JORVEZA

What it is

Jorveza is budesonide supplied as orally disintegrating tablets containing either 0.5 mg or 1 mg of budesonide. The 0.5 mg tablet is white or almost white, round, and biplane with '0.5' debossed on one side, while the 1 mg tablet is white or almost white and round. Jorveza is taken after a meal by placing it on the tip of the tongue and gently pressing it against the roof of the mouth where it disintegrates, with the effervescence process stimulating saliva production in which the released budesonide mixes, enabling the oesophageal surface to be exposed to comparatively high concentrations of budesonide over a relatively long period, with the mucoadhesive properties of saliva facilitating optimal targeting of budesonide at the site of inflammation in the oesophagus.

Approved indications

— Treatment of eosinophilic oesophagitis (EoE) in adults.

Dosing overview

The recommended daily dose for induction treatment is 2 mg budesonide as one 1 mg tablet in the morning and one 1 mg tablet in the evening, with a usual duration of 6 weeks. For patients not appropriately responding during 6 weeks, treatment can be extended to up to 12 weeks. The recommended daily dose for maintenance of remission is 1 mg budesonide as one 0.5 mg tablet in the morning and one 0.5 mg tablet in the evening, or 2 mg budesonide as one 1 mg tablet in the morning and one 1 mg tablet in the evening, depending on the individual clinical requirement of the patient. The maintenance dose of 1 mg budesonide twice daily is recommended for patients with a long standing disease history and/or high extent of oesophageal inflammation in their acute disease state.

Key safety warnings

Suppression of the inflammatory response and immune function increases susceptibility to infections and their severity, with symptoms of infections potentially atypical or masked, and oral, oropharyngeal and oesophageal candida infections observed at high frequency in clinical studies. If indicated, symptomatic candidiasis of the mouth and throat can be treated with orally active antifungal therapy whilst continuing treatment with Jorveza. Chickenpox, herpes zoster and measles can have a more serious course in patients treated with glucocorticoids, and in patients who have not had these diseases, vaccination status should be checked with particular care taken to avoid exposure. Co-administration of live vaccines and glucocorticoids should be avoided as this is likely to reduce the immune response to vaccines, and the antibody response to other vaccines may be diminished. Systemic effects of glucocorticoids such as Cushing's syndrome, adrenal suppression, growth retardation, cataract, glaucoma, decreased bone mineral density and a wide range of psychiatric effects may occur, particularly when prescribed at high doses and for prolonged periods. Visual disturbance may be reported with systemic and topical glucocorticoid use, and if a patient presents with symptoms such as blurred vision or other visual disturbances, referral to an ophthalmologist should be considered for evaluation of possible causes including cataract, glaucoma or rare ocular diseases such as central serous chorioretinopathy (CSCR). Cases of angioedema and/or contact dermatitis have been reported with the use of Jorveza, mostly as part of an allergic reaction including rash and itching, and treatment should be stopped if a patient develops swelling of the face, particularly around the mouth (lips, tongue or throat) and/or difficulties to breathe or swallow.

Contraindications

Jorveza is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. Jorveza is contraindicated in patients with uncontrolled infections or active tuberculosis.

PBS listing

The 1 mg orally disintegrating tablet is listed on the PBS with 3 items, restriction type authority required, and ex-manufacturer price of A$540.00. The 0.5 mg orally disintegrating tablet is listed on the PBS with 2 items, restriction type authority required, and ex-manufacturer price of A$360.00.

Regulatory history

Jorveza budesonide 1 mg orally disintegrating tablet was first listed on the Australian Register of Therapeutic Goods on 15 September 2020. Jorveza budesonide 0.5 mg orally disintegrating tablet was first listed on the Australian Register of Therapeutic Goods on 6 September 2021.