What are the best practices for instructing patients on how and when to take Lialda (mesalamine)?

From the Guidelines

Lialda (mesalamine) should be taken once daily with a meal, with the tablets swallowed whole and never crushed, broken, or chewed to preserve the delayed-release coating. Patients should take the prescribed dose consistently at the same time each day, typically with the largest meal, to maintain steady blood levels and optimize effectiveness 1. The standard adult dose is 2.4 to 4.8 grams once daily, though specific dosing depends on the severity of the inflammatory bowel condition being treated.

• Patients should continue taking Lialda even when feeling well, as stopping prematurely can lead to symptom recurrence.
• It's essential to inform patients that the tablet shell may appear in stool, which is normal and doesn't indicate reduced efficacy.
• Patients should store Lialda at room temperature away from moisture and light.
• They should also be advised to report any worsening symptoms, severe abdominal pain, bloody diarrhea, fever, headache, or rash to their healthcare provider immediately.
• Lialda works by reducing inflammation in the colon through local anti-inflammatory effects, which explains why it must be taken consistently to maintain remission of ulcerative colitis or other inflammatory bowel conditions. The AGA suggests using once-daily dosing rather than multiple times per day dosing for patients with mild-moderate UC being treated with oral mesalamine, as it improves adherence and allows patients to achieve a higher daily dose of mesalamine 1.
• In patients with mild-moderate ulcerative colitis, the AGA suggests using standard-dose oral mesalamine or diazo-bonded 5-ASA rather than budesonide MMX or controlled ileal release budesonide for induction of remission.
• The quality of evidence supporting this recommendation was rated as moderate quality, and evidence was rated down due to imprecision with wide confidence intervals for the effect estimates 1.

From the FDA Drug Label

Instruct patients: •Swallow mesalamine tablets whole; do not split or crush. •Take mesalamine tablets with food [see Clinical Pharmacology (12. 3)]. •Urine may become discolored reddish-brown while taking mesalamine when it comes in contact with surfaces or water treated with hypochlorite-containing bleach. •Drink an adequate amount of fluids [see Warnings and Precautions (5.8)].

The best practices for instructing patients on how and when to take Lialda (mesalamine) include:

• Swallowing the tablets whole without splitting or crushing them
• Taking the tablets with food
• Drinking an adequate amount of fluids to minimize the risk of kidney stone formation Patients should also be advised to report any discolored urine to their healthcare provider only if it is discolored on leaving the body, before contact with any surface or water 2

From the Research

Best Practices for Patient Instructions on Lialda (Mesalamine)

When instructing patients on how and when to take Lialda (mesalamine), several key points should be considered:

• Dosage and Administration: Lialda should be taken once daily, with or without food, as this formulation is designed for delayed release and can be administered once daily 3, 4, 5.
• Importance of Adherence: Patients should be advised on the importance of adhering to their prescribed regimen to maintain endoscopic remission and reduce the risk of relapse 3, 6.
• Monitoring and Follow-Up: Regular monitoring and follow-up appointments are crucial to assess the efficacy of the treatment and to manage any potential side effects 6, 7.
• Potential Side Effects: Patients should be informed about the potential side effects of mesalamine, including worsening of colitis, interstitial pneumonitis, and nephritis, and advised to report any concerns to their healthcare provider 6.
• Convenience and Tolerability: The once-daily dosing regimen of Lialda can improve treatment adherence due to its convenience and lower pill burden compared to other mesalamine formulations 3, 5, 7.

Key Considerations for Healthcare Providers

Healthcare providers should:

• Assess Patient Suitability: Evaluate the suitability of Lialda for each patient, considering factors such as disease severity, medical history, and potential interactions with other medications 6, 7.
• Provide Clear Instructions: Ensure that patients receive clear instructions on how to take Lialda, including the importance of taking the medication as directed and not crushing or chewing the tablets 3, 5.
• Monitor Treatment Outcomes: Regularly monitor patients' treatment outcomes, adjusting the dosage or formulation as needed to achieve optimal results 3, 6.