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

Information about Ulcerative Colitis

Clinical Characteristics of Ulcerative Colitis

Ulcerative colitis (UC) is a chronic disease characterized by diffuse mucosal inflammation of the colon. UC usually involves the rectum and may extend to the large intestine to varying degrees.1,2

  • Proctitis – inflammation is limited to the rectum.1,3
  • Proctosigmoiditis/left-sided colitis – inflammation in the rectum and sigmoid colon, and may extend up to the splenic flexure.1,3
  • Pancolitis/extensive colitis – inflammation extends into the transverse colon and may include the ascending colon.1,3

The extent of involvement does not always correspond to the severity of disease, but it does impact prognosis and influence treatment choice.1,3

Disease severity may be classified as2:

  • Mild – less than 4 stools daily, with or without blood, no systemic signs of toxicity, and a normal erythrocyte sedimentation rate (ESR)
  • Moderate – more than 4 stools daily but with minimal signs of toxicity
  • Severe – more than 6 bloody stools daily, and evidence of toxicity as showed by fever, tachycardia, anemia, or an elevated ESR
  • Fulminant – may have more than 10 bowel movements daily, continuous bleeding, toxicity, abdominal tenderness and distension, may require blood transfusion, and colonic dilation on abdominal plain films

The clinical course of UC is marked by exacerbations (flares) and remissions, which may occur spontaneously or in response to changes in treatment or intercurrent illnesses.2

Presenting symptoms of UC are typically insidious rather than abrupt. Classic UC symptoms include1,4:

  • Intermittent bloody diarrhea
  • Rectal urgency
  • Tenesmus

Other symptoms may include1:

  • Constipation with interim passage of blood or mucus
  • Abdominal pain or cramps preceding bowel movements

 

 

Diagnosis of Ulcerative Colitis

Physical Exam and History

A differential diagnosis should rule out infectious colitis, Crohn’s disease, and irritable bowel syndrome (IBS).1,4,5 A thorough clinical history can provide clues on the etiologies of symptoms experienced in patients not previously diagnosed with UC. For example, abdominal pain that is relieved by a bowel movement may be an indicator of IBS rather than UC.4

A thorough physical exam should be conducted with every patient, keeping in mind that extraintestinal findings may be present in patients with UC.4

Diagnostic Testing

Laboratory tests may include2,4:

  • Stool examination for ova and parasites
  • Stool culture
  • Testing for Clostridium difficile toxin
  • Erythrocyte sedimentation rate
  • C-reactive protein
  • Complete blood count
  • Basic metabolic profile

Sigmoidoscopy or colonoscopy and biopsy2,4:

These tests are common for diagnosing UC. They can detect such characteristic changes as:

  • Loss of typical vascular pattern
  • Friability
  • Exudates
  • Ulcerations
  • Granularity

Ulcerative Colitis Treatment Options

Although there are no medications that cure ulcerative colitis, there are effective treatment options for managing symptoms.2,3,6 According to the American College of Gastroenterology guidelines, inducing and maintaining remission of symptoms are both goals of UC treatment.2 Various treatment options include2:

  • 5-aminosalicylic acids
  • Corticosteroids
  • Immunosuppressants
  • Biologic therapies
  • Surgery

 

 

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).