When treating mildly to moderately active ulcerative colitis (UC)...

GO WITH YOUR GUT and choose DELZICOL®

Advanced formulation with targeted delivery to the colon

Photo of DELZICOL capsule showing four 100 mg tablets inside; second photo with DELZICOL capsule opened to show 100 mg tablets outside of capsule for dosing flexibility.
  • Delayed-release capsules contain four 100 mg tablets that can be opened for patients who cannot swallow the capsules whole1
    • Two DELZICOL 400 mg capsules have not been shown to be interchangeable or substitutable with one mesalamine delayed-release 800 mg tablet1
  • Begins to dissolve at a pH of ≥71
  • Released at the terminal ileum and beyond for topical anti-inflammatory action in the colon1
The American College of Gastroenterology Guidelines recommend oral aminosalicylates as treatment options for mild to moderate UC2

DELZICOL provides dosing flexibility

DELZICOL delayed-release capsules are indicated for1:

  • The treatment of mildly to moderately active UC in patients 5 years of age and older:
DELZICOL treats mildly to moderately active UC in adult patients.

Adults: The recommended dosage is two DELZICOL 400 mg capsules three times daily (total daily dose of 2.4 g/d), with or without food, for a duration of 6 weeks

DELZICOL treats mildly to moderately active UC in pediatric patients.

Pediatric patients 5 years of age and older: Total daily dose is weight-based up to a maximum of 2.4 g/d, with or without food, divided into two daily doses for a duration of 6 weeks

  • The maintenance of remission of UC in adults:
    • The recommended dosage is 1.6 g/d in two to four divided doses, with or without food

Provide symptom improvement

  • In a pivotal trial, nearly half of patients had improved or were in remission at 6 weeks1,3*†‡
Comparison chart showing that 49% of patients had improved or were in remission at 6 weeks versus 23% using placebo.

*Improved was defined as reduction in the physician’s global assessment (PGA) score and in at least one other component score, with no score increased in severity.3

Remission was defined as complete resolution of all symptoms, with all assessment scores determined to be 0.3

A 6-week, multicenter, double-blind, placebo-controlled, randomized study of 158 patients with mildly to moderately active UC. The primary endpoint was treatment outcome (patients in remission, improved, maintained, or worsened) at 6 weeks. Treatment outcome was based on the following assessments: stool frequency, rectal bleeding, sigmoidoscopic findings, patient’s functional assessment, and PGA.3

  • In addition, 49% (21/43) of patients taking mesalamine delayed-release 2.4 g/d showed an improvement in sigmoidoscopic appearance of the bowel compared with 27% (12/44) of patients taking placebo (P=0.048)1‡
  • Significantly more patients in the mesalamine delayed-release 2.4 g/d group showed improvement in rectal bleeding and stool frequency1‡
  • The safety and efficacy of DELZICOL have been established based on adequate and well-controlled studies of mesalamine delayed-release tablets1

Help patients maintain remission

  • In a 6-month study of patients in remission at baseline, 70% (61/87) of patients taking mesalamine 1.6 g/d maintained remission at 6 months of treatment compared with 48% (42/87) for placebo (P=0.005)1,4§
Chart showing 70% of patients maintained remission at 6 months versus 48% using placebo.

§A 6-month, double-blind, randomized, multicenter, placebo-controlled trial of 264 patients with UC in remission at study entry. The primary endpoint was treatment outcome—either success, defined as maintenance of remission (as indicated by sigmoidoscopic evaluation) at the 6-month study visit, or failure, defined as sigmoidoscopic relapse at any time during the study or withdrawal due to an adverse event.4

IMPORTANT SAFETY INFORMATION
Contraindications
  • Patients with known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of DELZICOL.
Warnings and Precautions
Renal Impairment
  • Renal impairment, including minimal change nephropathy, acute and chronic interstitial nephritis, and renal failure, has been reported with products such as DELZICOL that contain or are converted to mesalamine. Evaluate renal function prior to initiation of DELZICOL and periodically while on therapy. Evaluate the risks and benefits of using DELZICOL in patients with known renal dysfunction, a history of renal disease, or who are taking concomitant nephrotoxic drugs.
Mesalamine-Induced Acute Intolerance Syndrome
  • Mesalamine treatment has been associated with an acute intolerance syndrome that may be difficult to distinguish from an exacerbation of UC. Symptoms include cramping, abdominal pain, 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 DELZICOL.
Hypersensitivity Reactions
  • Use caution when treating patients who are hypersensitive to sulfasalazine as they may have a similar reaction to DELZICOL.
  • Mesalamine-induced hypersensitivity reactions may present as internal organ involvement, including myocarditis, pericarditis, nephritis, hepatitis, pneumonitis, and hematologic abnormalities. Evaluate patients immediately if signs or symptoms of a hypersensitivity reaction are present. Discontinue DELZICOL if an alternative etiology for the signs or symptoms cannot be established.
Hepatic Failure
  • Hepatic failure has been reported in patients with pre-existing liver disease who have been administered mesalamine. Evaluate the risks and benefits of using DELZICOL in patients with known liver impairment.
Adverse Reactions
  • The most common adverse reactions (incidence ≥ 5%) in adults were eructation, abdominal pain, constipation, dizziness, rhinitis, back pain, and rash.
  • The most common adverse reactions (incidence ≥ 5%) in pediatric patients (5 to 17 years old) were nasopharyngitis, headache, abdominal pain, dizziness, sinusitis, rash, cough, diarrhea, fatigue, pyrexia, and increased lipase.
Drug Interactions
  • The risk of nephrotoxicity may be increased with the concurrent use of mesalamine and known nephrotoxic agents, including NSAIDs. Monitor patients taking nephrotoxic drugs for changes in renal function and mesalamine-related adverse reactions.
  • The risk for blood disorders may be increased with the concurrent use of mesalamine and azathioprine or 6-mercaptopurine. If concomitant use of DELZICOL and azathioprine or 6-mercaptopurine cannot be avoided, monitor blood tests, including complete blood cell counts and platelet counts.
Specific Populations
  • A higher incidence of blood dyscrasias (agranulocytosis, neutropenia, pancytopenia) has been reported in subjects receiving mesalamine who are 65 years or older compared to younger patients. Monitor complete blood cell counts and platelet counts in elderly patients during treatment with DELZICOL.
Indications

