Jorveza

/ Rafa

The treatment with this medicinal product should be initiated by a gastroenterologist or a physician experienced in the diagnosis and treatment of eosinophilic esophagitis.
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 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 long standing disease history and/or high extent of esophageal inflammation in their acute disease state.
The duration of maintenance therapy is determined by the treating physician.
See prescribing information for more details.

Treatment of eosinophilic esophagitis (EoE) in adults.

Hypersensitivity to the active substance or to any of the excipients.

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, oropharyngeal and esophageal candida infections have been observed with a high frequency.
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 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.
Systemic effects of glucocorticosteroids
Systemic effects of glucocorticosteroids (e.g., Cushing’s syndrome, adrenal suppression, growth retardation, cataract, glaucoma, decreased bone mineral density and a wide range of psychiatric effects) may occur. These adverse reactions depend on the duration of treatment, concomitant and previous glucocorticosteroid treatment and the individual sensitivity.
Angioedema
Angioedema has been reported, mostly as part of allergic reactions which included rash and itching. If signs of angioedema are observed, the treatment should be stopped.
Visual disturbance
Visual disturbance may be reported with systemic and topical corticosteroid 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 (CSCR) which have been reported after use of systemic and topical corticosteroids.
Others
Glucocorticosteroids may cause suppression of the hypothalamic–pituitary–adrenal (HPA) axis and reduce the stress response. When patients are subject to surgery or other stresses, supplementary systemic glucocorticosteroid treatment is therefore recommended.
Concomitant treatment with ketoconazole or other CYP3A4 inhibitors should be avoided.
Interference with serological testing
Because adrenal function may be suppressed by treatment with budesonide, an ACTH stimulation test for diagnosing pituitary insufficiency might show false results (low values).

Very common: Esophageal candidiasis, Oral and/or oropharyngeal candidiasis.
Common: Sleep disorder, Headache, dysgeusia, Dry eyes, Gastroesophageal reflux disease, nausea, oral paraesthesia, dyspepsia, upper abdominal pain, dry mouth, glossodynia, tongue disorder, oral herpes, Fatigue, Blood cortisol decreased.
See prescribing information for more details.

CYP3A4 inhibitors
Co-treatment with potent CYP3A inhibitors such as ketoconazole, ritonavir, itraconazole, clarithromycin, cobicistat and grapefruit juice may cause a marked increase of the plasma concentration of budesonide and is expected to increase the risk of systemic adverse reactions. Therefore, concomitant use should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid adverse reactions, in which case patients should be monitored for systemic corticosteroid adverse reactions.
Ketoconazole 200 mg once daily orally increased the plasma concentration of budesonide (3 mg single dose) approximately 6-fold during concomitant administration. When ketoconazole was administered approximately12 hours after budesonide, the plasma concentration of budesonide increased approximately 3-fold.
Oestrogens, oral contraceptives
Elevated plasma concentrations and enhanced effects of glucocorticosteroids have been reported in women also receiving oestrogens or oral contraceptives. No such effect has been observed with budesonide and concomitant intake of low-dose combination oral contraceptives.
Cardiac glycosides
The action of glycoside can be potentiated by potassium deficiency which is a potential and known adverse reaction of glucocorticoids.
Saluretics
Concommitant use of glucocorticoids may result in enhanced potassium excretion and aggravated hypokalaemia.

Pregnancy
Administration during pregnancy should be avoided unless there are compelling reasons for therapy with this drug. There are few data of pregnancy outcomes after oral administration of budesonide in humans. Although data on the use of inhaled budesonide in a large number of exposed pregnancies indicate no adverse effect, the maximal concentration of budesonide in plasma has to be expected to be higher in the treatment with oral budesonide compared to inhaled budesonide. In pregnant animals, budesonide, like other glucocorticosteroids, has been shown to cause abnormalities of fetal development. The relevance of this to man has not been established.
Breast-feeding
Budesonide is excreted in human milk (data on excretion after inhalative use is available). However, only minor effects on the breast-fed child are anticipated after oral use of budesonide within the therapeutic range. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

In case of short-term overdose no emergency medical treatment is required. There is no specific antidote. Subsequent treatment should be symptomatic and supportive.

Store below 25°C. Store in the original package in order to protect from light and moisture.