When treating mildly to moderately active ulcerative proctitis (UP)...

Fight flares with CANASA®

CANASA is a mesalamine suppository proven to relieve the symptoms of mildly to moderately active UP, such as rectal bleeding and stool frequency.1

Start at the site of rectal inflammation

  • CANASA 1000 mg, once daily, delivers mesalamine to the site of rectal inflammation1,2
    • Mesalamine suppositories can reach up to 15 to 20 cm of the rectum2-4
Illustration of colon and rectum showing that mesalamine suppositories can reach up to 15 to 20 cm of the rectum.
The American College of Gastroenterology Guidelines recommend topical mesalamine as a treatment option for mild to moderate UP5

Help patients achieve relief at 6 weeks

  • Two 6-week, placebo-controlled studies showed significant reductions in total DAI* score (stool frequency, rectal bleeding, mucosal appearance, and physician’s global assessment) at week 6 (P<0.01)1†‡
    • Total DAI score results from placebo-controlled Study 1 were similar to placebo-controlled Study 26†‡
Chart showing mesalamine suppositories delivered reductions in total DAI mean score at week 6.

Deliver effective symptom relief

  • In placebo-controlled Study 2, significantly more patients treated with mesalamine suppositories achieved individual DAI subscale scores of “normal” or “none” at endpoint compared with placebo1,6‡§‖
  • Individual DAI subscale scores from placebo-controlled Study 1 were similar to placebo-controlled Study 21,6†‡§‖
Chart showing mesalamine suppositories delivered higher reductions versus placebo in individual DAI subscale scores at endpoint.

*The Disease Activity Index (DAI) is a composite index reflecting 4 subscales.1

Results from a double-blind, placebo-controlled, multicenter study (N=79, mesalamine suppository 500 mg [dose no longer available] three times daily) in patients with mildly to moderately active UP. Efficacy measures included total DAI score and endoscopic evaluations at weeks 3 and 6.1

Results from a double-blind, placebo-controlled, multicenter study (N=94, mesalamine suppository 500 mg twice daily) in patients with mildly to moderately active UP. Efficacy measures included total DAI score and endoscopic evaluations at weeks 3 and 6.1

§Each subscale measure was assessed on a 4-point ordinal scale (0 to 3) with 0 being equivalent to normal consistency and frequency; no blood seen in stool; mucosa appears normal (on sigmoidoscopy); and normal physician’s overall assessment of disease severity; n numbers provided are the number of patients with a score of 0 for each subscale.6

Last available score.6

Help patients achieve flare remission

Image showing that 86% of patients using CANASA achieved flare remission after 6 weeks of treatment.
  • Results from a multicenter, randomized, parallel-group, 6-week, open-label (non-inferiority) study (N=99) comparing the safety and efficacy of mesalamine 500 mg suppositories twice daily vs CANASA 1000 mg suppositories once daily at bedtime in patients with mildly to moderately active UP. The efficacy was not different between the treatment groups. After 6 weeks of treatment, a DAI score of less than 3 was achieved in 78% of patients in the mesalamine 500 mg twice daily group and 86% of patients in the CANASA 1000 mg once daily group1
IMPORTANT SAFETY INFORMATION
Contraindications
  • Patients with known or suspected hypersensitivity to salicylates or aminosalicylates or to any ingredients in the suppository vehicle.
Warnings and Precautions
Renal impairment
  • Renal impairment, including minimal change nephropathy, acute and chronic interstitial nephritis, and renal failure, has been reported in patients given products such as CANASA that contain mesalamine or are converted to mesalamine. Evaluate renal function prior to initiation of and periodically while on CANASA therapy. Evaluate the risks and benefits of using CANASA in patients with known renal impairment or a history of renal disease or taking concomitant nephrotoxic drugs.
Mesalamine-induced acute intolerance syndrome
  • Monitor patients for worsening of the following symptoms: cramping, acute abdominal pain and bloody diarrhea, and sometimes fever, headache and rash. If acute intolerance syndrome is suspected, promptly discontinue CANASA.
Hypersensitivity reactions
  • As with sulfasalazine, 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 CANASA if an alternative etiology for the signs and symptoms cannot be established.
Hepatic failure
  • There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered other products containing mesalamine. Evaluate the risks and benefits of using CANASA in patients with known liver impairment.
Interaction with laboratory test for urinary normetanephrine
  • Use of mesalamine may lead to falsely elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection. Consider an alternative selective assay for normetanephrine.
Adverse Reactions
  • The most common adverse reactions occurring in more than 1% of mesalamine suppository-treated patients were dizziness, rectal pain, fever, rash, acne, and colitis.
Drug Interactions
  • Concurrent use of mesalamine with known nephrotoxic agents, including nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of nephrotoxicity. Monitor patients taking nephrotoxic drugs for changes in renal function and mesalamine-related adverse reactions.
  • Concurrent use of mesalamine with azathioprine or 6-mercaptopurine may increase the risk for blood disorders. 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 CANASA.
Indications and Usage

