PENTASA

What it is

PENTASA is a prolonged release medicine containing mesalazine. Prolonged release tablets are available in strengths of 0.5 g and 1 g mesalazine. Prolonged release granules in sachets are available in strengths of 1 g, 2 g and 4 g mesalazine.

Approved indications

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

Dosing overview

Do not crush or chew the tablets or granules. Tablets may be dispersed in 50 mL of cold water, stirred and drunk immediately to facilitate swallowing. The content of granule sachets should be emptied onto the tongue and washed down with water or juice, or alternatively taken with yoghurt and consumed immediately.

Key safety warnings

Severe cutaneous adverse reactions, 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/or 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) and serious blood dyscrasias have been reported rarely. Haematological investigations should be performed if the patient develops unexplained bleeding, bruising, purpura, anaemia, fever or sore throat. Concomitant treatment with mesalazine can increase the risk of blood dyscrasia in patients receiving azathioprine, or 6-mercaptopurine or tioguanine. Patients with inflammatory bowel disease are at risk of developing nephrolithiasis, and cases including kidney stones composed entirely of mesalazine have been reported with the use of mesalazine. It is recommended to ensure adequate fluid intake during treatment. Idiopathic intracranial hypertension (pseudotumour cerebri) has been reported in patients receiving mesalazine, and patients should be warned of signs and symptoms including severe or recurrent headache, visual disturbances or tinnitus.

Contraindications

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

PBS listing

Prolonged release tablets of 500 mg and 1 g are listed on the PBS with restriction type (2 items each), with ex-manufacturer prices of A$50.78 and A$56.97 respectively. Prolonged release granules sachets of 1 g, 2 g and 4 g are listed on the PBS with restriction type (2 items each), with ex-manufacturer prices of A$86.97, A$107.10 and A$107.10 respectively. Suppositories of 1 g and enemas of 1 g in 100 mL are also listed, with ex-manufacturer prices of A$64.80 and A$45.80 respectively.

Regulatory history

PENTASA mesalazine 1 g suppositories and 1 g enemas were first listed on the ARTG on 14 November 2003. The 0.5 g prolonged release tablets were registered on 2 January 2007, and the 1 g prolonged release tablets on 16 April 2010. Prolonged release granules sachets containing 1 g and 2 g were registered on 18 August 2009, and 4 g sachets on 14 August 2014. In March 2020, the PBAC recommended a change in maximum quantity for suppositories and modified release granules based on the change to pack sizes.