IMPORTANT SAFETY INFORMATION
Patients with known or suspected hypersensitivity to salicylates or aminosalicylates or to any ingredients in the suppository vehicle.
Warnings and Precautions
Renal impairment, including minimal change nephropathy, acute and chronic interstitial nephritis, and renal failure, has been reported in patients given products such as CANASA that contain mesalamine or are converted to mesalamine. Evaluate renal function prior to initiation of and periodically while on CANASA therapy. Evaluate the risks and benefits of using CANASA in patients with known renal impairment or a history of renal disease or taking concomitant nephrotoxic drugs.
Mesalamine-induced acute intolerance syndrome
Monitor patients for worsening of the following symptoms: cramping, acute abdominal pain and bloody diarrhea, and sometimes fever, headache and rash. If acute intolerance syndrome is suspected, promptly discontinue CANASA.
As with sulfasalazine, mesalamine-induced hypersensitivity reactions may present as internal organ involvement, including myocarditis, pericarditis, nephritis, hepatitis, pneumonitis and hematologic abnormalities. Evaluate patients immediately if signs or symptoms of a hypersensitivity reaction are present. Discontinue CANASA if an alternative etiology for the signs and symptoms cannot be established.
There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered other products containing mesalamine. Evaluate the risks and benefits of using CANASA in patients with known liver impairment.
Interaction with laboratory test for urinary normetanephrine
Use of mesalamine may lead to falsely elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection. Consider an alternative selective assay for normetanephrine.
The most common adverse reactions occurring in more than 1% of mesalamine suppository-treated patients were dizziness, rectal pain, fever, rash, acne, and colitis.
Concurrent use of mesalamine with known nephrotoxic agents, including nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of nephrotoxicity. Monitor patients taking nephrotoxic drugs for changes in renal function and mesalamine-related adverse reactions.
Concurrent use of mesalamine with azathioprine or 6-mercaptopurine may increase the risk for blood disorders. Monitor blood tests, including complete blood cell counts and platelet counts.
A higher incidence of blood dyscrasias (agranulocytosis, neutropenia, pancytopenia) has been reported in subjects receiving mesalamine who are 65 years or older compared to younger patients. Monitor complete blood cell counts and platelet counts in elderly patients during treatment with CANASA.
Indications and Usage
CANASA (mesalamine) 1000 mg rectal suppositories are indicated in adults for the treatment of mildly to moderately active ulcerative proctitis.
full Prescribing Information