What is the recommended treatment regimen for patients with ulcerative colitis using Lialda (mesalamine)?

From the Guidelines

The recommended treatment regimen for patients with ulcerative colitis using Lialda (mesalamine) is to take 2-3 grams per day, with a preference for once-daily dosing. This recommendation is based on the American Gastroenterological Association (AGA) clinical practice guidelines on the management of mild-to-moderate ulcerative colitis, which suggests using standard dose mesalamine (2–3 grams/d) for patients with extensive mild-moderate ulcerative colitis 1.

Key Considerations

• The AGA guidelines recommend using standard dose mesalamine (2–3 grams/d) rather than low dose mesalamine, sulfasalazine, or no treatment for patients with extensive mild-moderate ulcerative colitis 1.
• Once-daily dosing is preferred over multiple times per day dosing, as it has been shown to be effective and improve patient adherence 1.
• The effective dose of oral mesalamine to maintain remission is 2 g/day, and once-daily administration is the preferred dosing regimen 1.

Administration and Monitoring

• Lialda should be swallowed whole without breaking or crushing the tablets, as they have a special delayed-release coating designed to deliver the medication to the colon.
• Patients should take the medication consistently at the same time each day with food to enhance absorption.
• Regular follow-up with a healthcare provider is essential to monitor treatment effectiveness and adjust dosing if needed.

Side Effects and Contraindications

• Common side effects may include headache, flatulence, and abdominal pain.
• Patients should continue maintenance therapy even when feeling well, as stopping treatment prematurely can lead to disease flares.

From the FDA Drug Label

Mesalamine delayed-release tablets are indicated for the: induction and maintenance of remission in adult patients with mildly to moderately active ulcerative colitis.

A multicenter, randomized, double-blind, active comparator study (Study 3, NCT00151892) was conducted in a total of 826 adult patients in remission from ulcerative colitis. Patients were randomized in a 1:1 ratio to receive either mesalamine 2.4 g administered once daily or another mesalamine delayed-release product administered as 0.8 g twice daily.

The recommended treatment regimen for patients with ulcerative colitis using Lialda (mesalamine) is 2.4 g administered once daily for the maintenance of remission in adult patients 2, 2.

• Induction of remission: The dosage for induction of remission is not explicitly stated in the provided drug labels.
• Pediatric patients: For pediatric patients weighing at least 24 kg, the dosage is weight-based, but the exact recommended dosage is not provided in the given text.

From the Research

Treatment Regimen for Ulcerative Colitis using Lialda (Mesalamine)

• The recommended treatment regimen for patients with ulcerative colitis using Lialda (mesalamine) is to induce and maintain clinical remission 3, 4, 5.
• Mesalamine is a 5-aminosalicylic acid compound that is the first-line therapy to induce and maintain clinical remission in patients with mild-to-moderate ulcerative colitis 3, 5.
• Lialda (mesalamine) is an oral, once-daily tablet formulation of mesalamine used for the treatment of ulcerative colitis, with a dose of 2.4 or 4.8 g per day 3, 4.
• Once-daily dosing of MMX mesalamine 2.4 g/day has been shown to be well tolerated and non-inferior to twice-daily dosing with delayed-release mesalamine 1.6 g/day for maintenance of endoscopic remission in patients with ulcerative colitis 4.
• The pharmacokinetics of Lialda (mesalamine) have been evaluated in healthy adult volunteers, showing similar plasma and urine pharmacokinetics for Lialda and other oral delayed-release mesalamine formulations 6.

Dosage and Administration

• The dosage of Lialda (mesalamine) for the treatment of ulcerative colitis is 2.4 or 4.8 g per day, taken once daily 3, 4.
• The treatment regimen may vary depending on the severity of the disease and the patient's response to therapy 3, 5.
• Patients who are refractory to mesalamine or have more severe disease may require additional therapies, such as steroids, azathioprine/mercaptopurine, cyclosporine, or infliximab 3, 7.

Safety and Efficacy

• The overall safety profile of MMX mesalamine is similar to other oral mesalamine formulations 3.
• Lialda (mesalamine) has been shown to be effective in inducing and maintaining clinical remission in patients with mild-to-moderate ulcerative colitis 3, 4, 5.
• The use of once-daily formulations, such as Lialda, has led to intense interest in whether simplified pill regimens can improve patient adherence to mesalamine therapy 3.