BUDENOFALK

What it is

BUDENOFALK capsules contain 3 mg of budesonide within enteric-coated (gastro-resistant) granules as the active ingredient. BUDENOFALK 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 treatment over 8 weeks, the recommended dose is either 9 mg budesonide once daily in the morning, or 3 mg budesonide three times daily (morning, midday and evening). Continuous treatment beyond 8 weeks is not recommended. BUDENOFALK 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. At discontinuation, dosage should be tapered gradually over two weeks: in the first week reduce to two capsules daily (one morning, one evening), and in the second week take only one capsule in the morning, after which treatment can be discontinued.

Key safety warnings

Suppression of the inflammatory response and immune function increases susceptibility to infections and their severity. The risk of deterioration of bacterial, fungal, amoebic and viral infections during glucocorticoid treatment should be carefully considered. Serious infections such as septicaemia and tuberculosis may be masked and 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 should seek urgent medical attention. Systemic effects of glucocorticoids may occur, particularly when prescribed at high doses for prolonged periods, and may include Cushing's syndrome, adrenal suppression, growth retardation, decreased bone mineral density, cataract, glaucoma and a wide range of psychiatric or behavioural effects. Visual disturbance may be reported with glucocorticoid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, referral to an ophthalmologist is recommended for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy.

Contraindications

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

PBS listing

The 3 mg enteric capsule formulation is listed on the PBS with streamlined restriction at an ex-manufacturer price of A$25.18.

Regulatory history

BUDENOFALK budesonide 3 mg enteric capsules were first registered on the ARTG on 12 June 2012. An AusPAR (Australian Public Assessment Report) was issued on 11 May 2012 approving budesonide 3 mg enteric capsules for induction of remission in patients with mild to moderately active Crohn's disease affecting the ileum and/or the ascending colon. The TGA found no objections regarding chemistry, manufacturing and controls, and highlighted the drug's local action and low systemic bioavailability as beneficial for treating inflammatory bowel disease while limiting systemic side effects.