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Treatment With Lialda

Providing a highly concentrated tablet that delivers 1200 mg of mesalamine to adults with active, mild and moderate UC1

Learn how once-daily Lialda may induce or maintain UC remission1†

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Support Resources for Patients

With the Pharmacy Savings Card, most eligible, commercially insured patients will pay as little as $10 per month3*

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Commitment to the Community

Lialda is the #1 prescribed 5-ASA among gastroenterologists4

*Eligible, cash-paying patients will receive up to a $50 savings on their monthly prescription and generally pay more than $10.3

With the Lialda® (mesalamine) Pharmacy Savings Card, eligible commercially insured patients pay the first $10 per monthly supply. After paying the first $10, the maximum savings is up to $500 for the first three fills and $120 per monthly fill for the remainder of 2017. Eligible cash-paying patients receive up to a $50 savings on the cost of their monthly prescription and generally pay more than $10.

This program is valid 1/1/2017 through 12/31/17.

Patients eligible for any government health care program are not eligible for the Lialda Pharmacy Savings Card Program. Other restrictions apply. Please see ActivatePharmacyCard.com or call 1-866-250-8840 for additional program rules.

In 2007, the FDA approved Lialda for the induction of remission in adults with active, mild to moderate UC. In July 2011, Lialda was approved for the maintenance of remission of UC.2

UC = ulcerative colitis; 5-ASA = 5-aminosalicylic acid.

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.

References

  1. Lialda [Prescribing Information]. Lexington, MA: Shire US Inc.
  2. US Food & Drug Administration. Center for Drug Evaluation and Research website. Lialda Approval Letter. http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm. Accessed January 27, 2017.
  3. PSKW. Lialda OOP Distribution Report. December 2016.
  4. QuintilesIMS™ National Prescription Audit™, 2016.
  5. Fingertip Formulary®, DR/Decision Resources, LLC. Accessed .