Etrasimodside effects

The following serious adverse reactions are described elsewhere in the labeling:

Infections

Bradyarrhythmia and Atrioventricular Conduction Delays

Liver Injury

Macular Edema

Increased Blood Pressure

Fetal Risk

Cutaneous Malignancies

Posterior Reversible Encephalopathy Syndrome

Respiratory Effects

Unintended Additive Immune System Effects from Prior Treatment with Immunosuppressive or Immune-Modulating Drugs

Immune System Effects After Stopping VELSIPITY Most common adverse reactions (incidence ≥5%) are: headache, elevated liver tests, and dizziness. To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical

Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of VELSIPITY 2 mg once daily in subjects with moderately to severely active ulcerative colitis was evaluated in two randomized, placebo-controlled studies of 52 weeks (UC-1) and 12 weeks (UC-2) duration. Additional safety data were obtained from a randomized, double-blind, placebo-controlled dose-finding study of 12 weeks duration (UC-3). In the 52-week study (UC-1), 433 subjects were enrolled of whom 289 received VELSIPITY 2 mg once daily. In the 12-week studies (UC-2 and UC-3), 458 subjects were enrolled of whom 288 received VELSIPITY 2 mg once daily. Table 1 summarizes the adverse reactions reported in at least 2% of subjects and at a higher rate than placebo during UC-1.

Table 1: Adverse Reactions Reported in at least 2% of subjects and at a higher rate than placebo. in Subjects with Ulcerative Colitis in a Placebo-Controlled 52-Week Study (UC-1) Adverse Reaction VELSIPITY 2 mg Once Daily N = 289 % Placebo N = 144 % Headache Headache includes related terms headache, migraine, and tension headache. 9 5 Elevated liver tests Elevated liver tests includes related terms ALT increased, AST increased, blood alkaline phosphatase increased, cholestasis, GGT increased, hepatic enzyme increased, hyperbilirubinemia, liver function test increased, and transaminases increased. 6 5 Dizziness Dizziness includes related terms dizziness, dizziness exertional, and dizziness postural. 5 2 Arthralgia 4 2 Hypertension Hypertension includes related terms hypertension, and blood pressure increased. 3 1 Urinary tract infection Urinary tract infection includes related terms urinary tract infection and cystitis. 3 2 Nausea 3 1 Hypercholesterolemia Hypercholesterolemia includes related terms hypercholesterolemia and blood cholesterol increased. 3 0 Herpes viral infection Herpes viral infection includes related terms herpes zoster, oral herpes, and herpes simplex. 2 1 Table 2 summarizes the adverse reactions reported in at least 2% of subjects and at a higher rate than placebo during UC-2 and UC-3.

Table 2: Adverse Reactions Reported in at least 2% of subjects and at a higher rate than placebo. in Subjects with Ulcerative Colitis in Placebo-Controlled 12-Week Studies (UC-2 and UC-3) Adverse Reaction VELSIPITY 2 mg Once Daily N = 288 % Study-size adjusted % for each group are based on the Mantel-Haenszel weights. Placebo N = 170 % Headache Headache includes related terms headache, migraine, and sinus headache. 6 4 Elevated liver tests Elevated liver tests includes related terms ALT increased, AST increased, blood alkaline phosphatase increased, blood bilirubin increased, cholestasis, GGT increased, hepatic enzyme increased, hepatic function abnormal, liver function test abnormal, and transaminases increased. 5 <1 Nausea 4 2 Bradycardia Bradycardia includes related terms bradycardia, sinus bradycardia, and heart rate decreased. 3 0 Urinary tract infection Urinary tract infection includes related terms urinary tract infection, cystitis, and genitourinary tract infection. 3 0 Ophthalmologic Findings In UC-1, for subjects with a baseline and follow-up examination, a decrease in visual acuity was reported in 2.6% (4/156) of subjects who received VELSIPITY and no subjects who received placebo.