Rhapsido

Treatment should be initiated by physicians experienced in the diagnosis and treatment of chronic spontaneous urticaria. Posology The recommended dose of remibrutinib is 25 mg taken orally twice daily, once in the morning and once in the evening.

If a patient misses one or more doses of remibrutinib, the patient should be instructed to take the next dose at its regularly scheduled time. Extra doses of remibrutinib should not be taken to make up for the missed dose or doses. Prescribers are advised to periodically reassess the need for continued therapy.

Consideration should be given to discontinuing treatment in patients who have shown no response after 24 weeks of treatment for CSU. 8). 2). Limited data are available on the use of remibrutinib in patients older than 65 years. 2). Hepatic impairment No dose adjustment is required in patients with mild or moderate hepatic impairment.

2). g. generation of protective immunoglobulins and memory B cells). The safety and efficacy of remibrutinib in children and adolescents 6 to 18 years of age have not been established. No data are available. Method of administration Oral use.

Remibrutinib may be taken with or without food. Patients should be instructed to swallow the tablet whole with water. The tablets should not be split, crushed or chewed to ensure the entire dose is delivered correctly.

5%). Tabulated list of adverse reactions Adverse reactions are listed according to MedDRA system organ class. Within each system organ class, the adverse reactions are ranked by frequency, with the most frequent reactions first. In addition, the corresponding frequency category for each adverse reaction is 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); not known (cannot be estimated from available data).

7 Table 1 Adverse reactions* System organ class Adverse reaction Frequency Infections and infestations Upper respiratory tract infections1 Very common Herpes virus infections2 Common Nervous system disorders Headache Common Vascular disorders Bruising Common Petechiae Common Contusion3 Common Ecchymosis Common Purpura Uncommon Bleeding Common Haematuria Common Epistaxis Uncommon Conjunctival bleeding Uncommon Gingival bleeding Uncommon Gastrointestinal disorders Nausea Common Abdominal pain Common Musculoskeletal and connective tissue disorders Back pain Common General disorders and administration site conditions Pyrexia Common * 24-week placebo-controlled phase III studies in CSU 1 Upper respiratory tract infections include preferred terms: upper respiratory tract infection, acute sinusitis, chronic sinusitis, H1N1 influenza, influenza, laryngitis, nasopharyngitis, pharyngitis, pharyngitis streptococcal, pharyngotonsillitis, rhinitis, sinusitis, tonsillitis, tonsillitis bacterial, upper respiratory tract infection bacterial, upper respiratory tract infection viral 2 Herpes virus infections include preferred terms: herpes simplex, herpes zoster, oral herpes 3 Contusion includes preferred terms: contusion, increased tendency to bruise, haematoma The safety profile of remibrutinib in patients treated for up to 52 weeks in REMIX-1 and REMIX-2 remained consistent with the adverse reactions reported in Table 1.

8% of patients treated with remibrutinib. 3%). 0% were moderate in severity. The median time to onset was 25 days and the median duration was 22 days. All cases resolved spontaneously without additional treatment. No association between mucocutaneous bleeding events and low platelet counts was observed.

Risk of bleeding Mild to moderate mucocutaneous bleeding events have occurred in patients treated with remibrutinib. 8). Patients receiving antithrombotic agents with remibrutinib may be at an increased risk of bleeding. 5). Patients should be instructed to seek medical advice if signs and symptoms suggestive of significant bleeding occur.

If significant bleeding is suspected, treatment with remibrutinib should be interrupted. Upon resolution, treatment may be resumed if the benefit is expected to outweigh the risk. 2). Vaccinations The safety of remibrutinib with live or live-attenuated vaccines has not been studied.

5). 4 The safety of remibrutinib with non-live vaccines has been studied, therefore non-live vaccines can be given during remibrutinib treatment. 5). 5). Concomitant use with strong CYP3A4 inhibitors increases remibrutinib exposure and consequently may increase the risk for adverse reactions with remibrutinib.

5). Concomitant use with moderate or strong CYP3A4 inducers decreases remibrutinib exposure and consequently may decrease the efficacy of remibrutinib. 5). 5). Excipient with known effect This medicinal product contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially “sodium-free”.

1.