ADVERSE REACTIONS

LIALDA tablets have been evaluated in 655 ulcerative colitis patients in controlled and open-label trials.

In two 8-week placebo-controlled clinical trials involving 535 ulcerative colitis patients, 356 received 2.4g/day or 4.8g/day LIALDA tablets and 179 received placebo. More treatment emergent adverse events occurred in the placebo group (119) than in each of the LIALDA treatment groups (109 in 2.4g/day, 92 in 4.8g/day). A lower percentage of LIALDA patients discontinued therapy due to adverse events compared to placebo (2.2% vs 7.3%). The most frequent adverse event leading to discontinuation from LIALDA therapy was exacerbation of ulcerative colitis (0.8%).

The majority of adverse events in the double blind, placebo-controlled trials were mild or moderate in severity. The percentage of patients with severe adverse events was higher in the placebo group (6.1% in placebo; 1.1% in 2.4g/day; 2.2% in 4.8g/day). The most common severe adverse events were gastrointestinal disorders which were mainly symptoms associated with ulcerative colitis. Pancreatitis occurred in less than 1% of patients during clinical trials and resulted in discontinuation of therapy with LIALDA in patients experiencing this event.

Table 1. Treatment Related Adverse Events in Two Phase 3 Trials Experienced by at Least 1 % of the LIALDA Group and at a Rate Greater than Placebo

LIALDA

LIALDA

Placebo

2.4g/day

4.8g/day
Event

(n = 177)

(n=179)

(n=179)

Headache

10 (5.6%)

6 (3.4%)

1 (0.6%)

Flatulence

7 (4%)

5 (2.8%)

5 (2.8%)

Increased alanine
aminotransferase

1 (0.6%)

2 (1.1 %)

0

Alopecia

0

2 (1.1 %)

0

Pruritus

1 (0.6%)

2 (1.1 %)

0

Overall, the percentage of patients who experienced any adverse event was similar across treatment groups. Treatment related adverse events occurring in LIALDA or placebo groups at a frequency of at least 1% in two Phase 3, 8-week, double blind, placebo-controlled trials are listed in Table 1. The most common treatment related adverse events with LIALDA 2.4g/day and 4.8g/day were headache (5.6% and 3.4%, respectively) and flatulence (4% and 2.8%, respectively).

The following treatment-related adverse events, presented by body system, were reported infrequently (less than 1 %) by LIALDA-treated ulcerative colitis patients in controlled trials. Cardiovascular and Vascular: tachycardia, hypertension, hypotension

Dermatological: acne, prurigo, rash, urticaria

Gastrointestinal Disorders: abdominal distention, diarrhea, pancreatitis, rectal polyp, vomiting

Hematologic: decreased platelet count

Hepatobiliary Disorders: elevated total bilirubin

Musculoskeletal and Connective Tissue Disorders: arthralgia, back pain

Nervous System Disorders: somnolence, tremor

Respiratory, Thoracic and Mediastinal Disorders: pharyngolaryngeal pain

General Disorders and Administrative Site Disorders: asthenia, face edema, fatigue, pyrexia

Special Senses: ear pain

DRUG ABUSE AND DEPENDENCY

Abuse: None reported.

Dependency: Drug dependence has not been reported with chronic administration of mesalamine.

OVERDOSAGE

LIALDA is an aminosalicylate, and symptoms of salicylate toxicity may include tinnitus, vertigo, headache, confusion, drowsiness, sweating, hyperventilation, vomiting, and diarrhea. Severe intoxication may lead to disruption of electrolyte balance and blood-pH, hyperthermia, and dehydration.

Conventional therapy for salicylate toxicity may be beneficial in the event of acute overdosage. This includes prevention of further gastrointestinal tract absorption by emesis and, if necessary, by gastric lavage. Fluid and electrolyte imbalance should be corrected by the administration of appropriate intravenous therapy. Adequate renal function should be maintained.

DOSAGE AND ADMINISTRATION

The recommended dosage for the induction of remission in adult patients with active, mild to moderate ulcerative colitis is two to four 1.2g tablets to be taken once daily with meal for a total daily dose of 2.4g or 4.8g. Treatment duration in controlled clinical trials was up to 8 weeks.

Store at room temperature 15°C to 25°C (59°F to 77°F); excursions permitted to 30°C (86°F). See USP Controlled Room Temperature.

Manufactured for Shire US Inc., 725 Chesterbrook Blvd., Wayne, PA 19087, USA.

Category: Drugs / Tags: LIALDA, mesalamine

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