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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.
• 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.

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