• CANASA® (mesalamine, USP) 1000 mg Suppositories

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
INDICATION

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

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
  • Patients with known or suspected hypersensitivity to salicylates, aminosalicylates, or any ingredients in the suppository vehicle.
WARNINGS AND PRECAUTIONS
Renal impairment
  • Renal impairment, including minimal change disease, acute and chronic interstitial nephritis, and renal failure, has been reported. 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 and/or those taking concomitant nephrotoxic drugs. Discontinue CANASA if renal function deteriorates while on therapy.
Mesalamine-induced acute intolerance syndrome
  • Monitor patients for worsening of cramping, abdominal pain, bloody diarrhea, and sometimes fever, headache, malaise, pruritus, conjunctivitis, and rash and promptly discontinue CANASA if acute intolerance syndrome is suspected. Symptoms usually subside when CANASA is discontinued.
Hypersensitivity reactions
  • 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 and discontinue CANASA if a hypersensitivity reaction is suspected.
Hepatic failure
  • Hepatic failure has been reported in patients with preexisting liver disease who have been administered other products containing mesalamine. Evaluate the risks and benefits of using CANASA in patients with known liver impairment.
Severe cutaneous adverse reactions
  • Discontinue CANASA at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation.
Photosensitivity
  • Advise patients with preexisting skin conditions, such as atopic dermatitis and atopic eczema, to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors.
Nephrolithiasis
  • Mesalamine-containing stones are undetectable by standard radiography or computed tomography. Ensure adequate hydration during treatment.
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
  • The 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, 6-mercaptopurine, and/or other drugs known to cause myelotoxicity may increase the risk for blood disorders, bone marrow failure, and associated complications. Monitor blood tests, including complete blood cell counts and platelet counts, if concomitant use cannot be avoided.
SPECIFIC POPULATIONS
  • Geriatric use: A higher incidence of blood dyscrasias (agranulocytosis, neutropenia, pancytopenia) has been reported in patients 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.
INDICATION

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.

INDICATION

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

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
  • Patients with known or suspected hypersensitivity to salicylates, aminosalicylates, or any ingredients in the suppository vehicle.
WARNINGS AND PRECAUTIONS
Renal impairment
  • Renal impairment, including minimal change disease, acute and chronic interstitial nephritis, and renal failure, has been reported. 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 and/or those taking concomitant nephrotoxic drugs. Discontinue CANASA if renal function deteriorates while on therapy.
Mesalamine-induced acute intolerance syndrome
  • Monitor patients for worsening of cramping, abdominal pain, bloody diarrhea, and sometimes fever, headache, malaise, pruritus, conjunctivitis, and rash and promptly discontinue CANASA if acute intolerance syndrome is suspected. Symptoms usually subside when CANASA is discontinued.
Hypersensitivity reactions
  • 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 and discontinue CANASA if a hypersensitivity reaction is suspected.
Hepatic failure
  • Hepatic failure has been reported in patients with preexisting liver disease who have been administered other products containing mesalamine. Evaluate the risks and benefits of using CANASA in patients with known liver impairment.
Severe cutaneous adverse reactions
  • Discontinue CANASA at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation.
Photosensitivity
  • Advise patients with preexisting skin conditions, such as atopic dermatitis and atopic eczema, to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors.
Nephrolithiasis
  • Mesalamine-containing stones are undetectable by standard radiography or computed tomography. Ensure adequate hydration during treatment.
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
  • The 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, 6-mercaptopurine, and/or other drugs known to cause myelotoxicity may increase the risk for blood disorders, bone marrow failure, and associated complications. Monitor blood tests, including complete blood cell counts and platelet counts, if concomitant use cannot be avoided.
SPECIFIC POPULATIONS
  • Geriatric use: A higher incidence of blood dyscrasias (agranulocytosis, neutropenia, pancytopenia) has been reported in patients 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.
INDICATION

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]. Madison, NJ: Allergan, Inc.
  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.