DELZICOL is indicated for the treatment of mildly to moderately active ulcerative colitis (UC) in patients 5 years of age and older and for the maintenance of remission of UC in adults.

Please see full Prescribing Information for DELZICOL.

IMPORTANT SAFETY INFORMATION
IMPORTANT SAFETY INFORMATION
Contraindications
  • Patients with known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of DELZICOL.
Warnings and Precautions
Renal Impairment
  • Renal impairment, including minimal change nephropathy, acute and chronic interstitial nephritis, and renal failure, has been reported with products such as DELZICOL that contain or are converted to mesalamine. Evaluate renal function prior to initiation of DELZICOL and periodically while on therapy. Evaluate the risks and benefits of using DELZICOL in patients with known renal dysfunction, a history of renal disease, or who are taking concomitant nephrotoxic drugs.
Mesalamine-Induced Acute Intolerance Syndrome
  • Mesalamine treatment has been associated with an acute intolerance syndrome that may be difficult to distinguish from an exacerbation of UC. Symptoms include cramping, abdominal pain, 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 DELZICOL.
Hypersensitivity Reactions
  • Use caution when treating patients who are hypersensitive to sulfasalazine as they may have a similar reaction to DELZICOL.
  • Mesalamine-induced hypersensitivity reactions may present as internal organ involvement, including myocarditis, pericarditis, nephritis, hepatitis, pneumonitis, and hematologic abnormalities. Evaluate patients immediately if signs or symptoms of a hypersensitivity reaction are present. Discontinue DELZICOL if an alternative etiology for the signs or symptoms cannot be established.
Hepatic Failure
  • Hepatic failure has been reported in patients with pre-existing liver disease who have been administered mesalamine. Evaluate the risks and benefits of using DELZICOL in patients with known liver impairment.
Adverse Reactions
  • The most common adverse reactions (incidence ≥ 5%) in adults were eructation, abdominal pain, constipation, dizziness, rhinitis, back pain, and rash.
  • The most common adverse reactions (incidence ≥ 5%) in pediatric patients (5 to 17 years old) were nasopharyngitis, headache, abdominal pain, dizziness, sinusitis, rash, cough, diarrhea, fatigue, pyrexia, and increased lipase.
Drug Interactions
  • The risk of nephrotoxicity may be increased with the concurrent use of mesalamine and known nephrotoxic agents, including NSAIDs. Monitor patients taking nephrotoxic drugs for changes in renal function and mesalamine-related adverse reactions.
  • The risk for blood disorders may be increased with the concurrent use of mesalamine and azathioprine or 6-mercaptopurine. If concomitant use of DELZICOL and azathioprine or 6-mercaptopurine cannot be avoided, monitor blood tests, including complete blood cell counts and platelet counts.
Specific Populations
  • A higher incidence of blood dyscrasias (agranulocytosis, neutropenia, pancytopenia) has been reported in subjects receiving mesalamine who are 65 years or older compared to younger patients. Monitor complete blood cell counts and platelet counts in elderly patients during treatment with DELZICOL.
Indications

DELZICOL is indicated for the treatment of mildly to moderately active ulcerative colitis (UC) in patients 5 years of age and older and for the maintenance of remission of UC in adults.

Please see full Prescribing Information for DELZICOL.

References:

  1. DELZICOL [package insert]. Irvine, CA: Allergan USA, Inc.; 2016.
  2. Kornbluth A, Sachar DB; and Practice Parameters Committee of the American College of Gastroenterology. Ulcerative colitis practice guidelines in adults: American College of Gastroenterology, Practice Parameters Committee. Am J Gastroenterol. 2010;105(3):501-523.
  3. Sninsky CA, Cort DH, Shanahan F, et al. Oral mesalamine (Asacol) for mildly to moderately active ulcerative colitis: a multicenter study. Ann Intern Med. 1991;115(5):350-355.
  4. The Mesalamine Study Group. An oral preparation of mesalamine as long-term maintenance therapy for ulcerative colitis: a randomized, placebo-controlled trial. Ann Intern Med. 1996;124(2):204-211.