IMPORTANT SAFETY INFORMATION
- APRISO extended-release capsules are contraindicated in patients with hypersensitivity to salicylates or aminosalicylates, or to any of the components of APRISO capsules.
- Renal impairment, including minimal change nephropathy, acute and chronic interstitial nephritis, and, rarely, renal failure, has been reported in patients given products such as APRISO that contain mesalamine or are converted to mesalamine. It is recommended that patients have an evaluation of renal function prior to initiation of APRISO therapy and periodically while on therapy. Exercise caution when using APRISO in patients with known renal dysfunction or a history of renal disease.
- Mesalamine has been associated with an acute intolerance syndrome that may be difficult to distinguish from a flare of inflammatory bowel disease. Symptoms include cramping, acute abdominal pain and bloody diarrhea, sometimes fever, headache, and rash. If acute intolerance syndrome is suspected, promptly discontinue treatment with APRISO.
- 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 APRISO to patients with liver disease.
- Use of mesalamine may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection. Consider an alternative, selective assay for normetanephrine.
- Discontinue APRISO at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation.
- Patients with pre-existing skin conditions such as atopic dermatitis and atopic eczema have reported more severe photosensitivity reactions. Advise patients with pre-existing skin conditions to avoid sun exposure, wear protective clothing, and use a broad spectrum sun screen outdoors.
- Cases of nephrolithiasis have been reported with the use of mesalamine, Mesalamine-containing stones are radiotransparent and undetectable by standard radiography or computed tomography (CT). Ensure adequate fluid intake during treatment with APRISO.
- In clinical studies, the most common adverse reactions (occurring in ≥3% of APRISO patients and at a greater rate than placebo) were headache (11%), diarrhea (8%), upper abdominal pain (5%), nausea (4%), nasopharyngitis (4%), influenza and influenza-like illness (4%), and sinusitis (3%).
- Because dissolution of the coating of APRISO granules depends on pH, APRISO should not be co-administered with antacids.
- Because of the potential for blood dyscrasias in patients 65 years and older, caution should be taken to closely monitor blood cell counts during mesalamine therapy in these patients.
- Inform patients with phenylketonuria (PKU) or their caregivers that each APRISO capsule contains aspartame equivalent to 0.56 mg of phenylalanine, so that the recommended adult dosing provides an equivalent of 2.24 mg of phenylalanine per day.
To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-508-0024 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
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