Discover the updated formulationā€”same DELZICOLĀ®, more administration options

DELZICOL® offers the proven efficacy and reliability of ASACOL® (mesalamine delayed-release tablets)1

Choosing DELZICOL® for Your Patients

Discover why DELZICOL® might be the right medication for your patients.

The safety and efficacy of DELZICOL has been established based on adequate and well-controlled studies of mesalamine delayed-release tablets.

In a pivotal trial, nearly half of patients had improved or were in remission at 6 weeks3*

Improvement or remission at 6 weeks
  • 32% (14/43) of patients taking DELZICOL® 2.4 g/day experienced symptom improvement or were in remission at 3 weeks vs 9% (4/44) for placebo (P=0.003)3
  • In addition, 49% (21/43) of patients taking DELZICOL® 2.4 g/day showed an improvement in sigmoidoscopic appearance of the bowel compared to 27% (12/44) of patients taking placebo (P=0.048)1

Study Design:
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, PFA, and PGA.3

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In ASCEND I, patients experienced treatment success at 3 and 6 weeks4*

Improvement or remission at 6 weeks

Study Design:
A 6-week, double-blind, randomized, multicenter, active-controlled study that compared the safety and efficacy of mesalamine delayed-release (400 mg tablets) dosed at 2.4 g/day with mesalamine delayed-release 800 mg tablets dosed at 4.8 g/day. The primary endpoint was the percentage of patients in each treatment group whose treatment outcome was classified as treatment success at 6 weeks. Secondary endpoints included overall improvement at week 3 and individual clinical assessment improvement at weeks 3 and 6 (stool frequency, rectal bleeding, sigmoidoscopic findings, PFA, PGA), and tertiary endpoints included time to symptom relief.4

Mesalamine delayed-release dosed at 4.8 g/day is not an approved dosage for the treatment of mildly to moderately active ulcerative colitis. Two mesalamine delayed-release 400 mg tablets have not been shown to be bioequivalent to one mesalamine delayed-release 800 mg tablet and should not be used interchangeably. Mesalamine delayed-release 400 mg tablets were the control arm of the study.1,4

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In ASCEND I, patients experienced symptom improvement at 3 weeks and continued improvement at 6 weeks4*

Improvement or remission at 6 weeks

Study Design:
A 6-week, double-blind, randomized, multicenter, active-controlled study that compared the safety and efficacy of mesalamine delayed-release (400 mg tablets) dosed at 2.4 g/day with mesalamine delayed-release 800 mg tablets dosed at 4.8 g/day. The primary endpoint was the percentage of patients in each treatment group whose treatment outcome was classified as treatment success at 6 weeks. Secondary endpoints included overall improvement at week 3 and individual clinical assessment improvement at weeks 3 and 6 (stool frequency, rectal bleeding, sigmoidoscopic findings, PFA, PGA), and tertiary endpoints included time to symptom relief.4

Mesalamine delayed-release dosed at 4.8 g/day is not an approved dosage for the treatment of mildly to moderately active ulcerative colitis. Two mesalamine delayed-release 400 mg tablets have not been shown to be bioequivalent to one mesalamine delayed-release 800 mg tablet and should not be used interchangeably. Mesalamine delayed-release 400 mg tablets were the control arm of the study.1,4

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In ASCEND I, patients experienced improvement in symptoms in less than 2 weeks4*

Improvement or remission at 6 weeks

Study Design:
A 6-week, double-blind, randomized, multicenter, active-controlled, study that compared the safety and efficacy of mesalamine delayed-release (400 mg tablets) dosed at 2.4 g/day with mesalamine delayed-release 800 mg tablets dosed at 4.8 g/day. The primary endpoint was the percentage of patients in each treatment group whose treatment outcome was classified as treatment success at 6 weeks. Secondary endpoints included overall improvement at week 3 and individual clinical assessment improvement at weeks 3 and 6 (stool frequency, rectal bleeding, sigmoidoscopic findings, PFA, PGA), and tertiary endpoints included time to symptom relief.4

Mesalamine delayed-release dosed at 4.8 g/day is not an approved dosage for the treatment of mildly to moderately active ulcerative colitis. Two mesalamine delayed-release 400 mg tablets have not been shown to be bioequivalent to one mesalamine delayed-release 800 mg tablet and should not be used interchangeably. Mesalamine delayed-release 400 mg tablets were the control arm of the study.1,4

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In ASCEND I, patients experienced improvement in sigmoidoscopy score at 3 and 6 weeks4*

Improvement or remission at 6 weeks

Study Design:
A 6-week, double-blind, randomized, multicenter, active-controlled, study that compared the safety and efficacy of mesalamine delayed-release (400 mg tablets) dosed at 2.4 g/day with mesalamine delayed-release HD (mesalamine) 800 mg tablets dosed at 4.8 g/day. The primary endpoint was the percentage of patients in each treatment group whose treatment outcome was classified as treatment success at 6 weeks. Secondary endpoints included overall improvement at week 3 and individual clinical assessment improvement at weeks 3 and 6 (stool frequency, rectal bleeding, sigmoidoscopic findings, PFA, PGA), and tertiary endpoints included time to symptom relief.4

Mesalamine delayed-release dosed at 4.8 g/day is not an approved dosage for the treatment of mildly to moderately active ulcerative colitis. Two mesalamine delayed-release 400 mg tablets have not been shown to be bioequivalent to one mesalamine delayed-release 800 mg tablet and should not be used interchangeably. Mesalamine delayed-release 400 mg tablets were the control arm of the study.1,4

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References
  • DELZICOL® [Package Insert]. Irvine, CA: Allergan USA, Inc.; 2016.
  • IMS National Prescription Data: 1992-March 2014 (estimate derived from information used under license from IMS Health, Inc., which expressly reserves all rights, including rights of copying, distribution, and republication).
  • Sninsky CA, Cort DH, Shanahan F, et al. Oral mesalamine (Asacol) for mildly to moderately active ulcerative colitis. Ann Intern Med. 1991;115:350-355.
  • Data on file. Rockaway, NJ: Allergan USA, Inc.
  • 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;124:204-211.

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 about DELZICOL®.

The information provided in this site is intended for U.S. healthcare professionals only. The products described on this site may have different product labeling in countries outside of the United States.

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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 about DELZICOL®.

The information provided in this site is intended for U.S. healthcare professionals only. The products described on this site may have different product labeling in countries outside of the United States.