Atinvicitinib

Indications

NUMELVI is indicated for the control of pruritus associated with allergic dermatitis in dogs 6 months of age and older.

Dosage and Administration

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 below. NUMELVI should be administered with food. Dosing Table Body Weight Ranges (lb) Body Weight Ranges (kg) Number of Tablets to be Administered 4.8 mg tablets 7.2 mg tablets 21.6 mg tablets 31.6 mg tablets 4.4 - 6.5 2 - 2.9 0.5 6.6 - 9.5 3 - 4.3 0.5 9.6 - 13.3 4.4 - 6 1 13.4 - 19.9 6.1 - 9 1 20 - 29.8 9.1 - 13.5 0.5 29.9 - 42.6 13.6 - 19.3 0.5 42.7 - 58.4 19.4 - 26.5 1 58.5 - 87 26.6 - 39.5 1 87.1 - 118.9 39.6 - 54 1.5 119 - 174.2 54.1 - 79 2 ≥ 174.3 ≥79.1 Administer the appropriate combination of tablet strengths

Warnings

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

Description

The active ingredient in NUMELVI is atinvicitinib. Atinvicitinib is a synthetic selective Janus kinase (JAK) 1 inhibitor. The chemical (IUPAC) name of atinvicitinib is 1-[(3R,4S)-4-cyanooxan-3-yl]-3-[(2-fluoro-6-methoxypyridin-4-yl)amino]-1H-pyrazole-4-carboxamide.

Storage

NUMELVI tablets should be stored at 15 to 30°C (59 to 86°F).

FDA adverse event reports

The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming atinvicitinib as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.

These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.