Wayrilz

Treatment should be initiated and remain under the supervision of a physician who is experienced in the treatment of haematological diseases. Posology The recommended dose of rilzabrutinib is 400 mg twice daily. 5). 3 Table 1: Use with CYP3A inhibitors or inducers and gastric acid reducing agents Co-administered medicinal product Recommended use CYP3A inhibitors Strong and moderate CYP3A inhibitor Avoid co-administration of rilzabrutinib with moderate or strong CYP3A inhibitors.

If these inhibitors will be used short-term (such as anti- infectives for up to seven days), interrupt rilzabrutinib. Avoid co-administration of grapefruit, starfruit and products containing these fruits, and Seville oranges with rilzabrutinib, as these are moderate or strong inhibitors of CYP3A.

Weak CYP3A inhibitor No dose adjustment. CYP3A inducers Strong and moderate CYP3A inducers Avoid co-administration of rilzabrutinib with moderate or strong CYP3A inducers. Weak CYP3A inducer No dose adjustment. Gastric acid reducing agents Proton pump inhibitors (PPIs) Avoid co-administration of rilzabrutinib with PPIs.

H2-receptor antagonists or antacid If treatment with a gastric acid reducing agent is required, consider using a H2-receptor antagonist (H2RA) or antacid. Take rilzabrutinib at least 2 hours before taking the H2RA or antacid. Missed dose If a dose of rilzabrutinib is missed, patients should take the missed dose as soon as possible on the same day with a return to the regular schedule the following day.

The missed dose and the next regular scheduled dose must be taken more than 2 hours apart. Extra tablets should not be taken to make up for the missed dose. Discontinuation Treatment with rilzabrutinib should be discontinued after 12 weeks of rilzabrutinib therapy if the platelet count does not increase to a level sufficient to avoid clinically important bleeding.

2). Renal impairment No dose modification is required in patients with mild or moderate renal impairment. 2). 4 Hepatic impairment No dose modification is required in patients with mild (Child-Pugh Class A) hepatic impairment. Rilzabrutinib has not been studied in clinical trials in patients with severe (Child-Pugh Class C) hepatic impairment.

2). Paediatric population The safety and efficacy of rilzabrutinib in children and adolescents below 18 years of age with ITP have not been established. No data are available. Method of administration Rilzabrutinib is for oral use. 2).

3%). 7%), were diarrhoea, nausea, headache, and pneumonia. 1). 8 months). Adverse reactions are organised according to primary system organ class (SOC) for each preferred term in MedDRA. The adverse reactions are ranked by frequency within each SOC, and presented in order of decreasing seriousness.

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) and not known (cannot be estimated from the available data). 6%). The majority of infections were Grade 1 or 2 and resolved within 8 days.

7 months). 5% in the rilzabrutinib group and placebo group, respectively. 8% in the rilzabrutinib group and none in the placebo group. 5%) patients in the rilzabrutinib group, including a fatal case of pneumonia due to aspergillosis and COVID-19, and none in the placebo group.

8%). Majority of GI reactions were Grade 1 and resolved with median duration of 19 days for nausea, 12 days for abdominal pain, and approximately 7 days for diarrhoea. 7 months). Rash Among patients exposed to rilzabrutinib, rash (including rash maculo-papular, rash papular, rash erythematous, rash pruritic, erythema, erythema nodosum, urticaria) were all non-serious.

All were Grade 1 or 2. 7 months). 9%) patients were 65 years of age or older. 9%) patients experienced serious adverse reactions of pneumonia. 3%) patients had serious adverse reactions of pneumonia and COVID-19. 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.

8). Monitor patients for signs and symptoms of infection and treat appropriately. 6). Pregnancy status of females of child-bearing potential should be verified prior to initiating treatment. 2). Bilirubin and transaminases are to be evaluated at baseline and as clinically indicated during treatment with rilzabrutinib.

For patients who develop abnormal liver tests after rilzabrutinib, continue to monitor for liver test abnormalities as well as clinical signs and symptoms as clinically indicated. QT shortening In the clinical trials with ITP patients, there were no clinically meaningful QTc interval changes.

1). , Congenital Short QT Syndrome or patients with a family history of such a syndrome). Excipients Sunset yellow FCF 5 This medicinal product contains azo colouring agent sunset yellow FCF (E 110), which may cause allergic reactions.

Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.

1.