Indication

Lialda is indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis (UC) and for the maintenance of remission of UC.

Important Safety Information

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For Active, Mild to Moderate Ulcerative Colitis (UC)

Important Safety Information

  • Lialda is contraindicated in patients with known hypersensitivity to
    salicylates or aminosalicylates or to any of the ingredients of Lialda.

See Full Safety Information

Support resources for you and your patients

The resources below are designed to help you support your patients as they get started on their treatment plan. This information may also help them have a better understanding of active, mild to moderate UC and Lialda.

Resources for you

Lialda Resources – On Call

Lialda Resources OnCall

Get answers to your questions about patient coverage, copays, and prior authorizations. You can also receive information about product samples, the Lialda Pharmacy Savings Card Program, and patient education materials.

Customer Service Representatives are available toll-free at 1-800-828-2845, 8:00 am to 8:00 pm ET, Monday through Friday.

Lialda Online Sample Ordering

Lialda Online Sample Ordering

With 24/7 access to the Lialda Sample Center, eligible health care professionals can order Lialda samples quickly and conveniently.

Start here >

 

 

 

Resources For Patients

At Shire, we believe that when patients have a better understanding of their UC and their medication — such as the potential benefits and safety information — it may lead to better dialogue with their health care providers and better understanding of their treatment plans.

Patient Starter Kit brochure

Lialda Patient Brochure

A brochure that provides patients with information about UC and prescription savings, as well as potential benefits and safety information about Lialda.

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Pharmacy Savings Card Program

Lialda Pharmacy Savings Card Program

An overview of the Pharmacy Savings Card Program, which may help patients reduce their out-of-pocket costs for Lialda.

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Shire Cares™

Shire Cares™

Information about programs from Shire created to help patients who don't have insurance or are having trouble affording their medications.

Read more now

 

 

 

 

Important Safety Information

  • Lialda is contraindicated in patients with known hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of Lialda.
  • Renal impairment, including minimal change nephropathy, acute and chronic interstitial nephritis, and, rarely, renal failure, has been reported with products such as Lialda that contain mesalamine or are converted to mesalamine. It is recommended that patients have an evaluation of renal function prior to initiating use of Lialda and periodically while on therapy. Exercise caution when using Lialda in patients with known renal dysfunction or a history of renal disease.
  • Mesalamine has been associated with an acute intolerance syndrome (3% of patients in clinical trials with mesalamine or sulfasalazine) that may be difficult to distinguish from an exacerbation of ulcerative colitis. Symptoms include cramping, acute abdominal pain and bloody diarrhea, and sometimes fever, headache, and rash. Observe patients closely for worsening of these symptoms while on treatment. If acute intolerance syndrome is suspected, promptly discontinue treatment with Lialda.
  • Some patients who have experienced a hypersensitivity reaction to sulfasalazine may have a similar reaction to Lialda or compounds that contain or are converted to mesalamine. Mesalamine-induced cardiac hypersensitivity reactions (myocarditis and pericarditis) have been reported with Lialda and other mesalamine-containing medications. Caution should be taken when prescribing Lialda to patients with conditions predisposing them to the development of myocarditis or pericarditis.
  • 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 Lialda to patients with liver disease.
  • Pyloric stenosis or other organic or functional obstruction in the upper gastrointestinal tract may cause prolonged gastric retention of Lialda, which would delay mesalamine release in the colon.
  • Use of mesalamine may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection because of the similarity in the chromatograms of normetanephrine and mesalamine's main metabolite, N-acetylaminosalicylic acid (N-Ac-5-ASA). An alternative, selective assay for normetanephrine should be considered.
  • In clinical trials, the most common adverse reactions (incidence ≥2%) were ulcerative colitis, headache, flatulence, liver function test abnormality, and abdominal pain. Pancreatitis occurred in <1% of patients and resulted in discontinuation of therapy with Lialda.
  • The concurrent use of mesalamine with known nephrotoxic agents, including non-steroidal anti-inflammatory drugs (NSAIDs) may increase the risk of renal reactions. The concurrent use of mesalamine with azathioprine or 6-mercaptopurine can increase the potential for blood disorders.
  • Safety and effectiveness of Lialda in pediatric patients have not been established.

Indication

Lialda is indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis (UC) and for the maintenance of remission of UC.

Please click here for Full Prescribing Information for Lialda (mesalamine).