CANASA (mesalamine) 1000 mg rectal suppositories are indicated in adults for the treatment of mildly to moderately active ulcerative proctitis.

Please see full Prescribing Information for CANASA.

IMPORTANT SAFETY INFORMATION
IMPORTANT SAFETY INFORMATION
Contraindications
  • Patients with known or suspected hypersensitivity to salicylates or aminosalicylates or to any ingredients in the suppository vehicle.
Warnings and Precautions
Renal impairment
  • Renal impairment, including minimal change nephropathy, acute and chronic interstitial nephritis, and renal failure, has been reported in patients given products such as CANASA that contain mesalamine or are converted to mesalamine. Evaluate renal function prior to initiation of and periodically while on CANASA therapy. Evaluate the risks and benefits of using CANASA in patients with known renal impairment or a history of renal disease or taking concomitant nephrotoxic drugs.
Mesalamine-induced acute intolerance syndrome
  • Monitor patients for worsening of the following symptoms: cramping, acute abdominal pain and bloody diarrhea, and sometimes fever, headache and rash. If acute intolerance syndrome is suspected, promptly discontinue CANASA.
Hypersensitivity reactions
  • As with sulfasalazine, 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 CANASA if an alternative etiology for the signs and symptoms cannot be established.
Hepatic failure
  • There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered other products containing mesalamine. Evaluate the risks and benefits of using CANASA in patients with known liver impairment.
Interaction with laboratory test for urinary normetanephrine
  • Use of mesalamine may lead to falsely elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection. Consider an alternative selective assay for normetanephrine.
Adverse Reactions
  • The most common adverse reactions occurring in more than 1% of mesalamine suppository-treated patients were dizziness, rectal pain, fever, rash, acne, and colitis.
Drug Interactions
  • Concurrent use of mesalamine with known nephrotoxic agents, including nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of nephrotoxicity. Monitor patients taking nephrotoxic drugs for changes in renal function and mesalamine-related adverse reactions.
  • Concurrent use of mesalamine with azathioprine or 6-mercaptopurine may increase the risk for blood disorders. 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 CANASA.
Indications and Usage

CANASA (mesalamine) 1000 mg rectal suppositories are indicated in adults for the treatment of mildly to moderately active ulcerative proctitis.

Please see full Prescribing Information for CANASA.

References:

  1. CANASA [package insert]. Irvine, CA: Allergan USA, Inc.; September 2016.
  2. Regueiro M, Loftus EV Jr, Steinhart AH, Cohen RD. Clinical guidelines for the medical management of left-sided ulcerative colitis and ulcerative proctitis: summary statement. Inflamm Bowel Dis. 2006;12(10):972-978.
  3. Williams CN, Haber G, Aquino JA. Double-blind, placebo-controlled evaluation of 5-ASA suppositories in active distal proctitis and measurement of extent of spread using 99mTc-labeled 5-ASA suppositories. Dig Dis Sci. 1987;32(12 suppl):71S-75S.
  4. Williams CN. Role of rectal formulations: suppositories. Scand J Gastroenterol. 1990;25(suppl 172):60-62.
  5. 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.
  6. Data on file. Aptalis Pharma US, Inc.