[(2,2,2-trifuoroethyl)amino]ethyl. Indications: NexGard kills adult feas and is indicated for the treatment and prevention of fea infestations (Ctenocephalides felis), and the treatment and control of Black-legged tick (Ixodes scapularis), American Dog tick (Dermacentor variabilis), Lone Star tick (Amblyomma americanum), and Brown dog tick (Rhipicephalus sanguineus) infestations in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body weight or greater, for one month. Dosage and Administration: NexGard is given orally once a month, at the minimum dosage of 1.14 mg/lb (2.5 mg/kg). Dosing Schedule: NexGard can be administered with or without food. Care should be taken that the dog consumes the complete dose, and treated animals should be observed for a few minutes to ensure that part of the dose is not lost or refused. If it is suspected that any of the dose has been lost or if vomiting occurs within two hours of administration, redose with another full dose. If a dose is missed, administer NexGard and resume a monthly dosing schedule. Flea Treatment and Prevention: Treatment with NexGard may begin at any time of the year. In areas where feas are common year-round, monthly treatment with NexGard should continue the entire year without interruption. To minimize the likelihood of fea reinfestation, it is important to treat all animals within a household with an approved fea control product. Tick Treatment and Control: Treatment with NexGard may begin at any time of the year (see Effectiveness). Contraindications: There are no known contraindications for the use of NexGard. Warnings: Not for use in humans. Keep this and all drugs out of the reach of children. In case of accidental ingestion, contact a physician immediately. Precautions: The safe use of NexGard in breeding, pregnant or lactating dogs has not been evaluated. Use with caution in dogs with a history of seizures (see Adverse Reactions). Adverse Reactions: In a well-controlled US feld study, which included a total of 333 households and 615 treated dogs (415 administered afoxolaner; 200 administered active control), no serious adverse reactions were observed with NexGard. Over the 90-day study period, all observations of potential adverse reactions were recorded. The most frequent reactions reported at an incidence of > 1% within any of the three months of observations are presented in the following table. The most frequently reported adverse reaction was vomiting. The occurrence of vomiting was generally self-limiting and of short duration and tended to decrease with subsequent doses in both groups. Five treated dogs experienced anorexia during the study, and two of those dogs experienced anorexia with the frst dose but not subsequent doses. Table 1: Dogs With Adverse Reactions. 1 Number of dogs in the afoxolaner treatment group with the identifed abnormality. 2 Number of dogs in the control group with the identifed abnormality. In the US feld study, one dog with a history of seizures experienced a seizure on the same day after receiving the frst dose and on the same day after receiving the second dose of NexGard. This dog experienced a third seizure one week after receiving the third dose. The dog remained enrolled and completed the study. Another dog with a history of seizures had a seizure 19 days after the third dose of NexGard. The dog remained enrolled and completed the study. A third dog with a history of seizures received NexGard and experienced no seizures throughout the study. To report suspected adverse events, for technical assistance or to obtain a copy of the MSDS, contact Merial at 1-888-637- 4251 or www.merial.com/NexGard. 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. Mode of Action: Afoxolaner is a member of the isoxazoline family, shown to bind at a binding site to inhibit insect and acarine ligand-gated chloride channels, in particular those gated by the neurotransmitter gamma-aminobutyric acid (GABA), thereby blocking pre- and post-synaptic transfer of chloride ions across cell membranes. Prolonged afoxolaner-induced hyperexcitation results in uncontrolled activity of the central nervous system and death of insects and acarines. The selective toxicity of afoxolaner between insects and acarines and mammals may be inferred by the differential sensitivity of the insects and acarines' GABA receptors versus mammalian GABA receptors. Effectiveness: In a well-controlled laboratory study, NexGard began to kill feas four hours after initial administration and demonstrated >99% effectiveness at eight hours. In a separate well-controlled laboratory study, NexGard demonstrated 100% effectiveness against adult feas 24 hours post-infestation for 35 days, and was ≥ 93% effective at 12 hours post-infestation through Day 21, and on Day 35. On Day 28, NexGard was 81.1% effective 12 hours post-infestation. Dogs in both the treated and control groups that were infested with feas on Day -1 generated fea eggs at 12- and 24-hours post-treatment (0-11 eggs and 1-17 eggs in the NexGard treated dogs, and 4-90 eggs and 0-118 eggs in the control dogs, at 12- and 24-hours, respectively). At subsequent evaluations post-infestation, feas from dogs in the treated group were essentially unable to produce any eggs (0-1 eggs) while feas from dogs in the control group continued to produce eggs (1-141 eggs). In a 90-day US feld study conducted in households with existing fea infestations of varying severity, the effectiveness of NexGard against feas on the Day 30, 60 and 90 visits compared with baseline was 98.0%, 99.7%, and 99.9%, respectively. Collectively, the data from the three studies (two laboratory and one feld) demonstrate that NexGard kills feas before they can lay eggs, thus preventing subsequent fea infestations after the start of treatment of existing fea infestations. In well-controlled laboratory studies, NexGard demonstrated >97% effectiveness against Dermacentor variabilis, >94% effectiveness against Ixodes scapularis, and >93% effectiveness against Rhipicephalus sanguineus, 48 hours post-infestation for 30 days. At 72 hours post-infestation, NexGard demonstrated >97% effectiveness against Amblyomma americanum for 30 days. Animal Safety: In a margin of safety study, 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. Dogs in the control group were sham-dosed. There were no clinically-relevant effects related to treatment on physical examination, body weight, food consumption, clinical pathology (hematology, clinical chemistries, or coagulation tests), gross pathology, histopathology or organ weights. Vomiting occurred throughout the study, with a similar incidence in the treated and control groups, including one dog in the 5x group that vomited four hours after treatment. In a well-controlled feld 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. Storage Information: Store at or below 30°C (86°F) with excursions permitted up to 40°C (104°F). How Supplied: NexGard is available in four sizes of beef-favored soft chewables: 11.3, 28.3, 68 or 136 mg afoxolaner. Each chewable size is available in color-coded packages of 1, 3 or 6 beef-favored chewables. NADA 141-406, Approved by FDA Marketed by: Frontline Vet Labs™, a Division of Merial, Inc. Duluth, GA 30096-4640 USA Made in Brazil. ®NexGard is a registered trademark, and TM FRONTLINE VET LABS is a trademark, of Merial. ©2015 Merial. All rights reserved. 1050-4493-03 Rev. 1/2015 Today's VeTerinary PracTice | July/august 2015

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