Asacol HD

ASACOL HD- mesalamine tablet, delayed release
Procter & Gamble Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE

Asacol HD is indicated for the treatment of moderately active ulcerative colitis. Safety and effectiveness of Asacol HD beyond 6 weeks has not been established.

2 DOSAGE AND ADMINISTRATION

For the treatment of moderately active ulcerative colitis, the recommended dose of Asacol HD in adults is two 800 mg tablets to be taken three times daily with or without food, for a total daily dose of 4.8 g, for a duration of 6 weeks. Asacol HD use beyond 6 weeks has not been evaluated. Asacol HD should be swallowed whole without cutting, breaking, or chewing. One Asacol HD 800 mg tablet has not been shown to be bioequivalent to two Asacol 400 mg tablets [see Clinical Pharmacology (12.3)].

3 DOSAGE FORMS AND STRENGTHS

Asacol HD delayed-release tablets are available as red-brown, capsule-shaped tablets containing 800 mg mesalamine and imprinted with “PG 800” in black.

4 CONTRAINDICATIONS

Asacol HD is contraindicated in patients with hypersensitivity to salicylates or aminosalicylates or to any of the components of Asacol HD tablets.

5 WARNINGS AND PRECAUTIONS

5.1 Renal Impairment

Renal impairment, including minimal change nephropathy, acute and chronic interstitial nephritis, and, rarely, renal failure, has been reported in patients taking products such as Asacol HD that contain or are converted to mesalamine.

It is recommended that all patients have an evaluation of renal function prior to initiation of Asacol HD and periodically while on therapy. Exercise caution when using Asacol HD in patients with known renal dysfunction or history of renal disease.

In animal studies (rats, mice, dogs), the kidney was the principal organ for toxicity [see Nonclinical Toxicology (13.2)].

5.2 Exacerbation of Ulcerative Colitis Symptoms

Exacerbation of the symptoms of colitis has been reported in 2.3% of Asacol HD-treated patients in controlled clinical trials. This acute reaction, characterized by cramping, abdominal pain, bloody diarrhea, and occasionally by fever, headache, malaise, pruritus, rash, and conjunctivitis, has been reported after the initiation of Asacol HD tablets as well as other mesalamine products. Symptoms usually abate when Asacol HD tablets are discontinued.

5.3 Hypersensitivity

Some patients who have experienced a hypersensitivity reaction to sulfasalazine may have a similar reaction to Asacol HD tablets or to other compounds that contain or are converted to mesalamine.

5.4 Pyloric Stenosis

Patients with pyloric stenosis may have prolonged gastric retention of Asacol HD tablets, which could delay release of mesalamine in the colon.

5.5 Use in Hepatic Impairment

There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered mesalamine. Caution should be exercised when administering Asacol HD to patients with liver disease.

6 ADVERSE REACTIONS

The most serious adverse reactions seen in Asacol HD clinical trials or with other products that contain or are metabolized to mesalamine were:

  • Renal impairment, including renal failure (rare) [see Warnings and Precautions (5.1)]
  • Acute exacerbation of colitis [see Warnings and Precautions (5.2)]
  • Hypersensitivity reactions [see Warnings and Precautions (5.3)]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Asacol HD has been evaluated in 896 patients with ulcerative colitis in controlled studies. Three six-week, active-controlled studies were conducted comparing Asacol HD 4.8 g/day with Asacol (mesalamine) 2.4 g/day as control in patients with mildly to moderately active ulcerative colitis. In these studies, 727 patients were dosed with the Asacol HD tablet and 732 patients were dosed with the Asacol 400 mg tablet. (One Asacol HD 800 mg tablet has not been shown to be bioequivalent to two Asacol 400 mg tablets [see Clinical Pharmacology (12.3)].)

The most common reactions reported in the Asacol HD group were headache (4.7%), nausea (2.8%), nasopharyngitis (2.5%), abdominal pain (2.3%), exacerbation of ulcerative colitis (2.3%), diarrhea (1.7%), and dyspepsia (1.7%); Table 1 enumerates adverse drug reactions that occurred in the three studies. The most common reactions in the primary efficacy population of patients with moderately active ulcerative colitis (602 patients dosed with Asacol HD and 618 patients dosed with the Asacol 400 mg tablet) were the same as all treated patients. The majority of adverse reactions with Asacol HD in the double-blind, active-controlled trials were mild or moderate in severity and were reversible.

Discontinuations due to adverse reactions occurred in 3.9% of patients in the Asacol HD group and in 4.2% of patients in the Asacol 400 mg tablet comparator group. The most common cause for discontinuation was gastrointestinal symptoms associated with ulcerative colitis.

Severe adverse reactions occurred in 7.6% of patients in the Asacol HD group and in 7.6% of patients in the Asacol 400 mg tablet comparator group. Most of these reactions were gastrointestinal symptoms related to ulcerative colitis. Serious adverse reactions occurred in 0.8% of patients in the Asacol HD group and in 1.8% of patients in the Asacol 400 mg tablet comparator group. The majority involved the gastrointestinal system.

Table 1. Adverse Reactions Occurring in 1% or More of All Treated Patients (Three studies combined; Intent-to-treat population)

N = number of patients within specified treatment group

% = percentage of patients in category and treatment group

*One Asacol HD 800 mg tablet has not been shown to be bioequivalent to two Asacol 400 mg tablets [see Clinical Pharmacology (12.3)].

Asacol*
2.4g/day
Asacol HD*
4.8g/day
(400 mg Tablet) (800 mg Tablet)
MedDRA Preferred Term (N=732) (N=727)
Headache 4.9 % 4.7 %
Nausea 2.9 % 2.8 %
Nasopharyngitis 1.4 % 2.5 %
Abdominal pain 2.3 % 2.3 %
Ulcerative Colitis 2.7 % 2.3 %
Diarrhea 1.9 % 1.7 %
Dyspepsia 0.8 % 1.7 %
Vomiting 1.6 % 1.4 %
Flatulence 0.7 % 1.2 %
Influenza 1.2 % 1.0 %
Pyrexia 1.2 % 0.7 %
Cough 1.4 % 0.3 %
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