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Jorveza (Budesonide)

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4.1 Therapeutic indications Jorveza is indicated for the treatment of eosinophilic esophagitis (EoE) in adults (older than 18 years of age). 4.2 Posology and method of administration The treatment with this medicinal product should be initiated by a physician experienced in the diagnosis and treatment of eosinophilic esophagitis. Posology Induction of remission The recommended daily dose is 2 mg budesonide as one 1-mg-tablet in the morning and one 1-mg-tablet in the evening. The usual duration of induction treatment is 6 weeks. For patients who are not appropriately responding during 6 weeks the treatment can be extended to up to 12 weeks. Maintenance of remission The recommended daily dose 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. A maintenance dose of 1 mg budesonide twice daily is recommended for patients with a long standing disease history and/or high extent of esophageal inflammation in their acute disease state, see also section 5.1. The duration of maintenance therapy is determined by the treating physician. Special populations Renal impairment There are currently no data available for patients with renal impairment. Because budesonide is not excreted via the kidneys, patients with mild to moderate impairment may be treated with caution with the same doses as patients without renal impairment. Budesonide is not recommended for use in patients with severe renal impairment. Hepatic impairment During treatment of patients with hepatic impairment with other budesonide containing medicinal products, budesonide levels were increased. However, no systematic study investigating different levels of hepatic impairment is available. Patients with hepatic impairment should not be treated (see sections 4.4 and 5.2). Paediatric population The safety and efficacy of Jorveza in children and adolescents under the age of 18 years have not been established. No data are available.

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Infections Suppression of the inflammatory response and immune function increases the susceptibility to infections and their severity. Symptoms of infections can be atypical or masked. In clinical studies conducted with Jorveza oral, oropharyngeal and esophageal candida infections have been observed with a high frequency (see section 4.8). If indicated, symptomatic candidiasis of the mouth and throat can be treated with topical or systemic anti-fungal therapy whilst still continuing treatment with Jorveza. Chickenpox, herpes zoster and measles can have a more serious course in patients treated with glucocorticosteroids. In patients who have not had these diseases, the vaccination status should be checked, and particular care should be taken to avoid exposure. Vaccines The co-administration of live vaccines and glucocorticosteroids should be avoided as this is likely to reduce the immune response to vaccines. The antibody response to other vaccines may be diminished. Special populations Patients with tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma, cataract, family history of diabetes or family history of glaucoma may be at higher risk of experiencing systemic glucocorticosteroid adverse reactions (see below and section 4.8) and should therefore be monitored for the occurrence of such effects. Reduced liver function may affect the elimination of budesonide, causing higher systemic exposure. The risk of adverse reactions (systemic glucocorticosteroid effects) will be increased. However, no systematic data are available. Patients with hepatic impairment should therefore not be treated.