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
- Patients with pre-existing skin conditions such as atopic dermatitis and atopic eczema have reported
more severe photosensitivity reactions. Advise patients with pre-exiting 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.
Please click here for full Prescribing Information for APRISO extended-release capsules. OR Please see full Prescribing Information for APRISO extended-release capsules.
For product information, adverse event reports, and product complaint reports, please contact:
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