atinvicitinib

For the control of pruritus associated with allergic dermatitis in dogs 6 months of age and older.

Numelvi™

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

Numelvi™ (atinvicitinib tablets)

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Numelvi™ (atinvicitinib tablets)

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 below. Table 1. Adverse Reactions through Day 28 Adverse Reaction NUMELVI (N=144) Number of dogs (%) Placebo (N=144) Number of dogs (%) Vomiting or nausea 10 (6.9%) 6 (4.2%) Otitis externa 9 (6.3%) 8 (5.6%) Hematuria (without urinary tract infection) 7 (4.9%) 6 (4.2%) Anorexia 6 (4.2%) 5 (3.5%) Bacterial skin infection 6 (4.2%) 10 (6.9%) Diarrhea 6 (4.2%) 15 (10.4%) Crystalluria 5 (3.5%) 2 (1.4%) Lethargy 5 (3.5%) 5 (3.5%) Urinary tract infection 5 (3.5%) 5 (3.5%) Upset stomach, including flatulence, retching, and bloating 3 (2.1%) 0 Neurological disorder (e.g., tremors, ataxia) 2 (1.4%) 1 (0.7%) Ocular discharge 2 (1.4%) 1 (0.7%) Coughing 1 (0.7%) 0 Granuloma 1 (0.7%) 0 Increased urination 1 (0.7%) 0 Abnormal hematology results likely related to NUMELVI administration included leukopenia, neutropenia, eosinopenia, monocytopenia, and lymphocytosis. Abnormal serum chemistry results likely related to NUMELVI administration included increased alanine aminotransferase (ALT), aspartate aminotransferase (AST), and symmetric dimethylarginine (SDMA), and hypercholesterolemia. Three NUMELVI-treated dogs withdrew from the study early due to an adverse reaction, two of which were considered likely related to NUMELVI treatment (i.e., diarrhea). Two placebo-treated dogs also withdrew from the study early due to an adverse reaction (i.e., diarrhea).

Numelvi™ (atinvicitinib tablets)

Administer orally, once daily, with food, at a dose of 0.36 to 0.54 mg atinvicitinib/lb (0.8 to 1.2 mg atinvicitinib/kg) body weight.

Oral

Numelvi™

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

ORAL

Numelvi™ (atinvicitinib tablets)