Your Health, We Care
Another NameBelumosudil Mesylate Tablets,甲磺酸贝舒地尔片,易来克
IndicationsiIndicated for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease .
Reg No.06 L 1108/24
Inspection NO.1227-24
Rezurock is an innovative drug developed and produced by French company Sanofi. It received market approval from the US Food and Drug Administration (FDA) in July 2021 and is the first ROCK2 inhibitor approved by the FDA.
The Lucius version of Rezurock has a drug specification of 200mg * 30Tablets, which meets the treatment needs of different patients.
Rezurock is a small molecule inhibitor of Rho associated spiral kinase (ROCK), which may help restore Th17/Treg balance, reduce inflammatory response, and alleviate symptoms of cGVHD by inhibiting the ROCK signaling pathway.
Rezurock
Rezurock is indicated for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy.
There are no available human data on Rezurock use in pregnant women to evaluate for a drug-associated risk.
Advise pregnant women and females of reproductive potential of the potential risk to the fetus.
There are no data available on the presence of belumosudil or its metabolites in human milk or the effects on the breastfed child, or milk production. Because of the potential for serious adverse reactions from belumosudil in the breastfed child, advise lactating women not to breastfeed during treatment with Rezurock and for one week after the last dose.
Advise females of reproductive potential to use effective contraception during treatment with Rezurock and for one week after the last dose of Rezurock. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be informed of the potential hazard to a fetus.
Advise males with female partners of reproductive potential to use effective contraception during treatment with Rezurock and for one week after the last dose of Rezurock.
The safety and effectiveness of Rezurock in pediatric patients less than 12 years old have not been established.
No clinically meaningful differences in safety or effectiveness of Rezurock were observed in comparison to younger patients.
Treatment with Rezurock has not been studied in patients with pre-existing severe renal impairment. For patients with pre-existing severe renal impairment, consider the risks and potential benefits before initiating treatment with Rezurock.
Avoid use in patients with moderate hepatic impairment or severe hepatic impairment without liver GVHD.
No dosage adjustment is recommended for patients with mild hepatic impairment.
Drug overdose is not yet clear.
Store at room temperature, 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F).
Dispense to patient in original container only. Store in original container to protect from moisture. Replace cap securely each time after opening. Do not discard desiccant.
Median Tmax of belumosudil at steady state was 1.26 to 2.53 hours following administration of 200 mg once daily or twice daily in patients. The mean (%CV) bioavailability was 64% (17%) following a single belumosudil dose in healthy subjects.
from FDA，2024.04
