JORVEZA Orodispersible tablet Ref.[116522] Active ingredients: Budesonide

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.

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 orodispersible tablets in children and adolescents under the age of 18 years have not been established. No data are available. Jorveza 0.2 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. Any oral solutions, sprays or chewable tablets should be used at least 30 minutes before or after administration of Jorveza.

The orodispersible tablet should not be chewed or swallowed undissolved. These measures ensure optimal exposure of the esophageal mucosa to the active substance by using the adhesive characteristics of mucins in the saliva.

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

2 years.

Do not store above 25°C. Store in the original package in order to protect from light and moisture.

Alu/Alu-blister.

Jorveza 0.5 mg orodispersible tablets:

Pack sizes of 20, 60, 90, 100 or 200 orodispersible tablets.

Jorveza 1 mg orodispersible tablets:

Pack sizes of 20, 30, 60, 90, 100 or 200 orodispersible tablets.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.