What if I take DELZICOL?

  • How DELZICOL may help you achieve your treatment goals
  • For adults, there are 2 goals of UC therapy. The first is to quickly bring symptoms under control. The second is to prevent (or delay) flares from coming back.1,2

    An important part of successful DELZICOL therapy is taking your medication exactly how your doctor has prescribed. If you are prescribed DELZICOL, you take the capsules a few times a day; this will help ensure that mesalamine is being delivered throughout the day to continue to help soothe the inflammation in your colon.

    Other things to keep in mind when taking DELZICOL:

    • DELZICOL can be taken with or without food.
    • The recommended adult dosage for mildly to moderately active disease, or during a flare, is 2 DELZICOL delayed-release capsules 3 times a day for adults (a total of 6 capsules or 2.4 grams per day) for a duration of 6 weeks.3
    • The recommended dosage of DELZICOL delayed-release capsules in adults for remission is a total of 1.6 grams or 4 capsules daily, in divided doses.3

    Note that these are recommended doses only. Your doctor will determine the dose that is best for you. If your symptoms remain under control, your doctor may adjust the number of capsules you have to take each day. Remember to always take the medication as your doctor has recommended.

  • DELZICOL may help you achieve and stay in remission
  • Remember, UC has no cure, but DELZICOL can help control your symptoms during periods when your UC is active.4

    This section will provide results of important DELZICOL adult clinical trials.

    Achieving symptom improvement or remission

    In Study 1, nearly half (49%) of patients on DELZICOL (6 capsules daily) experienced improvement or remission at 6 weeks versus 23% of those receiving a placebo. Some patients in this study experienced symptom improvement or were in remission as early as the third week.4

    • This study included 158 people with mildly to moderately active UC.
    • "Remission" meant complete remission of all symptoms, with assessment scores determined to be zero.
    • “Symptom improvement” meant a physician’s measurement showed the patient had improved, plus showed a decrease in rectal bleeding, stool frequency, or inflammation in their colon.

    Achieving treatment success

    In Study 2, over half (51%) of the patients on DELZICOL had achieved treatment success at 6 weeks, with some achieving it as early as the third week.5

    • This study included 150 people with mildly to moderately active UC who were taking 2.4 grams (or 6 DELZICOL capsules) per day.
    • "Treatment success" meant that patients either achieved complete remission of their rectal bleeding and stool frequency (among other clinical assessments) by 3 and 6 weeks, or they saw partial improvement in at least one clinical assessment and no worsening of the others.

    Time to symptom improvement

    In Study 2, over 60% of patients on DELZICOL saw improvement of rectal bleeding and stool frequency by 6 weeks, with some experiencing improvement as soon as 3 weeks.5

    • In this trial, "improvement" from baseline could mean either partial response or a complete resolution of symptoms.5

    In this same study, the median time to symptom resolution of rectal bleeding was 9 days, and 11 days for total resolution of stool frequency.5

    • "Time to symptom resolution" meant how long it took for complete resolution of the symptom from the first day of taking the medicine to the first day of symptom relief.5

    Maintenance of remission

    Most patients who stayed on treatment with DELZICOL stayed in remission.

    In a third clinical study lasting 6 months, 70% of people on DELZICOL maintenance therapy finished the study in remission, versus 48% of those taking a placebo.6

    • Study 3 included 264 patients with UC who were in remission at the beginning of the study.
    • These patients took 1.6 grams per day of DELZICOL, meaning 4 capsules per day taken in divided doses.
    • "Remission" meant that there was no inflammation in the patient’s colon at the beginning of the study and 6 months later, as indicated by diagnostic evaluation.
  • What is DELZICOL?
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  • My child and DELZICOL
  • References

  • 1.
    Crohn's & Colitis Foundation of America. Aminosalicylates. http://www.ccfa.org/assets/pdfs/aminosalicylates.pdf. Accessed January 7, 2015.
  • 2.
    Crohn's & Colitis Foundation of America. Treatment Options. http://www.ccfa.org/what-are-crohns-and-colitis/newly-diagnosed/treatments.pdf. Accessed January 7, 2015.
  • 3.
    Delzicol [package insert]. Parsippany, NJ: Warner Chilcott (US), LLC; 2015.
  • 4.
    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.
  • 5.
    Data on file. Rockaway, NJ: Warner Chilcott (US), LLC.
  • 6.
    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.
  • See More Important Risk Information

    IMPORTANT RISK INFORMATION

    Who should not take DELZICOL?

    • Do not take DELZICOL if you are allergic to:
      • salicylates, such as aspirin or medications that contain aspirin
      • aminosalicylates
      • any of the ingredients of DELZICOL

    What should I tell my healthcare provider before taking DELZICOL?

    Tell your healthcare provider if you:

    • Have or have had kidney problems
    • Are allergic to sulfasalazine
    • Have or have had heart-related allergic reactions, such as inflammation of the heart muscle (myocarditis) or inflammation of the lining of the heart (pericarditis)
    • Have or have had liver problems
    • Have or have had a stomach blockage
    • Have any other medical conditions

    What are the possible side effects of DELZICOL?

    DELZICOL may cause serious side effects, including:

    • Kidney problems: Your doctor may check to see how your kidneys are working before taking DELZICOL. It is important to complete all blood tests ordered by your doctor.
    • A condition that may be hard to tell apart from a UC flare: Symptoms include cramping, stomachache, bloody diarrhea, and sometimes fever, headache, and rash. If you experience any of these symptoms while on treatment, call your doctor right away. He or she may tell you to stop taking DELZICOL.
    • Hypersensitivity (allergic) reactions: If signs and symptoms of hypersensitivity occur, immediately call your doctor.
    • Liver failure: In patients that have or have had liver disease.
    • Blood Disorders: Elderly patients and patients taking azathioprine or 6-mercaptopurine need to monitor complete blood cell counts and platelet counts while taking DELZICOL.

    The most common side effects of DELZICOL include:

    • Adults: belching, stomachache, constipation, dizziness, runny nose, back pain, rash, upset stomach, and flu symptoms.
    • Children (5 to 17 years of age): inflammation of the nose and pharynx, headache, stomachache, dizziness, inflammation of the sinuses, rash, cough, diarrhea, tiredness, fever, and increased lipase.

    Tell your doctor if you have any side effect that bothers you or does not go away. These are not all the possible side effects of DELZICOL.

    Before starting DELZICOL, tell your doctor about all medications you are taking, including:

    • Non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen and naproxen. Taking these medications with DELZICOL may increase your risk of kidney problems.
    • Azathioprine or 6-mercaptopurine. Taking these medications with DELZICOL may increase your risk of blood disorders.

    What is DELZICOL?

    DELZICOL (mesalamine) delayed-release capsules is a prescription medication approved 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.

    To report a side effect from one of our products, please call the Allergan Drug Safety Department at 1-800-678-1605.

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