Voydeya

Treatment should be initiated by a healthcare professional experienced in the management of patients with haematological disorders. 3 Posology The recommended starting dose is 150 mg three times a day administered orally, approximately 8 hours apart (± 2 hours).

Dose can be increased to 200 mg three times a day after a minimum of 4 weeks of treatment depending on clinical response. Missed doses If a dose is missed, patients should be advised to take it as soon as it is remembered unless it is almost time for the next dose in which case patients should skip the missed dose and take the medicinal product at the next regularly scheduled time.

Patients should be advised not to take 2 doses or more at the same time. 4), if treatment is discontinued, the dose should be tapered over a 6-day period until complete cessation, as follows: - 100 mg regimen: 100 mg twice a day for 3 days, followed by 100 mg once a day for 3 days.

- 150 mg regimen: 100 mg three times a day for 3 days, followed by 50 mg three times a day for 3 days. - 200 mg regimen: 100 mg three times a day for 3 days, followed by 100 mg twice a day for 3 days. Special populations Elderly No dose adjustment is required in elderly patients.

1). 73 m2) renal impairment. 73 m2), the recommended starting dose is 100 mg three times a day administered orally, approximately 8 hours apart (± 2 hours). 2). 2). Studies have not been conducted in patients with severe (Child-Pugh Class C) hepatic impairment.

4). Paediatric population The safety and efficacy of Voydeya in children aged less than 18 years have not yet been established. No data are available. Method of administration Oral use. 2).

5%). Tabulated list of adverse reactions Table 1 includes adverse reactions reported in clinical trials with danicopan. Adverse reactions are listed by system organ class and preferred term using MedDRA frequency convention very common (≥ 1/10), common (≥ 1/100 to < 1/10), and uncommon (≥ 1/1 000 to < 1/100).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.

Table 1:

Tabulated list of adverse reactions MedDRA system order Class Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Nervous system disorders Headache Vascular disorders Hypertension Gastrointestinal disorders Vomiting Hepatobiliary disorders Hepatic enzyme increaseda Musculoskeletal and connective tissue disorders Pain in extremity General disorders and administration site conditions Pyrexia a Hepatic enzyme increased includes preferred terms alanine aminotransferase increased, hepatic function abnormal, hepatic enzyme increased, and transaminases increased.

0% of patients on danicopan. 3% of patients. All patients were asymptomatic, and all elevations were transient. Some elevations occurred in the context of haemolysis.. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

General Danicopan must not be administered as monotherapy as the efficacy has not been established. It should only be prescribed as an add-on to ravulizumab or eculizumab. Serious infections Meningococcal infections Patients receiving complement inhibitor therapy may have increased susceptibility to meningococcal infections (Neisseria meningitidis).

Patients must be up to date on their meningococcal vaccines according to current national guidelines for vaccination use, prior to receiving the first dose of danicopan. Patients who initiate treatment less than 2 weeks after receiving a meningococcal vaccine must receive treatment with appropriate prophylactic antibiotics until 2 weeks after vaccination.

Patients must be vaccinated against serogroups A, C, Y, and W135 to prevent the commonly pathogenic meningococcal serogroups. Vaccination against serogroup B, where available, is also recommended. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

All patients treated with danicopan should be monitored for early signs of meningococcal infection and sepsis, evaluated immediately if infection is suspected, and treated with appropriate antibiotics. Patients should be informed of these signs and symptoms and steps should be taken to seek medical care immediately.

Other serious infections Danicopan should be administered with caution to patients with active systemic infections. Danicopan selectively blocks the activation of the complement alternative pathway; therefore, patients may have increased susceptibility to serious infections (other than Neisseria meningitidis).

Prior to initiating danicopan as add-on to ravulizumab or eculizumab, it is recommended that patients initiate immunisation according to current immunisation guidelines. Severe renal impairment Patients with severe renal impairment that dose escalate to 150 mg three times a day should be monitored for adverse events during treatment with danicopan due to higher exposure expected in these patients.

1. 4). 4).