APRISO (mesalamine) Extended-Release Capsules for Maintenance of Ulcerative Colitis Remission

APRISO is an extended-release mesalamine capsule approved for the maintenance of remission in adults with ulcerative colitis. It is designed to release mesalamine steadily in the gastrointestinal tract to help control inflammation associated with this chronic bowel disease.

APRISO is used to maintain remission in adult patients with ulcerative colitis, a chronic inflammatory condition of the colon. It helps keep the disease in a controlled state after initial treatment to reduce symptoms and prevent flare-ups.

mesalamine

Mesalamine, the active ingredient in APRISO, works by reducing inflammation directly in the lining of the colon. It acts locally to inhibit the production of inflammatory chemicals, helping to soothe the intestinal tissue and maintain remission in ulcerative colitis.

Adults: The recommended dose of APRISO is 1.5 g taken orally once daily in the morning, which corresponds to four capsules of 0.375 g each.

Administration instructions:

• Swallow capsules whole; do not cut, break, crush, or chew.
• Take APRISO without regard to meals.
• Adequate fluid intake is advised during treatment.
• Avoid taking APRISO concurrently with antacids as they may interfere with the capsule's release mechanism.
• Before starting treatment, renal function should be evaluated, and monitored periodically during therapy.

Do not use APRISO in patients with known hypersensitivity to salicylates, aminosalicylates, or any component of APRISO capsules.

Renal Impairment: Assess kidney function before and during treatment; discontinue APRISO if renal function worsens. Use caution in patients with existing kidney problems or those on nephrotoxic drugs.

Mesalamine-Induced Acute Intolerance Syndrome: Symptoms mimicking a flare of ulcerative colitis (e.g., abdominal pain, cramping, bloody diarrhea, fever) may occur. Monitor and discontinue APRISO promptly if suspected.

Hypersensitivity Reactions: Serious allergic reactions including myocarditis, pericarditis, nephritis, hepatitis, pneumonitis, and blood abnormalities can occur. Stop treatment immediately if such reactions are suspected.

Hepatic Failure: Evaluate risks in patients with liver impairment before use.

Severe Skin Reactions: Discontinue APRISO at the first sign of severe cutaneous adverse reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis.

Photosensitivity: Patients with skin conditions should avoid excessive sunlight, wear protective clothing, and use sunscreen.

Nephrolithiasis: Kidney stones containing mesalamine may form and are undetectable by standard imaging. Maintain adequate hydration during treatment.

Phenylketonuria: APRISO contains phenylalanine from aspartame; consider total phenylalanine intake in patients with PKU.

Laboratory Test Interference: APRISO can cause false elevations in urinary normetanephrine tests when using specific detection methods; alternative assays should be considered.

Common (≥3%) side effects in clinical trials:

• Headache (11%)
• Diarrhea (8%)
• Upper abdominal pain (5%)
• Nausea (4%)
• Nasopharyngitis (4%)

Less common adverse reactions (reported in less than 3%): tinnitus, vertigo, alopecia, lower abdominal pain, rectal hemorrhage, elevated triglycerides, decreased hematocrit and hemoglobin, fatigue, cholestatic hepatitis, elevated liver enzymes, decreased creatinine clearance, hematuria, musculoskeletal pain, arthralgia, dyspnea.

Postmarketing reports: lupus-like syndrome, drug fever, pericarditis, myocarditis, pancreatitis, cholecystitis, gastrointestinal bleeding, liver failure, hematologic disorders such as agranulocytosis and aplastic anemia, neurological disorders including Guillain-Barré syndrome, interstitial nephritis, nephrolithiasis, severe skin reactions like Stevens-Johnson syndrome, reversible oligospermia, and vasculitis.

Antacids: Avoid concomitant use as antacids can interfere with the pH-dependent dissolution of APRISO's coating.

Nephrotoxic agents (including NSAIDs): Concurrent use may increase risk of kidney damage; monitor renal function closely.

Azathioprine or 6-Mercaptopurine: Co-administration may increase risk of blood disorders; monitor complete blood counts and platelets.

Pregnancy: Available data do not reliably associate mesalamine with major birth defects or miscarriage. Animal studies showed no evidence of fetal harm at doses higher than recommended. Increased disease activity in ulcerative colitis itself may increase pregnancy risks.

Lactation: Mesalamine and its metabolite are present in human milk in small amounts. Diarrhea has been reported in breastfed infants exposed to mesalamine. Breastfeeding mothers should monitor infants for diarrhea and weigh benefits of breastfeeding against potential risks.