VELSIPITY™ Adverse Reactions

(etrasimod)

6 ADVERSE REACTIONS

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

Infections [see Warnings and Precautions (5.1)]
Bradyarrhythmia and Atrioventricular Conduction Delays [see Warnings and Precautions (5.2)]
Liver Injury [see Warnings and Precautions (5.3)]
Macular Edema [see Warnings and Precautions (5.4)]
Increased Blood Pressure [see Warnings and Precautions (5.5)]
Fetal Risk [see Warnings and Precautions (5.6)]
Malignancies [see Warnings and Precautions (5.7)]
Posterior Reversible Encephalopathy Syndrome [see Warnings and Precautions (5.8)]
Respiratory Effects [see Warnings and Precautions (5.9)]
Unintended Additive Immune System Effects from Prior Treatment with Immunosuppressive or Immune-Modulating Drugs [see Warnings and Precautions (5.10)]
Immune System Effects After Stopping VELSIPITY [see Warnings and Precautions (5.11)]

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 [see Clinical Studies (14)]. 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* in Subjects with Ulcerative Colitis in a Placebo-Controlled 52-Week Study (UC-1)
*
Reported in at least 2% of subjects and at a higher rate than placebo.
Headache includes related terms headache, migraine, and tension headache.
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.
§
Dizziness includes related terms dizziness, dizziness exertional, and dizziness postural.
Hypertension includes related terms hypertension, and blood pressure increased.
#
Urinary tract infection includes related terms urinary tract infection and cystitis.
Þ
Hypercholesterolemia includes related terms hypercholesterolemia and blood cholesterol increased.
ß
Herpes viral infection includes related terms herpes zoster, oral herpes, and herpes simplex.

Adverse Reaction

VELSIPITY

2 mg Once Daily

N = 289

%

Placebo

N = 144

%

Headache

9

5

Elevated liver tests

6

5

Dizziness§

5

2

Arthralgia

4

2

Hypertension

3

1

Urinary tract infection#

3

2

Nausea

3

1

HypercholesterolemiaÞ

3

0

Herpes viral infectionß

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* in Subjects with Ulcerative Colitis in Placebo-Controlled 12-Week Studies (UC-2 and UC-3)
*
Reported in at least 2% of subjects and at a higher rate than placebo.
Study-size adjusted % for each group are based on the Mantel-Haenszel weights.
Headache includes related terms headache, migraine, and sinus headache.
§
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.
Bradycardia includes related terms bradycardia, sinus bradycardia, and heart rate decreased.
#
Urinary tract infection includes related terms urinary tract infection, cystitis, and genitourinary tract infection.

Adverse Reaction

VELSIPITY

2 mg Once Daily

N = 288

%

Placebo

N = 170

%

Headache

6

4

Elevated liver tests§

5

<1

Nausea

4

2

Bradycardia

3

0

Urinary 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 [see Warnings and Precautions (5.4)].

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Adverse Reactions

6 ADVERSE REACTIONS

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

Infections [see Warnings and Precautions (5.1)]
Bradyarrhythmia and Atrioventricular Conduction Delays [see Warnings and Precautions (5.2)]
Liver Injury [see Warnings and Precautions (5.3)]
Macular Edema [see Warnings and Precautions (5.4)]
Increased Blood Pressure [see Warnings and Precautions (5.5)]
Fetal Risk [see Warnings and Precautions (5.6)]
Malignancies [see Warnings and Precautions (5.7)]
Posterior Reversible Encephalopathy Syndrome [see Warnings and Precautions (5.8)]
Respiratory Effects [see Warnings and Precautions (5.9)]
Unintended Additive Immune System Effects from Prior Treatment with Immunosuppressive or Immune-Modulating Drugs [see Warnings and Precautions (5.10)]
Immune System Effects After Stopping VELSIPITY [see Warnings and Precautions (5.11)]

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 [see Clinical Studies (14)]. 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* in Subjects with Ulcerative Colitis in a Placebo-Controlled 52-Week Study (UC-1)
*
Reported in at least 2% of subjects and at a higher rate than placebo.
Headache includes related terms headache, migraine, and tension headache.
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.
§
Dizziness includes related terms dizziness, dizziness exertional, and dizziness postural.
Hypertension includes related terms hypertension, and blood pressure increased.
#
Urinary tract infection includes related terms urinary tract infection and cystitis.
Þ
Hypercholesterolemia includes related terms hypercholesterolemia and blood cholesterol increased.
ß
Herpes viral infection includes related terms herpes zoster, oral herpes, and herpes simplex.

Adverse Reaction

VELSIPITY

2 mg Once Daily

N = 289

%

Placebo

N = 144

%

Headache

9

5

Elevated liver tests

6

5

Dizziness§

5

2

Arthralgia

4

2

Hypertension

3

1

Urinary tract infection#

3

2

Nausea

3

1

HypercholesterolemiaÞ

3

0

Herpes viral infectionß

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* in Subjects with Ulcerative Colitis in Placebo-Controlled 12-Week Studies (UC-2 and UC-3)
*
Reported in at least 2% of subjects and at a higher rate than placebo.
Study-size adjusted % for each group are based on the Mantel-Haenszel weights.
Headache includes related terms headache, migraine, and sinus headache.
§
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.
Bradycardia includes related terms bradycardia, sinus bradycardia, and heart rate decreased.
#
Urinary tract infection includes related terms urinary tract infection, cystitis, and genitourinary tract infection.

Adverse Reaction

VELSIPITY

2 mg Once Daily

N = 288

%

Placebo

N = 170

%

Headache

6

4

Elevated liver tests§

5

<1

Nausea

4

2

Bradycardia

3

0

Urinary 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 [see Warnings and Precautions (5.4)].

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