• ASACOL® HD (mesalamine) delayed-release tablets

For the treatment of moderately active ulcerative colitis (UC)...

ASACOL® HD provided symptom improvement

ASACOL HD delayed-release tablets are indicated for the treatment of moderately active UC in adults1

  • The recommended dosage in adults is two 800 mg tablets three times daily, taken on an empty stomach, at least 1 hour before and 2 hours after a meal, for a total daily dose of 4.8 g for a duration of 6 weeks1
  • It is recommended that patients have a renal function evaluation prior to initiating use of ASACOL HD1
  • Swallow ASACOL HD tablets whole; do not cut, break, or chew the tablets. One ASACOL HD 800 mg tablet has not been shown to be bioequivalent to two mesalamine delayed-release 400 mg tablets1
  • The safety and effectiveness of ASACOL HD beyond 6 weeks have not been established1
The American College of Gastroenterology Guidelines recommend oral aminosalicylates as treatment options for mild to moderate UC2

The ASACOL HD delivery system

  • Delayed-release mesalamine is formulated for targeted delivery to the colon1
    • Begins to dissolve at a pH of ≥71
    • Released at the terminal ileum and beyond for topical anti-inflammatory action in the colon1

70% of patients with moderately active UC achieved overall improvement with ASACOL HD at 4.8 g/d1,3,4*†

Comparison chart showing how ASACOL HD helped patients achieve overall improvement at 6 weeks.
  • Overall improvement was determined by physician’s global assessment (PGA). PGA encompasses clinical assessments of rectal bleeding, stool frequency, sigmoidoscopy findings, and patient’s functional assessment (PFA). PFA was not included in PGA assessment in ASCEND III3,4
  • One ASACOL HD 800 mg tablet has not been shown to be bioequivalent to two mesalamine delayed-release 400 mg tablets and should not be used interchangeably1

*A 6-week, multicenter, randomized, double-blind, active-controlled study to assess the noninferiority of ASACOL HD 4.8 g/d (800 mg tablet) compared with mesalamine delayed-release 2.4 g/d (400 mg tablet) in 772 patients with moderately active UC. The primary endpoint was treatment success (overall improvement) at week 6, defined as improvement in the PGA (based on clinical assessments of rectal bleeding, stool frequency, and sigmoidoscopy), with no worsening in any individual clinical assessment.3

A 6-week, double-blind, randomized, multicenter, active-controlled study to evaluate the safety and efficacy of ASACOL HD 4.8 g/d (800 mg tablet) vs mesalamine delayed-release 2.4 g/d (400 mg tablet) in patients with moderately active UC. Patients were randomly assigned to receive either mesalamine delayed-release 2.4 g/d (400 mg tablet) or ASACOL HD 4.8 g/d (800 mg tablet). Up to 386 patients were enrolled in the study, of whom approximately 268 were patients with moderately active disease. The primary efficacy endpoint for this study was the treatment outcome at the end of the study (ie, treatment success or failure at week 6) for patients with moderate disease at baseline. Treatment success was defined as either a complete or partial response to treatment.4

P=NS.3

§P<0.05 between 4.8 g/d and 2.4 g/d.4

IMPORTANT SAFETY INFORMATION
Contraindications
  • Patients with known hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of ASACOL HD.
Warnings and Precautions
Renal impairment
  • Renal impairment, including minimal change disease, acute and chronic interstitial nephritis, and rarely, renal failure, has been reported. Evaluate renal function prior to initiation of treatment and periodically while on therapy. Evaluate the risks and benefits of using ASACOL HD in patients with known renal impairment or history of renal disease or taking concomitant nephrotoxic drugs.
Mesalamine-induced acute intolerance syndrome
  • Monitor patients for worsening of the following symptoms: cramping, abdominal pain, bloody diarrhea, and occasionally fever, headache, malaise, pruritus, rash, and conjunctivitis. Symptoms usually subside when ASACOL HD tablets are discontinued. Monitor for worsening symptoms and promptly discontinue if acute intolerance syndrome is suspected.
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 ASACOL HD if a hypersensitivity reaction is suspected.
Hepatic failure
  • Hepatic failure has been reported in patients with pre-existing liver disease who have been administered mesalamine. Evaluate the risks and benefits in patients with known liver impairment.
Photosensitivity
  • Advise patients with pre-existing 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.
Iron Content
  • ASACOL HD contains iron oxide. Consider the iron content of ASACOL HD in patients taking iron supplementation and those at risk of iron overload.
Interference with Laboratory Tests
  • 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
  • In clinical trials, the most common adverse reactions (observed in ≥ 2% of patients) were headache, nausea, nasopharyngitis, abdominal pain, and worsening of UC.
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 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 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 ASACOL HD.
Indication

ASACOL HD (mesalamine) delayed-release tablets are indicated for the treatment of moderately active ulcerative colitis (UC) in adults. The safety and effectiveness of ASACOL HD beyond 6 weeks have not been established.

Please see full Prescribing Information for ASACOL HD.

IMPORTANT SAFETY INFORMATION
IMPORTANT SAFETY INFORMATION
Contraindications
  • Patients with known hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of ASACOL HD.
Warnings and Precautions
Renal impairment
  • Renal impairment, including minimal change disease, acute and chronic interstitial nephritis, and rarely, renal failure, has been reported. Evaluate renal function prior to initiation of treatment and periodically while on therapy. Evaluate the risks and benefits of using ASACOL HD in patients with known renal impairment or history of renal disease or taking concomitant nephrotoxic drugs.
Mesalamine-induced acute intolerance syndrome
  • Monitor patients for worsening of the following symptoms: cramping, abdominal pain, bloody diarrhea, and occasionally fever, headache, malaise, pruritus, rash, and conjunctivitis. Symptoms usually subside when ASACOL HD tablets are discontinued. Monitor for worsening symptoms and promptly discontinue if acute intolerance syndrome is suspected.
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 ASACOL HD if a hypersensitivity reaction is suspected.
Hepatic failure
  • Hepatic failure has been reported in patients with pre-existing liver disease who have been administered mesalamine. Evaluate the risks and benefits in patients with known liver impairment.
Photosensitivity
  • Advise patients with pre-existing 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.
Iron Content
  • ASACOL HD contains iron oxide. Consider the iron content of ASACOL HD in patients taking iron supplementation and those at risk of iron overload.
Interference with Laboratory Tests
  • 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
  • In clinical trials, the most common adverse reactions (observed in ≥ 2% of patients) were headache, nausea, nasopharyngitis, abdominal pain, and worsening of UC.
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 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 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 ASACOL HD.
Indication

ASACOL HD (mesalamine) delayed-release tablets are indicated for the treatment of moderately active ulcerative colitis (UC) in adults. The safety and effectiveness of ASACOL HD beyond 6 weeks have not been established.

Please see full Prescribing Information for ASACOL HD.

References:

  1. ASACOL HD [package insert]. Madison, NJ: Allergan, Inc.; October 2020.
  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. Sandborn WJ, Regula J, Feagan BG, et al. Delayed-release oral mesalamine 4.8 g/day (800-mg tablet) is effective for patients with moderately active ulcerative colitis. Gastroenterology. 2009;137(6):1934-1943.
  4. Hanauer SB, Sandborn WJ, Kornbluth A, et al. Delayed-release oral mesalamine at 4.8 g/day (800 mg tablet) for the treatment of moderately active ulcerative colitis: the ASCEND II trial. Am J Gastroenterol. 2005;100(11):2478-2485.