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

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

Read the Apriso (mesalamine extended-release capsules) Side Effects Center for a complete guide to possible side effects »

Based on in vitro studies, APRISO (mesalamine extended-release capsules) is not expected to inhibit the metabolism of drugs that are substrates of CYP1A2, CYP2C9, CYP2C19, CYP2D6, or CYP3A4.

Antacids

Because the dissolution of the coating of the granules in APRISO (mesalamine extended-release capsules) capsules depends on pH, APRISO (mesalamine extended-release capsules) capsules should not be co-administered with antacids.

Last reviewed on RxList: 9/14/2009
This monograph has been modified to include the generic and brand name in many instances.