The Shire Commitment to GI

Shire Mesalamines Offer Distinct Formulations for Your Flaring UC Patients

PENTASA is delivered throughout the small and large intestine.

Lialda^® is delivered to and throughout the colon.

The active ingredient in both Lialda and PENTASA is mesalamine.
Lialda and PENTASA are contraindicated in patients with hypersensitivity to salicylates (including mesalamine) or to any of the components of Lialda or PENTASA.
The majority of patients who are intolerant or hypersensitive to sulfasalazine can take mesalamine medications without risk of similar reactions. However, caution should be exercised when treating patients allergic to sulfasalazine.
Mesalamine has been associated with an acute intolerance syndrome (3% of patients in clinical trials with mesalamine or sulfasalazine) that may be difficult to distinguish from a flare of inflammatory bowel disease. If acute intolerance syndrome is suspected, prompt withdrawal is required.
Reports of renal impairment have been associated with mesalamine medications. In patients with renal impairment, caution should be exercised, and Lialda or PENTASA should be used only if the benefits outweigh the risks.
Caution should be used in patients with impaired hepatic function.
Mesalamine-induced cardiac hypersensitivity reactions (myocarditis and pericarditis) have been reported.

Lialda is indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis.
Safety and effectiveness of Lialda beyond 8 weeks have not been established.
Caution should be exercised when treating patients with pyloric stenosis as this could delay the release of Lialda in the colon.
Lialda is generally well tolerated. The majority of adverse events in the double-blind, placebo-controlled trials were mild or moderate in severity. In clinical trials (N=535), the most common treatment-related adverse events with Lialda 2.4g/day, 4.8g/day and placebo were headache (5.6%, 3.4% and 0.6%, respectively) and flatulence (4%, 2.8% and 2.8%, respectively). Pancreatitis occurred in less than 1% of patients during clinical trials and resulted in discontinuation of therapy with Lialda.

PENTASA is indicated for the induction of remission and for the treatment of patients with mildly to moderately active ulcerative colitis.
PENTASA is generally well tolerated. In worldwide clinical trials (N>2100), the most common adverse events were diarrhea (3.4%), headache (2.0%), nausea (1.8%), abdominal pain (1.7%), dyspepsia (1.6%), vomiting (1.5%), and rash (1.0%).