Jorveza

The treatment with this medicinal product should be initiated by a gastroenterologist or 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. 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.

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. 2). Paediatric population The safety and efficacy of Jorveza orodispersible tablets in children and adolescents under the age of 18 years have not been established.

No data are available. 2 mg/mL oral suspension is available for paediatric EoE patients. Method of administration Oral use. The orodispersible tablet should be taken immediately once removed from the blister package. The orodispersible tablet should be taken after a meal.

It should be placed on the tip of the tongue and gently pressed against the top of the mouth, where it will disintegrate. This will usually take at least two minutes but can take up to 20 minutes. The effervescence process of the tablet starts after Joreveza comes into contact with saliva and stimulates the production of further saliva.

The budesonide-loaded saliva should be swallowed little by little while the orodispersible tablet disintegrates. The orodispersible tablet should not be taken with liquid or food. There should be at least 30 minutes before eating or drinking or performing oral hygiene.

Summary of the safety profile Fungal infections in the mouth, pharynx and the oesophagus were the most frequently observed adverse reactions in clinical studies with Jorveza. 4%) exposed to Jorveza experienced cases of suspected fungal infections associated with clinical symptoms, which were all of mild or moderate intensity.

9%). Long-term treatment with Jorveza of up to 3 years (48-weeks in the BUL-2/EER followed by 96-week open-label treatment) did not increase the rate of side effects including local candidiasis. Tabulated list of adverse reactions Adverse reactions observed in clinical studies with Jorveza are listed in the table below, by MedDRA system organ class and frequency.

Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) or not known (cannot be estimated from the available data). MedDRA system organ class Very common Common Uncommon Infections and infestations Esophageal candidiasis, oral and/or oropharyngeal candidiasis Nasopharyngitis, pharyngitis Immune system disorders Angioedema Psychiatric disorders Sleep disorder anxiety, agitation Nervous system disorders Headache, dysgeusia Dizziness Eye disorders Dry eyes Vascular disorders Hypertension Respiratory, thoracic and mediastinal disorders Cough, dry throat, oropharyngeal pain Gastrointestinal disorders Gastroesophageal reflux disease, nausea, oral paraesthesia, dyspepsia, upper abdominal pain, dry mouth, glossodynia tongue disorder, oral herpes Abdominal pain, abdominal distension, dysphagia, erosive gastritis, gastric ulcer, lip edema, gingival pain, Skin and subcutaneous tissue disorders Rash, urticaria General disorders and administration site conditions Fatigue Sensation of foreign body Investigations Blood cortisol decreased Osteocalcin decreased, weight increased The following known adverse reactions of the therapeutic class (corticosteroids, budesonide) could also occur with Jorveza (frequency = not known).

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. 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. 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.

8). These adverse reactions depend on the duration of treatment, concomitant and previous glucocorticosteroid treatment and the individual sensitivity. Angioedema Angioedema has been reported with the use of Jorveza, 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.

1.