Rezurock

Treatment should be initiated and supervised by physicians experienced in the management of cGVHD. Posology The recommended dose is 200 mg given orally once daily with a meal. Treatment is recommended until disease progression or unacceptable toxicity.

4). 5 × 109/L should be based on close monitoring of laboratory values and clinical assessment. 4). The recommended dose modifications in case of adverse reactions are provided in Table 1. 5 to 3 × ULN) Hold treatment until recovery to ≤ Grade 1, then resume belumosudil recommended dose and monitor laboratory tests for toxicity.

Grade 4 ALT or AST (> 20 × ULN) or Grade ≥ 3 bilirubin (> 3 × ULN) Permanently discontinue treatment. 8) Grade 3 Hold treatment until recovery to ≤ Grade 1, then resume belumosudil recommended dose and monitor for toxicity. Grade 4 Permanently discontinue treatment.

ALT = alanine aminotransferase; AST = aspartate aminotransferase; ULN = upper limit of normal *Grade 1 is mild, Grade2 is moderate, Grade 3 is severe, Grade 4 is life-threatening. 5). Strong CYP3A inducers The recommended dose is 200 mg twice daily with a meal when co-administered with strong CYP3A inducers.

Proton pump inhibitors The recommended dose is 200 mg twice daily with a meal when co-administered with proton pump inhibitors. 5) For the next dose, the usual schedule should be resumed. 5) For the next dose, the usual schedule should be resumed.

If a patient vomits following the intake of a dose, the next dose should be taken at the usual time. In case of missed dose, the patient should be instructed not to take extra doses to make up the missed dose. 3). 2). 2). Renal impairment No dose adjustment is recommended in patients with mild or moderate renal impairment (creatinine clearance ≥ 30 mL/min).

2). Patients should be carefully monitored with regard to safety and efficacy during belumosudil treatment. 2). Paediatric population The safety and efficacy of REZUROCK in paediatric patients aged less than 12 years and with a bodyweight of less than 40 kg have not been established.

No data are available. Method of administration For oral use. 2).

3%). 1% each). 1% each). 1%). 1% each). 8% of patients in the 200 mg once daily group experienced at least one related adverse reaction. 1%). Tabulated list of adverse reactions Table 2 presents the frequency category for adverse reactions reported in all open-label clinical trials with belumosudil 200 mg once daily in 94 patients.

75 months). Their frequency is defined using the following conventions: 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 the available data).

Within each system organ class, adverse reactions are presented in order of decreasing seriousness. 1) 0 10 Description of selected adverse reactions Liver enzyme increase AST, ALT and GGT increased within the first month of belumosudil treatment with the incidence decreasing thereafter.

2. 4. 2% of patients. There were no consistent differences in the time to first occurrence of anaemia across dose groups in the pooled analysis. The highest incidence of anaemia was between 3 and < 6 months. e. approximately 8 months after initiating treatment with belumosudil.

2. Renal impairment There were no differences in adverse reaction frequency for mild and moderate cGVHD patients when evaluated based on normal renal function, mild and moderate renal impairment. For severe cGVHD patients, a higher frequency of adverse […]

Women of childbearing potential Women of childbearing potential must have their pregnancy status verified prior to initiating treatment with belumosudil and must use highly effective contraception during treatment with belumosudil and for at least one week after the last dose of belumosudil.

6). Patient must be informed of the potential hazard to the foetus. Male patients with female partners of childbearing potential While taking belumosudil, male patients with female partners of childbearing potential must be advised that their female partners should avoid becoming pregnant and of the potential risks to a foetus.

6). 6). 6). 8). 2). CYP3A4 and P-gp substrates Belumosudil is an inhibitor of both CYP3A4 and P-gp. 5). As a result, dose adjustments may be required in accordance with the respective prescribing information. Close therapeutic drug monitoring until steady state is achieved is recommended.

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

6). 2). 1.