1. Induction of UC Remission
2. Maintenance of UC Remission
3. Dosing
4. Formulary Access
5. Professional Resources
6. Patient Resources
7. Sign Up for Updates
8. Important Safety Information
9. Full Prescribing Information

Important Safety Information (cont'd)

• 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 (mesalamine).
• Some patients who have experienced a hypersensitivity reaction to sulfasalazine may have a similar reaction to Lialda (mesalamine) 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 (mesalamine) 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 (mesalamine), 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 (mesalamine).
• 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 (mesalamine) in pediatric patients have not been established.

Please see Full Prescribing Information.