Numelvi Atinvicitinib Tablets for Dogs

Numelvi is indicated for the control of pruritus associated with allergic dermatitis in dogs 6 months of age and older. Numelvi (atinvicitinib tablets) is The Future of Itch Relief! The First and Only Second-Generation Janus Kinase (JAK) Inhibitor for Dogs.

How Its 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.

Special Precautions

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.

Animal Safety Warnings:

Dogs should be monitored for the development of infections because NUMELVI may increase susceptibility to opportunistic infections, including demodicosis and interdigital furunculosis (see Target Animal Safety).

Numelvi is not for use in dogs with serious infections.

Numelvi is a JAK inhibitor. New neoplastic conditions (benign and malignant) have been reported in dogs treated with other JAK inhibitors. Consider the risks and benefits of treatment prior to initiating NUMELVI in dogs with a history of recurrent demodicosis.

Numelvi modulates the immune system.

Numelvi is not for use in dogs less than 6 months of age (see Target Animal Safety).

Keep Numelvi in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

PRECAUTIONS: The effectiveness and safety of Numelvi have not been evaluated in a field study beyond 28 days (see Adverse Reactions and Effectiveness). The safe use of Numelvi has not been evaluated in breeding, pregnant, or lactating dogs. Decreased mean testes weight was observed in a laboratory safety study (see Target Animal Safety). The safe use of Numelvi has not been evaluated in combination with glucocorticoids, cyclosporine, or other systemic immunosuppressive agents.

Side Effects

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.

Overdose Information

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.

Storage

Store at room temperature between 59-86°F

Active Ingredients

Atinvicitinib

¹Over the other JAK enzymes in in vitro assays.²In a canine interleukin-31 (cIL-31)-induced pruritus model.³A ?2 cm reduction in owner Pruritus Visual Analog Scale.⁴Numelvi is taken at or around mealtime