RHINOCORT

What it is

RHINOCORT contains budesonide 3 mg within enteric-coated (gastro-resistant) granules as the active ingredient. RHINOCORT capsules are presented as pink opaque, oblong hard gelatin capsules. The medicine contains excipients of known effect including sugars (lactose monohydrate and sucrose).

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 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. At the end of treatment, the dosage should be tapered gradually to avoid insufficient function of the adrenal cortex. 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. RHINOCORT 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

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 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. Systemic effects of glucocorticoids may occur, particularly when prescribed at high doses. Such effects may include Cushing's syndrome, adrenal suppression, growth retardation, decreased bone mineral density, cataract, glaucoma and a wide range of psychiatric and behavioural effects. Glucocorticoids may cause suppression of the HPA axis and reduce the stress response. When patients are subject to surgery or other stresses, supplementary systemic glucocorticoid treatment is recommended. Visual disturbance may be reported with systemic and topical glucocorticoid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy.

Contraindications

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

PBS listing

RHINOCORT is listed on the PBS for eosinophilic oesophagitis as a General Schedule unrestricted benefit listing of 4 mg suppository, cost-minimised to the lowest cost comparator on a cost of treatment per day basis.

Regulatory history

RHINOCORT Aqueous Nasal Spray products were first registered on the ARTG on 24 August 2000, with variants containing budesonide 32 microgram per actuation and 64 microgram per actuation. A hayfever and allergy formulation was listed on 3 May 2001. In March 2019, PBAC recommended RHINOCORT for mild to moderate Crohn disease affecting the ileum and/or ascending colon on a cost-minimisation basis against a weighted mixed comparator of mesalazine and prednisolone. This recommendation was withdrawn by the PBAC in November 2021 with the support of the sponsor. In November 2021, PBAC recommended RHINOCORT for eosinophilic oesophagitis, with subsequent recommendations in March and July 2023 relating to prescriber eligibility and histological assessment timeframes. In March 2024, PBAC recommended RHINOCORT for Crohn disease. In November 2024, PBAC recommended RHINOCORT for mild to moderate ulcerative colitis limited to the rectum.