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Clinical Studies Experience
The data described below reflect exposure to APRISO in 557 patients, including 354 exposed for at least 6 months and 250 exposed for greater than one year. APRISO was studied in two placebo-controlled trials (n = 367 treated with APRISO) 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 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-treated patients experienced an adverse reaction compared with 64% of placebo patients. Most adverse reactions with APRISO were mild or moderate in severity. Severe adverse reactions occurred in 6% of APRISO-treated patients and 5% of placebo-treated patients. Discontinuations due to adverse reactions occurred in 11% of APRISO-treated patients and 17% of placebotreated patients; the most common adverse reaction resulting in study discontinuation was recurrence of ulcerative colitis (APRISO 6%, placebo 14%). The most common reactions reported with APRISO ( ≥ 3%) are shown in Table 1 below.
Table 1: Treatment-Emergent Adverse Reactions during
Clinical Trials Occurring in at Least 3% of APRISO-Treated Patients and at a
Greater Rate than with Placebo
|MedDRA Preferred Term||APRISO 1.5g/day
|Abdominal Pain Upper||5%||3%|
|Influenza & Influenza-like illness||4%||4%|
The following adverse reactions, presented by body system, were reported at a frequency less than 3% in patients treated with APRISO for up to 24 months in controlled and open-label trials.
Dermatological Disorder: alopecia
General Disorders and Administration Site Disorders: fatigue
Hepatic: hepatitis cholestatic, transaminases increased
Renal Disorders: creatinine clearance decreased, hematuria
Musculoskeletal: pain, arthralgia
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. 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
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 is not expected to inhibit the metabolism of drugs that are substrates of CYP1A2, CYP2C9, CYP2C19, CYP2D6, or CYP3A4.
Because the dissolution of the coating of the granules in APRISO capsules depends on pH, APRISO capsules should not be co-administered with antacids.
Read the Apriso Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 4/14/2016
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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