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Clinical Studies Experience

The data described below reflect exposure to APRISO (mesalamine extended-release capsules) in 557 patients, including 354 exposed for at least 6 months and 250 exposed for greater than one year. APRISO (mesalamine extended-release capsules) was studied in two placebo-controlled trials (n = 367 treated with APRISO (mesalamine extended-release capsules) ) and in one open-label, long-term study (n = 190 additional patients). The population consisted of patients with ulcerative colitis; the mean age was 47 years, 54% were female, and 93% were white. Patients received doses of APRISO (mesalamine extended-release capsules) 1.5 g administered orally once per day for six months in the placebo-controlled trials and for up to 24 months in the open-label study.

Because clinical studies 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 practice.

In the two placebo-controlled trials, 59% of APRISO (mesalamine extended-release capsules) -treated patients experienced an adverse reaction compared with 64% of placebo patients. Most adverse reactions with APRISO (mesalamine extended-release capsules) were mild or moderate in severity. Severe adverse reactions occurred in 6% of APRISO (mesalamine extended-release capsules) -treated patients and 5% of placebo-treated patients. Discontinuations due to adverse reactions occurred in 11% of APRISO (mesalamine extended-release capsules) -treated patients and 17% of placebo treated patients; the most common adverse reaction resulting in study discontinuation was recurrence of ulcerative colitis (APRISO (mesalamine extended-release capsules) 6%, placebo 14%). The most common reactions reported with APRISO (mesalamine extended-release capsules) ( ≥ 3%) are shown in Table 1 below.

Table 1: Treatment-Emergent Adverse Reactions during Clinical Trials Occurring in at Least 3% of APRISO (mesalamine extended-release capsules) -Treated Patients and at a Greater Rate than with Placebo

MedDRA Preferred Term APRISO 1.5 g/day
Headache 11% 8%
Diarrhea 8% 7%
Abdominal Pain Upper 5% 3%
Nausea 4% 3%
Nasopharyngitis 4% 3%
Influenza & Influenza-like Illness 4% 4%
Sinusitis 3% 3%

The following adverse reactions, presented by body system, were reported at a frequency less than 3% in patients treated with APRISO (mesalamine extended-release capsules) for up to 24 months in controlled and open-label trials.

Ear and Labyrinth Disorders: tinnitus, vertigo

Dermatological Disorder: alopecia

Gastrointestinal: abdominal pain lower, rectal hemorrhage

Laboratory Abnormalities: increased triglycerides, decreased hematocrit and hemoglobin

General Disorders and Administration Site Disorders: fatigue

Hepatic: hepatitis cholestatic, transaminases increased

Renal Disorders: creatinine clearance decreased, hematuria

Musculoskeletal: pain, arthralgia

Respiratory: dyspnea

Adverse Reaction Information from Other Sources

The following adverse reactions have been identified during clinical trials of a product similar to APRISO and post approval use of other mesalamine-containing products such as APRISO (mesalamine extended-release capsules) . Because many of these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Body as a Whole: lupus-like syndrome, drug fever

Cardiovascular: pericarditis, pericardial effusion, myocarditis

Gastrointestinal: pancreatitis, cholecystitis, gastritis, gastroenteritis, gastrointestinal bleeding, perforated peptic ulcer

Hepatic: jaundice, cholestatic jaundice, hepatitis, liver necrosis, liver failure, Kawasakilike syndrome including changes in liver enzymes

Hematologic: agranulocytosis, aplastic anemia

Neurological/Psychiatric: peripheral neuropathy, Guillain-Barré syndrome, transverse myelitis

Respiratory/Pulmonary: eosinophilic pneumonia, interstitial pneumonitis

Skin: psoriasis, pyoderma gangrenosum, erythema nodosum

Renal/Urogenital: reversible oligospermia