ENTOCORT

What it is

ENTOCORT contains 3 mg of budesonide within enteric-coated (gastro-resistant) granules as the active ingredient. ENTOCORT capsules are presented as pink opaque, oblong hard gelatin capsules.

Approved indications

— Induction of remission in patients with mild to moderately active Crohn's disease affecting the ileum and/or the ascending colon.

Dosing overview

For acute Crohn's disease (for 8 weeks), the dose is either 9 mg budesonide once daily in the morning, or 3 mg budesonide 3 times daily (morning, midday and evening). Continuous treatment beyond 8 weeks is not recommended. Patients may receive episodic treatment. At the end of treatment, the dosage should be tapered gradually to avoid the possibility of insufficient function of the cortex of the suprarenal gland. In the first week of tapering, the dosage should be reduced to two capsules daily, one in the morning and one in the evening. In the second week of tapering, only one capsule should be taken in the morning. After two weeks of gradual dose reduction, treatment can be discontinued. ENTOCORT capsules may be taken whole, without chewing or crushing, about 30 minutes before meals with sufficient water. Patients with difficulty swallowing the capsules may open the capsule and administer the enteric-coated granules without chewing or crushing and with plenty of liquid.

Key safety warnings

Caution is required in patients with tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma, cataracts, family history of diabetes, family history of glaucoma, or any other condition in which glucocorticoids may have undesirable effects. Systemic effects of glucocorticoids may occur, particularly when prescribed at high doses for prolonged periods and for those agents which are highly absorbed systemically. Such effects may include Cushing's syndrome, adrenal suppression, growth retardation, decreased bone mineral density, cataract, glaucoma and a wide range of psychiatric or behavioural effects. Suppression of the inflammatory response and immune function increases the susceptibility to infections and their severity. The risk of deterioration of bacterial, fungal, amoebic and viral infections during glucocorticoid treatment should be carefully considered. The clinical presentation may often be atypical and serious infections such as septicaemia and tuberculosis may be masked, and therefore may reach an advanced stage before being recognised. Chickenpox is of particular concern since this normally minor illness may be fatal in immunosuppressed patients. Patients without a definite history of chickenpox should be advised to avoid close personal contact with chickenpox or herpes zoster and if exposed they should seek urgent medical attention. Live vaccines should not be given to individuals with chronic corticosteroid use.

Contraindications

ENTOCORT capsules are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients, and in patients with hepatic cirrhosis.

PBS listing

ENTOCORT capsules 3 mg modified release are listed on the PBS with streamlined restriction at an ex-manufacturer price of A$38.85.

Regulatory history

ENTOCORT was first registered on the ARTG on 16 January 1998 as a modified release capsule. In July 2018, the PBAC recommended listing for mild to moderate Crohn disease on a cost minimisation basis against a weighted mixed comparator of mesalazine and prednisolone. In July 2021, the PBAC extended the recommendation for 6 months.