Indication

Lialda is indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis (UC) and for the maintenance of remission of UC.

Important Safety Information

Read More Below

For Active, Mild to Moderate Ulcerative Colitis (UC)

Important Safety Information

  • Lialda is contraindicated in patients with known hypersensitivity to
    salicylates or aminosalicylates or to any of the ingredients of Lialda.

See Full Safety Information

Lialda Resources - On Call

Call 1-800-828-2845 to request samples and get real-time answers on patient Rx coverage and support.

Request samples >   Learn more >

Induction of UC Remission

In two pivotal trials, Lialda (mesalamine) induced remission of active, mild to moderate UC using clinical and endoscopic criteria2,3*†‡:

Kamm and Lichtenstein study findings on Lialda

*STUDY DESIGN: Patients with active, mild to moderate UC were included in two separate 8-week, randomized, double-blind, placebo-controlled trials. Data reflect the intent-to-treat population defined as all randomized subjects who received at least one dose of study medication.2,3

REMISSION: Defined as a modified Ulcerative Colitis Disease Activity Index (UC-DAI) of ≤1, with scores of 0 for both rectal bleeding and stool frequency, and a sigmoidoscopy score reduction of ≥1 point from baseline.2,3

SCORING CRITERIA: Modified UC-DAI2,3:

  • Rectal bleeding score: 0 (none), 1 (streaks of blood), 2 (obvious blood), or 3 (mostly blood)
  • Stool frequency score: 0 (normal), 1 (1-2 more than normal/day), 2 (3-4 more than normal/day), or 3 (>4 more than normal/day)
  • Sigmoidoscopic (mucosal) appearance score [friability score moved from 1/mild to 2/moderate]: 0 (normal), 1 (mild: no friability, erythema, minimal granularity, decreased vascular pattern), 2 (moderate: marked erythema, friability, granularity, bleeding with minimal trauma, absent vascular pattern, no ulcerations), or 3 (severe: ulceration, spontaneous bleeding)
  • Physician’s Global Assessment (PGA) score: 0 (no active disease), 1 (mild), 2 (moderate), or 3 (severe)

Important Safety Information

  • Lialda is contraindicated in patients with known hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of Lialda.
  • Renal impairment, including minimal change nephropathy, acute and chronic interstitial nephritis, and, rarely, renal failure, has been reported with products such as Lialda that contain mesalamine or are converted to mesalamine. It is recommended that patients have an evaluation of renal function prior to initiating use of Lialda and periodically while on therapy. Exercise caution when using Lialda in patients with known renal dysfunction or a history of renal disease.
  • 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 an exacerbation of ulcerative colitis. Symptoms include cramping, acute abdominal pain and bloody diarrhea, and sometimes fever, headache, and rash. Observe patients closely for worsening of these symptoms while on treatment. If acute intolerance syndrome is suspected, promptly discontinue treatment with Lialda.
  • Some patients who have experienced a hypersensitivity reaction to sulfasalazine may have a similar reaction to Lialda or compounds that contain or are converted to mesalamine. Mesalamine-induced cardiac hypersensitivity reactions (myocarditis and pericarditis) have been reported with Lialda and other mesalamine-containing medications. Caution should be taken when prescribing Lialda to patients with conditions predisposing them to the development of myocarditis or pericarditis.
  • There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered mesalamine. Caution should be exercised when administering Lialda to patients with liver disease.
  • Pyloric stenosis or other organic or functional obstruction in the upper gastrointestinal tract may cause prolonged gastric retention of Lialda, which would delay mesalamine release in the colon.
  • Use of mesalamine may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection because of the similarity in the chromatograms of normetanephrine and mesalamine's main metabolite, N-acetylaminosalicylic acid (N-Ac-5-ASA). An alternative, selective assay for normetanephrine should be considered.
  • In clinical trials, the most common adverse reactions (incidence ≥2%) were ulcerative colitis, headache, flatulence, liver function test abnormality, and abdominal pain. Pancreatitis occurred in <1% of patients and resulted in discontinuation of therapy with Lialda.
  • The concurrent use of mesalamine with known nephrotoxic agents, including non-steroidal anti-inflammatory drugs (NSAIDs) may increase the risk of renal reactions. The concurrent use of mesalamine with azathioprine or 6-mercaptopurine can increase the potential for blood disorders.
  • Safety and effectiveness of Lialda in pediatric patients have not been established.

Indication

Lialda is indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis (UC) and for the maintenance of remission of UC.

Please click here for Full Prescribing Information for Lialda (mesalamine).