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Issue link: http://todaysveterinarypractice.epubxp.com/i/619503
tvpjournal.com | January/February 2016 The Back Page: VeTeRINaRY VIeWPOINTS Free advisory panel, which has been lecturing and teaching widely. We helped create a Fear Free resource center, and developed a brochure on the Top 10 Ways to Get Started with Fear Free Veterinary Visits (available at dvm360.com/ fearfree or through the local representative for Boehringer Ingelheim, CEVA Animal Health, or Elanco Animal Health). We've also formed task forces to create training modules that will enable veterinarians, veterinary technicians, and other team members to become certifed in Fear Free, which is a collaborative effort with AAHA and NAVC and will be hosted on VetFolio (due to be available this year). Why should veterinarians take this initiative seriously? I grew up in the "hell-care" system of the 1950s and 1960s. At both doctor and dentists' offces, the focus was only on our physical well- being, not our comfort and emotions. Human health care professionals, especially those involved with children, realized things had to change. Now when a child—like my 6-year-old granddaughter—needs to visit a pediatrician or child-friendly dentist, it's like going to a medical offce disguised as a spa. As veterinary health care professionals, we are basically pet pediatricians for life. As such, we have to take steps to make sure that the pets under our care aren't just physically healthy, but emotionally healthy. What is the value of becoming certifed as a Fear Free veterinarian, technician, team member, or practice? Some people mistakenly think anxiety, stress, and fear are mostly feline problems. They're not. Fear affects almost every pet. The great news is that between the incredible foundation veterinary behaviorists have created and the work of the Fear Free Advisory Panel, we now know the simple, almost surefre steps that veterinary health care professionals can take to reduce or remove anxiety/stress/fear triggers. By taking advantage of the cornucopia of Fear Free materials already out there and by becoming Fear Free certifed, everybody wins. We get to "Do well by doing good!" Turn to page 8 to read this issue's Editor's Note in which Dr. Lesley King shares her thoughts on the Fear Free initiative and its importance in practice. 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 Continued from page 136