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REZUROCK is a brand name for Belumosudil. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Rezurock is indicated for the treatment of patients aged 12 years and older with chronic graft-versus-host disease (chronic GVHD) who have received at least two prior lines of systemic therapy.
Verbatim from this product's MHRA label. Tap a section to expand.
Rezurock treatment should be initiated and supervised by physicians experienced in the management of chronic GVHD. Posology The recommended dose of Rezurock is 200 mg administered orally once daily at approximately the same time with a meal.
Treatment should continue until disease progression or unacceptable toxicity. A complete blood cell count and liver function test must be performed before initiating therapy with Rezurock. 4). The recommended Rezurock dose modifications for hepatotoxicity and other adverse reactions are provided in Table 1.
5 to 3 × ULN) Hold Rezurock until recovery to ≤ Grade 1, then resume Rezurock at the recommended dose at physician’s discretion. Grade 4 ALT or AST (>20 × ULN) or Grade ≥3 bilirubin (>3 × ULN) Permanently discontinue Rezurock. Other Grade 3 adverse reactions Hold Rezurock until recovery to ≤ Grade 1, then resume Rezurock at the recommended dose at physician’s discretion.
Other Grade 4 adverse reactions Permanently discontinue Rezurock. ALT = alanine aminotransferase; AST = aspartate aminotransferase; ULN = upper limit of normal. *Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life- threatening.
3). 8. 5). Strong CYP3A Inducers Increase the dosage of Rezurock to 200 mg twice daily when co-administered with strong CYP3A inducers. Proton Pump Inhibitors Increase the dosage of Rezurock to 200 mg twice daily when co-administered with proton pump inhibitors.
Delayed or missed dose If a dose is missed or delayed for less than 12 hours after the scheduled dose, the dose should be taken as soon as possible on the same day with a return to the normal schedule the following day. If a dose is missed or delayed for more than 12 hours after the scheduled dose, the dose should be taken at the usual time the following day.
If a patient vomits following the intake of a dose, the next dose should be taken at the usual time the following day. Patients should not take extra doses to make up the missed dose. 2). Dose modification is not recommended when administering belumosudil to patients with mild hepatic impairment (Child-Pugh A).
Monitor patients frequently for adverse reactions. Renal impairment No dose modification of Rezurock is required in patients with mild or moderate renal impairment (creatinine clearance ≥ 30 mL/min). 2). Use with caution. 2). Paediatric population The posology is the same in adults and adolescents aged 12 to 18 years.
8. 5). Strong CYP3A Inducers Increase the dosage of Rezurock to 200 mg twice daily when co-administered with strong CYP3A inducers. Proton Pump Inhibitors Increase the dosage of Rezurock to 200 mg twice daily when co-administered with proton pump inhibitors.
Delayed or missed dose If a dose is missed or delayed for less than 12 hours after the scheduled dose, the dose should be taken as soon as possible on the same day with a return to the normal schedule the following day. If a dose is missed or delayed for more than 12 hours after the scheduled dose, the dose should be taken at the usual time the following day.
If a patient vomits following the intake of a dose, the next dose should be taken at the usual time the following day. Patients should not take extra doses to make up the missed dose. 2). Dose modification is not recommended when administering belumosudil to patients with mild hepatic impairment (Child-Pugh A).
Monitor patients frequently for adverse reactions. Renal impairment No dose modification of Rezurock is required in patients with mild or moderate renal impairment (creatinine clearance ≥ 30 mL/min). 2). Use with caution. 2). Paediatric population The posology is the same in adults and adolescents aged 12 to 18 years.
The safety and efficacy of Rezurock in children and adolescents aged below 12 years of age have not been established. 1). Method of administration For oral use. 2). The film-coated tablet should not be broken, crushed or chewed. 3 Contraindications Pregnancy.
1. 4 Special warnings and precautions for use Women of childbearing potential Women of childbearing potential should be advised to avoid becoming pregnant while taking belumosudil and of the potential risk to a foetus, and to have a pregnancy test prior to starting treatment with belumosudil.
3). Male patients Male patients with female partners of childbearing potential should be advised that their female partners should avoid becoming pregnant while taking belumosudil and of the potential risk to a foetus. 3). 6). 8). 5 Interaction with other medicinal products and other forms of interaction Effect of CYP3A inhibitors on belumosudil The co-administration of multiple doses of itraconazole (a strong CYP3A inhibitor) did not alter exposure to belumosudil to any clinically relevant extent.
Women of childbearing potential Women of childbearing potential should be advised to avoid becoming pregnant while taking belumosudil and of the potential risk to a foetus, and to have a pregnancy test prior to starting treatment with belumosudil.
3). Male patients Male patients with female partners of childbearing potential should be advised that their female partners should avoid becoming pregnant while taking belumosudil and of the potential risk to a foetus. 3). 6). 8). 2)
Pregnancy. 1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The safety and efficacy of Rezurock in children and adolescents aged below 12 years of age have not been established. 1). Method of administration For oral use. 2). The film-coated tablet should not be broken, crushed or chewed.
Effect of CYP3A inducers on belumosudil The co-administration of multiple doses of rifampin (a strong CYP3A4 inducer) decreased belumosudil Cmax by 59% and AUC by 72%. The co-administration of strong CYP3A4 inducers with belumosudil may decrease belumosudil exposure.
2). , efavirenz is predicted to have a reduced effect on belumosudil as compared to strong CYP3A4 inducers. The co- administration of moderate CYP3A4 inducers with belumosudil may decrease belumosudil exposure. No dose adjustment is recommended.
Effect of proton pump inhibitors on belumosudil The co-administration of multiple doses of rabeprazole decreased belumosudil Cmax by 87% and AUC by 80%. The co-administration of multiple doses of omeprazole decreased belumosudil Cmax by 68% and AUC by 47%.
The co- administration of proton pump inhibitors with belumosudil may decrease belumosudil exposure. 2). Effect of other gastric acid reducing agents on belumosudil The co-administration of belumosudil with gastric acid reducing agents other than proton pump inhibitors may decrease belumosudil exposure.
No dose adjustment is recommended, however belumosudil and the gastric acid reducing agent should be taken 12 hours apart. 65-fold, respectively. No dose adjustment is recommended. The co-administration of belumosudil may increase exposure of sensitive CYP3A4 substrates with a narrow therapeutic index such as ciclosporin and tacrolimus.
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