ASACOL

What it is

ASACOL contains mesalazine as the active ingredient. ASACOL is available as enteric coated tablets in strengths of 400 mg, 800 mg, and 1.6 g.

Approved indications

— Treatment of mild to moderate ulcerative colitis. — Treatment of mild to moderate Crohn's disease. — Maintenance of remission in ulcerative colitis and Crohn's disease.

Dosing overview

For ulcerative colitis, the treatment dose for active disease is up to 4 g daily given once daily or in divided doses. For maintenance treatment, the dose is 2 g once daily or individual dosage starting with 1.5–2 g daily in divided doses. For Crohn's disease, both active disease treatment and maintenance treatment use individual dosage up to 4 g daily in divided doses. The tablets should not be crushed or chewed.

Key safety warnings

Severe cutaneous adverse reactions (SCARs), including drug reaction with eosinophilia and systematic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), have been reported in association with mesalazine treatment. Treatment should be discontinued immediately in cases of acute intolerance reactions such as nausea, exacerbation of diarrhoea, abdominal cramps, acute abdominal pain, fever, severe headache, and the first appearance of signs and symptoms of severe skin reactions, such as skin rash, mucosal lesions, or any other signs of hypersensitivity. Mesalazine-induced cardiac hypersensitivity reactions (myocarditis and pericarditis) have been reported rarely, and serious blood dyscrasias have been reported rarely with mesalazine. Haematological investigations should be performed if the patient develops unexplained bleeding, bruising, purpura, anaemia, fever or sore throat, and treatment should be stopped if there is suspicion or evidence of blood dyscrasia. Patients with inflammatory bowel disease are at risk of developing nephrolithiasis, and cases of nephrolithiasis have been reported with the use of mesalazine including kidney stones composed entirely of mesalazine. It is recommended to ensure adequate fluid intake during treatment. Idiopathic intracranial hypertension (pseudotumor cerebri) has been reported in patients receiving mesalazine. Patients should be warned for signs and symptoms including severe or recurrent headache, visual disturbances or tinnitus, and discontinuation of mesalazine should be considered if this occurs.

Contraindications

ASACOL is contraindicated in patients with hypersensitivity to mesalazine or any of the excipients or salicylates, and in patients with severe liver or renal impairment.

PBS listing

ASACOL 1.6 g enteric coated tablets are listed on the PBS with 2 items under restricted (authority required) restrictions, with an ex-manufacturer price of A$64.32. ASACOL 800 mg enteric coated tablets are listed on the PBS with 2 items under restricted (authority required) restrictions, with an ex-manufacturer price of A$61.06.

Regulatory history

ASACOL 400 mg enteric coated tablets (ARTG 261419) were first registered on 21 September 2016. ASACOL 800 mg enteric coated tablets (ARTG 261420) were first registered on 21 September 2016. ASACOL 1.6 g enteric coated tablets (ARTG 322671) were first registered on 6 October 2020.