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Numelvi (atinvicitinib tablets) for Dogs Rx

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Product Description
Numelvi (atinvicitinib tablets) is a prescription medication for the control of itch associated with allergic dermatitis in dogs. Numelvi starts working in as little as 2 to 4 hours to relieve itch and deliver the comfort your dog deserves. Numelvi is given once daily with food at or around mealtime and is labeled for use in dogs and puppies 6 months of age and older.
Who is Numelvi (atinvicitinib tablets) for Dogs for?
Dogs (6 months of age or older)
Why use Numelvi (atinvicitinib tablets) for Dogs?
Product Benefits: -Acts fast: Absorbed quickly to start relieving allergic itch within 2-4 hours. -Suitable for young dogs: Labeled for use in dogs and puppies 6 months of age and older. -Easy, once daily dosing: Given once daily with food at or around mealtime. -No interference with routine treatments. Can be used with other routine treatments and vaccines.
How does Numelvi (atinvicitinib tablets) for Dogs work?
- At least 10X more selective for JAK11* - Starts reducing itch within 2-4 hours2† ->82% of dogs showed significant‡ improvement in itch within 1 week 3 - Approved for dogs and puppies as young as 6 months of age and can be used in dogs weighing at least 2 kg - Proven safety for dogs - Once-daily dosing from day 1§ *Over the other JAK enzymes in in vitro assays. † In a canine interleukin-31 (cIL-31)-induced pruritus model. ‡ A =2 cm reduction in owner Pruritus Visual Analog Scale. § Numelvi is taken at or around mealtime
Manufacturer:
Merck Animal Health
Active Ingredients(s):
Atinvicitinib
How is Numelvi (atinvicitinib tablets) for Dogs sold?
Sold as tablets in strengths of 4.8 mg, 7.2 mg, 21.6 mg or 31.6 mg in counts of 1, 30 or 90.
What are the side effects of Numelvi (atinvicitinib tablets) for Dogs?
ADVERSE REACTIONS: In a masked field study assessing effectiveness and safety of Numelvi for the control of pruritus associated with allergic dermatitis in dogs, 144 Numelvi-treated dogs and 144 placebo-treated dogs were evaluated for safety for up to 28 days. Adverse reactions seen during the field study are summarized in Table 1 on the label.
What special precautions are there?
Numelvi is not for use in dogs less than 6 months of age or those with serious infections. Numelvi may increase susceptibility to opportunistic infections, including demodicosis and interdigital furunculosis. Consider the risks and benefits of treatment prior to initiating Numelvi in dogs with a history of recurrent demodicosis. Numelvi is a JAK inhibitor. New neoplastic conditions (benign and malignant) have been reported in dogs treated with other JAK inhibitors. The effectiveness and safety of Numelvi have not been evaluated in a field study beyond 28 days. The safe use of Numelvi has not been evaluated in breeding, pregnant, or lactating dogs, nor in combination with glucocorticoids, cyclosporine, or other systemic immunosuppressive agents. For complete safety information, refer to the product label. User Safety Warnings: This product is not for human use. Keep this and all drugs out of reach of children. Wash hands thoroughly with soap and water immediately after handling tablets. In case of accidental ingestion, seek medical attention immediately. * In a canine interleukin-31 (cIL-31)-induced pruritus model. † No clinically relevant drug interactions observed during 28-day field trial in dogs with allergic dermatitis after use with antimicrobials (including topicals), ecto- and endoparasiticides (isoxazolines, milbemycins, avermectins, pyrethrins, and pyrethroids), analgesics, anesthetics, nutritional supplements, topical skin and ear cleansers that did not contain glucocorticoids, as well as medicated shampoos.1. Kowalski T, Prohaczik A, Locke K, et al. The second-generation Janus kinase inhibitor atinvicitinib significantly reduces pruritus 2-4 hours after dosing dogs in a canine interleukin-31 model. Vet Dermatol. 2026;0:17-18. https://doi.org/10.1111/vde.700462. Data on File. Study Summary REF-11196. Merck Animal Health
What to do if overdose?
Contact your nearest emergency animal hospital. For technical information or to report a suspected adverse event, please contact Merck Animal Health at 1-800-224-5318 or https://www.merck-animal-health-usa.com. Safety Data Sheets (SDSs) can be found at https://www.merck.com/products/safety-data-sheets/#. For additional information about reporting adverse drug experiences for animal drugs, contact FDA at 1-888-FDA-VETS or https://www.fda.gov/reportanimalae.
How can I store Numelvi (atinvicitinib tablets) for Dogs?
Store at room temperature between 59-86 degrees F
Overview
Use as directed by your Veterinarian. 

Numelvi should be administered orally, once daily, at a dose of 0.36 to 0.54 mg atinvicitinib/lb (0.8 to 1.2 mg atinvicitinib/kg) body weight according to the Dosing Table.  NUMELVI should be administered with food.
Main Ingredients
Active Ingredient:  Atinvicitinib

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